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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