QualityMentors Blog

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Documentation for organisational context


Asheef Mohamed from Muscat, Oman has asked: “For context of organisation what record can be used?  Internal and external issues logs or something else?”

Here are my views on this issue:

Except clause 4.3: Scope, the requirements of clause 4 of ISO 9001:2015 are not covered in the list of mandated documents. However, determination of external and internal issues, interested parties and their requirements are ‘shall statements’. Not only this, their  monitoring and review to ensure their continued suitability for the organization are also shall statements. How to achieve these requirements without excessive documentation is part of your question. Here are some of the ways you can achieve  this objective of yours:

Clause 4.1:

  • Organizational goals, purpose, intended outcomes may be in the form of mission, vision, Quality Policy and core value  statements
  • Internal and external issues may be included in organizational risk register, strategy, MoMs, email circulars, posters etc)
  • Context statement in  a few organization

Clause 4.2:

  • Applicable legislation and regulatory compliance register
  • Contracts with customers and suppliers
  • Complaints/ complements received from customers and others
  • Interested parties and their needs & expectations

Since your query is for organisational context, I take it for entire clause 4 of the stadard. Let me therefore include clauses 4.3 and clause 4.4 also.

Clause 4.3:

  • Documented Scope statement, which anyways remains a mandated requirement

Clause 4.4:

  • Defined process framework and interrelations between processes
  • Evidence and of continual improvement
  • Formats, guidelines, standards, checklists, directives etc.

Hope this satisfies your query. I will be pleased to more clarify issues …

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