ISO 9001 - 2015 Documentation Requirements - What Is Mandatory

4/5/2019 ISO 9001:2015 documentation requirements: What is mandatory?
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List of mandatory
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9001:2015
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Author: Strahinja Stojanovic

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Version 2015 of the ISO 9001 standard has brought some

changes, so it’s important to know which documents are Popular posts Recent posts
mandatory in this revision. How many documents are
required? List of mandatory documents
So, here is the list of ISO 9001 documentation requirements – required by ISO 9001:2015
below you will see not only mandatory documents, but also How to Write Good Quality
the most commonly used documents for ISO 9001 Objectives
implementation.
How to identify the context of the
Mandatory documents and records organization in ISO 9001:2015
required by ISO 9001:2015 ISO 9001 Requirements and

Structure
Here are the documents you need to produce if you want to
be compliant with ISO 9001:2015. (Please note that some of How to address risks and
the documents will not be mandatory if the company does opportunities in ISO 9001
not perform relevant processes.):
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)
And, here are the mandatory records (note that records

marked with * are only mandatory in cases when the
relevant clause is not excluded):
Monitoring and measuring equipment calibration

records* (clause 7.1.5.1)
Records of training, skills, experience and quali cations

(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)
Non-mandatory documents
There are numerous non-mandatory documents that can be
used for ISO 9001 implementation. However, I nd 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)
So, this is it – what do you think? Is this too much to write?

Do these documents cover all aspects of quality
management?
Click here to download a white paper: Checklist of Mandatory

Documentation Required by ISO 9001:2015, with more
detailed information on the most common ways to structure and
implement mandatory documents and records.
« How to comply with new leaders...
How to de ne the scope of the... »
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4/5/2019 ISO 9001:2015 documentation requirements: What is mandatory?

ISO 13485 IATF 16949 ISO 20000 / ITIL  Advisera Store

 CALL US +1 (646) 759 9933  ABOUT US CONTACT US

HOME DOCUMENTATION  PRICING BOOKS  FREE DOWNLOADS LEARNING CENTER 

TESTIMONIALS 2015 TRANSITION TOOLS  eTRAINING 

ISO 9001 Knowledge base

Home / Knowledge base / Documentation / List of mandatory

Author: Strahinja Stojanovic

Version 2015 of the ISO 9001 standard has brought some

required by ISO 9001:2015 ISO 9001 Requirements and

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

And, here are the mandatory records (note that records

Monitoring and measuring equipment calibration

Records of training, skills, experience and quali cations

Product/service requirements review records (clause

Record about design and development outputs review*

Records about design and development inputs* (clause

Records of design and development controls* (clause

Records of design and development outputs *(clause

Design and development changes records* (clause 8.3.6)

Characteristics of product to be produced and service to

Records about customer property (clause 8.5.3)

Production/service provision change control records

Record of conformity of product/service with acceptance

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)

Procedure for determining context of the organization

Procedure for addressing risks and opportunities (clause

Procedure for competence, training and awareness

Procedure for equipment maintenance and measuring

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

Warehousing procedure (clause 8.5.4)

Procedure for management of nonconformities and

Procedure for monitoring customer satisfaction (clause

Procedure for internal audit (clause 9.2)

Procedure for management review (clause 9.3)

So, this is it – what do you think? Is this too much to write?

Click here to download a white paper: Checklist of Mandatory

« How to comply with new leaders...

How to de ne the scope of the... »

If you enjoyed this article,

RECEIVE UPDATES BY EMAIL

You may unsubscribe at any time.

For more information on what personal data we collect, why

DNV GL Business Assurance is one of the leading providers

ISO 14001 Online ISO 45001 Online ISO 13485 Online

ISO Compliance & Company ISO online courses Leading books on

DOCUMENTATION LEARNING CENTER ABOUT SUPPORT

Product Tour What is ISO 9001? About us Free Consultation