410 09e Checkliste For Assessment 13485 MDD

Checklist for Assessment
ISO 13485 & MDD & 9001
Ref: xxxxxx
Checklist for the assessment based on the standards

 ISO 13485:2016
 ISO 13485:2016 associate with EC Directive 93/42 EEC
 Where applicable EC Directive 93/42/EEC Annex II/V/VI
Company:
Audit date 1. Year Auditor: Signature

Name
Jeder Nutzer ist dafür verantwortlich, ausschließlich mit dem jeweils gültigen Ausgabestand des Dokuments zu arbeiten!
Dieses Dokument wird bei Ausdrucken oder Ablage an einem anderen als dem ursprünglichen Speicherort ungültig.

Name

Name
410_09e_Checkliste_for_Assessment_13485_MDD.docx
Version: 1.0 1 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Explanations for the application of the DQS assessment check list

1. Applicable standards and marking
This assessment checklist is based on the requirements of the standards DIN EN ISO 13485:2016, DIN EN ISO
9001:2008, MDD 93/42/EEC, Annex II/V/VI and the German Medical Device Law (MPG).
The following references are used to address the requirements of the standards:
13485 Requirement of the DIN EN ISO 13485:2016
9001 Requirement of the DIN EN ISO 9001:2008
Special additional questions with regards to implants are marked with 13485 Impl. and special additional ques-
tions relevant for sterile products are marked with 13485 sterile.
MDD/MPG: Questions related to the requirements of the MDD 93/42/EEC (MPG, Germany, resp.).
The numbering of the QM-Elements of DIN EN ISO 13485:2016 is used for the chapters.
2. Use of the Assessment Checklist
The questions of this checklist are addressed to the auditor, who evaluates and documents the fulfillment of the
requirements. The auditor should formulate the questions asked to the company’s representative/s in a different
way, please remember your audit training.
The Checklist must be used for the documentation of the assessment.
The checklist will also be used for 5 years (Certification period for MDD). Therefore 5 columns for the assess-
ment results are given, one for each year. Certification period for 9001 and 13485 is 3 years.
 In the 1st year audit every requirements of the standards must be assessed (if applicable).
 In the 2nd to the 5th year the audit will be performed on a statistical basis, but in summery within these 4
years all requirements must be assessed.
 The requirements regarding Management responsibility, Internal Audits, Human resources and Corrective &
preventive actions must be audited every year.
The results of the assessment regarding the documentation and the realization of the QM-System has to be
documented as follows:
1 = fulfilled 2 = partially fulfilled, acceptable 3 = partially fulfilled, not acceptable

4 = not fulfilled n.a. = not applicable 0 = not audited
3. Audit protocol
The results of the audit and the objectives/findings must be documented on the protocol “Findings”.
In the row „Reference“ the objectives must be referenced to the nomenclature of the questions. Please
use the numbers given in the checklist with 2 digits only (e.g. 4.2 for „Documentation requirements” of
the ISO 13485). Additional pages, e.g. from the company’s documents should be added to the protocol and
numbered as pages.
4. Important Notes / Exemptions
Because the regulatory requirements of the MDD 93/42 and the German Medical Device Law permit exclusions
of design and development controls (see 7.3), this can be used as a justification for their exclusion from the
quality management system.
If any requirement(s) in Clause 7 of this International Standard is(are) not applicable due to the nature of
themedical device(s) for which the quality management system is applied, the organization does not need to
include such a requirement(s) in its quality management system, but a rational has to be provided [see 4.2.2 a)].
Version: 1.0 2 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
The processes required by this International Standard, which are applicable to the medical device(s), but which
are not performed by the organization, are the responsibility of the organization and are accounted for in the
organization’s quality management system [see 4.1 a)].
These regulations can provide alternative arrangements that are to be addressed in the quality management
system.
Eva- Eva- Eva-
lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
General
0
0.1 1.1 General questions for the certification

0.1.1 Is the guideline “Regulation for the use of the DQS certificate symbols, the
IQ-Net symbol, the DQS documents and the DQS-symbol“ applied cor-
rectly?
0.1.2 Are the improvement potentials to the QM-System, mentioned in the last
audit report used?
0.2 1.2 Additional requirements of the 93/42/EEC to establish

the procedure
MDD/MPG 0.2.1 Does the company keep the correspondence with DQS?
MDD/MPG 0.2.2 Was the company completely informed about the previous and present
(today’s) activities of the auditortor(s)? Is the declaration “ Auditors’/Experts’
Independence and Objectivity “ countersigned?
MDD/MPG 0.2.3 Are the company and the products registered to the legal authorities?
MDD/MPG 0.2.4 Is there a procedure in place to inform DQS about essential changes of the
Medical Devices covered by the Quality Management System? (Advice
company about the application forms 360.1.11 (Certification application) &
360.1.12 (Product application) and hand it out).
4 Quality management system

4.1 General requirements
MDD/MPG 4.1.1 Is the MDD 93/42/EEC Annex II/V/VI (and if necessary the MPG/the MPV
for Germany) referenced correctly?
MDD/MPG 4.1.2 Is, if necessary, an authorized representative designated within the EEC?
Version: 1.0 3 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485 4.1.3 Does the organization ensure the control of any outsourced processes, that
9001
affects product conformity with requirements and is the control of such out-
sourced processes identifiable within the QM system?
Version: 1.0 4 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485:2016 4.1.1 Does the organization document a quality management system and main-
tain its effectiveness in accordance with the requirements of this Interna-
tional Standard and applicable regulatory requirements?
13485:2016 Does the organization establish, implement and maintain any requirement,
procedure, activity or arrangement required to be documented by this Inter-
national Standard or applicable regulatory requirements?
13485:2016 Does the organization document the role(s) undertaken by the organization
under the applicable regulatory requirements?

13485:2016 4.1.2 Does the organization…
13485:2016 a) determine the processes needed for the quality management system and
the application of these processes throughout the organization taking into
account the roles undertaken by the organization?
13485:2016 b) apply a risk based approach to the control of the appropriate processes
needed for the quality management system?
13485:2016 c) determine the sequence and interaction of these processes?
13485:2016 4.1.3 Does the organization… for each quality management system process?
13485:2016 a) …determine criteria and methods needed to ensure that both the opera-
tion and control of these processes are effective…
13485:2016 b) …ensure the availability of resources and information necessary to sup-

port the operation and monitoring of these processes…
13485:2016 c) …implement actions necessary to achieve planned results and maintain

the effectiveness of these processes…
13485:2016 d) …monitor, measure as appropriate, and analyse these processes…
13485:2016 c) …establish and maintain records needed to demonstrate conformance to

this International Standard and compliance with applicable regulatory re-
quirements…
13485:2016 4.1.4 The organization shall manage these quality management system proc-
esses in accordance with the requirements of this International Standard
and applicable regulatory requirements. Are the following changes to these
processes made:
Version: 1.0 5 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485:2016 4.1.4.1 a) evaluated for their impact on the quality management system?
13485:2016 b) evaluated for their impact on the medical devices produced under this
quality management system?
13485:2016 c) controlled in accordance with the requirements of this International Stan-

dard and applicable regulatory requirements?
13485:2016 4.1.5 Does the organization monitor and ensure control to any outsourced proc-
esses that affects product conformity to requirements?
13485:2016 Does the organization retain responsibility of conformity to this International

Standard and to customer and applicable regulatory requirements for out-
sourced processes?
13485:2016 Are the controls proportionate to the risk involved and the ability of the ex-
ternal party to meet the requirements in accordance with 7.4?
13485:2016 Do the controls include written quality agreements?
13485:2016 4.1.6 Does the organization document procedures for the validation of the appli-
cation of computer software used in the quality management system?
13485:2016 Are such software applications validated prior to initial use and, as appro-
priate, after changes to such software or its application?
13485:2016 Are the specific approach and activities associated with software validation
and revalidation proportionate to the risk associated with the use of the
software?
13485:2016 Are records of such activities maintained (see 4.2.5)?
4.2 Documentation requirements
4.2.1 General
Does the quality manual include…
13485
- a quality manual?
9001 - documented procedures as required by the standard?
- all other by national or regional regulations required documents and re-
cords?
13485
- documented statements of a quality policy and quality objectives?
Version: 1.0 6 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
9001
13485
- documents needed by the organization to ensure the effective planning,
9001 operation and control of its processes?
13485
- records as required by the standard?
9001
13485:2016 4.2.1
General
13485:2016
Does the quality management system documentation (see 4.2.4) include:
13485:2016
a) documented statements of a quality policy and quality objectives?
13485:2016
b) a quality manual?
13485:2016
c) documented procedures and records required by this International
Standard?
13485:2016
d) documents, including records, determined by the organization to be
necessary to ensure the effective planning, operation, and control of its
processes?
13485:2016
e) other documentation specified by applicable regulatory requirements?
4.2.3 Product documentation
13485
Are files available, containing all products specifications and quality assur-
ance specifications, or is the location of those documents described ex-
actly? ( NB-MED 2.5.1-5)
(see also Annex II / V/ VI 93/42/EWG and if necessary DQS-Support check-
lists)
13485 Is this information available and comprehensible for each type or each
model of the medical device? (if necessary also the information for installa-
tion / maintenance)
MDD/MPG Are correct declarations of conformity issued?

( EK-MED 3.9 A4)
MDD/MPG Are the classifications of the Medical Devices traceable to the MDD?
MDD/MPG Are designated harmonized standards, which are applicable to the product /
procedures defined and available (Is the adherence systematically en-
sured)? If no harmonized standards are available, is there proof, which en-
sures the safety and suitability of the products?
MDD/MPG Is it defined and documented for each product how the applicable “Essential
Requirements (Annex I)“ are fulfilled and are there proofs to validate the
statements made?
Version: 1.0 7 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
MDD/MPG Are there, for all products/product groups, complete risk analyses defined
and documented? (copy the risk analysis to the documents for the DQS as
example; if necessary apply 370.2.13 Checklist Risk Management)
MDD/MPG Are all the possible safety risks comprehensibly determined? Are the initial
risks evaluated? Is the evaluation of the risks comprehensible?
MDD/MPG Do designated suppliers with activities having a substantial influence on the

quality identified exist?
(EK-MED 3.9 B17) (see 360.1.5 BasicData-Organization)
MDD/MPG Are they listed including their activities and are appropriate certificates of
the subcontractors/ suppliers available?
MDD/MPG If no appropriate certificates for subcontractors/suppliers are available, are

they appropriately assessed to fulfill the requirements of the suppliers / sub-
contractors?
MDD/MPG Are contractual declarations/agreements signed with subcontrac-

tors/suppliers with defined activities and responsibilities, if they have a sub-
stantial influence on the quality?
MDD/MPG Does the contract with e.g. OEM suppliers contain sufficient descriptions
and regulations on notification of the legal authorities and to ensure appro-
priate information in case of vigilance?
(EK-MED 3.9 B16)
MDD/MPG Is there a procedure to evaluate the actuality of the subcontrac-

tor’s/supplier’s proofs (certificates of analysis, etc.)?
MDD/MPG Has the company established that the purpose is fulfilled?

(in accordance with MDD Annex X)
MDD/MPG Are there corresponding pre-clinical product reviews for the products?
MDD/MPG Is there a evaluation of the essential requirements of the Machinery Direc-

tive, if this is applicable to the product?
(NB-MED 2.2 Rec. 5)
MDD/MPG If the destination of the products falls below the standards for personal pro-
tective equipment, is a notified body involved for this?
4.2.2 Quality manual
Does the quality manual include ...
Version: 1.0 8 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485
- the scope of the QM system, including details of and justifications for any
9001 exclusions and / or non-application?
13485
- the documented procedures established for the QM system, or reference
9001 to them?
- a description of the interaction between the processes of the QM system?
13485
- an overview of the structure of the used documentation?
13485:2016
Does the organization document a quality manual that includes:
13485:2016
a) the scope of the quality management system, including details of and
justification for any exclusion or non-application?

13485:2016
b) the documented procedures for the quality management system, or
reference to them?
13485:2016
c) a description of the interaction between the processes of the quality
management system?
13485:2016
Does the quality manual shall outline the structure of the documentation
used in the quality management system?
4.2.3 Control of documents
13485 Is there a procedure in place for control of documents (including external docu-
9001 ments)
4.2.3 Medical device file
13485:2016 Does the organization establish and maintain for each medical device type
or medical device family, one or more files either containing or referencing
documents generated to demonstrate conformity to the requirement of this
International Standard and compliance with applicable regulatory require-
ments?
13485:2016 Does the content of the file(s) include (but is not limited to):
13485:2016 a) general description of the medical device, intended use/purpose, and

labelling, including any instructions for use?
13485:2016 b) specifications for product?
13485:2016 c) specifications or procedures for manufacturing, packaging, storage, han-

dling and distribution?
13485:2016 d) procedures for measuring and monitoring?
13485:2016 e) as appropriate, requirements for installation?
13485:2016 f) as appropriate, procedures for servicing?
Version: 1.0 9 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
Has a documented procedure been established to define the controls

needed to ...
13485
- approve documents for adequacy prior to issue? Review and update
9001 documents as necessary and re-approve documents?
13485
- ensure that changes and the current revision status of documents are
9001 identified?
13485
- ensure that relevant versions of documents are available at point of use
9001 and that documents remain legible / readily identifiable?
13485
- ensure that documents of external origin are identified and that their dis-
9001 tribution is controlled?
13485
- prevent the unintended use of obsolete documents (to apply suitable iden-
9001 tification to them, if they are retained for any purpose)?
13485 Does the organization ensure that changes to documents are reviewed and
approved either by the original approving function or another designated
function which has access to pertinent background information upon which
to base its decisions?
13485 Is a retention period set for the keeping of at least one copy of outdated
9001
documents, especially if these documents contain specifications of how the
medical devices were manufactured? Are manufacturing and test docu-
ments for the life time of the medical device accessible?
13485 Is the useful life time of the product appropriately determined?
13485 Does period ensure that documents to which medical devices have been
manufactured and tested are available for at least the lifetime of the medical
device as defined by the organization, but not less than the retention period
of any resulting record (see 4.2.4), or as specified by relevant regulatory
requirements?
4.2.4 Control of records
13485 Has a documented procedure been established to define the controls of

9001
records (Identification, storage, protection, retrieval, legibility, retention periods and disposal
of records)?
13485 Are records established and maintained to provide evidence of conformity

9001
to requirements and of the effective operation of the QM system?
13485 Are the quality records maintained for the life time of the products (at least 2
years after product release / date of shipment) or
according to the storage require-
ments of the relevant rules (MPG min. 5 years, for implants min. 15 years)
Version: 1.0 10 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
4.2.4 Control of documents
13485:2016 Are documents controlled required by the quality management system?
13485:2016 Records are a special type of document. Are they controlled according to
the requirements given in 4.2.5?
13485:2016 Does a documented procedure define the controls needed to:
13485:2016 a) review and approve documents for adequacy prior to issue?

13485:2016 b) review, update as necessary and re-approve documents?
13485:2016 c) ensure that the current revision status of and changes to documents are
identified?
13485:2016 d) ensure that relevant versions of applicable documents are available at

points of use?
13485:2016 e) ensure that documents remain legible and readily identifiable?
13485:2016 f) ensure that documents of external origin, determined by the organization

to be necessary for the planning and operation of the quality management
system, are identified and their distribution controlled?
13485:2016 g) prevent deterioration or loss of documents?
13485:2016 h) prevent the unintended use of obsolete documents and apply suitable
identification to them?
5 Management responsibility
5.1 Management commitment
13485:2016 Does top management provide evidence of its commitment to the develop-
ment and implementation of the quality management system and mainte-
nance of its effectiveness by:
13485:2016 a) communicating to the organization the importance of meeting customer

as well as applicable regulatory requirements?
13485:2016 b) establishing the quality policy?
13485:2016 c) ensuring that quality objectives are established?
Version: 1.0 11 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485:2016 d) conducting management reviews?
13485:2016 e) ensuring the availability of resources?
13485 Communicating to the organization the importance of meeting customer, as

9001
well as statutory and regulatory requirements?
9001 Does top management provide evidence of its commitment to the continues
improvement of the quality system? Is the availability of necessary re-
sources ensured?
5.2 Customer focus
13485 Does top management ensure that customer requirements are determined
9001
and are met with the aim of enhancing customer satisfaction gets attended?
13485:2016 Does top management ensure that customer requirements and applicable
regulatory requirements are determined and met?
5.3 Quality policy
13485 Is the quality policy appropriate to the purpose of the organization and does
9001
it provide a framework for establishing and reviewing quality objectives?
13485 Does the quality policy include a commitment to comply with requirements
9001
and continually improve the effectiveness of the QM system?
13485 Is the quality policy communicated and understood within the organization?
9001
Is the quality policy reviewed for continuing suitability?
13485:2016 Does top management ensure that the quality policy:
13485:2016 a) is applicable to the purpose of the organization?
13485:2016 b) includes a commitment to comply with requirements and to maintain the

effectiveness of the quality management system?
13485:2016 c) provides a framework for establishing and reviewing quality objectives?
13485:2016 d) is communicated and understood within the organization?
13485:2016 e) is reviewed for continuing suitability?
Version: 1.0 12 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
5.4 Planing
5.4.1 Quality objectives
13485 Are quality objectives (preferably measurable) established at relevant func-

9001
tions and levels within the organization? Are the quality objectives measur-
able and consistent with the quality policy?
13485 Are there objectives needed to meet the requirements for products?
9001
13485:2016 Does top management shall ensure that quality objectives, including those
needed to meet applicable regulatory requirements and requirements for
product, are established at relevant functions and levels within the organiza-
tion?
13485:2016 Does the quality objectives shall be measurable and consistent with the
quality policy?
5.4.2 Quality management system planning
13485
Does top management ensure that the planning of the QM system is carried
9001 out in order to meet the requirements given in 4.1, as well as the quality
objectives?
13485 Is it ensured that the integrity of the quality management system is main-
9001
tained when changes to the quality management system are planned and
implemented?
13485:2016 Does top management ensure that:
13485:2016 a) the planning of the quality management system is carried out in order to
meet the requirements given in 4.1, as well as the quality objectives?
13485:2016 b) the integrity of the quality management system is maintained when

changes to the quality management system are planned and implemented?
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
13485 Does the top management ensure that the responsibilities and authorities
9001
are defined, communicated and documented within the organization?
13485:2016
13485 Does the top management establish the interrelation of all personnel who
manage, perform and verify work affecting quality?
Version: 1.0 13 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485 Is the necessary independence and authority to perform these tasks en-
sured and is particular attention paid to the nomination of specific persons
responsible for activities related to product monitoring from the post-
production stage and reporting adverse events?
13485:2016 Does top management shall document the interrelation of all personnel who
manage, perform and verify work affecting quality and shall ensure the in-
dependence and authority necessary to perform these tasks?
5.5.2 Management representative

Has the top management appointed a member of the organization's

13485:2016 management, who irrespective of other responsibilities, has responsi-
bility and authority that includes ...
13485
- ensuring that processes needed for the QM system are established, im-
9001 plemented and maintained?
13485
- reporting to top management on the performance of the QM system and
9001 any need for improvement?
13485
- ensuring the promotion of awareness of customer requirements through-
9001 out the organization?
13485:2016
a) ensuring that processes needed for the quality management system
are documented?
13485:2016
b) reporting to top management on the effectiveness of the quality man-
agement system and any need for improvement?
13485:2016
c) ensuring the promotion of awareness of applicable regulatory require-
ments and quality management system requirements throughout the or-
ganization?
MDD/MPG Who is appointed (and trained) as Medical Device Safety Representative?
Is the expertise provided sufficiently?
(§ 30 MPG;  Statement in the report)
MDD/MPG Are the Medical Device Safety Representative’s responsibilities and compe-
tencies defined and documented and was the Medical Device Safety Rep-
resentative notified to the legal authorities?
5.5.3 Internal communication
13485 Does top management ensure that appropriate communication processes

9001
are established within the organization and that communication takes place
regarding the effectiveness of the QM system?
13485:2016 Does top management shall ensure that appropriate communication proc-
esses are established within the organization and that communication takes
place regarding the effe tiveness of the quality management system?
Version: 1.0 14 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
5.6 Management review
5.6.1 General
13485 Does top management review the organization’s QM system at planned

9001
intervals, to ensure its continuing suitability, adequacy and effectiveness?
13485 Does this review include assessing opportunities for improvement and the
9001
need for changes of the QM system, including the quality policy and quality
objectives?
13485 Are records from management reviews maintained?

9001
13485:2016 Does the organization document procedures for management review. Top
management shall review the organization’s quality management system at
documented planned intervals to ensure its continuing suitability, adequacy
and effectiveness?
13485:2016 Does the review include assessing opportunities for improvement and the
need for changes to the quality management system, including the quality
policy and quality objectives?
13485:2016 Are records from management reviews maintained (see 4.2.5)?
5.6.2 Review input

Does the input to management review include information
on ...
13485
- results of audits?
9001 - customer feedback?
13485
- process performance and product conformity?
9001 - status of preventive and corrective actions?
13485
- follow-up actions from previous management reviews?
9001 - changes that could affect the QM system?
13485
- recommendations for improvement?
9001 - new or revised regulatory requirements?
13485:2016
Does the input to management review shall include, but is not limited to,
information arising from:
13485:2016
a) feedback?
13485:2016
b) complaint handling?
13485:2016
c) reporting to regulatory authorities?
Version: 1.0 15 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485:2016
d) audits?
13485:2016
e) monitoring and measurement of processes?
13485:2016
f) monitoring and measurement of product?
13485:2016
g) corrective action?
13485:2016
h) preventive action?
i) follow-up actions from previous management reviews?

13485:2016
13485:2016
j) changes that could affect the quality management system?
13485:2016
k) recommendations for improvement?
13485:2016
l) applicable new or revised regulatory requirements?
5.6.3 Review output

Does the output of the management review include any
decisions and actions related to ...
9001
- improvement of the effectiveness of the QM system and its processes?
13485
- improvements needed to maintain the effectiveness of the quality man-
agement system and related to customer requirements?
13485
- resource needs?
9001
13485:2016
Does the output from management review be recorded (see 4.2.5) and in-
clude the input reviewed and any decisions and actions related to:
13485:2016
a) improvement needed to maintain the suitability, adequacy, and effec-
tiveness of the quality management system and its processes?
13485:2016
b) improvement of product related to customer requirements?
13485:2016
c) changes needed to respond to applicable new or revised regulatory re-
quirements?
13485:2016
d) resource needs?
6 Resource management
6.1 Provision of resources

Does the organization determine and provide the resources needed
to…
9001
- to implement and maintain the quality management system, to continually
improve its effectiveness and enhance customer satisfaction by meeting
customer requirements?
Version: 1.0 16 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485
- to implement and maintain the quality management system, to continually
improve its effectiveness and to meet regulatory and customer require-
ments?
13485:2016
a) implement the quality management system and to maintain its effec-
tiveness?
13485:2016
b) meet applicable regulatory and customer requirements?
6.2 Human Resources

13485:2016 Does personnel performing work affecting product quality be competent on

the basis of appropriate education, training, skills and experience?
13485:2016 Does the organization document the process(es) for establishing compe-
tence, providing needed training, and ensuring awareness of personnel?
13485:2016 Does the organization:
13485:2016 a) determine the necessary competence for personnel performing work

affecting product quality?
13485:2016 b) provide training or take other actions to achieve or maintain the neces-
sary competence?
13485:2016 c) evaluate the effectiveness of the actions taken?
13485:2016 d) ensure that its personnel are aware of the relevance and importance of
their activities and how they contribute to the achievement of the quality
objectives?
13485:2016 e) maintain appropriate records of education, training, skills and experience

(see 4.2.5)?
6.2.1 General
13485 Is personnel competent on the basis of appropriate education, training,

9001
skills and experience if they perform work affecting conformity to product
requirements?
MDD/MPG Is the training of new medical device representatives and sales personnel
planned, executed and recorded?
Version: 1.0 17 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
6.2.2 Competence, training and awareness
Does the organization….
13485 determinate the necessary competence of personnel performing work af-

9001
fecting conformity to product requirements?
13485 provide training or take other actions to achieve the necessary compe-
9001
tence?
13485 evaluate the effectiveness of the actions taken?

9001
13485 ensure that its personnel are aware of the relevance and importance of their
9001
activities and how they contribute to the achievement of the quality objec-
tives?
13485 maintain appropriate records of education, training, skills and experience?

9001
6.3 Infrastructure
13485 Does the organization determine, provide and maintain the infrastructure
9001
needed to achieve conformity to product requirements?
13485 Does that include, as applicable, buildings, workspace and associated utili-
9001
ties, process equipment (both hardware and software) and supporting ser-
vices (such as transport, communication or information system)?
13485 Are the documented requirements for maintenance activities, including their
frequency established, when such activities or lack thereof can affect prod-
uct quality?
13485 Are records of such maintenance getting maintained?
13485:2016 Does the organization document the requirements for the infrastructure
needed to achieve conformity to product requirements, prevent product mix-
up and ensure orderly handling of product?
Infrastructure includes, as appropriate:

a) buildings, workspace and associated utilities;
b) process equipment (both hardware and software);
c) supporting services (such as transport, communication, or information
systems).
Version: 1.0 18 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485:2016 Does the organization document requirements for the maintenance activi-
ties, including the interval of performing the maintenance activities, when
such maintenance activities, or lack thereof, can affect product quality?
13485:2016 Does as appropriate, the requirements apply to equipment used in produc-

tion, the control of the work environment and monitoring and measurement?
13485:2016 Are records of such maintenance maintained (see 4.2.5)?

6.4 Work environment

13485 6.4.1 Does the organization determine and manage the work environment
9001
13485 6.4.2 Has the organization established documented requirements for health,
cleanliness and clothing of personnel, if contact between such personnel
and the product or work environment could adversely affect the quality of
the product?
If work environment conditions can have an adverse effect on product

quality:
13485 6.4.3 Does the organization establish documented requirements for the work
environment conditions and documented procedures or work instructions to
monitor and control these work environment conditions?
13485 6.4.4 Does the organization ensure that all personnel who are required to work
temporarily under special environmental conditions are appropriately trained
or supervised by a trained person?
13485 6.4.5 If necessary: are special arrangements established and documented for the
control of contaminated or potentially contaminated product in order to pre-
vent contamination of other product, the work environment or personnel?
6.4 Work environment and contamination control
13485:2016 6.4.1 Work environment
13485:2016 Does the organization document the requirements for the work environment
13485:2016 If the conditions for the work environment can have an adverse effect on
product quality, does the organization document the requirements for the
work environment and the procedures to monitor and control the work envi-
ronment?
Version: 1.0 19 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485:2016 Does the organization:
13485:2016 a) document requirements for health, cleanliness and clothing of personnel

if contact between such personnel and the product or work environment
could affect medical device safety or performance?
13485:2016 b) ensure that all personnel who are required to work temporarily under
special environmental conditions within the work environment are compe-
tent or supervised by a competent person?
13485:2016 6.4.2 Contamination control

13485:2016 Does, as appropriate, the organization plan and document arrangements for
the control of contaminated or potentially contaminated product in order to
prevent contamination of the work environment, personnel, or product?
13485:2016 Does the organization document for sterile medical devices, requirements
for control of contamination with microorganisms or particulate matter and
maintain the required cleanliness during assembly or packaging processes?
7 Product realization
7.1 Planning of product realization
13485 Does the organization plan and develop the processes needed for product
9001
realization? Is the planning of product realization consistent with the re-
13485:2016
quirements of the other processes of the QM system?
13485:2016 Does the organization document one or more processes for risk manage-
ment in product realization?
13485:2016 Are records of risk management activities maintained (see 4.2.5)?
Does the organization determine the following, as appropriate, in

planning product realization ...
13485
- quality objectives and requirements for the product?
9001
13485:2016
13485
- the need to establish processes and documents(see 4.2.4), and to pro-
9001 vide resources specific to the product including infrastructure and work
13485:2016 environment?
13485
- required verification, validation, monitoring, measurement, inspection and
9001 test activities storage, distribution and traceability specific to the product
13485:2016 together with the and the criteria for product acceptance?
13485
- records needed to provide evidence that the realization processes and
9001 resulting product meet requirements (see 4.2.5)?
Version: 1.0 20 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485:2016
13485 Is the output of this planning in a suitable form for the organization’s method
9001
of operations documented?
13485:2016
13485 Has the organization established the documented requirements for risk
management throughout product realization?
13485 Are records arising from risk management including the results getting
maintained?
(throughout the entire lifecycle of products, see for example EN ISO 14971)
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
9001 Are procedures and competencies for contract reviews defined?
Does the organization determine ...
13485
- requirements specified by the customer, including the requirements for
9001 delivery and post-delivery activities?
13485:2016
13485
- requirements not stated by the customer but necessary for specified or
9001 intended use, where known?
13485:2016
13485
- statutory and regulatory requirements applicable to the product and any
9001 additional requirements considered necessary by the organization?
13485:2016
- applicable regulatory requirements related to the product?
13485:2016
- any user training needed to ensure specified performance and safe use of
the medical device?
13485:2016
- any additional requirements determined by the organization?
7.2.2 Review of requirements related to the product
13485 Does the organization review the requirements related to the product? Is
9001
this review conducted prior to the organization’s commitment to supply a
13485:2016
product to the customer (for exemple: Submission of tenders, acceptance of contracts or
orders, acceptance of a contract or orders, acceptance of changes to contracts or orders)
Does this review ensure that ...
13485 a) product requirements are defined and the organization has (the ability to
9001
meet the) defined requirements?
13485:2016
Version: 1.0 21 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485 b) contract or order requirements differing from those previously expressed

9001
are resolved?
13485:2016
13485:2016 c) applicable regulatory requirements are met?
13485:2016 d) any user training identified in accordance with 7.2.1 is available or

planned to be available?
13485:2016 e) the organization has the ability to meet the defined requirements?
13485 Are the records of the results of the review and actions arising from the
9001
review maintained and stored (see 4.2.5)?
13485:2016
13485 Does the organization confirm the customer requirements before accep-
9001
tance, where the customer provides no documented statement of require-
13485:2016
ment?
13485 Does the organization ensure that relevant documents are amended and
9001
that relevant personnel are made aware of the changed requirements?
13485:2016
7.2.3 Customer communication
13485 1 Has the organization determined and implemented effective arrangements

9001
for communication with customers in relation to: product information, enquir-
ies, contracts or order handling, including amendments and customer feed-
back, including customer complaints and advisory notices (see 8.5.1)?
7.2.3 Communication
13485:2016 The organization shall plan and document arrangements for communicating
with customers in relation to:
13485:2016 a) product information?
13485:2016 b) enquiries, contracts or order handling, including amendments?
13485:2016 c) customer feedback, including complaints?
13485:2016 d) advisory notices?
13485:2016 Does the organization communicate with regulatory authorities in accor-

dance with applicable regulatory requirements?
Version: 1.0 22 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
7.3 Design and development
7.3.1 General
13485:2016 Does the organization document procedures for design and development?
7.3.1 Design and development planning
13485 Are documented procedures and the responsibilities and authorities for the
design and development determined?
Does the organization determine during the design and development

planning ......
13485
- the design and development stages, the review, verification and validation
9001 that are appropriate to each design and development stage?
13485
- design and development transfer activities? If the design and develop-
ment results to the manufacturing process proved to be suitable?
13485 Are the interfaces between different groups involved in design and devel-
9001
opment managed? Are effective communication and clear assignment of
responsibilities ensured?
9001 If the output of planning is updated, as the design and development pro-
gresses?
MDD/MPG If in the design planning, the legal requirements, especially in regard to the
licensing and reporting requirements are intent?
13485:2016 Does the organization plan and control the design and development of
product?
13485:2016 As appropriate, Are design and development planning documents main-

tained and updated as the design and development progresses?
13485:2016 During design and development planning, does the organization

document:
13485:2016 a) the design and development stages?
13485:2016 b) the review(s) needed at each design and development stage?
13485:2016 c) the verification, validation, and design transfer activities that are appro-
priate at each design and development stage?
13485:2016 d) the responsibilities and authorities for design and development?
Version: 1.0 23 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485:2016 e) the methods to ensure traceability of design and development outputs to

design and development inputs?
13485:2016 f) the resources needed, including necessary competence of personnel?
7.3.2
Design and development inputs
7.3.3
13485 Are inputs related to product requirements determined and records main-
9001
tained (see 4.2.5)?
13485:2016
Do these inputs include ...
13485
- functional, performance usability and safety requirements according to the
9001 intended use?
13485:2016
13485
- applicable (statutory and) regulatory requirements(, as well as the results
9001 from the risk management) and standards?
13485:2016
13485
- where applicable, information derived from previous similar designs and
9001 other requirements essential for design and development?
13485:2016
- applicable output(s) of risk management?
13485:2016
- as appropriate, information derived from previous similar designs?
13485:2016
- other requirements essential for design and development of the product
and processes?
13485 Are these inputs reviewed for adequacy and approved?
9001
13485:2016
13485 Are these requirements complete, unambiguous, able to be verified or vali-

9001
dated and not in conflict with each other?
MDD/MPG Has the applicable harmonized standards for safety requirements for medi-
cal devices systematically identified?
MDD/MPG If no harmonized standards were applied: Has the safety requirements

completely identified (systematically)?
13485:2016 Is the requirement related to the management of the interfaces between

different groups involved in design and development eliminated?
Version: 1.0 24 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
7.3.3
Design and development outputs
7.3.4
13485 Are the outputs of the design and development in a form suitable for verifi-
9001
cation against the design and development input and are approved prior to
13485:2016
release?
13485 Are the outputs of the design and development approved prior to release?
9001
Do the design and development outputs contain or reference product ac-
ceptance criteria?
13485 Do the design and development outputs provide appropriate information for
9001
purchasing, production and for service provision?
13485 Do the design and development outputs specify the characteristics of the
9001
product that are essential for its safe and proper use?
13485:2016 Do Design and development outputs …:
13485:2016 a) meet the input requirements for design and development?
13485:2016 b) provide appropriate information for purchasing, production and service

provision?
13485:2016 c) contain or reference product acceptance criteria?
13485:2016 d) specify the characteristics of the product that are essential for its safe
and proper use?
13485:2016 Are Records of the design and development outputs maintained (see
4.2.5)?
7.3.4
Design and development review
7.3.5
13485 Are systematic reviews of design and development performed at suitable

9001
stages to evaluate the ability of the results of design and development to
meet requirements and to identify any problems and propose necessary
actions?
13485 Do the participants in such reviews include representatives of functions

9001
concerned with the design and development stage(s) being reviewed? Is
specialist personnel included, where necessary?
13485 Are records of the results of the reviews and any necessary actions main-
9001
tained?
Version: 1.0 25 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485:2016 At suitable stages, are systematic reviews of design and development per-
formed in accordance with planned and documented arrangements to:
13485:2016 a) evaluate the ability of the results of design and development to meet
requirements?
13485:2016 b) identify and propose necessary actions?
13485:2016 Do participants in such reviews include representatives of functions con-

cerned with the design and development stage being reviewed, as well as
other specialist personnel?
13485:2016 Are Records of the results of the reviews and any necessary actions main-
tained and include the identification of the design under review, the partici-
pants involved and the date of the review (see 4.2.5)?
7.3.5
Design and development verification
7.3.6
13485 Is verification performed and recorded to ensure that design and develop-
9001
ment outputs have met the design and development input requirements?
13485:2016 Are design and development verification performed in accordance with

planned and documented arrangements to ensure that the design and de-
velopment outputs have met the design and development input require-
ments?
13485:2016 Does the organization document verification plans that include methods,
acceptance criteria and, as appropriate, statistical techniques with rationale
for sample size?
13485:2016 If the intended use requires that the medical device be connected to, or
have an interface with, other medical device(s), does verification include
confirmation that the design outputs meet design inputs when so connected
or interfaced?
13485:2016 Are records of the results and conclusions of the verification and necessary
actions maintained (see 4.2.4 and 4.2.5)?
7.3.6 Design and development validation

7.3.7
13485 Is the design and development validation performed to ensure that the re-
9001
sulting product is capable of meeting the requirements for the specified
application or intended use?
13485 Is validation completed prior to the delivery or implementation of the product

Version: 1.0 26 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
9001 or completed until the product has been formally transferred to the cus-
tomer?
13485 Are records of the results of validation and any necessary actions main-
9001
tained?
13485 Are sufficient clinical data provided, to prove that the product fulfills the per-
MDD/MPG
formance, design characteristics and intended purpose of the device as
stated in MDD 93/42/EEC Annex I (clinical evaluation or if necessary clinical
investigation)?
13485:2016 Are design and development validation performed in accordance with

planned and documented arrangements to ensure that the resulting product
is capable of meeting the requirements for the specified application or in-
tended use?
13485:2016 Does the organization document validation plans that include methods,
acceptance criteria and, as appropriate, statistical techniques with rationale
for sample size?
13485:2016 Are design validation conducted on representative product? Representative

product includes initial production units, batches or their equivalents.
13485:2016 Is the rationale for the choice of product used for validation recorded (see
4.2.5)?
13485:2016 As part of design and development validation, does the organization per-
form clinical evaluations or performance evaluations of the medical device
in accordance with applicable regulatory requirements? A medical device
used for clinical evaluation or performance evaluation is not considered to
be released for use to the customer.
13485:2016 If the intended use requires that the medical device be connected to, or
have an interface with, other medical device(s), does validation include
confirmation that the requirements for the specified application or intended
use have been met when so connected or interfaced?
13485:2016 Are validation completed prior to release for use of the product to the cus-
tomer?
13485:2016 Are records of the results and conclusion of validation and necessary ac-
tions maintained (see 4.2.4 and 4.2.5)?
7.3.8 Design and development transfer
13485:2016 Does the organization shall document procedures for transfer of design and
development outputs to manufacturing?
Version: 1.0 27 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485:2016 Are these procedures ensure that design and development outputs are
verified as suitable for manufacturing before becoming final production
specifications and that production capability can meet product require-
ments?
13485:2016 Are results and conclusions of the transfer shall be recorded (see 4.2.5)?
7.3.7 Control of design and development changes

7.3.9
13485:2016 Does the organization shall document procedures to control design and
development changes?
13485:2016 Does the organization determine the significance of the change to function,
performance, usability, safety and applicable regulatory requirements for
the medical device and its intended use?
13485 Are design and development changes identified and records maintained
9001
and reviewed, verified and validated, as appropriate? Are design and de-
13485:2016
velopment changes approved before implementation?
13485 Does the review of design and development changes include evaluation of
9001
the effect of the changes on constituent parts and product in process or
13485:2016
already delivered or outputs of risk management and product realization
processes?
13485 Are records of the results of the review of changes and any necessary ac-
9001
tions maintained? (see 4.2.5).
13485:2016
MDD/MPG Which procedures guarantee that the DQS is informed when substantial
modifications are done to the products?
7.3.10 Design and development files
13485:2016 Does the organization shall maintain a design and development file for each
medical device type or medical device family?
13485:2016 Does this file include or reference records generated to demonstrate con-
formity to the requirements for design and development and records for
design and development changes?
7.4 Purchasing
7.4.1 Purchasing process
13485 Have documented procedures been established to ensure that the pur-
Version: 1.0 28 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
9001 chased products conforms to specified purchase requirements?
13485 Does the organization evaluate and select suppliers to ensure that products
9001
are delivered in accordance with the requirements of the organization?
13485 Are the type and extent of control applied to the supplier and the purchased
9001
product dependent upon the effect of the purchased product on subse-
quent product realization or the final product?
13485 Are criteria established for selection, evaluation and reevaluation?

9001
Are records maintained of the results of evaluations and any necessary
actions?
13485:2016 Does the organization document procedures (see 4.2.4) to ensure that pur-
chased product conforms to specified purchasing information?
13485:2016 Does the organization establish criteria for the evaluation and selection of
suppliers? Are the criteria:
13485:2016 a) based on the supplier’s ability to provide product that meets the organiza-
tion’s requirements?
13485:2016 b) based on the performance of the supplier?
13485:2016 c) based on the effect of the purchased product on the quality of the medi-
cal device
13485:2016 d) proportionate to the risk associated with the medical device?
13485:2016 Does the organization plan the monitoring and re-evaluation of suppliers?
13485:2016 Does supplier performance in meeting requirements for the purchased

product be monitored?
13485:2016 Does the results of the monitoring provide an input into the supplier re-
evaluation process?
13485:2016 Are Non-fulfilment of purchasing requirements addressed with the supplier

proportionate to the risk associated with the purchased product and compli-
ance with applicable regulatory requirements?
13485:2016 Are records of the results of evaluation, selection, monitoring and re-
evaluation of supplier capability or performance and any necessary actions
arising from these activities maintained (see 4.2.5)?
Version: 1.0 29 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
7.4.2 Purchasing information
13485 Does the purchasing information describe the product to be purchased?

9001
13485:2016
Does the information include, where appropriate ...
13485:2016 a) product specifications?
13485 a) requirements for (approval of) product acceptance, procedures, proc-

9001
esses and equipment?
13485:2016
13485 b) requirements for qualification of personnel?

9001
13485:2016 d) quality management system requirements?
13485 Is the adequacy of specified purchase requirements ensured, prior to their

9001
communication to the supplier?
13485:2016
13485 Maintains the organization copies of the relevant purchasing information,

i.e. documents and records to the extent required for traceability?
13485:2016 Does purchasing information include, as applicable, a written agreement

that the supplier notify the organization of changes in the purchased product
prior to implementation of any changes that affect the ability of the pur-
chased product to meet specified purchase requirements?
13485:2016 To the extent required for traceability given in 7.5.9, does the organization
maintain relevant purchasing information in the form of documents (see
4.2.4) and records (see 4.2.5)?
7.4.3 Verification of purchased product
13485 Does the organization establish and implement the inspection or other ac-
9001
tivities necessary for ensuring that purchased product meets specified pur-
13485:2016
chase requirements?
13485:2016 Is the extent of verification activities based on the supplier evaluation results
and proportionate to the risks associated with the purchased product?
13485:2016 When the organization becomes aware of any changes to the purchased
product, does the organization determine whether these changes affect the
product realization process or the medical device?
13485 Where the organization or its customer intends to perform verification at the
9001
supplier’s premises: are the intended verification activities (arrangements)
13485:2016
Version: 1.0 30 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
and method of product release stated in the purchasing information?
13485:2016 Are records of the verification maintained (see 4.2.5)?
7.5 Production and service provision

7.5.1 Control of production and service provision
13485:2016 Are production and service provision planned, carried out, monitored and
controlled to ensure that product conforms to specification?

13485:2016 As appropriate, does production controls include but are not limited to:
13485:2016 a) documentation of procedures and methods for the control of production

(see 4.2.4)?
13485:2016 b) qualification of infrastructure?
13485:2016 c) implementation of monitoring and measurement of process parameters

and product characteristics?
13485:2016 d) availability and use of monitoring and measuring equipment?
13485:2016 e) implementation of defined operations for labelling and packaging?
13485:2016 f) implementation of product release, delivery and post-delivery activities?
13485:2016 Does the organization establish and maintain a record (see 4.2.5) for each
medical device or batch of medical devices that provides traceability to the
extent specified in 7.5.9 and identifies the amount manufactured and
amount approved for distribution?
13485:2016 Is the record verified and approved?
General Requirements
13485 Does the organization plan and carry out production and service provision
9001
under controlled conditions?
Do these controlled conditions include, as applicable ...
13485
- the availability of information that describes the characteristics of the
9001 product?
- and the availability of work instructions?
Version: 1.0 31 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485
- the use of suitable equipment and the availability?
9001 - the use of monitoring and measuring devices?
13485
- the implementation of monitoring and measurement?
9001 - as well as the implementation of defined operations for labeling and
packaging?
13485
- the implementation of release, delivery and post-delivery activities?
9001
13485 Does the organization establish and maintain a record for each batch of
medical devices that provides traceability to the extent specified in 7.5.3?
Specific requirements
Cleanliness of product and contamination control
13485 The organization shall establish documented requirements for cleanliness

of product if,
- the product is cleaned by the organization prior to sterilization and/or its use or,
- the product is supplied non-sterile to be subjected to a cleaning process prior to sterilization
and/or its use or,
- the product is supplied to be used non-sterile and its cleanliness is of significance in use or,
- process agents are to be removed from product during manufacture.
Installation activities (if applicable)
13485 Has the organization established documented requirements which contain

acceptance criteria for installing and verifying the installation of the medical
device?
13485 If the agreed customer requirements allow installation to be performed other

than by the organization or its authorized agent, has the organization pro-
vided documented requirements for installation and verification?
13485 Are records of installation and verification performed by the organization or

its authorized agent maintained (see 4.2.4)?
Servicing activities (if applicable)
13485 Has the organization established documented procedures, work instructions

and reference materials and reference measurement procedures, as nec-
essary, for performing servicing activities and verifying that they meet the
specified requirements?
13485 Are those records of servicing activities carried out by the organization
maintained?
Version: 1.0 32 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
Particular requirements for sterile medical devices
13485 Does the organization maintain records of the process parameters for the
Steril
sterilization process which was used for each sterilization batch, and are
these sterilization records traceable to each production batch of medical
devices (see 7.5.1.1)?
13485:2016 7.5.2 Cleanliness of product

13485:2016 Does the organization document requirements for cleanliness of product or

contamination control of product if:
13485:2016 a) product is cleaned by the organization prior to sterilization or its use?
13485:2016 b) product is supplied non-sterile and is to be subjected to a cleaning proc-

ess prior to sterilization or its use?
13485:2016 c) product cannot be cleaned prior to sterilization or its use, and its cleanli-
ness is of significance in use?
13485:2016 d) product is supplied to be used non-sterile, and its cleanliness is of signifi-

cance in use?
13485:2016 e) process agents are to be removed from product during manufacture?
13485:2016 Was the product cleaned in accordance with a) or b) above? (The require-
ments contained in 6.4.1 do not apply prior to the cleaning process)
7.5.2 Validation of processes for production and service provision
General requirements
13485 Does the organization validate any processes for production and service
9001
provision where the resulting output cannot be verified by subsequent moni-
toring or measurement?
( EK-MED 3.9 B18)
13485 Does this include any processes where, as consequence, deficiencies be-
9001
come apparent only after the product is in use or the service has been de-
livered?
13485 Does the validation demonstrate the ability of these processes to achieve
9001
planned results?
Version: 1.0 33 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485
Has the organization established arrangements for these processes
9001 including, as applicable ...
13485
- defined criteria for review and approval of the processes?
9001 - approval of equipment and qualification of personnel?
13485
- use of specific methods and procedures?
9001 - requirements for records (see 4.2.4.)?
13485
- revalidation?
9001
If software is used within the production process and in service delivery and
this has a influence to the product quality/specification:
13485 Are documented procedures for the validation of the application of computer
software (and changes and / or its application) for production and service
provision that affect the ability of the product to conform to specified re-
quirements established?
13485 Are such software applications validated prior to initial use?

Are records of validation maintained?
Particular requirements for sterile medical devices
13485 Has the organization established documented procedures for the validation
Steril
of sterilization processes?
13485 Are sterilization processes validated prior to initial use?

Steril
Are records of validation of each sterilization process maintained?
13485 Where such records of the production process stored (including steriliza-
Steril
tion) to demonstrate that the products were manufactured according to the
validated process?
Are the results recorder of each batch release?
Version: 1.0 34 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
7.5.3 Identification and traceability
13485:2016 7.5.3 Installation activities
13485:2016 Does the organization document requirements for medical device installa-
tion and acceptance criteria for verification of installation, as appropriate?
13485:2016 If the agreed customer requirements allow installation of the medical device
to be performed by an external party other than the organization or its sup-
plier, does the organization provide documented requirements for medical

device installation and verification of installation?
13485:2016 Are records of medical device installation and verification of installation

performed by the organization or its supplier maintained (see 4.2.5)?
Identification
13485 Does the organization identify the products by suitable means throughout
9001
product realization according to a documented procedure?
13485 Are documented procedures established to ensure that medical devices

returned to the organization are identified and distinguished from conform-
ing product?
Traceability
General
13485 Are documented procedures for traceability established?

Is the extent of product traceability defined and are the records required for
traceability defined (see 4.2.4, 8.3 and 8.5)?
13485 Does the documented and established traceability facilitate the necessary
corrective actions? (Note: e.g. simulate a product recall; time needed until the necessary
data and records are collected should be less than 1 day)
Particular requirements for active implant able medical devices and

implant able medical devices
13485 In defining the records required for traceability, are all components, materi-
Impl.
als and work environmental conditions included, if these could cause the
medical device does not fulfill its specified requirements?
13485 Does the organization require that its agents or distributors maintain records
Impl.
of the distribution of medical devices to allow traceability and are such re-
Version: 1.0 35 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
cords are available for inspection?
13485 Is ensured that the name and address of the shipping package consignee is
Impl.
recorded (see 4.2.4)?
Status identification
13485 Is the identification of product status maintained and recorded to ensure the
9001
monitoring and measurement requirements throughout production, storage,
installation and servicing of the product?
13485:2016 7.5.4 Servicing activities
13485:2016 If servicing of the medical device is a specified requirement, does the or-
ganization document servicing procedures, reference materials, and refer-
ence measurements, as necessary, for performing servicing activities and
verifying that product requirements are met?
13485:2016 Does the organization analyse records of servicing activities carried out by
the organization or its supplier:
13485:2016 a) to determine if the information is to be handled as a complaint?
13485:2016 b) as appropriate, for input to the improvement process?
13485:2016 Are Records of servicing activities carried out by the organization or its sup-
plier maintained (see 4.2.5)?
7.5.4 Customer property
13485 Does the organization exercise care with customer property while it is under
9001
the organization’s control or being used by the organization?
13485 Does the organization identify, verify, protect and safeguard customer prop-
9001
erty provided for use or incorporation into the product?
13485 Does the organization report to the customer and maintain records if any
9001
customer property is lost, damaged or otherwise found to be unsuitable for
use?
13485:2016 7.5.5 Particular requirements for sterile medical devices
13485:2016 Does the organization maintain records of the sterilization process parame-
ters used for each sterilization batch (see 4.2.5)?
13485:2016 Are sterilization records traceable to each production batch of medical de-
Version: 1.0 36 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
vices?
7.5.5 Preservation of product
13485 Are documented procedures established for preserving the conformity of

product during internal processing and delivery to the intended destination?
13485 Does this preservation include identification, handling, packaging, storage

9001
and protection?
13485 Does this preservation also apply to the constituent parts of a product?
9001
13485 Are documented procedures or documented work instructions established

for the control of product with a limited shelf-life or requiring special storage
conditions?
13485 Are such special storage conditions controlled and recorded?
13485:2016 7.5.6 Validation of processes for production and service provision
13485:2016 Does the organization validate any processes for production and service
provision where the resulting output cannot be or is not verified by subse-
quent monitoring or measurement and, as a consequence, deficiencies
become apparent only after the product is in use or the service has been
delivered?
13485:2016 Does validation demonstrate the ability of these processes to achieve

planned results consistently?
13485:2016 Does the organization document procedures for validation of processes,

including:
13485:2016 a) defined criteria for review and approval of the processes?
13485:2016 b) equipment qualification and qualification of personnel?
13485:2016 c) use of specific methods, procedures and acceptance criteria?
13485:2016 d) as appropriate, statistical techniques with rationale for sample sizes?
13485:2016 e) requirements for records (see 4.2.5)?
13485:2016 f) revalidation, including criteria for revalidation?
13485:2016 g) approval of changes to the processes?
Version: 1.0 37 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485:2016 Does the organization document procedures for the validation of the appli-
cation of computer software used in production and service provision?
software, including the effect on the ability of the product to conform to
specifications?
tions from the validation maintained (see 4.2.4 and 4.2.5)?
13485:2016 7.5.7 Particular requirements for validation of processes for sterilization

and sterile barrier systems
13485:2016 Does the organization shall document procedures (see 4.2.4) for the valida-
tion of processes for sterilization and sterile barrier systems?
13485:2016 Are processes for sterilization and sterile barrier systems validated prior to
implementation and following product or process changes, as appropriate?
13485:2016 Are records of the results and, conclusion of validation and necessary ac-
13485:2016 7.5.8 Identification
13485:2016 Does the organization document procedures for product identification and
identify product by suitable means throughout product realization?
13485:2016 Does the organization identify product status with respect to monitoring and
measurement requirements throughout product realization?
13485:2016 Is identification of product status maintained throughout production, storage,

installation and servicing of product to ensure that only product that has
passed the required inspections and tests or released under an authorized
concession is dispatched, used or installed?
13485:2016 If required by applicable regulatory requirements, does the organization

document a system to assign unique device identification to the medical
device?
13485:2016 Does the organization document procedures to ensure that medical devices
returned to the organization are identified and distinguished from conform-
ing product?
Version: 1.0 38 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485:2016 7.5.9 Traceability
13485:2016 7.5.9.1 General
13485:2016 Does the organization document procedures for traceability?
13485:2016 Do these procedures define the extent of traceability in accordance with

applicable regulatory requirements and the records to be maintained (see
4.2.5)?
13485:2016 7.5.9.2 Particular requirements for implantable medical devices
13485:2016 Do the records required for traceability include records of components, ma-
terials, and conditions for the work environment used, if these could cause
the medical device not to satisfy its specified safety and performance re-
quirements?
13485:2016 Does the organization require that suppliers of distribution services or dis-
tributors maintain records of the distribution of medical devices to allow
traceability and that these records are available for inspection?
13485:2016 Are records of the name and address of the shipping package consignee
maintained (see 4.2.5)?
13485:2016 7.5.10 Customer property
13485:2016 Does the organization identify, verify, protect, and safeguard customer
property provided for use or incorporation into the product while it is under
the organization’s control or being used by the organization?
13485:2016 If any customer property is lost, damaged or otherwise found to be unsuit-

able for use, does the organization report this to the customer and maintain
records (see 4.2.5)?
13485:2016 7.5.11 Preservation of product
13485:2016 Does the organization document procedures for preserving the conformity
of product to requirements during processing, storage, handling, and distri-
bution?
13485:2016 Does Preservation apply to the constituent parts of a medical device?
13485:2016 Does the organization protect product from alteration, contamination or

damage when exposed to expected conditions and hazards during process-
Version: 1.0 39 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
ing, storage, handling, and distribution by:
13485:2016 a) designing and constructing suitable packaging and shipping containers?
13485:2016 b) documenting requirements for special conditions needed if packaging

alone cannot provide preservation?
13485:2016 If special conditions are required, are they controlled and recorded (see
4.2.5)?
7.6 Control and monitoring of measuring equipment
13485 7.6.1 Are documented procedures established for the control of monitoring and
measuring equipment?
13485 7.6.2 Does the organization determine the monitoring and measurement to be
9001
taken and is the required monitoring and measuring equipment determined?
13485:2016 Does the organization determine the monitoring and measurement to be

undertaken and the monitoring and measuring equipment needed to pro-
vide evidence of conformity of product to determined requirements?
13485:2016 Does the organization shall document procedures to ensure that monitoring
and measurement can be carried out and are carried out in a manner that is
consistent with the monitoring and measurement requirements?
Is the measuring equipment, where necessary to ensure valid results,

...
13485 7.6.3
- be calibrated or verified, or both, at specified intervals, or prior to use,
9001 against measurement standards traceable to international or national
13485:2016 measurement standards?
13485 7.6.4
- is the basis used for calibration or verification recorded, where no such
9001 standards exist?
13485:2016
13485 7.6.5
- have identification in order to determine its calibration status, (be safe-
9001 guarded from adjustments that would invalidate the measurement result
and adjusted or re-adjusted, as necessary)?
13485:2016
- be safeguarded from adjustments that would invalidate the measurement
result?
13485 7.6.6
- be protected from damage and deterioration during handling, mainte-
9001 nance and storage?
13485:2016
13485:2016 Does the organization perform calibration or verification in accordance with

documented procedures?
Version: 1.0 40 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485 7.6.7 Is the validity of previous measuring results assessed and recorded, when
9001
the measuring equipment is found not to conform to requirements? Does
13485:2016
the organization take appropriate action on the measuring equipment and
any product affected?
13485 7.6.8 Are records of the results of calibration and verification maintained (see
9001
4.2.5).?
13485:2016
13485 7.6.9 Is the ability of computer software to satisfy the intended application con-
9001
firmed, when used in the monitoring and measurement of specified re-
quirements?
13485 7.6.10 Is this undertaken prior to initial use and reconfirmed, as necessary?
9001
13485:2016 Does the organization document procedures for the validation of the appli-
cation of computer software used for the monitoring and measurement of
requirements?
software, including the effect on the ability of the product to conform to
specifications?
8 Measurement, analysis and improvement

8.1 General
Does the organization plan and implement the monitoring, measurement,
analysis and improvement processes needed to ...
13485 8.1.1
- demonstrate conformity of the product?
9001
13485:2016
13485 8.1.2
- ensure conformity of the QM-System and to maintain the effectiveness of
9001 the QM-System?
13485:2016
13485 8.1.3
- continually improve the effectiveness of the QM-System?
9001
13485:2016
13485 8.1.4 Does this include determination of applicable methods, including statistical
Version: 1.0 41 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
9001 techniques, and the extent of their use?

13485:2016
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
13485 Does the organization monitor information relating to customer perception

9001
as to whether the organization has met customer requirements?
9001 Is this information, as one of the measurements of the performance of the

QM-System used and are the methods determined for obtaining and using
this information determined?
13485 Is a documented procedure for a feedback system established? Is this

feedback system used for early warning of quality problems and for input
into the corrective and preventive action processes?
13485:2016 8.2.1 Feedback
13485:2016 As one of the measurements of the effectiveness of the quality manage-

ment system, does the organization gather and monitor information relating
to whether the organization has met customer requirements?
13485:2016 Are the methods for obtaining and using this information documented?
13485:2016 Does the organization document procedures for the feedback process?
13485:2016 Does this feedback process include provisions to gather data from produc-
tion as well as post-production activities?
13485:2016 Does the information gathered in the feedback process serve as potential
input into risk management for monitoring and maintaining the product re-
quirements as well as the product realization or improvement processes?
13485:2016 If applicable regulatory requirements require the organization to gain spe-

cific experience from postproduction activities, does the review of this ex-
perience form part of the feedback process?
8.2.2 Internal audit
13485 Is there a documented process for planning / conducting internal audits?

9001 (Responsibilities, planning, execution, reporting, record keeping, corrective actions)
13485 Are internal audits at planned intervals conducted to determine whether or

9001
not the QM-System conforms to the requirements of this International stan-
Version: 1.0 42 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
dard and to the QM-System requirements established by the organization

and is effectively implemented and maintained?
13485 Is the audit programme planned taking into consideration the status and
9001
importance of the processes and areas to be audited, as well as the results
of previous audits?
(Audit criteria, scope, frequency, methods)
13485 Does the selection of auditors ensure objectivity and impartiality of the audit
9001
process?
(Auditors shall not audit their own work).

13485 Does the management responsible for the area being audited ensure that
9001
any necessary corrections and corrective actions are taken without undue
delay to eliminate detected nonconformities and their causes?
13485 Do follow-up activities include the verification of the actions taken and the
9001
reporting of verification results?
8.2.2 Complaint handling
13485:2016 Does the organization document procedures for timely complaint handling
in accordance with applicable regulatory requirements?
13485:2016 Do these procedures include at a minimum requirements and responsibili-

ties for:
13485:2016 a) receiving and recording information?
13485:2016 b) evaluating information to determine if the feedback constitutes a com-

plaint?
13485:2016 c) investigating complaints?
13485:2016 d) determining the need to report the information to the appropriate regula-
tory authorities?
13485:2016 e) handling of complaint-related product?
13485:2016 f) determining the need to initiate corrections or corrective actions?
13485:2016 If any complaint is not investigated, is justification documented?
13485:2016 Is any correction or corrective action resulting from the complaint handling
process documented?
13485:2016 If an investigation determines activities outside the organization contributed

Version: 1.0 43 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
to the complaint, are relevant information exchanged between the organiza-

tion and the external party involved?
13485:2016 Are complaint handling records shall be maintained (see 4.2.5)?
8.2.3 Monitoring and measurement of processes
13485 Does the organization apply suitable methods for monitoring and, where
9001
applicable, measurement of the QM-Systems processes?
13485 Do these methods demonstrate the ability of the processes to achieve

9001
planned results?
13485 Are correction and corrective action taken to ensure conformity of the prod-
9001
uct, as appropriate, when planned results are not achieved?
13485:2016 8.2.3 Reporting to regulatory authorities
13485:2016 If applicable regulatory requirements require notification of complaints that

meet specified reporting criteria of adverse events or issuance of advisory
notices, does the organization document procedures for providing notifica-
tion to the appropriate regulatory authorities?
13485:2016 Are records of reporting to regulatory authorities maintained (see 4.2.5)?
8.2.4 Monitoring and measurement of product
13485 Does the organization monitor and measure the characteristics of the prod-
9001
uct to verify that product requirements have been met?
13485 Is this carried out at appropriate stages of the product realization process in
9001
accordance with the planned arrangements and documented procedures?
13485 Is evidence of conformity with the acceptance criteria maintained and do the
9001
records indicate the person(s) authorizing release of product?
13485 Does product release and delivery of service not proceed until the planned
arrangements have been satisfactorily completed?
13485 Is the identity of personal recorded, which performs any inspection or test-
Impl.
ing?
8.2.4 Internal audit
13485:2016 Does the organization conduct internal audits at planned intervals to deter-
Version: 1.0 44 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
mine whether the quality management system:
13485:2016 a) conforms to planned and documented arrangements, requirements of

this International Standard, quality management system requirements es-
tablished by the organization, and applicable regulatory requirements?
13485:2016 b) is effectively implemented and maintained?
13485:2016 Does the organization document a procedure to describe the responsibili-

ties and requirements for planning and conducting audits and recording and
reporting audit results?
13485:2016 Is an audit program planned, taking into consideration the status and impor-
tance of the processes and area to be audited, as well as the results of
previous audits?
13485:2016 Are the audit criteria, scope, interval and methods defined and recorded
(see 4.2.5)?
13485:2016 Does the selection of auditors and conduct of audits ensure objectivity and
impartiality of the audit process?
13485:2016 Do Auditors not audit their own work?
13485:2016 Are records of the audits and their results, including identification of the
processes and areas audited and the conclusions, maintained (see 4.2.5)?
13485:2016 Does the management responsible for the area being audited ensure that
any necessary corrections and corrective actions are taken without undue
delay to eliminate detected nonconformities and their causes?
13485:2016 Do follow-up activities include the verification of the actions taken and the
reporting of verification results?
8.2.5 Monitoring and measurement of processes
13485:2016 Does the organization apply suitable methods for monitoring and, as appro-
priate, measurement of the quality management system processes?
13485:2016 Do these methods demonstrate the ability of the processes to achieve

planned results?
13485:2016 When planned results are not achieved, are correction and corrective action
taken, as appropriate?
Version: 1.0 45 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485:2016 8.2.6 Monitoring and measurement of product
13485:2016 Does the organization monitor and measure the characteristics of the prod-
uct to verify that product requirements have been met?
13485:2016 Is this carried out at applicable stages of the product realization process in
accordance with the planned and documented arrangements and docu-
mented procedures?
13485:2016 Is Evidence of conformity to the acceptance criteria maintained?

13485:2016 Is the identity of the person authorizing release of product recorded (see
4.2.5)?
13485:2016 As appropriate, do records identify the test equipment used to perform

measurement activities?
13485:2016 Does product release and service delivery not proceed until the planned
and documented arrangements have been satisfactorily completed?
13485:2016 For implantable medical devices, does the organization record the identity
of personnel performing any inspection or testing?
8.3 Control of nonconforming product
13485 8.3.1 Does the organization ensure that product which does not conform to prod-
9001
uct requirements is identified and controlled to prevent is unintended use or
13485:2016
delivery?
13485 8.3.2 Is there a documented procedure established to define the controls and
9001
related responsibilities and authorities for dealing with nonconforming prod-
13485:2016
uct?
Does the organization deal with nonconforming product by one or more of

the following ways ...
13485 8.3.3 - by taking action to eliminate the detected nonconformity or by taking ac-
9001
tion to preclude is original intended use or application?
13485 8.3.4
- by authorizing its use, release or acceptance under concession?
9001
13485:2016
Does the evaluation of nonconformity include a determination of the need
for an investigation and notification of any external party responsible for
the nonconformity?
13485 8.3.5 Are records of the nature of nonconformities and any subsequent actions
9001
taken, including the evaluation, any investigation and the rationale for deci-
13485:2016
sions concessions obtained maintained? (see 4.2.5)
Version: 1.0 46 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485 8.3.6 Is it ensured that nonconforming product is accepted by concession only if

regulatory requirements are met?
13485 8.3.7 Is the identity of the person(s) maintained who authorizes the concession?
13485 8.3.8 When nonconforming product is corrected; is it subject to re-verification to

demonstrate conformity to the requirements?
13485 8.3.9 Does the organization take action appropriate to the effects, or potential
effects, of the nonconformity when nonconforming product is detected after
delivery or use has started?
13485 8.3.10 If product needs to be reworked, does the organization document the re-
work process in a work instruction, which undergone the same authorization
and approval procedure as original work instruction?
13485 8.3.11 Prior to authorization and approval of the work instruction, is it assured that
a determination of any adverse effect of the rework upon product is made
and documented?
13485:2016 8.3.2 Actions in response to nonconforming product detected before deliv-

ery
13485:2016 Does the organization deal with nonconforming product by one or more of
the following ways:
13485:2016 a) taking action to eliminate the detected nonconformity?
13485:2016 b) taking action to preclude its original intended use or application?
13485:2016 c) authorizing its use, release or acceptance under concession?
13485:2016 Does the organization ensure that nonconforming product is accepted by

concession only if the justification is provided, approval is obtained and
applicable regulatory requirements are met?
13485:2016 Are records of the acceptance by concession and the identity of the person
authorizing the concession maintained (see 4.2.5)?
13485:2016 8.3.3 Actions in response to nonconforming product detected after delivery
13485:2016 When nonconforming product is detected after delivery or use has started,
does the organization take action appropriate to the effects, or potential
effects, of the nonconformity. Records of actions taken shall be maintained
(see 4.2.5)?
13485:2016 Does the organization document procedures for issuing advisory notices in
Version: 1.0 47 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
accordance with applicable regulatory requirements?
13485:2016 Are these procedures capable of being put into effect at any time?
13485:2016 Are records of actions relating to the issuance of advisory notices main-
tained (see 4.2.5)?
13485:2016 8.3.4 Rework
13485:2016 Does the organization perform rework in accordance with documented pro-
cedures that takes into account the potential adverse effect of the rework on
the product?
13485:2016 Do these procedures undergo the same review and approval as the original
procedure?
13485:2016 After the completion of rework, is product verified to ensure that it meets
applicable acceptance criteria and regulatory requirements?
13485:2016 Are records of rework maintained (see 4.2.5)?
8.4 Analysis of data
13485 8.4.1 Does the organization determine, collect and analyse appropriate data to
13485:2016
demonstrate the suitability and effectiveness of the QM system (and to as-
sess and evaluate where improvement of the effectiveness of the quality
management system can be made)?
13485:2016 Do the procedures include determination of appropriate methods, including

statistical techniques and the extent of their use?
13485 8.4.2 Does this include data generated as a result of monitoring and measure-
9001
ment and from other relevant sources?
Does the analysis provide information relating to ...
9001 8.4.3
- customer satisfaction?
13485
- customer feedback?
9001 - conformity to product requirements?
MDD/MPG 8.4.4
- monitoring the market about incidents with their own or similar products?
13485 8.4.5
- characteristics and trends of procedures, processes and products includ-
9001 ing opportunities for preventive action and suppliers?
13485 8.4.6 Are records of the results of the analysis of data be maintained?
Version: 1.0 48 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485:2016 Does the analysis of data include data generated as a result of monitoring
and measurement and from other relevant sources and include, at a mini-
mum, input from:
13485:2016 a) feedback?
13485:2016 b) conformity to product requirements?
13485:2016 c) characteristics and trends of processes and product, including opportuni-

ties for improvement?
13485:2016 d) suppliers?
13485:2016 e) audits?
13485:2016 f) service reports, as appropriate
13485:2016 If the analysis of data shows that the quality management system is not
suitable, adequate or effective, does the organization use this analysis as
input for improvement as required in 8.5?
13485:2016 Are records of the results of analyses maintained (see 4.2.5)?
8.5 Improvement
8.5.1 General
9001 Does the organization continually improve the effectiveness of the quality
management system through the use of the quality policy, quality objec-
tives, audit results, analysis of data, corrective and preventive actions and
management review?
13485 Does the organization identify and implement any changes necessary to
13485:2016
ensure and maintain the continued suitability, adequacy and effectiveness
of the quality management system as well as medical device safety and
performance through the use of the quality policy, quality objectives, audit
results, postmarket surveillance, analysis of data, corrective actions, pre-
ventive actions and management review?
13485 Are thereby used: the quality policy, quality objectives, audit results, analy-
sis of data, corrective and preventive actions and management review?
13485 Are documented procedures established for the issue and implementation
of advisory notices?
13485 Are these procedures capable of being implemented at any time?
Version: 1.0 49 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485 Are records of all customer complaint investigations maintained?
13485 If investigation determines that activities outside the organization contrib-

uted to customer complaints, is there relevant information between the or-
ganizations involved exchanged (see 4.1.)?
13485 If any customer complaint is not followed by corrective and/or preventive

action, is the reason authorized and recorded?
MDD/MPG Is a procedure defined and documented for notify the regulatory authorities
and the DQS of those adverse events which meet the reporting criteria?
(DIMDI-Data base for incidents, or rather initial and final reporting of incidents forms) (MED-
DEV 2.12/1)
8.5.2 Corrective action
13485 Does the organization take action to eliminate the causes of nonconform-
9001
ities in order to prevent recurrence?
13485:2016
13485 Are corrective actions appropriate to the effects of the nonconformities en-
9001
countered?
13485:2016
Is a documented procedure established to define requirements for ...
13485
- reviewing nonconformities (including customer complaints)?
9001 - determining the causes of nonconformity?
13485:2016
13485
- evaluating the need for action to ensure that nonconformities do not re-
9001 cur?
13485:2016
13485
- (determining and implementing) planning and documenting action
13485:2016 needed, including, if appropriate, updating documentation (see 4.2)?
13485:2016
- verifying that the corrective action does not adversely affect the ability to
meet applicable regulatory requirements or the safety and performance of
the medical device?
13485
- recording of the results of any investigation and of action taken?
13485:2016 - reviewing the corrective action taken and its effectiveness?
13485
- Are the results of recent risk evaluation included?
- Do the reflected results flow back to the risk management and are they
covered by the risk management documents?
13485
- Is it also checked in the analysis whether the error can occur for compa-
rable products/processes?
Version: 1.0 50 / 51
ISO 13485 & MDD & 9001
Ref: xxxxxx
Eva- Eva- Eva-

lua- lua- lua-
tion tion tion
1. 2. 3.
Year Year Year
13485:2016
Are records of the results of any investigation and of action taken main-
tained (see 4.2.5)?
8.5.3 Preventive action
13485 Does the organization determine action to eliminate the causes of potential
9001
nonconformities in order to prevent their occurrence?
13485:2016
Are preventive actions appropriate to the effects of the potential problems?
Is a documented procedure established to define requirements

for ...
13485
- determining potential nonconformities and their causes?
9001 - evaluating the need for action to prevent occurrence of nonconformities?
13485:2016
13485
- determining and implementing action needed?
9001 - recording of the results of any investigations and of action taken?
13485
- reviewing preventive action taken?
9001
13485:2016
- planning and documenting action needed and implementing such action,
including, as appropriate, updating documentation?
13485:2016
- verifying that the action does not adversely affect the ability to meet appli-
cable regulatory requirements or the safety and performance of the medi-
cal device?
13485:2016
- reviewing the effectiveness of the preventive action taken, as appropri-
ate?
13485:2016
Are records of the results of any investigations and of action taken main-
tained (see 4.2.5)?
Version: 1.0 51 / 51

410 09e Checkliste For Assessment 13485 MDD

Hochgeladen von

Dokumentinformationen

Originaltitel

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

410 09e Checkliste For Assessment 13485 MDD

Hochgeladen von

Copyright:

Verfügbare Formate

Checklist for Assessment

ISO 13485 & MDD & 9001

Checklist for the assessment based on the standards

Audit date 1. Year Auditor: Signature

Audit date 2. Year Auditor: Signature

Audit date 3. Year Auditor: Signature

Explanations for the application of the DQS assessment check list

1 = fulfilled 2 = partially fulfilled, acceptable 3 = partially fulfilled, not acceptable

0.1 1.1 General questions for the certification

0.2 1.2 Additional requirements of the 93/42/EEC to establish

4 Quality management system

Eva- Eva- Eva-

Eva- Eva- Eva-

under the applicable regulatory requirements?

13485:2016 4.1.2 Does the organization…

13485:2016 c) determine the sequence and interaction of these processes?

13485:2016 b) …ensure the availability of resources and information necessary to sup-

13485:2016 c) …implement actions necessary to achieve planned results and maintain

13485:2016 d) …monitor, measure as appropriate, and analyse these processes…

13485:2016 c) …establish and maintain records needed to demonstrate conformance to

Eva- Eva- Eva-

13485:2016 c) controlled in accordance with the requirements of this International Stan-

esses that affects product conformity to requirements?

13485:2016 Does the organization retain responsibility of conformity to this International

13485:2016 Do the controls include written quality agreements?

13485:2016 Are records of such activities maintained (see 4.2.5)?

4.2 Documentation requirements

Does the quality manual include…

Eva- Eva- Eva-

4.2.3 Product documentation

MDD/MPG Are correct declarations of conformity issued?

Eva- Eva- Eva-

MDD/MPG Do designated suppliers with activities having a substantial influence on the

MDD/MPG If no appropriate certificates for subcontractors/suppliers are available, are

MDD/MPG Are contractual declarations/agreements signed with subcontrac-

MDD/MPG Is there a procedure to evaluate the actuality of the subcontrac-

MDD/MPG Has the company established that the purpose is fulfilled?

MDD/MPG Is there a evaluation of the essential requirements of the Machinery Direc-

4.2.2 Quality manual

Does the quality manual include ...

Eva- Eva- Eva-

justification for any exclusion or non-application?

4.2.3 Control of documents

4.2.3 Medical device file

13485:2016 a) general description of the medical device, intended use/purpose, and

13485:2016 b) specifications for product?

13485:2016 c) specifications or procedures for manufacturing, packaging, storage, han-

13485:2016 d) procedures for measuring and monitoring?

13485:2016 e) as appropriate, requirements for installation?

13485:2016 f) as appropriate, procedures for servicing?

Eva- Eva- Eva-

Has a documented procedure been established to define the controls

13485 Is the useful life time of the product appropriately determined?

4.2.4 Control of records

13485 Has a documented procedure been established to define the controls of

13485 Are records established and maintained to provide evidence of conformity

Eva- Eva- Eva-

4.2.4 Control of documents

13485:2016 Are documents controlled required by the quality management system?

13485:2016 Does a documented procedure define the controls needed to:

13485:2016 a) review and approve documents for adequacy prior to issue?

13485:2016 b) review, update as necessary and re-approve documents?

13485:2016 d) ensure that relevant versions of applicable documents are available at