ISO9001:2015 and the Three Tier documentation approach

by Jon
(Rhode Island USA)

With my last employer, I've developed and maintained the Quality Management System through the 1994, 2000, and 2008 versions of the ISO9001 standard using the 3 tier documentation approach - the QA Manual, Tier 2 QMS documents, and work instructions. My current company employs 500 people with a presence in the US, Canada, Europe. We are going for certification to the 2015 standard next year. However, Tier 2 documents are not clearly defined and as a result, the QMS is somewhat fragmented within the organization. I am looking to move the QMS from mere certification toward an organization with measured process effectiveness and continual improvement at its core. First, the basics. I believe the three-tier approach and clear QMS documents that are aligned with "The Standard" form the basis for getting the most out of ISO9001:2015. But, are three tiers necessary. I think I know the answer but would like to hear from others on this topic.

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Maintain or phase out the Quality Manual
by: Augustine Hove

Although the 2015 ISO 9001 version is not explicit in its requirements for the need of a Quality Manual (1st tier document), it requires a documented Scope for your QMS.
A closer look into what a quality manual presents will get you realising its more towards QMS scope definition and for that reason i feel maintaining the quality manual as a central part of your QMS documentation process helps you to better outline your scope and key processes under your QMS.
Procedures and work instructions obviously can not be ignored.


by: Robert (webmaster)

The three-tier approach can still work with the 2015 version. However, you no longer need the top tier document, which is normally the QA Manual. But the QA Manual can significantly reduce your workload and help organize your systems.

There are many changes with the new standard. I recommend using our ISO 9001:2015 QMS Implementation Kit to help you over the hump.

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