Archive for the ‘From the Trenches’ Category

Internal auditing for the ISO9001:2015 quality management standard

Sunday, June 11th, 2017

Section 9.2.1 of the ISO9001:2015 standard requires us to conduct internal audits that, among other things, ensures that our quality management system conforms to the requirements of the ISO9001:2015 standard. Sounds like a no brainer, but it might be more complicated than you imagine. As with all things related to ISO9001:2015, your auditor’s interpretation makes […]

When should you change your ISO9001:2015 registrar?

Friday, October 21st, 2016

In the last couple of decades doing consulting for ISO9001:2015 (and 2008, and 2000, and 1994, etc) I’ve come across a few people who thought it was important to have a “prestigious” registrar company do their registration and surveillance audits. There are some really large companies providing ISO9001:2015 certification services, such as DNV, Lloyds, Intertek, […]

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 is ISO certification?

Tuesday, December 1st, 2015

Sometimes people ask for “ISO certification” and they don’t really know what they’re asking. What kind of ISO certification are you talking about?

Frustrations with the ISO9001-2008 certification process

Saturday, March 21st, 2015

Dear gentle readers, Today’s post is going to be a bit of a rant. I have been involved in the implementation and management of quality systems for over 25 years. Every once in a while something happens that makes me think I’m just bashing my head against the wall, wasting my time. Such an incident […]

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?

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.

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.

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?

ISO9001-2008 – how much work will it be?

Friday, April 27th, 2012

Can you just write a check to get ISO9001-2008 certification? Or is there actual work involved?

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 have ISO9001-2008? How well are your quality objectives working for you?

Wednesday, August 24th, 2011

Recently I performed a complete internal audit for a small manufacturing company that was soon to have their initial ISO9001-2008 registration audit. While going through their documentation, I found they had completely missed the boat on their quality objectives. Their quality objectives were too vague, and not measurable. It might be nice to say something […]

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.

ISO9001-2008: The dirty little secret?

Thursday, April 28th, 2011

Learn about ISO9001-2008’s dirty little secret.

OFI’s, or “opportunities for improvement”, in an ISO9001-2008 quality system.

Sunday, January 2nd, 2011

During an ISO9001-2008 audit, auditors often write up “OFI’s”, or “opportunities for improvement”. Do you need to act on these?

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?

Why having ISO9001:2008 is more important than ever

Thursday, 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.

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?

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.

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?

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”?

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?

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.

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 […]

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.

Alchohol and the Audit

Wednesday, June 13th, 2007

Politics and schmoozing — a last resort for a poor quality manual.

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

He Just Wouldn’t Shut Up!!!

Monday, May 21st, 2007

When some auditors get close to retirement, tracking orders might seem more like tracking game; docks aren’t for receiving packages, but for watching the sun go down; and scales aren’t for weighing packages, they’re what fish wear.

Quality Manual Motivation

Wednesday, May 9th, 2007

What’s your motivation to get ISO certified? I’ve seen the gamut of reasons.