ISO 9001 Implementation and Certification - 6 Years of Advice

[NewQM]

Re: ISO 9001 Implementation and Certification - Some advice

Because, IN THE VAST MAJORITY OF CASES, that is the approach which obviously brings no changes to the organization at hand. And, in general, no changes mean maintenance of substandard performance.

In my experience, the VAST MAJORITY of organizations require a profound cultural change to adapt and adopt the underlying concepts of an ISO 9001 based QMS.

Sure, if you have a high performing organization, which is culturally compatible with modern quality management practices, you might have a case for minimal impact onto them. But, if this organization is so good to start with, why would they be running a tribal-knowledge based, undocumented QMS? If they are so good, why would a customer require a non-value added certification?

Indeed.

I was arguing from the standpoint of a hypothetical company that has been around for 20 years. Their processes / customer service are obviously adequate (as they have been around for 20 years). Most likely, what they lack are things such as a documented management review/ internal audit, a formal CAR/PAR-ish program and a records process that would conform to 9000.

For this company, minimally invasive consulting is better.

Similarly, some companies maintain an undocumented QMS simply because they are a family owned/operated company and utilize "tribal knowledge" as you put it. Consultants must be even more careful about changing processes at these companies, or risk offending daddy.

In the case of a disorganized / young company, I say that it is probably okay to go ahead and "shake things up." Or create their QMS, rather. ON A CASE BY CASE BASIS.

In Houston, a lot of companies require registration for admittance to an AVL (or are forced to do customer audits).

Also, international contracts can require registration.

I wouldn't go so far as to say that large changes are never required, just not usually.

Then again, what do I know?

 

[Mecca]

Re: ISO 9001 Implementation and Certification - Some advice

Ack you folks are definetly arguing with each. Well I have taken a solid read at this forum and love all the good stuff that is provided by folks just like yourselves. So to make a halt to the discussion/argument I had a quick q for you folks.

I have gotten my hands on the Iso 9001:2008. I havent been able to get ISO:9004 but after reading a comment by JaneB I dont think I need that one just at this moment.

I did a preliminary Gap Analysis and as I expected there were many gaps especially from the fact that we didnt have a QM or QOPs... we have tons of stuff processed out in our minds but not on paper.

The company is a software and machine DESIGN firm we love computers and pretty much want to use Microsoft Infopath to make all our documents for the quality management system and use VISIO to make all the process maps.

I went to a local university and borrowed a book titled "ISO 9001:2000 for small businesses: Implementing Process Approach Quality Management
by Arpad Gaal. It is an amazing book and has a wealth of information on Quality Operating Procedures and even has an entire example for a hypothetical company and links it to the QM in the book with a bunch of forms in the back.

The other says that if your a manufacturing company you can literally take the documents in the book and place your name on them and start the implementation process (which will take a while but whatever) I do not intent to do that, but I do intend to use the process flowcharts and the QMs that I have found on the forum as examples.

Now the question is: is anyone familiar with this book. The book is specific to manufacturing firms but I am trying to modify it to use for a Design House like our firm. I am trying to make everything computer based... using XML to automatically plug and chug revision numbers upon use. Anyhow... I have a team of 3 employees. They are working right now to process out our operations and then we will have a meeting and review all the processes... and see whats accurate. Then I am suppose to review the whole thing using this book and some mad support from you great folks here at the COVE and then we will change our format. The cool thing is I have all the support of Management to change things.

This is too long now sorry

ps. I live in Canada (for the one who asked)

 

[Helmut Jilling]

Re: ISO 9001 Implementation and Certification - Some advice

I was arguing from the standpoint of a hypothetical company that has been around for 20 years. Their processes / customer service are obviously adequate (as they have been around for 20 years). Most likely, what they lack are things such as a documented management review/ internal audit, a formal CAR/PAR-ish program and a records process that would conform to 9000.

For this company, minimally invasive consulting is better.

For a company which has been working for 20 years, and their processes are performing "adequately," as you state it, the greatest thing they lack is not procedures but the ability to see how their processes can perform optimally. The difference is companies which are adequate vs optimal can be immense - in profit, market share, and future innovation. ISO does not require that companies be optimal, but obviously that is the best end result, and I would argue, what the standard infers as the ultimate goal of continual improvement.

I wouldn't go so far as to say that large changes are never required, just not usually.

Then again, what do I know?

We discuss and even debate robustly here at Elsmar, but the best information comes from "iron sharpening iron." Don't take criticism personally, but there is a great deal of collective wisdom to be found. You apparently know many things, but it seems to some of us you are approaching ISO from a somewhat limited expectation. That limits the full benefit you can provide clients.

 

[NewQM]

Re: ISO 9001 Implementation and Certification - Some advice

I did a preliminary Gap Analysis and as I expected there were many gaps especially from the fact that we didnt have a QM or QOPs...

This tends to be a common problem when you perform a gap anaylsis before you have anything to audit.

I know many will say that you can perform a gap anaylsis on processes that are in place and not documented....

But, for someone new to ISO, all you have is one big gap. it isn't very helpful as an initial step IMO.

I went to a local university and borrowed a book titled "ISO 9001:2000 for small businesses: Implementing Process Approach Quality Management
by Arpad Gaal.

Be carefull as you will be audited on ISO 9001:2008, not 9001:2000. It isn't very different, but it is different.

 

[Larry10d]

Re: ISO 9001 Implementation and Certification - Some advice

Hello All, I also have a few questions regarding certification from ISO9001:2000 to 9001:2008.

Our recert audit is schedule for early Jan 2010 and our cert expires Feb 2010. I have created the new Quality Manual for 9001:2008, but all of my internal Audits reference this year are to our current QM 9001:2000. Since our 3rd party audtior will recert to 2008 do I just leave the QM at 2000 and take a minor documentation finding for the QM or do I release the new 2008 version for this Audit? That is my plan... Then my Internal Audits during 2009 would not be for a full cycle to the new released QM. Would that be an issue?
LD

 

[Mecca]

Re: ISO 9001 Implementation and Certification - Some advice

Anyone know if we can make the whole QM and QOP and the majority of our procedures electronic rather than having to make a whole bunch of hard copies of everything.

 

[NewQM]

Re: ISO 9001 Implementation and Certification - Some advice

Anyone know if we can make the whole QM and QOP and the majority of our procedures electronic rather than having to make a whole bunch of hard copies of everything.

That is fine, just write your doc. control procedure to say that it is where they are kept/controlled.

And don't forget to say where/how/for how long docs/records are kept.

 

[Ted Schmitt]

Re: ISO 9001 Implementation and Certification - Some advice

Hello All, I also have a few questions regarding certification from ISO9001:2000 to 9001:2008.

Our recert audit is schedule for early Jan 2010 and our cert expires Feb 2010. I have created the new Quality Manual for 9001:2008, but all of my internal Audits reference this year are to our current QM 9001:2000. Since our 3rd party audtior will recert to 2008 do I just leave the QM at 2000 and take a minor documentation finding for the QM or do I release the new 2008 version for this Audit? That is my plan... Then my Internal Audits during 2009 would not be for a full cycle to the new released QM. Would that be an issue?
LD

There should be no reason to have a new manual for the 2008 version. Eliminate referencing the version of the ISO 9001 standard in your manual. Our CB did not require a full audit to the new standard...

 

[Larry10d]

Re: ISO 9001 Implementation and Certification - Some advice

Good Idea, I think I'll eliminate the reference to the QMS. Is it necessary to have a internal audit cycle to the new QM?

LD

 

[Ted Schmitt]

Re: ISO 9001 Implementation and Certification - Some advice

Good Idea,

Not really my idea... this was discussed greatly here on the Cove

I think I'll eliminate the reference to the QMS. Is it necessary to have a internal audit cycle to the new QM?

LD

I did my change over to 2008 in January 2009, our CB did not require a full audit cycle to the new standard.... best would be to check with your CB.