ISO9001-2015 Preparation

As I am working through creating a quality manual with a customer, I will address a few sections.

One section is titled ‘understanding your organization and its context’.  In it, ISO 9001-2015 calls for a Documentation Hierarchy and it identifies 3 levels.

Level 1 – The Quality Manual

The top level is the quality manual itself as called for in the ISO requirements.  It includes your corporate policies, procedures, laws, regulations, etc.  It describes in detail how your company does business.

Level2 – Policies & Procedures

This level will include a quality policy that will shape all of your procedures.  You will need to document all of your procedures including a verbal description and a graphical representation.  Other policies could include your safety policy and others that pertain to your business.

Level3 – Work Instructions

Work instructions describe how to perform activities identified in your procedures.  It will include all of the details on how to perform an activity.  Your guide is to write up the instructions so that if one of your employees is in a wreck and out of work for a month, another employee can read the instructions and follow them to complete the activity.

Authoring a quality manual takes a lot of thought and a lot of time but it is well worth the effort.


2 thoughts on “ISO9001-2015 Preparation

  1. All logical . . . what is your view on the usefulness of an “electronic” Quality Manual?

    . . . where you get to see (at a 3D graphic multi-root hierarchical Knowledgebase, with suitable masking because you will end up with something like 10,000 documents) all of “policies, procedures, laws, regulations” plus “procedures including a verbal description and a graphical representation” plus “all of the details on how to perform an activity”

    See “3D Strategic Planning – What you need to know about it”

  2. My customer will be using document management software with workflow, so all documents will be electronic. Obviously printed if needed. Attempting ISO only using paper would be many times more difficult…

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