› ISO 3485 and 41006

What information can you provide as the to correlation of ISO 9001 to the above identified ISO standards? Is there any?

ISO 13485 - Medical Devices Management Systems

ISO 46001 - unknown title.

Thank you.
quanjanim <rforrestr@yahoo.com>

qdigest 6/23/2005

I appreciate all your kind responses. Most all of you have confirmed my view on this subject. The Quality Policy is an important part of an organization's overall policies/strategies and everyone needs to understand how it applies to them so that quality objectives set by management are properly communicated and pursued.

Unfortunately, when I mentioned my concern to our Management Rep/VP Quality about the assessor ignoring the fact that these employees did not know the policy or how it related to them, the comment I got was "so what, it's just the Quality Policy".

Thanks again for all your comments.

cholka 6/23/2005

I think that more important than employees memorizing the quality policy is that they know what it means to them and how their job supports the company's ablity to conform to it.

dyancey 6/22/2005

Well, it is a requirement of the standard.

More importantly though, the QP is the reason for existance and doing the things that you do to deliver a product or service.

My guess is that if many employees don't know at least something about the quality policy there are probably bigger nonconformities that will manifest themselves during the audit. Training would be a potential link in this instance.

valerielinkva 6/21/2005

I think it is important for the employees to be able to tell you what it is, even if it is not word for word. Ours is rather long, so I don't expect people to know it by heart. When we were audited by a third party, it was hanging in the hall and at desks around the office in small frames. It was also part of our intro presentation with our auditor. I don't remember him asking anyone what it was.

billha 6/21/2005

ISO clause 5.3(d) says that the policy must be communicated and understood. Memorising, paraphrasing, or pointing to a wall is only evidence of how well an individual can memorize, paraphrase, or recall which wall (or how well the person was coached the day before the audit). Where is the objective evidence that it is communicated and understood?

I believe that an auditor has a duty to look for that objective evidence. Data on product quality and customer satisfaction (which is usually contained somewhere in most polcies I've seen)would be objective evidence. An auditor needs to look at the policy and do a little digging as to what data would indicate that the policy is communicated and implemented. Don't know the policy? Maybe the evidence shows that they really do.

elaine 6/21/2005

Good day:

If you are registered, its a requirement that they know it, or know of it, or where to find it. Section 5.3(d) is quite clear on this.

If the registrar said OK, no problem, then there's a problem with the registrar. The registrar knows the requirements, if they don't note that this is a potential issue, then the regisrar is not doing their job.

hope this helps.
Elaine

cndynvk 6/21/2005

I recently has the "problem" of my third party auditor ask a Production line worker what the quality policy was and he drew a total blank and said "I don't know." The auditor is a great guy and because everyone else answered with what the quality policy meant to them, the auditor let it go. The employee, has all employees of my client have done, did have a copy of the quality policy and could show it to the auditor. In preparation for surveillance audits, I make a point of telling every employee of my client to be prepared for this question. From the receptionist to the President and I go one step further and tell them to write it down. No nervous stares when asked! If my auditor constantly heard from my client's employees that they didn't know and the auditor let it pass, I would be asked for a new auditor!

jfreed 6/21/2005

The Quality Policy should say what you do for your market and your customers, why you run your business, and is the foundation of the quality manual. Sounds like it's time for a new assessor. My internal auditors ask that question Tell me about the Quality policy in your own words?

dencas 6/21/2005

It is imperative. If we wish them to take ownership of their particular task, we must clearly define what is expected of them.

easyr 6/14/2005

Hello cpastore,
It seems to be one of those things that auditors found out about a year ago and the word started spreading like wild fire amongst them.
They probably have a chatroom some where and and share stories.Like "I did this audit today and I asked the guy sweeping the floor if he knew the quality policy and guess what? he didn't know it.I got em good on that one".

In my opinion it is just another one of those well intention paragraphs in ISO that in reality has no added value to the employee. Proper training and support from management is the true key. As far as the auditor is concerned, if he askes any question he is obligated to follow up if it is a unknown response. If not, why ask it at all?

PS: Also...watch out when they ask everyone what the quality objective is and how each employee contributes to it.


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