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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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