Advice on writing your ISO9001-2008 quality system documents

August 10th, 2010
Tips on writing your quality system documentation, from someone who’s done it many times.

Writing Your ISO9001:2008 Documentation? KISS!

June 22nd, 2010
There’s no need for your ISO9001:2008 quality system documentation to be overly complex. The more complicated you make it, the harder it is to follow, and the less your people will want to do it. So why do people insist on lengthly, complex documents?

Writing a Corrective Action Request to a Vendor

June 17th, 2010
Corrective action requests are not limited to your internal operations. You can issue them to suppliers as well. But there are things to consider when sending a vendor corrective action request.

What If Governments Followed ISO9001:2008?

June 8th, 2010
Companies follow ISO9001:2008 in order to reduce mistakes, improve themselves, and improve the bottom line. What if governements followed ISO9001:2008?

Your ISO9001:2008 quality system: A real effort at improving, or the bare minimum?

May 20th, 2010
Do you have ISO9001:2008? Does your company genuinely want to improve? Or do you do the bare minimum needed to keep your certificate?

Quality system consultant available

May 13th, 2010
Are you thinking about getting registered to ISO9001-2008? Want someone to help you with documentation, training, internal audits, and guiding you through the process?

Say What You Do, Do What You Say…what does it mean to ISO9001-2008?

March 25th, 2010
Have you ever heard the phrase “say what you do, do what you say”? Is this a good idea?

ISO9001-2008 Helps Auto Dealer Get Paid!

March 18th, 2010
Fitzgerald Auto Malls successfully implemented an ISO9001 quality management system, and it has paid off for them.
Last summer, during the “Cash For Clunkers” program, there were reports that some auto dealers were not being paid by the federal government. Fitzgerald Auto Malls used their ISO9001 system to develop work instructions for their employees as [...]

Why having ISO9001:2008 is more important than ever

February 18th, 2010
In our crappy economy, you might think having an ISO9001:2008 quality management system is a frivolous expense. Nothing could be further from the truth. Here’s why you NEED an ISO9001 quality system NOW!

Why the very first ISO9001-2008 audit is the easiest you’ll ever have.

January 15th, 2010
You might think your first ISO9001-2008 audit will be your hardest. While the preparation may take a long time, in some ways this will be your easiest audit.

Jitters about first ISO9001:2008 registration audit

December 30th, 2009
Have you gone through your first ISO9001:2008 registration audit? How nervous were you? How did you do? Was the nervousness justified?

Differences between ISO9001:2000 and ISO9001:2008

November 27th, 2009
Is your quality system ready for the latest revision of the ISO9001 quality system standard?

Have a quality Thanksgiving!

November 25th, 2009
We wish everyone (in the US and Canada, at least!) a happy, quality filled Thanksgiving Day holiday. We give thanks for all the great people we get to work with, and for family and friends who have always been there for us.

My biggest pet peeve regarding ISO9001:2008

October 17th, 2009
Probably the most annoying part of being an ISO9001:2008 consultant is trying to deal with employees who are perfectly competent, but have no interest in participating in the quality system.

ISO9001:2008 clause 7.5.3 how do you identify your products?

October 15th, 2009
ISO9001:2008 clause 7.5.3 requires us to identify products throughout the production process. There are many ways to do this, some not so obvious. How do you do it?

How much can you tailor ISO9001:2008 to your company?

September 22nd, 2009
One of the beautiful features of the ISO9001:2008 quality standard is that it gives users a lot of leeway in how to structure your quality system. But there’s a limit to how far you can go.

How ISO9001:2008 can make you a better motorcycle rider

January 18th, 2009
The principles of ISO9001:2008 can apply to things you might not consider. Like motorcycle road racing. Huh?

Why I think Santa Claus uses ISO9001-2008

December 19th, 2008
Does Santa Claus follow ISO9001-2008? We think so. Here are some reasons why.

More on how to write your ISO9001-2008 Quality Objectives

December 12th, 2008
Felix writes: “Greetings, can you please send details about Quality Objectives explanation, including how to create Quality Objectives (Referring Quality Policy), how to link with Quality Policy, how to achieve Quality Objectives (With example). If not meeting the requirement how to close. Can you please provide all with examples.”
Here’s a stab at [...]

Tips on how to be an effective internal auditor in ISO9001:2008

October 22nd, 2008
OK, this is it….this is officially the first time I’ve used the term ISO9001:2008 in a blog post. We all have to get used to it eventually, so I thought I’d try it out. Not so painful after all.
The ISO gods have blessed us with a revised quality standard that’s really not so [...]

Information on ISO9001:2008 – its almost here!

September 10th, 2008
The ISO9001:2008 revision is almost here. Will you have to rewrite your manual? Inquiring minds want to know.

Apply ISO9001-2000 to your daily life!

August 6th, 2008
Ever wonder if you can take ISO9001-2000 out of the office and into daily life? Not as crazy as you might think.

So you’ve got your new ISO9001:2000 certificate. Now what?

July 4th, 2008
Hooray! You’ve just passed your first ISO9001:2000 registration audit. Now what do you do?

Using outside companies as part of your Production Process in ISO9001:2000

May 15th, 2008
In an ISO9001:2000 quality management system, is it OK to use an outside company as part of your production process?

How many Corrective Action Requests are enough in ISO9001:2000?

May 5th, 2008
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?

Notes on ISO9001:2000 Management Review

April 21st, 2008
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?

ISO9001:2000: Is An Easy Auditor a Good Thing?

April 5th, 2008
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 Part 2

March 9th, 2008
How long will it take us to get our ISO9001:2000 accreditation?
This is a really tough question, kind of like asking “how long will it take us to get our company organized?”. It all depends, and on several factors.
It depends on things like:
The size of your organization
The quantity and complexity of your processes

ISO9001:2000 Frequently Asked Questions – FAQ’s part 1

February 18th, 2008
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?

To Calibrate or Not to Calibrate Devices in ISO9001:2000

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?

Preventive Action Request- Ambiguous? Ever done one?

January 26th, 2008
One of the six required procedures in an ISO9001:2000 quality system is regarding preventive action requests. You gotta have a procedure, but have you ever done a preventive action request? Ever seen one? Would you know one if it hit you in your face?

ISO9001:2000 section 5.5 Responsibility, Authority, Communication

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?

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?

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

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?

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?

The 21 records required by ISO9001:2000

November 1st, 2007
For those about to implement an ISO9001:2000 quality management system, here’s a handy little list of the 21 records required by the standard.

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

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

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

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 [...]

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

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?

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 [...]

Control of Nonconforming Product in an ISO9001:2000 Quality

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?

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?

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

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?

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?

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 [...]

Root analysis for someone who makes repeated mistakes

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 [...]

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

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, [...]