(ISO) Quality Manual Chat

How do you deal with ISO9001:2000 section 8.4? What kind of data must you gather and analyze? This is the one area of ISO that is probably the most confusing to people trying to implement a new quality management system.

How should you write your work instructions? Is there a standard format? Are work instructions a requirement of your ISO9001:2000 quality management system?

You’re trying to implement an ISO9001:2000 quality system. You can’t do it alone. How do you get others in the organization to get on board? Whips? Threats? Cursing? If these sound good to you, you need to read this.

What, exactly, is your top management responsible for in your ISO9001:2000 quality management system? Clue: its not just writing a check to pay for the audit.

The ISO9001:2000 quality standard says that you must review product requirements prior to your organization commiting to supply the product to your customer. Different companies handle this in wildly different ways, it all depends on what kind of company you are, and what your product is.
For some companies this is easy. You get [...]

Do you have measuring devices as part of your quality control system? Ever wonder how you need to control them if you want to get ISO9001:2000 registered?

ISO9001:2000 section 4.2 states the requirement to have a documented quality policy. Cynical people might look at the quality policy as a bunch of horse dung. And lord knows I’ve seen quite a few companies that don’t take any part of their quality system seriously. So its not surprising that some folks [...]

There are so many nuances to document control within an ISO9001:2000 quality management system. Here’s some more to chew on.

Thinking about doing ISO9000 yourself? Ever wonder if you should buy one of those do-it-yourself manuals online? Read more here.

One of the somewhat nebulous and confusing terms in ISO is “product realization”. It took me a while to understand this concept, and I know I’m not alone. The reality is that it is an extremely simple concept.
Product Realization is simply realizing your product. OK, maybe that’s a little too simple.
Here is [...]

According to reliable sources, it looks like ISO9001:2009 will be the next revision. The ISO Quality Standard has been undergoing much debate over how much to change it, and what kind of changes to make. There was a lot of speculation that 2008 would be the year, but it has been delayed until, [...]

Here are some useful tips on what you and your organization should do, and NOT do, during your ISO9001:2000 registration audit:
1. Make sure everyone has been trained and knows as much as possible about what their areas of responsibility.
2. Don’t lie.
3. If you don’t know the answer to a question, tell the [...]

Can you have quality objectives that are not measurable?

Does ISO9001:2000 apply to every type of business? What about a website that’s a forum, with advertising? What’s your product? Who are your customers? Does ISO apply here?

Customer Related Processes are particular to your company, but some may be pretty common. Here we discuss how to handle customer sales order changes to prevent the wrong items from being shipped.

Is it necessary to incorporate your employee manual into your ISO9001:2000 quality manual? Would you want to do this? What are the pros and cons?

You don’t really have to measure top management’s commitment to your Quality Management System. This is a topic that quality people often discuss, it can reveal a lot about the potential for success…or disaster…for a company’s quality system.

Does your organization use externally generated documents? Do you wonder if you have to control these? How should you control these?

Do you really need to do a vendor evaluation on your janitor? This has been suggested.

Does your quality management system have a section devoted to customer satisfaction?

Does Design and Development belong in your quality management system? Some say yes.

ISO Training: availability and responsibility.

Will your organization provide the required resources necessary for implementation of a quality management system? Should you include such a section in your quality manual?

Setting up and laying the format for your management review. Example inputs.

Plotting a course and setting measurable goals.

Paper or electronic record keeping?

What is ‘control of records’? Are your records properly controlled?

Have you set aside floor space for your unacceptable shipments?

Whether you are selling critical aircraft components or non-critical motorcycle exhaust systems, is your customer happy?