What are the Pros & Cons of ISO 9001?

Question

I'm particularly interested in personal experiences of those working in a molecular biology lab or similar.
I've already done some research on Wikipedia etc so please don't just copy and paste sections from other sites - It's personal experiences I'm looking for.
Thanks in advance!

Answer 1

I've found ISO accreditaion to be a pain in the posterior. It creates "procedures" so that A) any interaction with the outside world is consistent and B) New hires/transfers can pick up the idiot manual and know how to do the job.

Unfortuantely, The ISO auditors usually know nothing about the process they're assessing and base their "pass/fail" decision on presentation alone (does it look nice, is the spelling correct, have we avoided any breaches of Political Correctness?)

Silly example of a procedure:

"How do we reduce the mortality rate on NHS wards?"
"Send them home before they croak"

If presented well and convincingly, this sort of detritus would pass, and you could put that nice little laurel-leaf logo on all your stationery.

But is it right?

Answer 2

ISO 9001 of itself does not improve the quality of a product. It i the process of Continuous Improvement that does this. If you produce rubbish now, ISO 9001 will mean that you will have fancy written down procedures to show how you make that rubbish.

Answer 3

David Davies is correct!
I am in internal auditor. I have watched the evolution of quality standards for over 20 years. I saw BS5750 and the ISO family of standards evolve over this time. First experiences were with the early Training and Enterprise ouncils especially Aztec where I was employed as an internal auditor. The Government funding departments all demanded that the outputs i.e. the authorised paperwork if these stringent procedures were applied then the payment was made to our suppliers who provided such things as Youth Training.
What was sad was that several training providers brandished ISO 9001 before me as a crucifix is brandished before a vampire. I was completely unfazed as a cursory glance at the written procedures indicate that they there was little or no control awareness i.e. not checks and balances to ensure that no output is of the best possible standard.
Of course if these stringent controls were not applied for every incorrect or unsupported piece of documentation we found the TEC could legitimately refuse payment. Of Course on Provider decided to get slick and sent their external accountants and auditors to challenge me. I was young and studying to be an ACCA myself. I was slightly in awe of the qualified. The day came and he kept presenting me his working papers to explain why we must pay £40K over and when. I read out the relevant sections of his client’s contract - the bits that mentioned that payment was subject to valid and supported paperwork and sent him off with a flea in his ear!
I know of one specialist Company who have used ISO 9001 in a brilliant manner. This company moved its printing function to the Philippines and us the logo as a Marketing tool to imply that they have translated developed world quality to a third world location.
It may be better to ask your internal audit team in and ask them to conduct a systems review as you will get an unbiased opinion and systems documentation of a professional standard.

Answer 4

I think 9001 works for manufacturing and to a degree to research and development. Consistency in processes and traceability in products can save time and fix problems. However applying these standards to everything as other people have mentioned is frankly stupid!

Answer 5

Prons is the business is promoted in the market because of the tag that people thought the production with ISO is not fake but cons is that small scale business may decline.

Answer 6

The pros, it makes for higher quality in products!
The cons, its costly and it makes no sense! I.E., Our standards are high yet the products we import dont use these standards for the most part! They tell us that we must follow these standards in the U.S. and then purchase substandard products from other countries! In the end, it loses American jobs!