ISO 13485 2003 Vs ISO 13485 2016 Matrix EN

ISO 13485:2016 vs.
ISO 13485:2003 matrix
Copyright ©2017 Advisera Expert Solutions Ltd. All rights reserved.

Copyright © 2017 Advisera Expert Solutions Ltd. All rights reserved. 1
ISO 13485:2016 ISO 13485:2003 Explanation
Introduction Introduction
Both the 2003 and 2016 versions of the ISO 13485 standard cover
fundamentally the same topics. However, there are some important
differences.
0.1 General 0.1 General
Now the standard can be used by any organization that is involved in any
stage of the product life cycle, which means that external parties or
suppliers can also certify themselves on standard requirements.
This is a new addition in the latest version of the standard; it clarifies the
concepts of some of the terminology used in the standard. For example,
0.2 Clarification of concepts
“risk” is being used for safety or performance requirements of medical
devices and devices meeting the regulatory requirements.
The description of the clause is almost the same; however, in the new
version of the standard it emphasizes the importance of using a process
0.3 Process approach 0.2 Process approach
approach in meeting requirements, value, process performance and
effectiveness, and improving the process by setting objectives.
Both versions of the ISO 13485 standard are based on ISO 9001; ISO
0.3 Relationship with other
0.4 Relationship with ISO 9001 13485:2016 is based on ISO 9001:2008, whereas ISO 13485:2003 is based
standards
on ISO 9001:2000.
0.5 Compatibility with other 0.4 Compatibility with other Both versions of the standard allow integration with other management
management systems management systems systems.
Quality Management System Quality Management System
Requirements Requirements
1 Scope 1 Scope Scope in the latest version of the standard defines other organizations,
such as suppliers or external parties, as eligible to implement the ISO
2 Normative references 2 Normative references 13485 standard. All the other points in this clause are almost the same for
both versions of the standard.
Some new terms are introduced in the newest version of the standard,
3 Terms and definitions 3 Terms and definitions
such as “sterile barrier system,” “medical device family,” etc.

4 Quality Management System 4 Quality Management System
In the latest version of the standard, more focus has been given to
applicable regulatory requirements and the controls associated to meet
4.1 General requirements 4.1 General requirements these requirements. Moreover, controls also encompass “risk” of external
parties to meet applicable regulatory requirements, and written quality
agreements to ensure that external parties meet those requirements.
Almost all the requirements are the same, except that the new version of
4.2 Documentation the standard identifies and explains the requirements of medical device
4.2 Documentation requirements
requirements files. For more information, read: How to meet ISO 13485:2016
requirements for medical device files.
All clauses are the same in both versions of the standard, except in some
subclauses where the new version of the standard demands management
5 Management responsibility 5 Management responsibility
commitment to applicable regulatory requirements, which need to be
identified and met.
All requirements are almost the same, except a few modifications to the
5.1 Management commitment 5.1 Management commitment terms are included in the new version of the standard; for example, in the
old version of the standard the term “statutory” has been removed and
covered in applicable regulatory requirements.
In the old version it was mandatory to understand, identify, and meet
only customer requirements, while in the new version, along with
5.2 Customer focus 5.2 Customer focus
customer requirements, it is mandatory to identify and meet regulatory
requirements as well.
There are no changes in the requirements. See the sample document
5.3 Quality policy 5.3 Quality policy
here: Quality Policy.
5.4 Planning 5.4 Planning
The requirements are similar except that in the new version the
5.4.1 Quality objectives 5.4.1 Quality objectives organization is required to set quality objectives for meeting applicable
regulatory requirements.
No significant changes have been implemented in this clause.
5.4.2 Quality management 5.4.2 Quality management
system planning system planning

5.5.1 Responsibility and There are no changes in this clause.
5.5.1 Responsibility and authority
authority
5.5.2 Management All requirements for management representative are the same in both
5.5.2 Management representative
representative versions of the standard.
Requirements for internal communication are the same in both versions
5.5.3 Internal communication 5.5.3 Internal communication
of the standard.
5.6 Management review 5.6 Management review
The organization is now required to document a procedure for
5.6.1 General 5.6.1 General management review. All other requirements were not modified. See the
sample document here: Procedure for Management Review.
Reporting to regulatory requirements and customer complaints have
5.6.2 Review input 5.6.2 Review input
been added as review inputs in the new version of the standard.
In the latest version, the review output is adapted to support the
5.6.3 Review output 5.6.3 Review output
modifications included in the review input.
6 Resource management 6 Resource management
6.1 Provision of resources 6.1 Provision of resources No significant changes have been implemented in this clause.
In the new version of the standard it is mandatory for the organization to
6.2 Human resources 6.2 Human resources document the processes for establishing competence, providing required
trainings, and ensuring awareness of employees.
There is a new requirement for infrastructure, which should prevent
product mix-ups and ensure orderly handling. Moreover, information
technology has been added as an infrastructure requirement in
supporting services. For more information, read: Managing medical
6.3 Infrastructure 6.3 Infrastructure
device infrastructure requirements according to ISO 13485:2016.
See the sample document here: Procedure for Infrastructure and Work
Environment.

6.4 Work environment and This clause has been split in two in the new standard.
6.4 Work environment
contamination control
In the new version of the standard the organization is required to
document the requirements of the work environment, rather than just
6.4.1 Work environment determining and managing it. Unlike the previous version of the standard,
in the new version, a procedure to monitor and control the work
environment should be established.
Contamination control has been separated as a subclause; it adds a
mandatory requirement for sterile medical devices, in which
6.4.2 Contamination control
requirements for control of contamination with microorganism or
particulate matter should be documented.
7 Product realization 7 Product realization
There are no significant changes to this clause, except in the need to
7.1 Planning of product
7.1 Planning of product realization establish processes and documentation, resources for maintaining
realization
infrastructure and work environment have to be provided.
7.2 Customer-related processes 7.2 Customer-related processes
The new version of the standard includes a requirement for the
7.2.1 Determination of 7.2.1 Determination of
organization to determine if users need to be trained in order to ensure
requirements related to product requirements related to product
specified performance and safe use of medical devices.
The new version of the standard includes a requirement for the
7.2.2 Review of requirements 7.2.2 Review of requirements
organization to review whether they need to train the users in order to
related to product related to product
ensure specified performance and safe use of medical devices.
All requirements regarding the communication with customers are the
7.2.3 Communication 7.2.3 Communication same; however, the new standard also mandates that the organization
communicate with regulatory bodies when needed.

7.3 Design and development 7.3 Design and development
A new clause has been added as “General” in the “Design and
Development” section. It mandates the organization to establish a
7.3.1 General
procedure for design and development as per the new requirements. See
the sample document here: Procedure for design and development.
The new version of the standard includes requirements related to
development of a method to ensure traceability for design and
7.3.2 Design and development 7.3.1 Design and development
development outputs against design and development inputs. Also, the
planning planning
new version of the standard states adequate resources to be identified in
the planning phase.
In the new version of the standard, design and development inputs should
incorporate usability requirements for the product; moreover, output of
inputs inputs
risk management has to be included in design and development inputs.
7.3.4 Design and development 7.3.3 Design and development The requirements are the same in both versions.
outputs outputs
With the earlier requirements, the new standard also mandates records
7.3.5 Design and development 7.3.4 Design and development for personnel involved in the process of review. Those designs under
review review review should be identified with the status “under review.” See the
following sample document: Design Review Minutes.
The new version of the standard includes mandatory documents and
procedures to ensure that the design and development outputs have met
7.3.6 Design and development 7.3.5 Design and development the input requirements. Verification plans, which include acceptance
verification verification criteria and statistical techniques with rationale for sample size, should be
documented.
See the sample document: Verification Report.

In the new version of the standard, the organization is required to
maintain documented records for design validation as well. Design
validation should be done on representative product, which can be initial
validation validation
production units, batches, etc. Records of validation conclusion should
also be maintained. See the sample document: Validation Report.
This is a new requirement in the latest version; an organization is now
required to document a procedure to transfer design and development
7.3.8 Design and development outputs to manufacturing. These outputs should be verified before
transfer becoming final specifications. Moreover, production capability should
meet product requirements. See the sample document here: Design and
Development Transfer Record.
The procedure for design and development in the new standard should
7.3.9 Control of design and 7.3.7 Control of design and include protocols to control design and development changes. Before
development changes development changes implementation, the change should be reviewed, verified, validated, and
approved. See the sample document here: Change Review Record.
This is a new requirement. The organization should maintain a design and
development file for each medical device type or family. This file has to
7.3.10 Design and development
include reference records of conformity to design and development
files
requirements and records for changes. See the sample document here:
Design and Development File.
7.4 Purchasing 7.4 Purchasing
The purchasing process has also been modified in the new version. The
old section on purchasing has been subdivided into four new
requirements. While the old standard expected the organization to
establish supplier selection and evaluation criteria, it didn’t provide any
details. The new version of the standard includes criteria for the
7.4.1 Purchasing process 7.4.1 Purchasing process
supplier—for example, supplier’s impact on quality of medical product,
supplier’s ability to meet organization’s requirements, performance of
supplier in terms of timely delivery, and supplier’s impact on risk for
medical device performance and safety. See the sample document here:
Procedure for Purchasing and Evaluation of Suppliers.

The new version of the standard mandates that product specifications
7.4.2 Purchasing information 7.4.2 Purchasing information should be shared with the supplier as well. See the sample document
here: Request and Order for Purchasing.
In the new version of the standard, this clause extends risk analyses to
suppliers. The organization must consider the risk whenever suppliers
underperform and should have documented adequate risk treatments.
7.4.3 Verification of purchased 7.4.3 Verification of purchased
When unplanned changes are embedded in purchased products, the
product product
organization is required to determine whether or not these changes affect
the medical device or product realization process. See the sample
document here: Purchasing Verification Record.
7.5 Production and service 7.5 Production and service
provision provision.
7.5.1 Control of production and 7.5.1 Control of production and
service provision service provision
In the new version of the standard, this clause is extended and the
organizations are required to identify products that cannot be cleaned
7.5.1.2.1 Cleanliness of product and
7.5.2 Cleanliness of product prior to sterilization or use. For more information, read the following
contamination control
article: Managing cleanliness of a product and contamination control
according to ISO 13485:2016.
7.5.3 Installation activities 7.5.1.2.2 Installation activities Requirements are the same in both of the standards.
Requirements are almost the same, except the new standard requests
that the organization analyze service records either as complaints or as
7.5.4 Servicing activities 7.5.1.2.3 Servicing activities
input for any improvement activity. See the sample document here:
Record of Servicing Activities.
Both versions have the same requirements for sterile medical devices. For
7.5.5 Particular requirements 7.5.1.3 Particular requirements for
more information, check the following article: How to manage the
for sterile medical devices sterile medical devices
medical device sterilization process according to ISO 13485:2016.

Both versions of the standard require companies to establish procedures
to validate production and delivery processes that generate outputs that
7.5.6 Validation of processes for can't be verified until the product is placed in use or the service has been
7.5.2 Validation of processes for
production and service provided. With the modifications included in the new version, the
production and service provision
provision organization is also required to establish validation plans and to revalidate
processes whenever necessary. See sample documentation here: Record
of Production Process Validation.
7.5.7 Particular requirements This is a new requirement. Process validation is required for sterilization
for validation of processes for and sterile barrier systems. The organizations are required to develop
sterilization and sterile barrier validation procedures, which will be used to establish, implement, and
systems maintain validation for sterilization and sterile barrier systems.
With the modifications in the new standard, it is required from the
organization to document a procedure for the identification of product by
suitable means through product realization. The identification procedure
7.5.8 Identification 7.5.3 Identification and traceability
shall encompass all stages of the product life cycle, and will provide a way
for monitoring and measurement of product. If mandated by regulatory
laws, the organization shall maintain unique device identification.
The organization is now required to develop a procedure for traceability.
For implantable medical devices, traceability records for components and
7.5.9 Traceability materials should be maintained. For more information, read the following
article: How to use ISO 13485:2016 to manage implantable medical
devices.
7.5.10 Customer property 7.5.4 Customer property Requirements are the same in both versions of the standard.
The new standard clarifies the meaning of preservation by mandating that
the organization prevent medical device damage, alteration, and
7.5.11 Preservation of product 7.5.5 Preservation of product
contamination. Also, the organization is required to protect products
when exposed to hazards.

Requirements are almost the same, except in the new version the
7.6 Control of monitoring and 7.6 Control of monitoring and organization is required to develop monitoring and measurement
measuring equipment measuring devices software validation procedures. See the following sample document:
Procedure for Documentation and Validation of Computer Software.
8 Measurement analysis and 8 Measurement analysis and
improvement improvement
8.1 General 8.1 General Requirements are the same in both versions of the standard.
8.2 Monitoring and
8.2 Monitoring and measurement
measurement
In the new standard, the feedback process should include provisions to
gather data from production, as well as post-production activities. The
information gathered in the feedback process serves as a potential input
8.2.1 Feedback 8.2.1 Feedback
into risk management for monitoring and maintaining the product
requirements, as well as the product realization or improvement
processes.
This is a new requirement; the organization is required to establish,
document, implement, and maintain complaint-handling procedures.
8.2.2 Complaint handling
For more information, read the following article: How to comply with ISO
13485:2016 requirements for handling complaints.
This is a new requirement; the organization is required to establish,
8.2.3 Reporting to regulatory document, implement, and maintain reporting procedures when
authorities regulators expect the organization to report to them. See this sample
document: Procedure for Adverse Event Investigation and Reporting.
8.2.4 Internal audit 8.2.2 Internal audit Requirements are the same in both versions of the standard.
8.2.5 Monitoring and 8.2.3 Monitoring and measurement There are no significant differences in the requirements between the two
measurement of processes of processes versions of the standard.
In the new standard, the identity of the person authorizing the release of
8.2.6 Monitoring and 8.2.4 Monitoring and measurement
product shall be recorded, and records of test equipment used for release
measurement of product of product
should be maintained.
8.3 Control of nonconforming 8.3 Control of nonconforming
product product

In the new standard, a procedure is required to define controls and
related responsibilities and authorities for the identification,
documentation, segregation, evaluation, and disposition of
8.3.1 General nonconforming product. The evaluation of nonconformity should include
a determination of the need for an investigation and notification of any
external party responsible for the nonconformity. See this sample
document: Procedure for Control of Non-Conforming Products.
This requirement has been added in a subclause in the new standard to
emphasize it separately. Requirements include dealing with
8.3.2 Actions in response to
nonconforming products prior to delivery, taking actions to eliminate
nonconforming product
detected nonconformities, preventing the product's unintended use or
detected before delivery
application and, if needed, authorizing nonconforming product use and
release.
This requirement has been added in a subclause in the new standard to
emphasize it separately. Requirements include identification of
nonconforming products after delivery or after use, actions to be taken
8.3.3 Actions in response to
against the effects that have been identified, record keeping of the
nonconforming product
actions taken, issuances and management of advisory notices, and record
detected after delivery
keeping of actions taken against issued advisory notices. For more
information, read the following article: ISO 13485:2016 nonconforming
product – How to approach the post-delivery actions.
This is a new requirement that mandates that the organization clarify how
8.3.4 Rework product rework should be performed, verified, reviewed, approved, and
recorded.
Requirements of analysis of data are the same; however, in the new
version of the standard, analysis should also be performed on audits and
8.4 Analysis of data 8.4 Analysis of data
service reports. See the following sample document: Procedure for Data
Analysis.

8.5 Improvement 8.5 Improvement
Requirements are almost the same, except that in the new version of the
8.5.1 General 8.5.1 General standard, medical device safety and performance must be taken into
consideration during improvement activities.
Both versions of the standard have the same requirements for corrective
8.5.2 Corrective action 8.5.2 Corrective action
actions.
Both versions of the standard have the same requirements for preventive
8.5.3 Preventive action 8.5.3 Preventive action
actions.

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