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ISO 9001 Documentation Requirements – The complete list

Updated: July 7, 2023.

Version 2015 of the ISO 9001 standard has brought some changes, so it’s important to know which documents are mandatory in this revision. How many documents are required in the QMS documents list?

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

Some of the ISO 9001 mandatory documents and records:
  • Scope of the QMS
  • Quality policy
  • Quality objectives
  • Records of training, skills, experience, and qualifications
  • Product/service requirements review records

ISO 9001 mandatory documents and records

Here is the quality documents list 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)

Besides this quality documentation list, here are the mandatory records:

What must be documented ISO 9001 reference
Monitoring and measuring equipment calibration records* clause
Records of training, skills, experience and qualifications clause 7.2
Product/service requirements review records clause
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 10.2

*Note that records marked with * are only mandatory in cases when the relevant clause is not excluded
Diagram displaying the mandatory documents and records for ISO 9001

Non-mandatory documents

There are numerous non-mandatory documents that can be used for ISO 9001 implementation. However, these non-mandatory documents are the most commonly used:

What must be documented ISO 9001 reference
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, to resume, we have listed the most frequently asked questions about ISO 9001 documentation requirements below.

What are the six documents required by ISO 9001?

While the previous version of ISO 9001 included six required procedures, ISO 9001:2015 does not have any required procedures. The organization needs to determine which procedures are needed within the QMS scope to avoid nonconformity in the processes.

What are the mandatory documents and records required by ISO 9001:2015?

The four documents and 18 records listed above are the ISO 9001 mandatory documents required by the standard; however, each can be removed from the list if that requirement is not included in the QMS scope.

What records must be kept to comply with ISO 9001?

The mandatory records for ISO 9001 include the 18 records above, which need to be kept, unless the specific requirement is excluded from the Quality Management System in the scope document.

How many mandatory procedures are there in ISO 9001:2015?

ISO 9001:2015 includes no mandatory procedures in the requirements; however, organizations may need to include them to ensure that processes occur as planned.

Does ISO 9001 require a quality manual?

While a quality manual is not required by ISO 9001:2015, many companies will create one in response to a customer requirement, or as a way to compile the four mandatory documents of the QMS – scope, quality policy, quality objectives, and supplier selection criteria – into one document.

So, this is it – it might seem like a lot to write, but once you do it, you will have all the aspects of quality management in your company covered.

This ISO 9001 Documentation Toolkit helps with structuring and implementing mandatory documents and records.

Advisera Strahinja Stojanovic
Strahinja Stojanovic

Strahinja Stojanovic is certified as a lead auditor for the ISO 13485, ISO 9001, ISO 14001, and OHSAS 18001 standards by RABQSA. He participated in the implementation of these standards in more than 100 SMEs, through the creation of documentation and performing in-house training for maintaining management systems, internal audits, and management reviews.