August 10th, 2010Tips on writing your quality system documentation, from someone who’s done it many times.
June 17th, 2010Corrective 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.
May 13th, 2010Are you thinking about getting registered to ISO9001-2008? Want someone to help you with documentation, training, internal audits, and guiding you through the process?
March 18th, 2010Fitzgerald 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 [...]
December 30th, 2009Have you gone through your first ISO9001:2008 registration audit? How nervous were you? How did you do? Was the nervousness justified?
November 27th, 2009Is your quality system ready for the latest revision of the ISO9001 quality system standard?
November 25th, 2009We 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.
October 17th, 2009Probably 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.
October 15th, 2009ISO9001:2008 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?
September 22nd, 2009One 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.
January 18th, 2009The principles of ISO9001:2008 can apply to things you might not consider. Like motorcycle road racing. Huh?
December 19th, 2008Does Santa Claus follow ISO9001-2008? We think so. Here are some reasons why.
December 12th, 2008Felix 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 [...]
October 22nd, 2008OK, 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 [...]
September 10th, 2008The ISO9001:2008 revision is almost here. Will you have to rewrite your manual? Inquiring minds want to know.
August 6th, 2008Ever wonder if you can take ISO9001-2000 out of the office and into daily life? Not as crazy as you might think.
July 4th, 2008Hooray! You’ve just passed your first ISO9001:2000 registration audit. Now what do you do?
May 15th, 2008In an ISO9001:2000 quality management system, is it OK to use an outside company as part of your production process?
May 5th, 2008Ok, 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?
April 21st, 2008Management 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?
April 5th, 2008Working 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”?
March 9th, 2008How 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
[...]
February 18th, 2008ISO9001:2000 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?
February 4th, 2008What 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?
January 26th, 2008One 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?
January 6th, 2008The 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?
December 24th, 2007Do 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?
December 11th, 2007You’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?
November 26th, 2007How 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.
November 12th, 2007How should you write your work instructions? Is there a standard format? Are work instructions a requirement of your ISO9001:2000 quality management system?
November 1st, 2007For those about to implement an ISO9001:2000 quality management system, here’s a handy little list of the 21 records required by the standard.
October 22nd, 2007You’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.
October 1st, 2007What, 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.
September 25th, 2007The 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 [...]
September 18th, 2007Do 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?
September 11th, 2007ISO9001:2000 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 [...]
September 5th, 2007What is nonconforming product? Do you really have to deal with it? How would YOU deal with it?
August 27th, 2007How can you meet the requirements of ISO9001:2000 Section 7.2 when your customer gives you poor product requirements?
August 21st, 2007Numerous 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.
August 21st, 2007There are so many nuances to document control within an ISO9001:2000 quality management system. Here’s some more to chew on.
August 13th, 2007Thinking about doing ISO9000 yourself? Ever wonder if you should buy one of those do-it-yourself manuals online? Read more here.
August 7th, 2007One 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 [...]
August 1st, 2007One 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 [...]
August 1st, 2007According 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, [...]
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