(ISO) Quality Manual Chat

Hooray! You’ve just passed your first ISO9001:2000 registration audit. Now what do you do?

Ok, you’ve got your ISO9001:2000 quality management system in place. You know you’ve got to write up corrective actions, right? But you would really rather not, right? OK, so to satisfy the auditor at the next audit, how many corrective actions should you do?

Management review meetings are a necessary part of your ISO9001:2000 quality management system. But are they a complete waste of time? What can you do to keep them short and effective?

Working as an ISO9001:2000 consultant, I’ve seen all manner of auditors. Tough ones can make life very difficult. Easy ones are much more pleasant to work with. But is there a point where an auditor can be “too easy”?

ISO9001:2000 FAQ’s - Frequently Asked Questions. What is ISO9001? Does it apply to my company? Why would I want to get certified? What will it cost me?

What devices do you use to make measurements in your processes? Do you keep gauges around that aren’t calibrated? If so, why? What value is there in keeping “reference only” measuring devices on hand?

The ISO9001:2000 quality standard requires that appropriate communication processes are established and documented, and that you’re actually communicating within your organization regarding the effectiveness of the quality system. How are you going to do this?

Do you post signs around your building stating your company’s quality policy, as written in your ISO9001:2000 quality system manual? Do you think this is a good idea, or a complete waste of time?

You’ve got to decide who’s going to be the management representative to your ISO9001:2000 quality management system. Your choice here can make or break the success of your quality system? Who’s the best choice?

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 [...]

What is nonconforming product? Do you really have to deal with it? How would YOU deal with it?

How can you meet the requirements of ISO9001:2000 Section 7.2 when your customer gives you poor product requirements?

Numerous websites are out there claiming you can fork over your hard earned cash….or credit card number….and receive a ready-to-roll, plug-and-play ISO9001:2000 quality management system. Nothing could be further from the truth. Do such websites offer anything of value? Probably they do. But don’t think you’re getting off without having to do any work on your own.

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 [...]

One question that I’ve struggled with over the years…and still struggle with…is how to properly address the problem of an employee who makes the same mistake over and over. Sure, in the magical fairy tale land of ISO9001:2000, it’s easy to blame it on “insufficient training” and be done with it. But there [...]

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 [...]

Do you really need to have ISO9001:2000? If you don’t have a customer requirement for such a quality management system, what benefits are there to going thru the time and expense of creating and maintaining an ISO quality system?

Let’s say you own a small shop that manufactures spare parts. It is a sole proprietorship with you as the sole full time employee. You want to streamline your manual and procedures as much as possible, to include only the bare essentials to conform to ISO9001:2000. You’re the only person there, you [...]

The time needed for preparing your quality manual and quality management system can vary greatly. It largely depends upon the pressures you have to deal with.

The ISO9001:2000 quality standard requires that you ensure control over outsourced processes that affect your product’s quality. How are you going to do that?

This is part 2 of a series on the General Requirements of an ISO9001:2000 quality management system, which is section 4.1 in the standard.

This is part one of a primer on the general requirements of the ISO9001:2000 quality management system. You can find the general requirements in section 4.1 of the standard.

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.

It’s a really good idea to have a written purchase order, but if you’ve had a long lasting relationship with your customers, and have done business for years verbally or by e-mail, there are ways to continue such business while still satisfying the requirements if ISO9001:2000

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.

Total Quality Management, so popular in the early 90’s, how is TQM faring today? How many implementations are there?

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?