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Mandatory Documentation Required by

ISO 9001:2015
May 18, 2017 gulfnde
It is easy to become overwhelmed with documentation in the belief that every single
process that is in place in an organization must be documented, without realizing that this is
not necessary to meet the requirements of the ISO 9001 standard. The 2015 revision of the
standard become more liberal regarding documentation requirements, meaning that there
are no longer six mandatory procedures as in the previous 2008 version of the standard.
ISO 9001 also identifies many records that need to be maintained, which are generated by
the processes of the Quality Management System. Below is discussed which documents
and records are mandatory, and which are optional.

1) Which documents and records are required?


Mandatory Documents
1. Scope of the Quality Management System (ISO9001-2015 Clause 4.3)
2. Quality Policy (ISO9001-2015 Clause 5.2)
3. Quality Objectives and Plans for Achieving Them (ISO9001-2015 Clause 6.2)
4. Procedure for Control of Externally Provided Processes, Products and Services
(outsourced processes)(ISO9001-2015 Clause 8.4.1)
Mandatory Records
1. Record of Maintenance and Calibration of Monitoring and Measuring Equipment
(7.1.5.1)
2. Competence Records (7.2)
3. Product/Service Requirements Review Record (8.2.3.2)
4. Record of New Requirements for Product or Service (8.2.3.2)
5. Design and Development Inputs Record (8.3.3)
6. Record of Design and Development Controls (8.3.4)
7. Design and Development Outputs Record (8.3.5)
8. Record of Design and Development Changes (8.3.6)
9. Record of Evaluation of External Provider (supplier) (8.4.1)
10. Record of Product/Service Characteristics (8.5.1)
11. Record of Changes on Customer’s Property (8.5.3)
12. Record of Changes in Production/Service Provision (8.5.6)
13. Evidence of Product/Service Conformity (8.6)
14. Record of Nonconformity (8.7.2, 10.2.2)
15. Monitoring Performance Information (9.1.1)
16. Internal Audit Program and Results (9.2.2)
17. Management Review Results (9.3)
18. Nonconformities and Corrective Action (10.2.2)
2) Commonly used non-mandatory documents
Non-Mandatory Procedures
1. Determining Context of the Organization and Interested Parties (4.1, 4.2)
2. Procedure for Addressing Risks and Opportunities (6.1.)
3. Competence, Training and Awareness Procedure (7.2, 7.3)
4. Procedure for Control of Documents and Records (7.5)
5. Sales Procedure (8.2)
6. Procedure for Design and Development (8.3)
7. Procedure for Production and Service Provision (8.5)
8. Warehousing Procedure (8.5.4)
9. Procedure for Measuring Customer Satisfaction (9.1.2)
10. Procedure for Internal Audit (9.2)
11. Procedure for Management Review (9.3)
12. Procedure for Nonconformity and Corrective Action (10.2)
3) How to structure documents and records
 Determining Context of the Organization and Interested Parties
 QMS Scope
 Quality Policy
 Risks and Opportunities that need to be addressed
 Quality Objectives and Plans for Achieving Them
 Competence, Training and Awareness records
 Procedure for Control of Documents and Records
 Sales procedure
 Procedure for Design and Development
 Procedure for control of externally provided processes, products and services
(outsourced processes)
 Procedure for production and service provision
 Warehousing procedure
 Monitoring performance information
 Internal audit
 Management review
 Nonconformity and corrective action