ISO 9001 Implementation and Certification - 6 Years of Advice

[mikeb]

I am new to the position of Quality Assurance Specialist.
I am taking my company to ISO 9001-2000 certification, I was wondering if there was some advice anyone had for me. For you registrars out there are there any small misses that most people overlook on their first try. I am curious to know what percentage of people get it their first shot
I would like to thank all who reply to my thread.
Thanks
mikeb

 

[Jim Wynne]

I am new to the position of Quality Assurance Specialist.
I am taking my company to ISO 9001-2000 certification, I was wondering if there was some advice anyone had for me. For you registrars out there are there any small misses that most people overlook on their first try. I am curious to know what percentage of people get it their first shot
I would like to thank all who reply to my thread.
Thanks
mikeb

welcome to the Cove, Mike

I was wondering if there was some advice anyone had for me.

You betcha. There are lots of experienced people here who can help you along. Because the subject is so broad, though, it's best to post questions about specific issues as you go along. You should also feel free to search the threads; there's a wealth of information available on the subject.

For you registrars out there are there any small misses that most people overlook on their first try. I am curious to know what percentage of people get it their first shot.

We have several experienced registrars' representatives here who will answer, I'm sure.

 

[Justin]

I am new to the position of Quality Assurance Specialist.
I am taking my company to ISO 9001-2000 certification, I was wondering if there was some advice anyone had for me. For you registrars out there are there any small misses that most people overlook on their first try. I am curious to know what percentage of people get it their first shot
I would like to thank all who reply to my thread.
Thanks
mikeb

Welcome to the Cove mikeb

I just took a company through a iso 9001:2000 certification, my 12th in 15 years. It has been my experience that most companies who commit resources to becoming certified, do in fact get their certification on the first try. In performing Gap Analysis over the years, it has also been my experience that companies are mostly lacking in the area of Corrective and Preventive Action Programs. Usually, they don't even have an implemented system or if they do, it is seriously left wanting.

Anyways, probably not much help, but I wish you luck. If you ever need any help or advice, feel free to send me an email.

GOOD LUCK

 

[mikeb]

Do any of my procedures need to be in place for any length of time before the auditors come through, Is the gap analysis tool the best way to check my system. I am pretty sure that I have all my doc's complete am at the point of implementation. how long should everything be implemented before I start audits.
thanks
mikeb

 

[mike101338]

The requried documented procedures must be in place before you can achieve registration. Remaining documentation is only necessary if it is necessary for your system to function.

As for time frames before auditing, I would begin auditing as soon as you have suffecient objective evidence of conformance. That can be as soon as a month after implementation. Pick areas that requried little to no change from before you began implementing ISO 9000 procedures as the first to audit. The history for audits will already be in place.

In addition to the corrective/preventive action area of weakness, continuous improvement is also a common struggle. Many company improve themselves on an oning basis but struggle with doing so in a regimented fashion.

If your company has the financial resources to do a Gap analysis, do it. It definately helps you when going through the registration audit. Have the auditor for the registration company you've chosen perform the Gap.

 

[JRKH]

Do any of my procedures need to be in place for any length of time before the auditors come through, Is the gap analysis tool the best way to check my system. I am pretty sure that I have all my doc's complete am at the point of implementation. how long should everything be implemented before I start audits.
thanks
mikeb

There really isn't a specific time called out. I would recommend starting with some "training" audits, Get everyone use to the process, and see where that leads you. Do record these as actual audits, but keep them informal.

At the registration audit of course you will need to be able to show objective evidence of implementation, even if its only a few months. The auditor may have some issues with the depth of evidence, but the ones I've worked with take it in stride during a registration audit. My take is they are more interested in seeing the training in place - everyone on the same page - Then the evidence follows.

 

[qualitygoddess - 2010]

It has been my experience that it takes a few months for people to get comfortable doing things the "new" way, even if it isn't new at all! I think the practice/training audits is a great way to go.

Now your registrar can answer this better, but usually the auditor wants to see a full systems audit prior to doing the initial assessment. Can you really do an effective audit until everything is in place, and people are using the system? I'm sure there could be debate about that. One suggestion is to take advantage of the registration firm's pre-assessment audit. It's a good way to have the auditor come in for a day and assess certain aspects of your system. I like to have them look at 2 good areas/process steps, and 2 that I think need a little TLC. The feedback from the auditor is GREAT for convincing the 1 or 2 uncertain management types about what has to be done to implement an effective system.

--QG

Do any of my procedures need to be in place for any length of time before the auditors come through, Is the gap analysis tool the best way to check my system. I am pretty sure that I have all my doc's complete am at the point of implementation. how long should everything be implemented before I start audits.
thanks
mikeb

 

[Randy]

KISS!

Don't over document

Don't over engineer

Don't overkill the system

 

[Helmut Jilling]

I am new to the position of Quality Assurance Specialist.
I am taking my company to ISO 9001-2000 certification, I was wondering if there was some advice anyone had for me. For you registrars out there are there any small misses that most people overlook on their first try. I am curious to know what percentage of people get it their first shot
I would like to thank all who reply to my thread.
Thanks
mikeb

Welcome to the Cove, Mike. I wish you well on your trek.

To your question, there are a few problem areas I see frequently, both as a registrar auditor, and as a trainer/consultant. The main problem is many folks do not adequately define the processes and criteria and metrics as defined by clause 4.1. This is a key hub of the system that promotes much of the future improvements.

The other key problem is that usually the management team has not had adequate training, which makes implementation much more difficult. It is harder to do it well unless one fully understands the principles.

Beyond that, problems include the internal audits not auditing the process approach, corrective action/preventive action, management review, calibration.

Hope that helps?

 

[Carl Keller]

Welcome to the cove.

My best advice is RELAX.

I have been doing ISO for 15 years and have not seen anyone fail yet, so just try to go through the standard and for each section ask yourself "what evidence do I have to show that we actually do this? Make a system that benefits your company and don't try too hard to make sure every nuance fits the standard.

As intimidating as it can be, it isn't rocket science and it is in the best interest of your registrar to have you pass. Just listen, they will lead you through.

Carl-