Mandatory documents and records required by ISO 9001:2015
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.):
The Mandatory documents
- 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)
The mandatory records
And, here are the mandatory records (note that records marked with * are only mandatory in cases when the relevant clause is not excluded):
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- 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)
to download ISO 9001:2015 Standard
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)
So, this is it – what do you think? Is this too much to write? Do these documents cover all aspects of quality management?
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