ISO 9001:2015

DOCUMENTED INFORMATION

GUIDLINES
 Clause 7.5 of
ISO 9001:2015

• The term documented information refers to information

that must be controlled and maintained and its
supporting medium.

• Documented information can be in any format and on

any medium and can come from any source
 Objectives of Documented
information

• Communication of Information
• Evidence of conformity
• Knowledge sharing
• Preserve the organization’s experiences.
 Documents may be in
any form or type of
medium

• paper
• magnetic
• electronic or optical computer disc
• photograph
• master sample
DOCUMENTED INFORMATION

Shall include?
Documents Required for ISO 9001:2015 &
Documents necessary for the effectiveness
of the quality management system
D.I - Needed to be maintained by the organization for the
purposes of establishing a QMS

−The scope of the quality management system

(clause 4.3).

−Documented information necessary to support theScope of

operation of processes (clause 4.4). Quality p
Quality o
Criteria fo
−The quality policy (clause 5.). suppliers

−The quality objectives (clause 6.2).

−This documented information is subject to the

requirements of clause 7.5.
Mandatory documents and records
required by ISO 9001:2015
SCope of the QMS (clause 4.3)
Quality policy (clause 5.2)
Quality objectives (clause 6.2)
Criteria for evaluation and selection of suppliers (clause 8.4.1)
Documented information necessary for the
organization to operate

−Organization charts

−Process maps, process flow charts and/or process

descriptions

−Procedures

−Work and/or test instructions

−Specifications

−Documents containing internal communications

…………Continue
Documented information necessary for the
organization to operate

− Production schedules

− Approved supplier lists

− Test and inspection plans

− Quality plans

− Quality manuals

− Strategic plans

− Forms
DOCUMENTED INFORMATION

RECORDS
 Records are:

• Documented information needed to be retained

by the organization for the purpose of providing
evidence of result achieved
 Records Include:

• −Documented information to the extent necessary to have confidence that

the processes are being carried out as planned (clause 4.4).
• −Evidence of fitness for purpose of monitoring and measuring resources
(clause 7.1.5.1).
• −Evidence of the basis used for calibration of the monitoring and
measurement resources (when no international or national standards exist)
(clause 7.1.5.2).
• −Evidence of competence of person(s) doing work under the control of the
organization that affects the performance and effectiveness of the QMS
(clause 7.2).
 Records Include:

• −Results of the review and new requirements for the products and
services (clause 8.2.3).
• Records needed to demonstrate that design and development
requirements have been met (clause 8.3.2)
• −Records on design and development inputs (clause 8.3.3).
• −Records of the activities of design and development controls
(clause 8.3.4).
• −Records of design and development outputs (clause 8.3.5).
 Records Include:

• −Design and development changes, including the results of the review and
the authorization of the changes and necessary actions (clause 8.3.6).
• −Records of the evaluation, selection, monitoring of performance and re‐
evaluation of external providers and any and actions arising from these
activities (clause 8.4.1)
• Evidence of the unique identification of the outputs when traceability is a
requirement (clause 8.5.2).
• −Records of property of the customer or external provider that is lost,
damaged or otherwise found to be unsuitable for use and of its
communication to the owner (clause 8.5.3).
 Records Include:

• −Results of the review of changes for production or service provision, the

persons authorizing the change, and necessary actions taken (clause
8.5.6).
• −Records of the authorized release of products and services for delivery to
the customer including acceptance criteria and traceability to the
authorizing person(s) (clause 8.6).
• −Records of nonconformities, the actions taken, concessions obtained and
the identification of the authority deciding the action in respect of the
nonconformity (clause 8.7).
 Records Include:

• −Results of the evaluation of the performance and the effectiveness of the

QMS (clause 911)
• −Evidence of the implementation of the audit programme and the audit
results (clause 9.2.2).
• −Evidence of the results of management reviews (clause 9.3.3).
• −Evidence of the nature of the nonconformities and any subsequent
actions taken (clause 10.2.2).;
• −Results of any corrective action (clause 10.2.2).
 Mandatory documents and records
required by ISO 14001:2015
Scope of the EMS (clause 4.3)
Environmental policy (clause 5.2)
Risk and opportunities to be addressed and processes needed (clause 6.1.1)
Criteria for evaluation of significant environmental aspects (clause 6.1.2)
Environmental aspects with associated environmental impacts (clause 6.1.2)
Significant environmental aspects (clause 6.1.2)
Environmental objectives and plans for achieving them (clause 6.2)
Operational control (clause 8.1)
Emergency preparedness and response (clause 8.2)
And, here are the mandatory records:
Compliance obligations record (clause 6.1.3)
Records of training, skills, experience and qualifications (clause 7.2)
Evidence of communication (clause 7.4)
Monitoring and measurement results (clause 9.1.1)
Internal audit program (clause 9.2)
Results of internal audits (clause 9.2)
Results of the management review (clause 9.3)
Results of corrective actions (clause 10.1)
 Mandatory records marked with *are only mandatory
when relevant clause is not excluded
Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
Records of training, skills, experience and qualifications (clause 7.2)
Product/service requirements review records (clause 8.2.3.2)
Record about design and development outputs review* (clause 8.3.2)
Records about design and development inputs* (clause 8.3.3)
Records of design and development controls* (clause 8.3.4)
Records of design and development outputs *(clause 8.3.5)
Design and development changes records* (clause 8.3.6)
Characteristics of product to be produced and service to be provided (clause
8.5.1)
Records about customer property (clause 8.5.3)
Production/service provision change control records (clause 8.5.6)
Record of conformity of product/service with acceptance criteria (clause 8.6)
Record of nonconforming outputs (clause 8.7.2)
Monitoring and measurement results (clause 9.1.1)
Internal audit program (clause 9.2)
Results of internal audits (clause 9.2)
Results of the management review (clause 9.3)
Results of corrective actions (clause 10.1)
 Mandatory records marked with *are only mandatory
when relevant clause is not excluded
Non-mandatory documents
There are numerous non-mandatory documents that can be used for ISO 9001
implementation. However, I find these non-mandatory documents to be most commonly
used:
Procedure for determining context of the organization and interested parties (clauses 4.1
and 4.2)
Procedure for addressing risks and opportunities (clause 6.1)
Procedure for competence, training and awareness (clauses 7.1.2, 7.2 and 7.3)
Procedure for equipment maintenance and measuring equipment (clause 7.1.5)
Procedure for document and record control (clause 7.5)
Sales procedure (clause 8.2)
Procedure for design and development (clause 8.3)
Procedure for production and service provision (clause 8.5)
Warehousing procedure (clause 8.5.4)
Procedure for management of nonconformities and corrective actions (clauses 8.7 and
10.2)
Procedure for monitoring customer satisfaction (clause 9.1.2)
Procedure for internal audit (clause 9.2)
Procedure for management review (clause 9.3)
 Non-mandatory documents

Procedure for determining context of the organization and interested

parties (clauses 4.1 and 4.2)
Procedure for identification and evaluation of environmental aspects and
risks (clauses 6.1.1 and 6.1.2)
Competence, training and awareness procedure (clauses 7.2 and 7.3)
Procedure for communication (clause 7.4)
Procedure for document and record control (clause 7.5)
Procedure for internal audit (clause 9.2)
Procedure for management review (clause 9.3)
Procedure for management of nonconformities and corrective
actions (clause 10.2)
ISO 45001 Mandatory Records
Scope of the OH&S management system (clause 4.3)
OH&S policy (clause 5.2)
Responsibilities and authorities within OH&SMS (clause
5.3)
OH&S process for addressing risks and opportunities
(clause 6.1.1)
Methodology and criteria for assessment of OH&S risks
(clause 6.1.2.2)
OH&S objectives and plans for achieving them (clause
6.2.2)
Emergency preparedness and response process (clause
8.2)
 ISO 4501 mandatory records:
-

1. OH&S risks and opportunities and actions for addressing them (clause
6.1.1)
2. Legal and other requirements (clause 6.1.3)
3. Evidence of competence (clause 7.2)
4. Evidence of communications (clause 7.4.1)
Plans for responding to potential emergency situations (clause 8.2)
Results on monitoring, measurements, analysis and performance
evaluation (clause 9.1.1)
Maintenance, calibration or verification of monitoring equipment (clause
9.1.1)
Compliance evaluation results (clause 9.1.2)
Internal audit program (clause 9.2.2)
Internal audit report (clause 9.2.2)
Results of management review (clause 9.3)
Nature of incidents or nonconformities and any subsequent action taken
(clause 10.2)
Results of any action and corrective action, including their effectiveness
(clause 10.2)
Evidence of the results of continual improvement (clause 10.3)
 ISO 4501 Non mandatory Dcoumnets
-

There are numerous non-mandatory documents that can be used for ISO 45001
implementation. However, these are the non-mandatory documents that are most
commonly used:
Procedure for Determining Context of the Organization and Interested Parties (clause
4.1)
OH&S Manual (clause 4)
Procedure for Consultation and Participation of Workers (clause 5.4)
Procedure for Hazard Identification and Assessment (clause 6.1.2.1)
Procedure for Identification of Legal Requirements (clause 6.1.3)
Procedure for Communication (clause 7.4.1)
Procedure for Document and Record Control (clause 7.5)
Procedure for Operational Planning and Control (clause 8.1)
Procedure for Change Management (clause 8.1.3)
Procedure for Monitoring, Measuring and Analysis (clause 9.1.1)
Procedure for Compliance Evaluation (clause 9.1.2)
Procedure for Internal Audit (clause 9.2)
Procedure for Management Review (clause 9.3)
Procedure for Incident Investigation (clause 10.1)
Procedure for Management of Nonconformities and Corrective Actions (clause 10.1)
Procedure for Continual Improvement (clause 10.3)
Thank You