Duncan –
You ask the point of the bureaucracy.
There are two.
One is the obvious, that of trying to ensure that goods are sold fit for purpose.
The other, and hinted at by contributors, is mere protectionism.
When the subject first appeared for us with the Pressure Equipment Regulations I bought copies of the two official documents. One is the law itself, seeming written by lawyers for lawyers who wouldn't know a toothed steel bar is a 'file' but had heard of pressure-vessels made from aluminium-alloy and stainless-steel. The other is a booklet by our own DTI and clearly written by professional engineers and legal advisors to help professional engineers to comply with the law.
It is clear from the UK-law version of the EU document, that product safety is the lesser consideration, versus trade-barrier and money-spinner for "Notified Bodies". The document even gives a little drawing showing the correct form and proportions of the CE label.
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I worked for some ten years at a lowly level in the scientific civil-service. Then we were sold off, rather dodgily that elicited Questions in Parliament, whereupon the non-ISO-registered Govt. agency that was still our primary customer insisted we had to be ISO-9001 accredited. We felt insulted because our work was not changing and They had always been happy with it.
We were all sent on short courses that explained that ISO9001 drew heavily on the old UK DEF-STAN system, a genuine technical guarantee scheme; but the Americans refuse to recognise any foreigners' standards although they tolerate ISO. However, ISO9001 is a guarantee not of quality necessarily, but of consistency.
The course failed to warn of us of ISO900x's deadening top-down stifling of initiative and even suggestions – "Sorry – can't. Not in the Procedures." It did though question the idea that low-quality work can gain ISO900x if it is consistent, and to written processes. Whilst theoretically true that would obviously be commercially self-destructive.
So we laboriously wrote hundreds of Guides, Work Instructions and Procedures, differing by degrees of prescription. The templates were credibly, allegedly copied from some American business-school text-book, so had 2 A4 pages of useful stuff, several of waffle and a few "intentionally blank" – no-one knew why – but added the real instructions as a mere Appendix!
I prepared one for a particular piece of lab equipment, and it became what I called "Auditor Bait" for the company's internal auditors to make them feel – and the WI look – useful enough to avoid awkward questions. I hung the folder invitingly from the equipment; and watched the posse, clip-boards drawn a la Clint Eastwood, come in, tick off the WI's existence, title and page-width Master Copy reference- number, and be happy.
They never knew because they never asked, that the instructions were out of date! For soon after my writing them my manager heavily modified the rig to perform the same tests in a very different way. Unfortunately the old Work Instructions were by now lithified in the 3rd draw of the 4th filing-cabinet of Room…, so the Auditor Bait remained just that. We who were paid to use it, knew how to use it.
The real, external auditors did give the company the ISO9001 ticket we'd been forced into striving for – but only after we'd stripped our newly-invented bureaucracy back to what was necessary.
So much for ISO9001. QA? Not really. It's a costly management-control scheme.