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Home / Knowledge base / Documentation / List of mandatory documents required by ISO 9001:2015

List of mandatory documents required by ISO

9001:2015
Author: Strahinja Stojanovic

Since the publication of the new revision of ISO 9001 last month, many people have been wondering what

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documents are mandatory in this new 2015 revision. How many documents are required?

So, here is the list – below you will see not only mandatory documents, but also the most commonly used
documents for ISO 9001 implementation.

Mandatory documents and records required by ISO 9001:2015

Here are the documents you need to produce if you want to be compliant with ISO 9001:2015. (Please note
that some of the documents will not be mandatory if the company does 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 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)

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)

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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?

To learn more about changes in the new version of ISO 9001, see the How useful is ISO 9001? survey
results.

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14 Comments 9001Academy 1 Login

Recommend 9 Share Sort by Best

Join the discussion…

luxorion • 22 days ago

By minima documents, you only listed the operational files, records, and other forms. The
processes and procedures that need to be documented are missing.
• Reply • Share ›

Wendie • 5 months ago

Where can I find any information about the Retained documents that need to be created by the
client. Are they comparable to the PRMs in the 2008?
• Reply • Share ›

Redzuan Mohd • 7 months ago

Dear sir, it is greatly appreciated if you can advise where you get this mandatory clause for the
ISO 9001:2015 and how strong this statement support the implementation of Iso 900:2015. My
question is apart of this mandatory clause, other clause is not applicable?meaning to say we can
ignore it? your answer is greatly appreciated as i got a lot of question about it. Thanks sir.
• Reply • Share ›

kristan ashly • 8 months ago

I have in communication about Ready QMS 9001:2015 documentation kit..Is it worth to buy it?
• Reply • Share ›

mohd khateeb kristan ashly • 25 days ago

Would you please give more details , if I understand you correctly , you have ISO kit want
to sell , if yes am interested
• Reply • Share ›

Strahinja Stojanovic Mod mohd khateeb • 24 days ago

Hi Mohd, we do have an ISO 9001 Documentation Toolkit, you can download a
free preview here http://advisera.com/9001academ...
• Reply • Share ›

kristan ashly • 8 months ago

Good info. It will realy helpful. Some consultants are selling QMS documents online for ISO
9001:2015. Is it worth to use it while going for certification? any ideas..
• Reply • Share ›

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