Examining Common ISO 9000 Misconceptions

[Don Winton]

My apologies for not responding to this thread sooner. I have a client that is preparing for a State inspection and the last couple of days have been hectic. Christian, “approved” does not mean a signature is required, nor does the standard require “signatures” unless you are a “regulated” industry. The company’s procedures shall state when review and approval is accomplished. No more, no less. Of course, objective evidence is required, but this evidence should be the company’s, not the assessors. As far as continuous improvement is concerned, that is a different story. When a company decides to adopt a quality standard as their business core principle, the company decides which practices are best for them, with the primary goal being “to stay in business.” Customer satisfaction, making money, etc. Barb, preconceptions are not to be allowed or to be tolerated. I agree. The assessors job is to obtain objective evidence of “compliance or noncompliance.” No more, no less. I have stated earlier that when an assessor “suggests” things required for compliance, this is a no-no. I also agree that some (not all, by no means) consultants may try to mold a company’s policies and procedures to their (the consultant's) mold, not the standards. Things adopted by the company may not add value, but an assessors job is not to determine this. Again, “compliance or noncompliance” is the issue for them. Barb, a company with 5 or 10 employees do not need reams of paperwork or unnecessary documents to comply (see misconceptions above). As a matter of fact, other than the costs, small companies are the easiest to register. That is the magic and magical purpose of ISO 900x. It IS that flexible. There is much benefit to using ISO 900x to improve a business operations. This is determined by the company, and company only. The purpose of the list was to highlight what those who do not know try to know. By the way Marc, DCAS was my most driving force to be in this business (doing things right, not by the so-called rules). I have a good story I will forward at a later time.

[Marc]

Common Misconceptions:

1) The standard requires that you document what you do and do what you document
2) You have to appoint a Quality Manager
3) Job descriptions are required
4) Everyone should be able to recite the quality policy
5) All out of date documents have to be removed
6) All purchases have to be from approved suppliers
7) Purchase orders must be signed
8) doucments have to carry an approval signature
9) There has to be only one index of documention
10) Work instuctions are required for all operations that affect quality
11) All measurements have to made with calibrated instruments
12) All verification activities have to be performed by staff independant of those responsible for the activities being verified
13) The location of items in stock has to identified
14) Records of corrective actions have to be retained for a defined period
15) All auditors have to undergo formal training
16) All incoming supplies are subject to receipt inspection
17) Storage areas have to be locked at all times
18) The quality record requirements apply to all records.
------snippo-----
Any comments folks?

You certainy know how to get attention; I was told that at least 3/4 of your list are absolutes! Especially the first..."it's just like OSHA, if it's not written down it didn't happen". Help; we are just at the desk audit stage and I don't want to expend energy where it isn't needed. Could you clarify please?

Thanks

[barb butrym]

Well, definetely a list of COMMON misconceptions. I hear them all the time. lets start with just one shall we.

"Job descriptions are required. "
Well, responsibilities and authority must be clearly defined for all activities effecting quality. People use the job description as one means of assigning responsibility, and delegating authority. Its also a means of identifying training needs and resourses. By no means the only way of providing this information.....the confusion is a result of non creative-people deciding they need to see a job description in order to have evidence of the requirements. Consultants also add to this misconception by leading their clients down that road.

NEXT???????

Hi,
I'll take the next one.

2. You have to appoint a quality manager.

the standard tells us we have to appoint a "management rep.", in fact it is better if the rep. isn't the Quality Manager he is busy doing other things.

[Don Winton]

I will take #5. Refer to 4.5.2(b). The KEY point in the statement is "or otherwise assured against unintended use." Just identify obsolete documents as such and state that you do so in your procedures.

I'm still listening. You've already identified one and that was the job description. I was told by my "auditor" that I had to have them.
thank you.....I do love learning the right way

[Don Winton]

Pat,
I will probably take some flack for this one. Try #10. This misconception stems mainly from section 4.9(a) which states "documented procedures defining the manner of production, installation, and servicing, where the absence of such procedures could adversely affect quality;" The key phrase here is "where the absence of such procedures could adversely affect quality" Justify the lack of the procedures (read work instructions) by the best method suited for your operation and back up with objective evidence and work instructions are not required. Period. For example, give a master machinist a drawing and the proper machine(s) and say "make 300 of these." He will supply you with the 300 pieces, to print, without further instructions. Remember, ISO 900x and registrars work for you, not you for THEM. By the way, any auditor (assessor?) that tells you what you must do is NOT an ISO assessor, just some "consultant."
By the way Marc, I would appreciate your input to my interpretation. Thanks, Don