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    List of mandatory documents required by ISO 9001:2015

    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?

    So, here is the list of ISO 9001 documentation requirements – 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)
    • 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?

    Click here to download a white paper: Checklist of Mandatory Documentation Required by ISO 9001:2015, with more detailed information on the most common ways to structure and implement mandatory documents and records.

    Advisera Strahinja Stojanovic
    Author
    Strahinja Stojanovic
    Strahinja Stojanovic is certified as a lead auditor for ISO 13485, ISO 9001, ISO 14001 and OHSAS 18001 standards by RABQSA. He participated in implementation of these standards in more than 100 SMEs, through creation of documentation and performing in-house trainings for maintaining management system, internal audit and management review.