Documentation in ISO 9001-2015

The International Organization for Standardization (ISO) technical committee has recently released a guidance document- “Guidance on the Requirements for Documented Information of ISO 9001:2015”. The purpose this guidance document is to help the implementers of ISO 900- 2015 with specific regards to documented information.

ISO 9001-2015 allows flexibility for an organization in the way it chooses to document its Quality Management System (QMS). ISO 9001-2008 demanded a set of mandatory procedures. In ISO 9001-2015 there is no demand for record or procedures, instead it is stated as documented information. Based on the new version, organization can choose the type and formats for documenting the QMS. It could be of any media / any type of file (e.g. checklists, flowchart etc)

This doesn’t mean that documentation is going away from ISO 9001-2015. Documentation is required and it should be kept under control too.  It is not required to rewrite the existing QMS in an organization already compliant to ISO 9001-2008 to meet the requirements of IS 9001-2015. Organizations can use terms which suit their operations, e.g., records, documentation, protocols, etc. rather than documented information.

About

The author is a Quality Assurance professional by experience. Part Quantitative data analyst, part consultant for quality and information security practices, part software tester, she is a writer by passion and blogs at https://wordsandnotion.wordpress.com and http://qualitynotion.com/.

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One thought on “Documentation in ISO 9001-2015

  1. Leonora Raad

    March 28, 2016 at 6:19pm

    Do you have any video of that? I’d love to find out some additional information.

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    • Author

      Akhila

      March 31, 2016 at 3:18pm

      So far i don’t have any video on this topic. Kindly let me know what more information you are looking for.
      thanks for being here

      Permalink  ⋅ Reply
  2. K3Cottage

    July 1, 2016 at 5:59pm

    Since the publication of the new revision of ISO 9001 last month, many people have been wondering what documents are mandatory in this new 2015 revision. How many documents are required?

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    • Author

      Akhila

      August 9, 2016 at 2:14pm

      thanks for being here. as you know, this is a revised version, build upon the older version. And so there is no big change happened in the documentation requirements. instead of documented procedures the new version is demanding documented information.. ultimately everything the same

      Permalink  ⋅ Reply
  3. ArtMoney

    July 11, 2016 at 1:32pm

    So, this is it – what do you think? Is this too much to write? Do these documents cover all aspects of quality management?

    Permalink  ⋅ Reply
    • Author

      Akhila

      August 9, 2016 at 2:12pm

      thanks for being here, in fact there is no much difference in the documentation requirements..instead of documented procedures the new version is demanding documented information.. ultimately everything the same

      Permalink  ⋅ Reply

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