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The new revision to ISO 9004 came off the press in the last quarter of 2009. It is significantly different from its predecessor. ISO 9004:2009 embodies the quality management principle relating to continual improvement. The technical experts made bold strides in their quest to address market needs by producing a standard that would help organizations maintain and improve their quality management systems over time. While that was the stated intent with the 2000 version, the fact is that the majority of users considered it a road map for implementing ISO 9001.
Individuals who were familiar with the 2000 version will have several questions. The first is: “Where’s 9001?” In ISO 9004:2000 the entire text of ISO 9001:2000 was embedded into the standard. The clauses, by and large, mirrored ISO 9001 and the structure was identical. Those who utilized ISO 9004 as a how-to guide for ISO 9001 had no trouble finding the relevant clauses. The only problem with that approach is that ISO 9004 was not intended to be a handbook on how to implement ISO 9001. It was intended, as the title plainly indicated, to provide “Guidelines for performance improvements.”
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Comments
Too much?
It is one thing to establish and maintain a quality system but to continuously monitor down to minute details and document is getting a bit too much. What ever happened to the Paper Reduction Act of 1995?
I will use my company as an example... We are a major distributor or raw stock titanium. We stock three grades of titanium in selective shapes and sizes. We do not have nor possess any manufacturing and/or special processing capabilities nor do we machine or alter the material in any way other than cutting it down to a smaller size (per our customer's request).
We are a small, veteran owned business, with less than 25 employees, and have been doing basically the same thing since the early 70's with almost no change in our business practices. Our company has a great reputation among our customers and within our industry because we provide quality product to our customers. For us, the quality and traceability of product is key and considered the two main factors in our business.
There is very little room to move or improve upon because are processes are simple and straightforward and have been nearly perfected in the almost 40 years since we have been in business.
The current ISO 9001:2000 quality system already has us repeatedly documenting many of our processes over and over again in a repetitive manner to the point where we could photocopy it once and reuse it again and again and again, etc.
To add more documentation on top of all the current documentation seems a bit redundant and wasteful especially in today's "green" environment.
Of course this is just one opinion from a certain point of view but I think that there are a lot of people out there who have a similar situation where they also feel that by adding more documentation still does not necessarily make things more quality efficient.
You're a stockist!
Hi there JToler,
I sympathise. The fact is you're a stockist, and back in the day, there was a UK version of BS 5750 (now ISO 9001) that was designed to cover off exactly what you do. I agree that your processes are simple, probably a cuppla deployment flowcharts is all you need. The Registered Stockist Scheme, as it was called, used a version of ISO 9002 (BS 5750 Pt 2) that was slightly more than than ISO 9003 (BS750 Pt 3). In today's parlance of course, the extent of your ISO 9001 conformity should be seeking exclusions from much of section 7, and the extent of your documentation should reflect this. So if your system is document heavy and complex, once again you are the victim of incompetent certifers/registrars and ineffective accreditation bodies.
Having said that, I'm sure you would agree that being innovative in how you keep your customers satisfied and acknowledging that you apply a commensurate duty of care is how you stay in business. This angle is the approach in ISO 9004:2009 as Denise points out. It's also how the UK Chartered Quality Institue (try this link http://www.thecqi.org/Knowledge-Hub/What-is-quality/) defines quality.
I suggest the following; first draw up a conformity matrix of your system documentation against the pertinent clauses of the standard. Rows for the clauses, columns for your activity areas or processes (eg Management, Purchasing, Stores, Order processing, Despatch, etc). As you go through it, discard all documentation that adds no value, is duplicated elsewhere, or exerts no control. As the acid test, ask the lottery question ("what would happen if XYZ won the lottery and didn't come back to work?"....that's coz it's nicer than the "run over by a bus" version but the effect is the same!). And use diagrams and pictures rather than text wherever you can.
When your registrar's auditors turn up next time give them the matrix and ask them to point out exactly ("put your finger on the words in The Standard") what's wrong with your interpretation if they raise issues. Demand your certifcation money back if they come up with rubbish and complain to the accreditation body.
I hope this helps.
Ian
ISO 9004 It sure looks different.
Denise you are a delight your words of wisdom ring true. Finally we have a "Quality" document that says all the right things and the target is sustain ability. Finally they got it right. Early in my quality life i took this approach and was machined gunned out of the sky with consultants advising that I had it all wrong.
Consultants have a lot to answer for. In past cases the blind leading the blind. What seems never to be asked is does it work for the this companies CEO? If it does then how does it align with ISO if seeking Certification?
The trick is the auditor needs to understand the business need not the business understand what the auditor wants. How often have I witnessed business changing they way they have been doing things for the last 40 years because the auditor thought it didn't fit.
To have been in existance for say 5 years or more means that this business must be doing something right. They do have a quality system else they would not survive. Is it based on ISO 9001:2009 ? Perhaps not but then the skilled auditor can match what the business has done to the Standard and hence is a support to the business. Too often I hear all this quality stuff is just more and more red tape. When in fact it is about lifting the bottom line and securing the businesses sustain ability.
When talking about a quality systems documentation the real question here is why do we need this documentation? What is its purpose? Quality systems are risk management systems. So if the document did not exist what is the threat to the business. If none then ditch the document as it serves no useful purpose. Documenting process for the sake of it is futile and serves no purpose.
What is good about this Digest is that in this case JToler actually read the paper and gave a good honest comment. It has been my experience as an auditor that most seeking Certification are doing it for the wrong reasons. Many have bought off the shelf systems only to discover that they don't fit. ISO 9004:2009 is a great step foward. Perhaps at first a little overwhelming but if one reads it section by section with a fine wine or indeed a good coffee; take the time to reflect on ones own business. Then it will be clear what has to happen or indeed does not have to happen if seeking complience. We should all remember that one can have a quality system that is not Certified. It is just that it is not recognised by outsiders. But a quality system exists never the less. It is the auditors role to recognise the quality system for what it is.
Rob Langdon
Quality Manager
Biomedical Technology Services
Brisbane
Queensland
Australia
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