ISO 9001 Implementation and Certification - 6 Years of Advice

[Brunetta]

Re: ISO 9001 Implementation and Certification - Some advice

My $.02 is that if you are a succesfull company, you are probably already "following" the standard.

What is most important is to WRITE WHAT YOU ARE ALREADY DOING, keep good records and hire a consultant for atleast one day that can tell you what you will need.

of course, that is optional but for (consultants that i know, myself included charge) $400, you will save a week of dead ends.

I will be happy to help if you want to e-mail me directly.

also, find a concise QSM (quality system manual) and use it as a reference, at the top click the green box that says "post attachments list" and you will find examples.

AGAIN, WRITE WHAT YOU ARE ALREADY DOING.

start small, just the 6 required procedures to start. pay close attention to a design procedure also.

and KEEP RECORDS OF EVERYTHING.

also, an internal audit and management review meeting are required. keep records of customer communication and all quality focused meetings.

IMO a gap anaylsis isn't really effective if you have no manual or procedures in place..........how can you see any gaps if that is all you have?

If you are advising them to write what they are already doing, and that most successful companies are following the standard, then why can't the gap analysis occur before they have a manual or procedures produced?
This does not make sense to me, we did our gap analysis prior to creating our documentation in order for us to plan adequately for how we needed to close the gaps.
Figuring out how we already met the requirements, and then asking about those requirements where we could not provide an answer for to fully understand what the shortfall (gap) to the requirements helped us to plan adequately.
Our main shortfalls were true corrective and preventive actions, documentation (kinda a duh there since we had not created it yet) and internal audits.

I don't understand the logic of your advice?

 

[Jim Wynne]

Re: ISO 9001 Implementation and Certification - Some advice

That's definitely not one of Randy's mottoes. Nor mine.

Depends of course what you mean by 'over' simplify. I always advocate simplifying things - including the Standard - whenever and wherever one can without (of course) losing or compromising things that ought not to be lost or compromised.

That's not over-simplifying to me it's making them practical and accessible. And Randy, based on my long experience of reading his posts, is a master at it. I think it takes considerable knowledge, skill and experience to understand how, when and where to simplify a Standard and do it effectively. But then, I believe over-complicating a Standard is detrimental and counter-productive.

Yes--there's a difference between "simple" and "simplism."

 

[Jim Wynne]

Re: ISO 9001 Implementation and Certification - Some advice

AGAIN, WRITE WHAT YOU ARE ALREADY DOING.

start small, just the 6 required procedures to start. pay close attention to a design procedure also.

and KEEP RECORDS OF EVERYTHING.

also, an internal audit and management review meeting are required. keep records of customer communication and all quality focused meetings.

IMO a gap anaylsis isn't really effective if you have no manual or procedures in place..........how can you see any gaps if that is all you have?

Are you saying that in order to perform a gap analysis processes must already be documented? If there is no existing documentation, gap analysis should proceed by evaluating the processes (which exist exclusive of documentation) to determine (a) whether the way they operate is compliant with the standard and (b) what documentation, if any, is needed. The document is not the process.

 

[NewQM]

Re: ISO 9001 Implementation and Certification - Some advice

Are you saying that in order to perform a gap analysis processes must already be documented? If there is no existing documentation, gap analysis should proceed by evaluating the processes (which exist exclusive of documentation) to determine (a) whether the way they operate is compliant with the standard and (b) what documentation, if any is needed. The document is not the process.

Not at all, but in my experience until you can clearly see a process/procedure, there is no use in doing the gap anaylsis. this doesn't have to be written of course, but for someone new to QMS's, i would suggest writing down how you do you design (etc) process and then comparing it to the standard as your "gap anaylsis." otherwise, people tend to regurgitate the standard when they write their QMS.

To put it in other words, if you do a gap anaylsis before you understand how the process works, you may tend to write more of a "regurgitation"

it doesn't have to be a formal process/procedure, just some notes of the steps that are already taken. and add the documenation requirements in order to comply.

then again, it is just my opinion, and in the past it has worked. i am not trying to say it is the only way to do it, just one way.

 

[Jim Wynne]

Re: ISO 9001 Implementation and Certification - Some advice

Not at all, but in my experience until you can clearly see a process/procedure, there is no use in doing the gap anaylsis. this doesn't have to be written of course, but for someone new to QMS's, i would suggest writing down how you do you design (etc) process and then comparing it to the standard as your "gap anaylsis." otherwise, people tend to regurgitate the standard when they write their QMS.

To put it in other words, if you do a gap anaylsis before you understand how the process works, you may tend to write more of a "regurgitation"

it doesn't have to be a formal process/procedure, just some notes of the steps that are already taken. and add the documenation requirements in order to comply.

then again, it is just my opinion, and in the past it has worked. i am not trying to say it is the only way to do it, just one way.

I agree that understanding of processes is necessary, and whatever helps in that regard is OK by me, but what you said was "IMO a gap anaylsis isn't really effective if you have no manual or procedures in place..." Having a manual and procedures is substantially different from taking notes while trying to understand a process.

 

[JaneB]

Re: ISO 9001 Implementation and Certification - Some advice

start small, just the 6 required procedures to start. pay close attention to a design procedure also.

You've given good advice about starting small etc, but this bit is bad advice - you are promoting a (mis)understanding that all that's required by the Standard is 6 procedures. Not true, and indicates a failure to grasp what the documentation requirements actually call for.

 

[Helmut Jilling]

Re: ISO 9001 Implementation and Certification - Some advice

My $.02 is that if you are a succesfull company, you are probably already "following" the standard.

What is most important is to WRITE WHAT YOU ARE ALREADY DOING, keep good records and hire a consultant for atleast one day that can tell you what you will need.

of course, that is optional but for (consultants that i know, myself included charge) $400, you will save a week of dead ends.

I will be happy to help if you want to e-mail me directly.

also, find a concise QSM (quality system manual) and use it as a reference, at the top click the green box that says "post attachments list" and you will find examples.

AGAIN, WRITE WHAT YOU ARE ALREADY DOING.

start small, just the 6 required procedures to start. pay close attention to a design procedure also.

and KEEP RECORDS OF EVERYTHING.

also, an internal audit and management review meeting are required. keep records of customer communication and all quality focused meetings.

IMO a gap anaylsis isn't really effective if you have no manual or procedures in place..........how can you see any gaps if that is all you have?

Wow, I would disagree with most statements you made in that post!

1. The point of ISO is not just in documenting what you "already do." What would be the point of that? You are already doing it. The point of ISO is to analyze and plan and measure the performance and interactions of each process in order to ensure continual improvement. Big difference.

2. You should not begin by writing procedures. You should begin by identifying the processes and the details required by clause 4.1. It is only after you have that base, that you should begin to write the procedures that support those processes.

3. For what it is worth, I agree a good consultant can be helpful to many companies, because it will speed up the process of implementation and prevent mistakes. But pick a good one. And, btw, most of the good ones I know charge quite a bit more than $400 (but we provide enough value to more than pay that back).

Best wishes, my friend, but I would encourage you to spend many more hours researching the past threads here on Elsmar. I think it would provide you with a lot of insight.

 

[Antonio Vieira]

Re: ISO 9001 Implementation and Certification - Some advice

.../...
3. For what it is worth, I agree a good consultant can be helpful to many companies, because it will speed up the process of implementation and prevent mistakes. But pick a good one. And, btw, most of the good ones I know charge quite a bit more than $400 (but we provide enough value to more than pay that back).
.../...

Is it just my feeling or the prices of quality management consultancy are also going low in the US?
Here, in the last 15 years, and specially with the appearance of 2k version those prices have gone to one quarter of what they were in 1995!

 

[Jim Wynne]

Re: ISO 9001 Implementation and Certification - Some advice

Is it just my feeling or the prices of quality management consultancy are also going low in the US?
Here, in the last 15 years, and specially with the appearance of 2k version those prices have gone to one quarter of what they were in 1995!

I don't know about the relative prices time-wise, but it seems logical to me from a supply and demand point of view. In 1995 there were lots more companies trying to get certified and that number jumped significantly a few years later when QS9000 reared its ugly head. Lots of need for certification and relatively few consultants made it a seller's market.

 

[Helmut Jilling]

Re: ISO 9001 Implementation and Certification - Some advice

Is it just my feeling or the prices of quality management consultancy are also going low in the US?
Here, in the last 15 years, and specially with the appearance of 2k version those prices have gone to one quarter of what they were in 1995!

The consultants I know have not dropped their prices, especially to one quarter. I have noticed they are not raising them in the current economy.