What Are The Mandatory Documents Required by ISO 9001:2015


I recently attended a Quality MeetUp and the discussion centered around ISO 9001:2015. Most had not read 9001:2015 so the discussion focused on what documents are required.

The central theme to ISO 9001:2015 is Risk and this really moves the discussion away from mandatory and required documents to a more holistic strategic approach.

While documents will be necessary and integral to achieve compliance with 9001:2015 the old paradigm of a checklist really is not the most effective approach.

So, what are the mandatory documents required by ISO 9001:2015?

  • Quality Management System (clause 4.3)
  • Quality Policies (clause 5.2)
  • Quality Objectives & Planning (clause 6.2)
  • External Processes, Products & Services (clause 8.4.1)

Really, that's it?

Actually no.

Depending on the depth and breadth of the above they could require extensive documentation to achieve the results. The diagram below is taken from ISO 9001:2015 and shows the interconnection between various elements.

ISO 9001:2015 Plan Do Check Act Cycle

plan do act check cycle of iso 9001 2015.png

Depending on your particular situation, ISO 9001:2015 could require more or less documentation than ISO 9001:2008. The reality is that it will no longer be adequate to just mimic a line-by-line checklist approach to your quality management system.  Input will be necessary from all parties that can effect the outcome of customer satisfaction.

Clause A.4 Risk-based thinking

" One of the key purposes of a quality management system is to act as a preventative tool."

The bottom line is your organization will need to spend time reading ISO 9001:2015 and focusing on inputs and processes and not a checklist.

You may also want to read:

Is your calibration program ready?

Calibration as a risk management strategy

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Phil Wiseman

Phil Wiseman

Phil Wiseman is Chief Marketing Officer at Alliance Calibration. He earned a B.S. in Chemical Physics from Centre College. Phil is an ASQ Certified Quality Auditor and ASQ Certified Manager of Quality/Organizational Excellence.

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