Archive for the ‘General quality system’ Category

ISO9001:2015 and Customer Audits

Wednesday, November 1st, 2017

Is your business subject to customer audits? Do you think that being certified to ISO9001:2015 will reduce of eliminate your customers’ desire to audit you?

Have you thought about buying your ISO9001:2015 quality manual online?

Thursday, January 5th, 2017

Have you thought about buying an ISO9001:2015 quality manual online? There are many companies that offer quality system documents. Some are better than others.

When will you transition to the ISO9001:2015 standard?

Tuesday, July 5th, 2016

Is your company certified to ISO9001:2008? Have you planned when you will transition to ISO9001:2015? Some planning now could save you a ton of money later.

What processes should be on your internal audit schedule?

Monday, June 6th, 2016

In your ISO9001:2015 quality management system, you must conduct internal audits of your processes. But which processes? All of them?

Implementing ISO9001

Monday, August 17th, 2015

Are you ready to implement your ISO9001 quality management system?

What to look for in your ISO9001-2008 internal audits

Sunday, February 8th, 2015

What do you check when you’re conducting internal audits to support your ISO9001-2008 quality management system?

What processes should be audited in your ISO9001-2008 quality management system?

Sunday, September 21st, 2014

What should be included in your internal audit program? Does everything need to be audited? What can you leave out?

Controlling paper documents in an ISO9001-2008 quality system

Thursday, August 14th, 2014

Why would anyone want to control hard copy quality management system documents?

Does ISO9001-2008 apply to your business?

Saturday, December 21st, 2013

Does ISO9001-2008 apply to your business? Most likely it does. It’s up to you to decide if the benefits justify the time and expense.

Do you need FMEA and PPAP in your ISO9001-2008 Quality System?

Tuesday, October 8th, 2013

Has someone told you that your organization needs to do PPAP and/or FMEA as a part of your ISO9001-2008 quality management system?

ISO9001-2008 Problems That Won’t Go Away…What To Do?

Saturday, August 3rd, 2013

How do you deal with an issue that you thought you already addressed? Is it OK to issue multiple corrective action requests for the same problem?

Control of Records in your ISO9001-2008 Quality Management System

Thursday, June 27th, 2013

ISO9001-2008 requires that you keep records and have a procedure to control them. But the standard gives us a lot of latitude in how we achieve this. As with most of the standard, whether or not your method of records control meets the standard is subject to interpretation.

ISO9001-2008 Consultant, Teacher, Policeman, Therapist

Friday, May 3rd, 2013

As an ISO9001-2008 quality management system consultant, I play various roles in companies. Depending on the company and the day, I can be a teacher, a cop, or sometimes even a therapist.

ISO9001-2008 fantasy vs reality

Saturday, April 6th, 2013

Sometimes there’s a person who believes your ISO9001-2008 quality management system should be more. Apparently they believe people have time and motivation to review and revise documents, to generate corrective and preventive actions for every little issue, to write lengthy reports on every nonconforming part. Maybe they also believe in unicorns. Sometimes reality conflicts with the desire for perfection.

Internal auditing in ISO9001-2008: who does yours?

Thursday, March 14th, 2013

Who does your internal auditing? An outside consultant? An employee or 2? How are they doing?

Don’t overpay for your ISO9001-2008 certificate!

Wednesday, January 16th, 2013

How much will it cost to get ISO9001-2008 certification? Do some research, ask questions, get multiple quotes. It might be a lot less expensive than you think.

Assessing your ISO9001-2008 Quality System for the New Year

Sunday, December 30th, 2012

Did you accomplish your quality goals in 2012? What changes will you make in the new year?

Who attends your ISO9001-2008 Management Review?

Friday, November 23rd, 2012

Who attends your management review of your ISO9001-2008 quality management system? Is your management review helpful or a waste of time?

What Tolerance is Built Into Your ISO9001-2008 quality system?

Monday, August 27th, 2012

Few things are perfectly according to plan. Most products have slight tolerances, within which the product is, well, tolerated. How about your ISO9001-2008 quality management system? Do you have tolerances built into your quality system?

Surprise internal audits in your ISO9001-2008 Quality System

Friday, June 8th, 2012

I recently ran into a company that performs surprise internal audits on their people. Is this a good thing?

ISO9001-2008: It doesn’t have to be complicated

Thursday, April 5th, 2012

Some consultants and quality system managers overcomplicate ISO9001:2008 documents and procedures. Why do they do this? Is it just to create work for themselves?

Do you know a company that is ISO9001 certified, but maybe should not be?

Monday, October 10th, 2011

Have you dealt with a company that allegedly has ISO9001-2008 certification, but you wonder how they keep their certification?

Reap benefits of ISO9001-2008 without any cost

Thursday, June 16th, 2011

Here’s how you can reap some benefits of an ISO9001-2008 quality management system without incurring any of the costs.

Is it possible to get ISO9001-2008 accredited before you start a business?

Wednesday, November 17th, 2010

Recently I had a few phone calls, and a brief introductory meeting, with a gentleman who claimed he and his partner were in business making electronic devices. He said a large, well-known company wanted to do business with him, and the potential customer insisted he have his ISO9001-2008 certificate. We talked quite a bit, I […]

ISO9001-2008 Similarities to Government

Tuesday, October 19th, 2010

The other day it dawned on me that ISO9001-2008 performs a function similar to governments. How so?

Are you ISO9001-2008 certified? There are 2 kinds of ISO9001 companies. Which one are you?

Tuesday, October 5th, 2010

In my opinion there are basically 2 kinds of companies that are registered to ISO9001-2008. Which one are you?

Advice on writing your ISO9001-2008 quality system documents

Tuesday, August 10th, 2010

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

Writing Your ISO9001:2008 Documentation? KISS!

Tuesday, 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

Thursday, 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.

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

Thursday, 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?

ISO9001-2008 Helps Auto Dealer Get Paid!

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

Friday, 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

Wednesday, 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

Friday, November 27th, 2009

Is your quality system ready for the latest revision of the ISO9001 quality system standard?

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

Thursday, 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?

Tuesday, 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.

Information on ISO9001:2008 – its almost here!

Wednesday, September 10th, 2008

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

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

Friday, July 4th, 2008

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

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

Monday, 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

Monday, 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?

Saturday, 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 Frequently Asked Questions – FAQ’s part 1

Monday, 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

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?

Preventive Action Request- Ambiguous? Ever done one?

Saturday, 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

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?

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 […]