RIP, Quality Manual

The revised ISO 9001 won’t be a slave to formality, but the quality manual is still worth keeping

A quality manual will not be a mandatory document for a quality management system (QMS), according to the available version of the ISO/DIS 9001:2015 standard. How did that happen? The quality manual was one of the first documents that a certification body asked for before the certification audit. How has it suddenly lost its purpose and importance?

Most quality manuals manage to formally meet the requirements of ISO 9001, yet miss the point of the document. The result is a lot of time and effort spent on creating a fundamental QMS document that no one reads. I’ve often run across quality manuals with 20, 50, or more pages, and they made me wonder whether “quality management system” would be more accurately called “quantity management system.” It’s too bad these overwritten documents put people off.

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More relevant

The document that you describe has the advantage that staff might actually read it.

Make it relevant, cut down on 'impressive' ISO-ese language, gear it to the organization's business plans.

The history is important..

Good article, very valid...as always history provides an explanation..

Pre 2000, ISO 9001 etc demanded 20 sets of documented procdures. It did not require a single Quality Manual.

Pre 1987, in the UK, the standard was BS 5750 that was all but the same. This is important because the UK National Campaign (UKNQC, circa 1983-1991) is where the scene was set because the UK goverment paid for it. NACCB (now UKAS) was born from the UKNQC as the first serious Management System Accreditation Body, and the mainstream certifiers built their busnesses on those years of huge goverment funding (I was the Quality Manager for one them from 1988 to 1992).

On the implementation side, the UKNQC re-imbursed 2/3 of the fees from up to 15 days consultancy to any Birtish company employing less than 600 people. All they needed to do was achieve NACCB accredited certification and record it in the Dept of Trade and Industry (DTI) Register. This of course is where the so-called "conflict-of-interest" came from regarding consultants.

Now, "What You Measure Is What You Get - WMYWYG", so the 15 day QMS was the progeny of the UKNQC and it's been a curse to our profession ever since because this British model infected the rest of the world (you can stll buy fill-in-the-gaps systems from the web and doubtless get them certified). You see, the manifestation of these QMSs was nearly always a so called Quality Manual "sign-posted" to the (up to) 20 documented procedures called up in BS 5750 Part x or ISO 900x. It was habitual to leave out the Design & Development clauses even for companies responsible for the products and services they sold; another facet that has been a curse in our profession ever since.

These "Quality Manuals" were as detached from reality then as their equivalents are now...as indeed Strahinya points out, but they presented a patina of conformity to their auditors that certifiers were happy to sign-off on, if only to capitalise on the billing opportunity.

Little has changed over the years....my fear is that the change of approach in the 2015 version will be beyond the grasp not only of many certification auditors, but the CBs who employ them and the Accreditation Bodies there to maintain service standards.

All we have ever needed is documentation sufficient to exert control over those parts of our systems and processes where their lack would lead to a loss of control over the capability of our deliverables to meet our customers' expectations. We don't really need either of the words "quality" or "manual" and never have.

I hope this helps.