Archive for the ‘ISO9001:2000 blog’ Category

To Calibrate or Not to Calibrate Devices in ISO9001:2000

Monday, February 4th, 2008

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?

ISO9001:2000 section 5.5 Responsibility, Authority, Communication

Sunday, January 6th, 2008

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 ISO9001:2000 related signs around your office?

Monday, December 24th, 2007

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?

Who is the best management representative to your ISO9001:2000 quality system?

Tuesday, December 11th, 2007

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 to satisfy section 8.4 Analysis of Data in ISO9001:2000

Monday, November 26th, 2007

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.

In an ISO9001:2000 quality system, how do you write work instructions?

Monday, November 12th, 2007

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

How do you get people to cooperate with ISO9001:2000?

Monday, October 22nd, 2007

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.

Management Responsibility in an ISO9001:2000 Quality Management System

Monday, October 1st, 2007

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.

Review of product requirements in an ISO9001:2000 Quality Management System

Tuesday, September 25th, 2007

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 a […]

Control of Monitoring and Measuring Devices in an ISO9001:2000 Quality Management System

Tuesday, September 18th, 2007

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?

Does Your Company Take Its Quality Policy Seriously?

Tuesday, September 11th, 2007

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 might not take […]

Control of Nonconforming Product in an ISO9001:2000 Quality

Wednesday, September 5th, 2007

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

How to live with ISO9001:2000 when customer requirements are poorly defined?

Monday, August 27th, 2007

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

Thinking of “buying” your ISO9001:2000 quality manual and procedures?

Tuesday, August 21st, 2007

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.

More on Document Control for an ISO9001:2000 Quality Management System

Tuesday, August 21st, 2007

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

Should you buy an ISO9001:2000 quality manual on the internet?

Monday, August 13th, 2007

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

What is Product Realization in an ISO9001:2000 quality system?

Tuesday, August 7th, 2007

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 Webster’s […]

Root analysis for someone who makes repeated mistakes

Wednesday, August 1st, 2007

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 are times […]

When is the next revision to the ISO 9001 quality standard?

Wednesday, August 1st, 2007

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, most likely, […]

ISO9001:2000 Registration

Thursday, July 26th, 2007

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 ISO9001:2000?

Saturday, July 14th, 2007

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?

ISO9001:2000 minimum requirements for one person shop

Friday, July 13th, 2007

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 need to maximize […]

Quality Manual Prep: How Long Does It Take?

Tuesday, July 10th, 2007

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.

4.1 General Requirements of an ISO9001:2000 Quality Management System

Monday, July 2nd, 2007

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?

ISO9001:2000 Section 4.1 General Requirements Part 2

Tuesday, June 26th, 2007

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.

ISO9001:2000 Section 4.1 General Requirements Part 1

Thursday, June 21st, 2007

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 defined objectives that are not measurable?

Tuesday, June 19th, 2007

Can you have quality objectives that are not measurable?

How would you implement an ISO9001:2000 quality system for your website?

Friday, June 15th, 2007

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

Thursday, June 14th, 2007

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.

Do you need a formal purchase order to satisfy ISO9001:2000?

Wednesday, May 23rd, 2007

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

Incorporating your Employee Manual into your Quality Manual?

Saturday, May 12th, 2007

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?

Measuring Top Management Committment to your ISO9001:2000 Quality Management System

Monday, April 30th, 2007

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.

Controlling external documents in your ISO9001:2000 Quality Management System

Wednesday, April 25th, 2007

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

Vendor Evaluations

Tuesday, April 17th, 2007

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

Customer Focus

Friday, April 13th, 2007

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

Is Design and Development a part of your QMS?

Wednesday, April 4th, 2007

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

Competence, Awareness and Training

Wednesday, March 28th, 2007

ISO Training: availability and responsibility.

TQM Losing Ground

Saturday, March 17th, 2007

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

Provision of Resources in an ISO9001:2000 Quality Management System

Saturday, March 17th, 2007

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?

Inputs to Management Review in an ISO9001:2000 Quality Management System

Wednesday, March 14th, 2007

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

Quality Policy Statement and Quality Objectives

Monday, March 12th, 2007

Plotting a course and setting measurable goals.

Controlling Electronic Records and Documents

Friday, March 9th, 2007

Paper or electronic record keeping?

Control of Records for your Quality Management System

Thursday, March 8th, 2007

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

Create a Segregated Area for Nonconforming Material

Sunday, March 4th, 2007

Have you set aside floor space for your unacceptable shipments?

Determining and Meeting Customer Requirements

Friday, March 2nd, 2007

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

Get a good book on ISO9001:2000, Think About Doing it Yourself

Thursday, March 1st, 2007

Do-it-yourself ISO Certification — book and template recommendation.

Corrective and Preventive Actions

Wednesday, February 28th, 2007

You’ve just been hit with a CAR, how should you resolve it?

Document Control in your Quality Management System

Tuesday, February 27th, 2007

What is ‘document control’ and how do you go about it? Is it required in the ISO standard?

The Future of ISO9000 and ISO9001

Saturday, February 24th, 2007

What’s in store for ISO over the next few years? Does self-certification carry any weight?

Measuring Customer Satisfaction in an ISO9001:2000 System

Friday, February 23rd, 2007

Should you mess around with a customer satisfaction survey? What other metrics can you use?