The 2015 revision of the ISO9001 quality management standard contains some new requirements. One of the new requirements is that the quality management system must determine the risks and opportunities that need to be addressed, and we must also plan actions to address those risks and opportunities. Preventive actions are no longer required under the […]
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?
The new ISO9001:2015 quality management standard has some strange language in it, compared to the 2008 version. Have you read the 2015 version yet? What do you think?
Are you ready to implement your ISO9001 quality management system?
The upcoming ISO9001:2015 quality management standard includes much more language about risk analysis than ISO9001:2008. Are you ready for the new risk analysis requirements?
If you’re looking to get certified to ISO9001, should you go for ISO9001-2008 or ISO9001-2015?
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 do you check when you’re conducting internal audits to support your ISO9001-2008 quality management system?
Sure, your vendor has told you that they’re ISO9001 certified. Maybe they’ve even sent you a copy of their certificate. But are you sure it’s a legitimate, valid certificate? Here is an excellent article describing how you can find out for yourself if a company’s ISO9001-2008 certificate is real, and valid. http://www.qualitydigest.com/inside/quality-insider-article/how-find-out-if-iso-9001-certificate-valid.html?utm_source=MadMimi&utm_medium=email&utm_content=Best+of+Quality+Digest+Daily+2014&utm_campaign=20141222_m123691587_QDD+12-22-14+ASQ&utm_term=How+to+Find+Out+If+an+ISO+9001+Certificate+Is+Valid
What should be included in your internal audit program? Does everything need to be audited? What can you leave out?
Why would anyone want to control hard copy quality management system documents?
ISO9001-2015 is coming! Will there be a lot of changes? What do you need to do now?
You may have heard all sorts of advice on how often you have to do things required by ISO9001-2008. How often should you communicate to staff? How often should you conduct internal audits? How often should you do management review?
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.
Has someone told you that your organization needs to do PPAP and/or FMEA as a part of your ISO9001-2008 quality management system?
Are you registered to the ISO9001-2008 quality standard? Would you like to be? Do you have a copy of the ISO9001-2008 quality standard? Do you need one?
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?
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.
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.
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.
Who does your internal auditing? An outside consultant? An employee or 2? How are they doing?
Too busy to write your new ISO9001-2008 quality system manual and procedures? Not sure what forms are needed? We offer a custom document service tailored to your company’s processes.
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.
Did you accomplish your quality goals in 2012? What changes will you make in the new year?
Who attends your management review of your ISO9001-2008 quality management system? Is your management review helpful or a waste of time?
It happened again last week. I visited a new client who wants to get their ISO9008-2008 certification. They already have a quality system that’s largely in conformance with the ISO9001-2008 quality standard. But it goes far beyond the requirements of the standard. In fact, it goes much farther than the company actually needs. This company, […]
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?
You’re probably aware that one of the requirements of the ISO9001-2008 quality standard is to have a Corrective Action Program. ISO9001-2008 also requires Preventive Actions, but that’s not my topic for today. A corrective action program should be available for anyone in your organization to use. Corrective action requests are generated whenever there is a […]
I recently ran into a company that performs surprise internal audits on their people. Is this a good thing?
Can you just write a check to get ISO9001-2008 certification? Or is there actual work involved?
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?
How often should you conduct internal audits? Get ’em all out of the way once a year? Or maybe a little each month? Like many things in life, it depends on your priorities.
There can come a point when your quality system reaches a limit- a human limit. How do you continually improve on near-perfection?
Yes, even in the dull world of ISO9001-2008 quality management systems, you can find things to be thankful for.
When is it time to change your quality objectives in your ISO9001:2008 quality management system? How long have you had the same objectives? How much improvement have you experienced? Is it time for new objectives?
Have you dealt with a company that allegedly has ISO9001-2008 certification, but you wonder how they keep their certification?
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 […]
Any organization with more than 1 person has experienced compromise. Your quality management system is a compromise, whether you want to admit it or not.
Here’s how you can reap some benefits of an ISO9001-2008 quality management system without incurring any of the costs.
Do you have the right personality to manage an ISO9001-2008 quality management system?
Learn about ISO9001-2008’s dirty little secret.
Internal audits, as part of an ISO9001-2008 quality management system, can be compared to pizza. Even when it’s not great, it’s still good!
Recently I spoke with a very experienced auditor who also audits the AS9100 standard. I, your faithful writer, worked with AS9100 in the distant past, but haven’t been keeping up with the latest revision. It seems the new AS9100C is going to cause quite a bit of heartache out in the world. A local company […]
During an ISO9001-2008 audit, auditors often write up “OFI’s”, or “opportunities for improvement”. Do you need to act on these?
2011 is almost here. While I believe every year above ground is a good one, 2010 certainly presented many of us with many, many challenges. I’m definitely looking forward to 2011 with hope and optimism. The economy is crap. Many businesses are suffering. You can sit and sulk and brood and go nowhere. Or you […]
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 […]
The other day it dawned on me that ISO9001-2008 performs a function similar to governments. How so?
In my opinion there are basically 2 kinds of companies that are registered to ISO9001-2008. Which one are you?
There’s a company I work with that has been registered to ISO9001-2008 for about a year. They’re a great bunch of people to work with, and I very much look forward to visiting them. They’ve got about 100 employees. This company is extremely concerned with quality, and they put out excellent products. In general they’re […]
Tips on writing your quality system documentation, from someone who’s done it many times.