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  ISO 9001/4:2000
  ISO 9K2K Transition Process

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Author Topic:   ISO 9K2K Transition Process
Russ
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Posts: 17
From:Tipton, IN
Registered: Apr 2001

posted 12 April 2001 08:47 AM     Click Here to See the Profile for Russ   Click Here to Email Russ     Edit/Delete Message   Reply w/Quote
I have been formally contacted by my registrar about our transition plan to ISO-9K2K. We are on a May-Nov. surveillance audit schedule, so I have 4 surveillance audits after next month to clear all elements of the new standard. This will still give me some breathing room at the end of 2003, which is what I want. Having just gotten started in the transition, does anyone have any input as to what would be the best wat for me to guide this transition in the next 3-4 surveillance audits?

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Marc Smith
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From:West Chester, OH, USA
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posted 20 April 2001 08:48 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
First things first. Specifically what system changes do you intend to make?

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donnammurphy
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From:Athens, GA, USA
Registered: Dec 2000

posted 23 April 2001 03:56 PM     Click Here to See the Profile for donnammurphy   Click Here to Email donnammurphy     Edit/Delete Message   Reply w/Quote
Our company is on an April/October periodic audit schedule. During the audit in April I requested the auditor spend an additional 1/2 day for questions and answers. During this time I shared my transition plan with him and discussed what items auditors were looking for when auditing to the 2000 standard. During this time I was able to get him to explain certain clauses in the standard that I didn't understand. I did have the option of having a gap analysis done or a "pre-assessment" to the new standard, but for my learning purposes, I felt as though I would better utilize his time and mine with a review of our plans. The auditor then shared his opinion of my transition plan and how I should proceed. Hope this information helps.

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Russ
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From:Tipton, IN
Registered: Apr 2001

posted 24 April 2001 08:36 AM     Click Here to See the Profile for Russ   Click Here to Email Russ     Edit/Delete Message   Reply w/Quote
Marc,
We have a good system in place, the only changes I see making are those we need to comply with the greater customer emphasis. Since we are certified to both ISO & QS, I want to wait a while before completely overhauling our Q Manual. We have just not gone thru a standard update, and just not sure if there is a "best" place to start.

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Russ
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Posts: 17
From:Tipton, IN
Registered: Apr 2001

posted 24 April 2001 08:38 AM     Click Here to See the Profile for Russ   Click Here to Email Russ     Edit/Delete Message   Reply w/Quote
Thanks donnammurphy, that sounds like a good game plan.

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Marc Smith
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posted 24 April 2001 09:23 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I would do an internal gap analysis. There's one in the pdf_files directory. I think you'll find there's not much else you have to do.

Changes Being Introduced
* Communicate with customers (7.2.3).
* Identify customer needs and expectations (5.2, 7.2.1).
* Meet customer needs and expectations (5.2).
* Measure and monitor customer satisfaction (8.2.1).
* Meet regulatory requirements (5.1, 5.2).
* Meet statutory (legal) requirements (5.1, 5.2).
* Support internal communication (5.5.4).
* Provide quality facilities (6.3).
* Provide a quality work environment (6.4).
* Evaluate the effectiveness of training (6.2.2 c).
* Measure and monitor realization processes (8.2.3).
* Evaluate the effectiveness and suitability of quality system (8.4).
* Identify quality management system improvements (5.1, 8.4).
* Improve quality management system (5.1, 8.5).

Now - just what is it that you're not doing now?

donnammurphy:
What are you going to have to do that you're not doing now? Can you tell us a bit about your proposed transition plan?

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Raffy
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Posts: 38
From:Manila, Philippines
Registered: Mar 2001

posted 18 May 2001 11:58 PM     Click Here to See the Profile for Raffy     Edit/Delete Message   Reply w/Quote
Hi,
Our Certificate would expire on November 2001. Our GM recommends that if we were going to be recertify, we have to upgrade to ISO9000:2000 so that we will be ahead of others in the market.Since we will be having our transition. I gathered some possible training firms to help us on the upgrade. Last April it was been approved (the ISO9000:2000 Training as I call it). This month of May, we start from Introductory Seminar on ISO9000:2000, followed by FMEA since an excerpt from QS9000 was included in this new version. Last week we attended the Document and Record Management and probably next week, we'll start on the IQA Seminar the Transition Course. In preparation with this, We have a meeting to have a gap analysis from 1994 to 2000. The pdf_files has help us achieve what we want.
In addition with the concern: Are we on the RIGHT track to ISO9000:2000 Certification, since we have six months from now? Since we are the client of the certifying body, can we request them to extend our certification? Please comment.
Thanks in advance,
Raffy

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Marc Smith
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posted 19 May 2001 11:07 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
You're going through a lot of effort and cost to upgrade. Two of my former implementation clients have gone through the upgrade - it took each of them them about 1 week total to 'upgrade'.

What you have to do depends upon whether your original implementation was a serious effort, to be blunt about it. In fact, I had planned to do a set of slides (a guide) on upgrading, but after going through 2 upgrades - well, there isn't much to tell folks, much less charge them for. We made a cross-reference matrix and did a few 'explainations' and that was it. No new systems or procedures. No special training. Internal communication was a no-brainer - already defined within procedures and systems. Customer focus/satisfaction - nothing new here either.

-> FMEA since an excerpt from QS9000 was included in this
-> new version.

Please cite the section / paragraph you are referring to.

I see no requirement for an FMEA system. I believe you are mis-reading / mis-understanding the standard or someone has inappropriately advised you on the requirements. ISO is such a profit center anymore it's becoming silly. I see consultants saying stuff like this - the myth of an FMEA requirement is becoming more and more pervasive - but there is no such requirement in ISO 9001:2000.

I am 'PRO' FMEA - I believe they are a very good idea, but it is not an ISO 9001:2000 requirement. Between 2 upgrades and 2 current implementation clients, none address preventive action through FMEA. None have FMEA systems!

-> Are we on the RIGHT track to ISO9000:2000 Certification,
-> since we have six months from now?

Bottom line is if you did a thorough job when you implemented ISO 9001:1994 you shouldn't need more than a week or two - much less 6 months - to comply with the 2000 version. On the other hand, if your original implementation was poorly done, it may take 6 months.

One area where you might find it will take some time is if you have decided to use FMEA(s) to address one aspect of preventive action. Understand that just doing FMEAs does not completely fulfill this requirement. However, if your company is not doing FMEAs now it will take some training and time to bring up this new system. It is no different than implementing any new business system. If you do not already have the in-house knowledge, it will take some months for training to 'take' and it will take a year to 2 years before the FMEA process becomes 'routine'.

-> Since we are the client of the certifying body, can we
-> request them to extend our certification?

You can continue your registration to the 1994 version for 3 years from December 2000, as I understand it.

[This message has been edited by Marc Smith (edited 19 May 2001).]

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Marc Smith
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posted 19 May 2001 11:24 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
quote:
Originally posted by Russ:

Marc,

We have a good system in place, the only changes I see making are those we need to comply with the greater customer emphasis. Since we are certified to both ISO & QS, I want to wait a while before completely overhauling our Q Manual. We have just not gone thru a standard update, and just not sure if there is a "best" place to start.


Since you are QS meeting ISO 9001:2000 requirements should not be an issue at all. Both of the upgrades I experienced rewrote their manuals in a day. Their old ones were basically the ISO text with references and a few comments. We took the new iso text and pasted references in and pasted comments from the old manual. That was it. The manual is typically the last document I do in an implementation - well, let's say it's done concurrently in a new implementation. Don't over complicate the process.

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Dan Larsen
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Posts: 137
From:Sussex, WI
Registered: Feb 2001

posted 22 May 2001 11:01 PM     Click Here to See the Profile for Dan Larsen   Click Here to Email Dan Larsen     Edit/Delete Message   Reply w/Quote
Marc,

Hear, hear! I fully agree that a QS house should easily meet the new ISO requiremnts. The only issue is to know where in the system the requirements are addressed. There definitely seems to be a problem with overcomplication.

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donnammurphy
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Posts: 18
From:Athens, GA, USA
Registered: Dec 2000

posted 23 May 2001 09:21 AM     Click Here to See the Profile for donnammurphy   Click Here to Email donnammurphy     Edit/Delete Message   Reply w/Quote
Here goes my best shot at explaining my transition plan. First I did a gap analysis. This basically consisted of the ISO 2000 checklist with weighted ratings. For each question, I stated the objective evidence we have in place, which is documented, that meets the standard. Any question, that I could not provide objective evidence for, I rated as such. This analysis once completed, produced a pareto chart that indicated my weakest areas of the standard. I now focus on those areas to bring them to compliance. I used a cross reference matrix of the 2000 and 1994 standards to reorganize the quality manual. Since the 2000 standards is the 1994 standard plus additonal requirements, I "rearranged" the quality manual to the new structure of the 2000 standard. Any where there is a new requirements, I would highlight the area to be addresses to become compliant. Since the company I work for already has a strong focus on customer satisfaction, all I needed to do is to document how we meet the standard for that requirement. I also created myself a booklet that showed the requirements of the 94 standard along with the 2000 standard as a part of training for me. I developed what I call an "executive" overview of the new standard, but in the 1994 format. Managers tend to understand the 20 elements. This was quite difficult to do with the structure of the new standard, but managers/executives better understood the additional requirements in the old format. I also have a overview of the requirements of the new standard in the new format in order to train my internal auditors. My next steps...I will be visiting with sister companies next week to review this transition plan and they also will provide information of their plan. This way, hopefully we are not all reinventing the wheel. After the trip I plan to organize implementation teams, if necessary, to meet requirements that are not met. Or just simply document what is needed and implement. In July, I will be training my internal auditors in the new standard and audits will begin that month. I will audit to the new standard July, August, September and October. My next audit is in October and I will "try" to become compliant at that time. Also, during this time I shall be seaking advice from the cayman forums..Hope this information is helpful. I will gladly share any information I have with anyone interested...

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Marc Smith
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From:West Chester, OH, USA
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posted 23 May 2001 09:45 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
What did your gap analysis reveal? What were/are you 'missing'? What was on your pareto chart of strong and weak areas?

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donnammurphy
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Posts: 18
From:Athens, GA, USA
Registered: Dec 2000

posted 23 May 2001 02:19 PM     Click Here to See the Profile for donnammurphy   Click Here to Email donnammurphy     Edit/Delete Message   Reply w/Quote
First, I have a base line of acceptability. This I have set at 90%. In other words, I have to be 90% complete in meeting the standard before I would initiate a third party audit for compliance to 2000. The pareto shows me how close I am to meeting the standard 100%. I also have this calculated in to show an average for the entire system and its rating. Since the gap is done by a weighted average on a scale of 1-5, anything between 0-3 is highlighted red, 3-4 is highlighed blue. This allows me a visual of the items that are most important. I can then plan a time-line for completion on these items.

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Marc Smith
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From:West Chester, OH, USA
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posted 23 May 2001 04:00 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
OK. That tells us about the format and general chart - project mechanics. But can you tell us specifically what you determined you have to do to meet the new standard? That is, what do you have to do that you weren't doing before?

For example, were you already compliant with 5.5.3 Internal Communication or do you have to add a new system or change an old one?

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donnammurphy
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From:Athens, GA, USA
Registered: Dec 2000

posted 23 May 2001 04:44 PM     Click Here to See the Profile for donnammurphy   Click Here to Email donnammurphy     Edit/Delete Message   Reply w/Quote
Yes. I did find that I was compliant to 5.5.3 Internal Communication but that I had not stated how this internal communication took place. Also, I found that in section 5.2 Customer focus, we were ensuring customer requirements are determined and are met at the aim of enhancing customer satisfaction and this process needed to be verified and documented. Another example is in section 4.2.2 C, I did not have in the quality manual the discription of the interactions of the processes of the QMS. I found that with the new requirements of the 2000 standard, most of them my company currently has systems in place, but never identified the process as part of the QMS. I will now include these and begin evaluating the effectiveness of our systems. For new requirements that we have never met, a team will be developed to determine how this will happen. Such as section 4.1 last paragraph "where an organization chooses to outsource any process", does this mean if I outsource the process of manufacturing a particular part that I use in production or would that fall under supplier responsibility. Does this outsourcing of processes refer to processes such as engineering and logistics. This I do not have an answer to yet, but maybe you can give it a shot....Hope I've answered your question...Thanks.

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Marc Smith
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From:West Chester, OH, USA
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posted 23 May 2001 05:12 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Exactly what I wanted to know and what I expected. This has also been my experience to date with 2 upgrades. Everything was already addressed! It was mostly a matter of updating some documentation.

Thanks for the details! I do appreciate it!

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