Quality Manuals Need Not Apply

The pragmatic fanatic discusses ISO 9001:2015

Thu, 03/17/2016 - 12:08

One of the more enjoyable discussions I’ve seen on the Internet recently has to be about what to do with the quality manual. A common question is, “So what do I call this thing I put all the procedures in, now that we can’t have a quality manual?” It’s part of the panic brewing among quality assurance professionals since the September 2015 update of the quality management system (QMS) standard, ISO 9001.

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Submitted by Ian Hendra on Thu, 03/17/2016 - 15:02

Thanks Steve,

I agree with you 100%; been my view too, actually since 1984 when I did my LA course long before IRQA (etc) was even half a thought of a candle-lit dinner.  

Like its military and national standards predesessors (eg BS5750) the 1987 version of ISO 900x called up docmented procedures but not a quality manual.  The 2000 version called up a minimal cross reference, that's all.  

So where did the "conventional" Quality Manual concept come from?

The answer is the UK and the 1984-1990 Dept of Trade & Industry UK National Quality Campaign (UKNQC) that launched the first accredited QMS CBs (LRQA was #1..BSI was #3..BVQI was #8 - I was their first Quality Manager in 1988) and the first QMS Accreditation Body (NACCB, now UKAS).  

The UKNQC also made available to British companies employing less than 600 people, reimbursement of 2/3 the cost of 15 days consultancy from a DTI approved consultant  upon achievement of accredited certification to BS 5750.  That's why the UK is still over represented per capita in analyses like the ISO (Mobil) survey; the UK went from zero to 10s of thousands of certifications within a few years, most paid for by UKNQC funding. 

Since "what you measure is what you get", the UKNQC spawned the "15 day" QMS that consisted of little more than a clause by clause "sign-posted" "Quality Manual" that was presented for review and audit by the CB as evidence that a QMS existed.  I saw many of these things in those days, sometimes from the same consultants vs the same templates and in places with the company names still unchanged from the previous client...I used to call them "wet ink manuals".  

From a CB manager and field auditor's point of view these things were almost impossible to challenge in the time available...but that issue remains as the most serious problem in certification to this day....and one that still remains ignored by the accreditation system worldwide.

Then in the early 1990s as the UKNQC ended, many from the UK did the Star Trek trick and boldy went where no QMS had gone before...some of them left to build certification businesses based on the UKNQC approach unchanged...with the "Quality Manual" concept firmly embedded in their psyches and training offerings. 

Far fewer others, like me, saw the folly and weaknesses in the UKNQC, and perceived a much better, more honest way of certification than the garbage that was being peddled in Britain at the time.  I emigrated to NZ in 1992, for example to set up a new CB based on a business development process driven auditng methodology long before ISO 9001:2000 was ever thouight of. 

Times have changed for sure, but not everywhere..and many still hang on unwittingly to a 30 year old British shortcut... 

By the way, ISO 9001 has never called up a Quality Manager either, but you can blame the UKNQC for that one too...

Cheers

Ian 

 

 

Even with a quality manual, auditors do have to think about how they observe people and the knowledge of quality that those people have against the basis for the quality system, which has included the QM, BUT not just the QM.  Other things are critical to see in audits, such as real-time practices, instruments and gages, etc.  As an auditor, I want to see that an employee has a consistent method of being trained, which has to be something more than "tribal culture" verbal training that can be very inconsistent from person to person.  Also, when I audit places, I ask people if they have seen and read the QM and if they were given a basic review of the QM.  The QM needs to be a useful and living method of communication, and not just the only one on quality.

I predict, though, that many companies are going to use this new change as an excuse for not having to really document much and that their employees will be left out in the dark even more than before.

Hi Catherine,

Mmm, sorry I'm not so much concerned about what you want to see as an auditor as in what your CB tells you to look for.  The CB issues the certifcate, not the auditor.  You are auditng for the CB, you are not consulting.

Having said that, how do you tell a staff member hasn't been trained?  Do you look for tangible errors or omissions (product nonconformities in other words) or do you just assume incompetence on the basis of how you think training ought to be done?  And how do you handle skilled staff that need no taining at all because they were employed as competent already?  

I am unaware of anything in any version of ISO 9001 or its predessors that has ever required staff members to be trained in the use of a so-called Quality Manual or even have any idea where to find one.  

Which clause (s) would you call up in ISO9001:2008, for example?

When I worked for a company that recently got registered to ISO 9001 and AS9100, the TUV registrar reviewed every clause on us, and then in the later periodic audits, would specifically point to the specific clauses that the auditors came to our place for.  Other companies who had different ISO registrars went through very similar experiences.  When I worked in the US Government on various types of projects and activities where the suppliers and contractors were reviewed for ISO 9001 conformanance to be qualified, we reviewed each clause one by one.  One of the things we looked for was how Management got quality rolled out, based on several sentences in the 9001 document.

Hi Catherine, thanks.

Auditors who audit by clause of the standard make two fundamental errors.  The first is assuming that all companies are configured to meet the standard.  In more than 2000 days of client contact over 20+ years as a professional CB manager and auditor I have never found a single one that fits accurately.  Auditing this way round only tests how well the standard fits the company.  It's a waste of time, unlikely to disclose anything of consequence.

So in my view, the second mistake is close to professional negligence.  It is a failure to take on board the requirements in the standard that call up a system of identified processes of defined sequence and interaction complete with performance measures that top management reviews and acts upon.  It follows that this sequence and interaction (etc) defines the external audit approach in assessing conformity.  In other words assessing how well the organisation's system fits the standard (not the other way round...).  This was a lesson that came across loud and clear during my 60-hours-in-5-days Lead Assessor course back in 1984 in the UK, where the training was run by instructors from the defence procurement agency. 

You see, ISO 9001 comes from, and hence only makes complete sense from, the buyer side of the supply agreement.  It was ever thus, check out clause #1 to see what I mean.

Few CBs have ever got this...so neither do their auditors, apparently.  As for Lead Auditor training these days, I have no idea who has lost sight of the ball..or how, because the concept is obvious... 

I hope this helps. 

ISO 9001:2015 has not solved the Quality Manual problem. The answer was already in ISO 9001:2008.

The lack of a requirement for a quality manual will not deter poorly skilled consultants and business managers from finding an over abundance of boiler-plate "documented information" to present to, likewise, poorly skilled auditors as evidence of conformance to ISO 9001:2015. The root cause is a desire for the certificate without a willingness to exert the effort.

Consultants who understood the Quality Manual requirements of ISO 9001:2008 will continue to lead their clients to comprehend the principles of a quality management system: version 2008, or version 2015. ISO 9001:2015 has not introduced any new management system principle that was not present in the 2008 edition. Skilled trainers, consultants, and managers will link their existing management and product/service processes to the revised standard with little effort.

The alignment of management systems standards to Annex SL should make conformance a much less complicated activity. However, only time will tell if the reworking of the standard will add value for the customer (organization seeking certification) and, therefore, meet customer expectations.

Terry

Various companies in our region had very similar experiences of the registrars' auditors going through every clause and looking for supporting objective evidence and documentation.

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