Has anybody run into this situation before?

New company, new registrar. I am told by my staff that our registrar requires that those attending management review meetings sign the minutes to "prove" that they were really there.

So I called the new Registrar and questioned this and was told that, indeed, they want the minutes signed, so no one can later claim they really weren't there. I asked where this was required in the standard, but they could not cite anything. (and I knew they couldn't)

I have worked with 3 other Registrars and have never had this issue. When I publish the meeting minutes, I list the attendees and also, those absent. I've never had a registrar question the veracity of this before. Why not just call us liars and question the truth of the minutes altogether?

Has anyone else fought this battle? What do you do when a Registrar has their feet planted on an issue, and it isn't specifically required by the standard? Should I fight this or give in?

What's the big deal? Each registrar has a right (within certain constraints) to make special requirements. It's their certificate, you're just renting it.

This is a nickle and dime issue as far as I'm concerned. Who's it going to hurt, how much sweat do you have to break,and how much will it cost? If you don't like it, get another registrar.

Interesting. But there is not requirement for Management Review Meetings . What if you elect to conduct management review without meetings? Randy has a good point with "What's the big deal?" If you are already doing things this way, then you are not really losing anything. If you are not, then that might be another story. I would begin to throw them a curve (because I hate to do things just becasue "I have to"). Instead of signing the minutes, I would have them sign an attendence sheet. A different time I would have them sign a letter. Or, start videotaping the meetings. A video tape is far better than minutes any day. Or I would stop, and let them write a nonconformance. Then esclate the nonconformance all the way up to IOS if necessary. But, I've also been called a jerk ( and worse) before. I guess the real question is how much bother is it really worth. Chose your battles. This might not be worth the fight (unless you are an idiot like me).

Hi Rosie - I agree with Randy.

I have dealt with a registrar that required we have a procedure for the use of their registration mark. So, even though we did not use their mark on any advertisements or business cards, etc., I took 15 minutes one day and wrote a quickie.

On the other hand, I once worked with a registrar that required we conduct Management Review meetings quarterly. On this I could not humor them. I used the "Do Not Concur" and I built a business case in response rather than a corrective action. This was accepted by the registrar without incident.

I guess the point is - pick and choose your battles. Not every issue is a hill to die for. BTW - I send out a memo that includes the required attendees and the agenda. What I do (not for an auditor, but because some personalities will try to say "I was never told this") is use my copy of the meeting memo and have the attendees initial next to their name as they sit down. Takes no time at all. The minutes are distributed, and my copy is attached to the memo/signin sheet.

Interesting. But there is not requirement for Management Review Meetings . What if you elect to conduct management review without meetings?

Good point! I have seen other threads discussing intranet management reviews.

...What I do (not for an auditor, but because some personalities will try to say "I was never told this") ...

This is probably the best argument for signatures. Not because the "auditor told me so", but because the reality of the situation dictates it. I wouldn't think this should be a problem with management review meetings because the "boss" is usually there. But I have seen where the boss was the biggest violater. Good work Cari! :agree:

How do you acquire signatures in a BIG or mulit-national company that might perform management reviews via conference call, video phone, or some form of online meeting?

If its not a major deal, just create an attendance signing sheet.

So much for paperless society. :p

I guess I get annoyed by all the little "special" interpretations I see from different Registrars, that were never directed or even inferred by the standard. In another example, I once had a registrar who insisted that employees have the quality policy memorized. The next registrar I had said his management would fire him if he insisted that a client have the quality policy memorized. Who is right?

Randy, it probably ISN'T a big deal for me to continue doing signatures, and I probably will, but this is one of the examples related to how ISO is interpreted, that has been discussed endlessly in these forums. It is a constant, irritating, frustration. And these things are not well advertized by registrars. They show up as "improvement notes" or "observations". If you're going to have quirky interpretations that differ form other registrars, then publish them in advance, don't make them surprises.

Randy, I realize you were being flip with your comment about changing registrars...that's hardly a quick and easy solution and nor is it one I can make on my own...I really wasn't looking for a flip answer.

I guess I get annoyed by all the little "special" interpretations I see from different Registrars, that were never directed or even inferred by the standard. In another example, I once had a registrar who insisted that employees have the quality policy memorized. The next registrar I had said his management would fire him if he insisted that a client have the quality policy memorized. Who is right?

Randy, it probably ISN'T a big deal for me to continue doing signatures, and I probably will, but this is one of the examples related to how ISO is interpreted, that has been discussed endlessly in these forums. It is a constant, irritating, frustration. And these things are not well advertized by registrars. They show up as "improvement notes" or "observations". If you're going to have quirky interpretations that differ form other registrars, then publish them in advance, don't make them surprises.

Randy, I realize you were being flip with your comment about changing registrars...that's hardly a quick and easy solution and nor is it one I can make on my own...I really wasn't looking for a flip answer.

Quirk:
Our registrar requires us to have a "deputy" management representative, which is basically a 2nd MR just in case the real MR is not available during an audit... Makes sense but did it need to be REQUIRED by the registrar? No Big deal, I added it to the Org Chart and Management Rep Work Instruction we already had. :rolleyes:

Quirk:
Our registrar requires us to have a "deputy" management representative, which is basically a 2nd MR just in case the real MR is not available during an audit... Makes sense but did it need to be REQUIRED by the registrar? No Big deal, I added it to the Org Chart and Management Rep Work Instruction we already had. :rolleyes:

I remember that one...it was two companies ago...BSI, right?

I remember that one...it was two companies ago...BSI, right?Yes. Not a big deal (unless you happen to have a 1 person company :biglaugh: )

I too have no qualms about disagreeing with an auditor. "Show me the Shall!!"

The selection of a registrar is a business decision. When you select one, you enter into a contractural relationship whereby the contractor and client agree to services & requirements vs compensation.

QMS Registrars are obligated to conform (give or take) to IAF Guide 62. The guide tells them the who, what, where, when and how of the registration business. They are bound to at the minimum insure conformance to the requirements of ISO 9001:2000 for registration, and they may also make certain other requirements of their own that may or may not be considered "excessive".

Absolute bottom line....it's a contractural relationship just like most other business arrangements. If you don't like it, get another contractor.

Rosie, another option for you - if you actually prepare a report (I do, but it is not necessary) on paper, and you file your report (control of records) for evidence that the meeting was held, and what was reported on, just have everyone initial YOUR copy at the beginning of the meeting.

I've had people tell me that they did not know about something, but I've never had anyone say they weren't at the management review meeting. Oh well, there are several quick and cost free options available, I don't think I'd bother fighting it.

I guess I get annoyed by all the little "special" interpretations I see from different Registrars, that were never directed or even inferred by the standard. ...but this is one of the examples related to how ISO is interpreted, that has been discussed endlessly in these forums. It is a constant, irritating, frustration. And these things are not well advertized by registrars. They show up as "improvement notes" or "observations". If you're going to have quirky interpretations that differ form other registrars, then publish them in advance, don't make them surprises...



This is one of my pet peeves as well. I'm not sure that it is a case of interpretation, as much as it is a case of application. Registrars, and auditors, see soo many companies with "just enough to keep the flag" QMS that they want to make sure your system is "real". But like you said earlier: "Why not just call us liars and question the truth of the minutes altogether?" When it is your integrity that gets challenged you tend to take it personally.

..."Show me the Shall!!"

Hey you stole my line!!!!!!

Rosie & group,

Interesting thread. Here's my take, for whatever it's worth. There are only four conditions that trigger my recommendation for taking any action within a company:
1) The action benefits your customers,
2) The action improves your internal performance,
3) The action removes a threat or thwarts a competitor,
4) The action is required by ISO 9001:2000 (...and this one is actually a distant fourth).

Do the *opinions* of the registrar fall into any of these categories? In this case, I don't think so. There certainly is no requirement that anyone sign anything related to the management review. Having the names of attendees typed on the records would be reasonable proof to me. If an auditor doubted the veracity of the names on the record, he could interview some people and determine in a matter of seconds whether the attendees were actually there or not.

Why fight something like this? Because over time there will be more invented requirements. As the years roll by, the accumulation of invented requirements will transform your management system into something unrecognizable. I come across this everyday in my work. I'll ask, "Why the heck are you guys doing this?" The answer, "Uh, I'm not really certain. I think it's something we did for the registrar. Not sure why."

I always require that auditors write their nonconformities in a two part "requirement / finding" format. This forces the discipline of finding a requirement before writing a nonconformity. Most of the questionable nonconformities go away when this format is used.

Talk to you soon,
CC

~~~~~~~~~~~~~~~~~~~~~~~~~~~
Craig Cochran
Center for International Standards & Quality
Georgia Institute of Technology
craig.cochran@edi.gatech.edu

As far as I am concerned, this registrar is in violation of bodies that the represent. If they do not cooperate and audit only to the standard itself, then I would report them to the appropriate governing bodies. This has nothing to do with Mgmt Review. It has everything to do with an objective and ethical audit process under the rules of the standard. What other registrar-imposed "shalls" will these clowns spring on you in the future ? Will they threaten your badge because they don't like the format of your process instructions ? Or your PM’s are not, in their opinion, frequent enough ?

If they can’t cite you verbatim from the standard itself, then you have zero obligation, period !

I don’t know about the rest of the gang, but it’s painful enough to struggle day in, day out for commitment from a pathetic and dimwitted management team. Now we will add more worthless tasks from an outside facsimile thereof ? :frust:

Another one of the many reasons why the registration process should be abolished, completely. Paying a lot of $$$ for more useless, opinion driven, busy-work, by a hapless auditor, yielding a negative return for YOU !

JMHO. Have a day ! :D

As far as I am concerned, this registrar is in violation of bodies that the represent. If they do not cooperate and audit only to the standard itself, then I would report them to the appropriate governing bodies. This has nothing to do with Mgmt Review. It has everything to do with an objective and ethical audit process under the rules of the standard. What other registrar-imposed "shalls" will these clowns spring on you in the future ? Will they threaten your badge because they don't like the format of your process instructions ? Or your PM’s are not, in their opinion, frequent enough ?

If they can’t cite you verbatim from the standard itself, then you have zero obligation, period !

I don’t know about the rest of the gang, but it’s painful enough to struggle day in, day out for commitment from a pathetic and dimwitted management team. Now we will add more worthless tasks from an outside facsimile thereof ? :frust:

Another one of the many reasons why the registration process should be abolished, completely. Paying a lot of $$$ for more useless, opinion driven, busy-work, by a hapless auditor, yielding a negative return for YOU !

JMHO. Have a day ! :D

Gee Mike tell us how you really feel! :biglaugh:

I don’t know about the rest of the gang, but it’s painful enough to struggle day in, day out for commitment from a pathetic and dimwitted management team. Now we will add more worthless tasks from an outside facsimile thereof ?

Another one of the many reasons why the registration process should be abolished, completely. Paying a lot of $$$ for more useless, opinion driven, busy-work, by a hapless auditor, yielding a negative return for YOU !

JMHO. Have a day !

It's been awhile since I have thought of this, but this thread reminds me of what I miss the least. This type of auditor sounds like the ones discussed in http://elsmar.com/Forums/showthread.php?t=4049 and elsewhere. Read through this thread for some silly auditor behavior. :vfunny: :smokin:

Has anybody run into this situation before?

New company, new registrar. I am told by my staff that our registrar requires that those attending management review meetings sign the minutes to "prove" that they were really there.

So I called the new Registrar and questioned this and was told that, indeed, they want the minutes signed, so no one can later claim they really weren't there. I asked where this was required in the standard, but they could not cite anything. (and I knew they couldn't)

Rosie lets look at this. Does your new company have a procedure for Mgmt review if so what does your internal procedure require?

As far as your Registrar requiring this as was stated before ask them where it is required that those in attendance sign or initial they were there. (unless you do have a procedure for Mgmt review that requires this). If not cite 5.6.1 "Records from Management Review shall be maintained (see 4.2.4)" and show your minutes/agenda or whatever you have from the meeting and state these are our records Buddy!

I don't think they were calling you liars but I could be wrong, it may be that they are just looking out for your best interest in that they know upper Mgmt has selective memory on certian topics. I know we have our Mgmt initial they attended for this reason alone.

Lets also look at how difficult it would be to pass the agenda around and have all those in attendance sign or initial your copy of the agenda??? Is it worth fighting, if you feel strongly about it and you have time to devote to it yes! Would I, no likely as it is such a minor issue and I am sure you have other more pressing issues to take care of.

If they write you up ask the audtior what the Registrara appeals process is.

JMHO pass the agenda around and have those in attendance initial it. :)

Hey you stole my line!!!!!!

Tee Hee

Actually, I had our Plant Manager in here reading a thread or two not too long ago. When he saw your "Where's the Shall" he laughed and said "great minds think alike".

Our company had a real problem with the first auditor out here for the gap analysis/desk audit back before I started working here. In reviewing the results in preparation for the registration audit (I started working here 4 weeks to the day before their registration audit) I agreed with them completely. We requested a different auditor and have been happy with him for 3 years now.

As something of a training experiment, I had the team use the standard and try to find the shall for each of the auditors observations. This was really helpful to the team, they feel much more confident in questioning the auditor's findings. "Show me the shall" is a very simple way to avoid coming off as overly defensive.

Tee Hee

Actually, I had our Plant Manager in here reading a thread or two not too long ago. When he saw your "Where's the Shall" he laughed and said "great minds think alike".

Our company had a real problem with the first auditor out here for the gap analysis/desk audit back before I started working here. In reviewing the results in preparation for the registration audit (I started working here 4 weeks to the day before their registration audit) I agreed with them completely. We requested a different auditor and have been happy with him for 3 years now.

As something of a training experiment, I had the team use the standard and try to find the shall for each of the auditors observations. This was really helpful to the team, they feel much more confident in questioning the auditor's findings. "Show me the shall" is a very simple way to avoid coming off as overly defensive.

The shall may not be in the standard but the shall may be in your internal procedure. Be careful with that.

Tee Hee

Actually, I had our Plant Manager in here reading a thread or two not too long ago. When he saw your "Where's the Shall" he laughed and said "great minds think alike".


I'm glad to see you took my comment the way it was intended. However, it might not be wise to associate me, and my thinking with someone else. :bonk:


As something of a training experiment, I had the team use the standard and try to find the shall for each of the auditors observations. This was really helpful to the team, they feel much more confident in questioning the auditor's findings. "Show me the shall" is a very simple way to avoid coming off as overly defensive.

This is a great idea!!!!!!! It builds understand of the requirements, but also insight into how your company implements those requirements! You get a gold star for the day!

Some of you folks must smoke some serious stuff. This piddly squaking falls into the same catagory as the complaints make by the grossly fat against fast food companies. Nobody held a gun to your head and made you eat or pick the registrar you have.

Think of the registration certificate as a license and the registrar as the licensing agency. The agency is bound by whatever regulatory requirements it has to meet and also is allowed to modify or stiffen them up somewhat. "You want my license, obey my rules."

The real problem here is not the additional requirements, it's the total failure and refusal of "function specific professionals" to get out of their collective states of "Tunopia" and understand business and business relationships.

Am I nasty...you betcha.

...
The real problem here is not the additional requirements, it's the total failure and refusal of "function specific professionals" to get out of their collective states of "Tunopia" and understand business and business relationships.

Am I nasty...you betcha.

I'm not sure what you are saying here Randy, remember not all of us are MENSA. In fact, I've been called a Neanderathal in a different thread. But, as many of us has pointed out is the point worth fighting.

As far as nasty....nah. Painfully blunt -- usually. Causticly abrasive (the largest words I know) -- often, but never nasty. Nasty infers that you intend to injure, I don't think you have malice....just skill! :smokin:

It's been awhile since I have thought of this, but this thread reminds me of what I miss the least. :vfunny: :smokin:

I agree ! This type of auditor behavior contradicts what effective systems are all about ! More waste= no chance of continuous improvement. :)

The shall may not be in the standard but the shall may be in your internal procedure. Be careful with that.

If he found the shall in my procedure then that's where he would show it to me. At that point I would have to consider why it is in my procedure.

db - This exercise is part of my internal auditor training as well - but that's another thread. :)

noboxwine-you have really hit right on the money. I have been in the quality management arena for 35 years, and it is getting way out of site. I always believed in good, quality practices and top management involvement, but these registrations, and registrars are big money makers for them, not us. Unfortunately a lot of companies just want the paper on the wall, not the real system. You and I are of one mind on this issue for sure.

As far as I am concerned, this registrar is in violation of bodies that the represent. If they do not cooperate and audit only to the standard itself, then I would report them to the appropriate governing bodies. This has nothing to do with Mgmt Review. It has everything to do with an objective and ethical audit process under the rules of the standard. What other registrar-imposed "shalls" will these clowns spring on you in the future ? Will they threaten your badge because they don't like the format of your process instructions ? Or your PM’s are not, in their opinion, frequent enough ?

If they can’t cite you verbatim from the standard itself, then you have zero obligation, period !

I don’t know about the rest of the gang, but it’s painful enough to struggle day in, day out for commitment from a pathetic and dimwitted management team. Now we will add more worthless tasks from an outside facsimile thereof ? :frust:

Another one of the many reasons why the registration process should be abolished, completely. Paying a lot of $$$ for more useless, opinion driven, busy-work, by a hapless auditor, yielding a negative return for YOU !

JMHO. Have a day ! :D

Am I nasty...you betcha.

Randy, I hope that made you feel better. If not, it might be time to seek a different career. Maybe energy can give you some tips. :D

Nobody held a gun to your head and made you eat or pick the registrar you have.

PS: I just started with this company. I have nothing to do with their choice of a registrar. (but I will make recommnedations in the future) My frustration stems from living through these undocumented expectations with almost every registrar I've had.

If there are good reasons for the "un-shalled" requirements, then have the courtesy to spell them out so we don't get the "observations" and "improvement notes" as a result.

Any industry that fails to listen to its customers is headed for failure. Registrars are no exception to thsi rule. You call it "piddly squaking", I call it a customer complaint.

The standard requires a record of the management review in 5.6.1. Therefore, this should indicate that the proper managers have reviewed what is stated as needed in order to conduct the review, in some way.

To get to the original question of signatures opposed to you listing who was present in the meeting, it is just BULL that the auditor/registrar said that you must have them sign.

I think you should take a stand and not let them tell you how to do it.

Don't lose sight of the fact that you are the CUSTOMER! Obviously they have, you should remind them. :lick:

Randy, I hope that made you feel better. If not, it might be time to seek a different career. Maybe energy can give you some tips. :D

My good friend Bill (energy) just started a new career through no fault of his own. As for me....I already have 2 retirements coming in and I only just turned 52. I have my own business (marginally successful I guess) and I'm fixing to open a storefront in my new town. How many more careers do I need to have?

BTW...It's their certificate not yours. Try reading IAF Guide 62 and the RAB's material for registrars to get a better handle on this.

Noboxwine....

I think the poor person that started this fun little escapade originally mentioned that it was the registrar's requirement and not the auditors. The auditor was apparently conducting him or herself in an ethical manner when trying to meet the requirements of the auditing agency.

It never ceases to amaze me the number of people who scream when their azz is on fire and all they have to do is walk out the door to escape the blaze.

[QUOTE=Randy]Nobody held a gun to your head and made you eat or pick the registrar you have.

PS: I just started with this company. I have nothing to do with their choice of a registrar. (but I will make recommnedations in the future) My frustration stems from living through these undocumented expectations with almost every registrar I've had.

If there are good reasons for the "un-shalled" requirements, then have the courtesy to spell them out so we don't get the "observations" and "improvement notes" as a result.

Any industry that fails to listen to its customers is headed for failure. Registrars are no exception to thsi rule. You call it "piddly squaking", I call it a customer complaint.

Rosie- I understand where you are coming from, do you know that when your current employer selected this registrar that it wasn't spelled out top them that these are what we require above and beyond ISO??? If you disagree with a finding you receive ask for their appeals process and follow it. If it is a improvement note that does not mean you have to change your process question it disagree with them.

Who ever said that Registrars don't listen to their customers that is an assumption that is made by many people, have you discussed this with your registrar? I know you said that you called and asked them if this is what they required and they were not able to cite any shall from ISO what else did they say, you left part of your conversation out.

In the grand scheme of things it is JMHO you are wasting too much time on something that is not very important. Question them if you want, but is it really worth the effort to "prove you were right" over something this minor??? :truce:

You got it ISO Guy. Fight the battles worth fighting. It's also kinda like "The Gambler"..."know when to hold them, know when to fold them, know when to walk away, and know when to run" This is one to walk away from.

My good friend Bill (energy) just started a new career through no fault of his own. As for me....I already have 2 retirements coming in and I only just turned 52. I have my own business (marginally successful I guess) and I'm fixing to open a storefront in my new town. How many more careers do I need to have?


It is very hard to let go of a lifetime of "Q" disciplines. However, one of the owners was a Quality Manager for a large firm in a previous life. We are both in "synch" when it comes to the Customer, records, responsibilities and, most of all, the "freedom" from all the extraneous crap that had developed over the years in the manufacturing sector. I'm slowly making the adjustment. Thanks for referring to me as "good friend", Jarhead!! :vfunny: :agree:

My good friend Bill (energy) just started a new career through no fault of his own.

And I wasn't inferring that energy did anything wrong, just that his posts have been much more upbeat since changing jobs, and he's clearly enjoying his new career.

Thank you all for your feedback. I appreciated most of it!

Not all of it? :(

Not all of it? :(

Let's see, in the course of the discussion, you've suggested:
1. that I am "smoking some serious stuff"
2. that my issue is "piddly squaking"
3. that my head is in "Tunopia" (whatever that is)
4. and you've inferred that I'm too clueless to remove myself from a burning building.

So, no. I didn't find any of that helpful. Sometimes I find your postings effective and informative, but today's posts were not. Perhaps you were having a bad hair day, or perhaps I am lost in "Tunopia" and just don't realize it. (the reference was a tad obscure, as references go)

Let's see, in the course of the discussion, you've suggested:
1. that I am "smoking some serious stuff" :thedeal:
2. that my issue is "piddly squaking"
3. that my head is in "Tunopia" (whatever that is) :smokin:
4. and you've inferred that I'm too clueless to remove myself from a burning building. :frust:

So, no. I didn't find any of that helpful. Sometimes I find your postings effective and informative, but today's posts were not. Perhaps you were having a bad hair day, or perhaps I am lost in "Tunopia" and just don't realize it. (the reference was a tad obscure, as references go)

TEEHEE
ROFL

Am I nasty...you betcha.
At least you admit it. But not something most people would be proud of. You have so much else to be proud of i.e. your multiple retirement incomes, careers/talents/businesses and of course your MENSA membership. But being proud of being nasty? :confused:

Maybe you need a vacation from all that work.

JMO.

"Tunopia" is a combination of tunnel vision and myopia. I use the word to describe the state that most function specific professionals exist in because they either refuse to, choose not to, cannot, will not, or do not understand business/organizational activities outside of their narrow band or range. Subsequently the FSP's confine themselves to non-issues to try to gain attention to their needs, have difficulties communicating beyond their borders and up the chain, and exist in the nether worlds of their organizations, unable to advance beyond 2nd or 3rd tier influence.

I use the term smoking stuff instead of telling people to pull their head out of their azz, especially when they seem to get wrapped around the axel over relatively minor issues (piddly stuff).

Maybe my hide is somewhat tougher than other folks. I guess it started getting tough when my 10th grade history teacher greeted us at the beginning of the year by telling all of us that we were ignorent and unlearned....turned out he was correct. Mr. Howard King use such language to incite within us a desire to prove him wrong, not to injure us.

Randy: I cannot decipher your analogies and vernacular, but I thought my response covered Rosie's question below. Anyway, if you agree to bow down to registrars that induce rules outside of the standard, no matter how 'piddly' it may be, that's fine. Run your biz as you see fit. However, my business practices cannot justify it, morally or financially. My data that proves this kind of 'practice' is fruitless.

Most importantly, I think, it makes those new to QA very uncomfortable and confused about what systems and ISO is all about. It's difficult enough for some newcomers to understand the written standard itself. Now, they may have interpret, outside the written standard, a new dialect for each registrar or auditor ? Nonsense.



Has anyone else fought this battle? What do you do when a Registrar has their feet planted on an issue, and it isn't specifically required by the standard? Should I fight this or give in?

"Tunopia" is a combination of tunnel vision and myopia. I use the word to describe the state that most function specific professionals exist in because they either refuse to, choose not to, cannot, will not, or do not understand business/organizational activities outside of their narrow band or range. Subsequently the FSP's confine themselves to non-issues to try to gain attention to their needs, have difficulties communicating beyond their borders and up the chain, and exist in the nether worlds of their organizations, unable to advance beyond 2nd or 3rd tier influence.


"Most function specific professionals"? Well, that covers most of us, for sure. This "Tunopia" and "wrapped around the axle" is found in a lot of Randy's posts. Do a search. One can see where newer members can be agitated by these responses, but I can tell you this: Under that gruff exterior is a softy. Being a former Policeman and Marine can dull you to the sensitivities of others, but there is no malice intended. A recognized Mensa member, (yes that's in a lot of posts, too) it should be understood that those "outside that particular box" have a limited grasp of what they are doing. Read between the lines and you get great information. Randy, my good man, tact is not one of your strong suits. Rosie, C'mon back! :bonk: :smokin:

Think of the registration certificate as a license and the registrar as the licensing agency. The agency is bound by whatever regulatory requirements it has to meet and also is allowed to modify or stiffen them up somewhat. "You want my license, obey my rules."



Issues of tact (or the lack thereof), smokin' stuff, "tunopia", piddly squeekin', (I'm suprized he forgot another of his favorites -- "getting your t*ts in a wringer"...) :vfunny: etc. aside...

This quote by Randy made me think. I think a good question when interviewing a potential registrar might be something like this: "Do you impose additional requirements, above and beyond the 'shalls' in ISO 9001, that must be met in order for you to issue a certificate?"

I wonder how many registrars would answer in the affirmative? And how many of those who answer "no" would later be found to be fibbing?

If they answered yes I'd think you had better get a complete list of what those additional requirements are, or else you could be in for a long, bumpy ride.

Issues of tact (or the lack thereof), smokin' stuff, "tunopia", piddly squeekin', (I'm suprized he forgot another of his favorites -- "getting your t*ts in a wringer"...) :vfunny: etc. aside...

This quote by Randy made me think. I think a good question when interviewing a potential registrar might be something like this: "Do you impose additional requirements, above and beyond the 'shalls' in ISO 9001, that must be met in order for you to issue a certificate?"

I wonder how many registrars would answer in the affirmative? And how many of those who answer "no" would later be found to be fibbing?

If they answered yes I'd think you had better get a complete list of what those additional requirements are, or else you could be in for a long, bumpy ride.

You hit the nail on the head!! ;) You are right on target and have grasped what I was alluding to.

Registrars have the absolute right to impose "special" requirements above and beyond just auditing the implimentation of the standard.

I work primarily in the EMS or ISO 14001 field. ISO 14001 does not require a "Manual", however some registrars require the existance of one and that it be provided to them during the Phase/Stage 1 Assessment. Also because of the legal liabilities of environmental issues within an EMS the absolute ability to be able to verify communication of information to/from Top Management is necessary. The registrars and auditors of a certificated EMS assume levels of liability in the process and they like to minimize it as much as possible, signatures of appropriate people on appropriate may help to minimize it and also help to provide evidence of communication/committment.

I will give you this....A signed pice of paper is quite honestly worthless unless some other type of objective, verifiable evidence can be shown. I could generate a document, sign all of your names (or have them signed) to it and say you were at a management review meeting when in fact you weren't. As an auditor, I attempt to interview folks whose names are on those things to see if they really know what was going on. If not, I cry BS. I may not use the term BS, but the auditee knows what I mean.

It is incumbent that organizations (and the folks making the decisions) that enter into arrangements ask questions and find out what the really need to do before they start crying and whining about being held to a requirement not in the standard. Most don't until after the fact.

I instruct/tutor a ton of implimentaion and other courses for 9K, 14K, IMS, and OHSAS and I tell everyone in every course..."ASK your registration body, if you are going for registration, what their requirements are and about the credentials of their auditors." Some of the folks that I have had the privilage of instructing come here and I think they will verify that. If you don't ASK, it's your fault not the registrar's. Hold the registrar's feet to the flame with what they tell you...get it in writing (Duh, what an original concept).

If you don't ASK, it's your fault not the registrar's.

I respectfully disagree here, Randy. Several years ago (the 70's), when I was in college I had a roommate that had fairly long hair. Mine was always cut close. One day he commented he needed a haircut, and asked where I had mine cut. He returned really ticked off. His hair was short!

The first thing a barber does is ask how you want your hair cut. His response was "over the ears", meaning overlapping, or covering the ears. The barber cut it "over the ears" or above the ears. They both said the same thing, but had two different concepts.

Clause 7 makes it pretty clear that it is the supplier's responsibility to make sure that the requirements are clearly defined. That means that it is the registrar's responsibility to tell, and not wait for you to ask. If I asked if you have any additional requirements, you could always just say yes, and we could go on for days, as I try to pull every last additional requirement out of you. Instead, you need to tell me up front what the requirements are. But when you engage "function specific professionals ", such as auditors, then the line gets fuzzy.

Clause 7 makes it pretty clear that it is the supplier's responsibility to make sure that the requirements are clearly defined. That means that it is the registrar's responsibility to tell, and not wait for you to ask. If I asked if you have any additional requirements, you could always just say yes, and we could go on for days, as I try to pull every last additional requirement out of you. Instead, you need to tell me up front what the requirements are. But when you engage "function specific professionals ", such as auditors, then the line gets fuzzy.

I don't know how many contracts you've reviewed, but the ones I have specific requirements were stipulated in the language.

As for Clause 7.....The customer is the one that determines and specifies the requirements of the product, the organization has to figure out how to meet the requirements and special issues involved in the realization of the product.

I'm not defending registrars in this, but people fail to accept that they can, and many times do say basically the following..."Yes, we will determine (for specified compensation) whether or not your organizations SYSTEM conforms to requirements and issue a certificate stating so. In order to do so you need to understand that we have requirements that we arte bound by and of our own which are....... Do you agree?" More often than not the questions asked by organizations are: How much? When? Nothing else. No questions about the credentials of audit staff, supplementary requirements and issues. NADA!!

We are in a place now where we have developed a mind-set...it's not my fault, I was force fed Big Mac's and cigarettes....... Same type of thing here with registrars and requirements "It's your fault because I didn't ask, I was only concered with cost and time."

[QUOTE=Randy] Registrars have the absolute right to impose "special" requirements above and beyond just auditing the implimentation of the standard. :confused:

Randy: I agree you're just an angry Teddy Bear and do very well with your programs. I sift through your posts and garner a lot of good points. That aside:

Why are we buying the ISO International Standards, if the registrars impose additional requirements ? Shouldnt we be buying a standard from the registrars, instead ?

Now, I'll put this in terms you'll understand.

Unless you can show me, in writing, where the governing bodies of ISO state that registrars can impose additional requirments outside of their International Standard, you're full of sh*t ! (I had a crabby 10th grade teacher, too) :vfunny:

[QUOTE=Randy] Registrars have the absolute right to impose "special" requirements above and beyond just auditing the implimentation of the standard. :confused:

Randy: I agree you're just an angry Teddy Bear and do very well with your programs. I sift through your posts and garner a lot of good points. That aside:

Why are we buying the ISO International Standards, if the registrars impose additional requirements ? Shouldnt we be buying a standard from the registrars, instead ?

Now, I'll put this in terms you'll understand.

Unless you can show me, in writing, where the governing bodies of ISO state that registrars can impose additional requirments outside of their International Standard, you're full of sh*t ! (I had a crabby 10th grade teacher, too) :vfunny:

And it (my "s") stinks too :biglaugh:

Here is a small excerpt from IAF Guide 62 (you may need to format it for easier viewing):

2.1.5. Conditions for granting, maintaining, extending, reducing, suspending, and withdrawing certification / registration IAF Guidance to clause 2.1.5. (G.2.1.42. – G.2.1.45.)

G.2.1.42. Clause 2.1.5 of ISO/IEC Guide 62 does not mention a specific period in which at least one complete internal audit and one management review of the organization’s quality management system shall take place. The certification / registration body may specify a period.

Irrespective of whether the certification / registration body has chosen to specify a minimum frequency, measures shall be established by the certification / registration body to ensure the effectiveness of the organization’s management review and internal audit processes.

G.2.1.43. Certification / registration shall not be granted until there is sufficient evidence to demonstrate that the arrangements for management review and internal audit have been implemented, are effective and will be maintained.

To counter your statement show me where thay can't impose requirements. They are "required to insure conformance or compliance to the applicable standard", how they do that is many times left to them and is a matter of contarctural agreement.

"It's your fault because I didn't ask, I was only concered with cost and time."

And how is this different than every other customer-supplier relationship? :bonk:

I agree with db. It IS the registrar's responsibility to define this during contract negotiations.

If a supplier of mine suddenly began to impose new requirements that hadn't come up in our previous negotiations, and I find them restrictive, expensive, or without merit, am I supposed to say, "Ok, no problem"? I think the answer is that we would complain, push back, or refuse to do whatever was being asked of us, if we saw no merit in it. And we have every right to be angry because these issues waited until after we signed a contract to be raised.

That has been my experience with 3 out of 4 of my ISO registrars.

Registrars need to be concerned about customer satisfaction. It's a customer-supplier relationship and just because there's a standard involved, doesn't mean we, the customer, have to put up with abuse.

Randy, for me, whatever good points you made got lost in your total lack of respect for me and your fellow Cove members. I'm not suing McDonalds or RJ Reynolds. I have read Guide 62, and I am not ignorant of the total business process.

And how is this different than every other customer-supplier relationship? :bonk:

and I am not ignorant of the total business process.

Just some of it? Which parts are you having problems with?



I'm sorry, the Devil made me do it ;)

And how is this different than every other customer-supplier relationship? ...
This is kind of my point. It would be sorta like I once went into a restaurant and ordered a Caesar’s salad. When it arrived, it had tomatoes on it. I told the server I did not like tomatoes and tomatoes are added to Caesar’s salad. The comment was that they do add it, and once a meal enters the dining area they are not allowed to take it back. I should have asked if it had tomatoes prior to ordering. I could pick off the tomatoes, if I didn’t like them and I still had to pay for the salad. I could pick off the tomatoes, if I didn’t like them, but I still had to pay for the salad. I told them I guess they had better call the cops, because I was leaving.
I really don’t care what the contract says. If any auditor writes a nonconformance against something that is not in either the standard, or my documentation, I would not accept it. There would be no response or corrective action. And I really don’t care what Guide 62 (or replacement) says. The registrar is my supplier. I am the customer. My QMS must meet MY requirements and the Standard requirements.

And Randy you are right, most don’t want to hear that stuff. But when you a cop, did you stop reading folks their rights because they didn’t want to hear it? No you read it to them anyway. They didn’t have to ask.

There's a big difference...I didn't want my rights read to me (which BTW happened a few times anyway) :biglaugh:

There's a big difference...I didn't want my rights read to me (which BTW happened a few times anyway) :biglaugh:

Tis more blessed to give than to receive.

And it (my "s") stinks too :biglaugh:


To counter your statement show me where thay can't impose requirements. They are "required to insure conformance or compliance to the applicable standard", how they do that is many times left to them and is a matter of contarctural agreement.

Randy, I applaud your research and attention to deail. But, now way would this stand a chance. Any audit criteria outside the standard is not permitted, period. :bigwave: Buh bye, for now !

When you hire a registrar there is a contract signed. What does the registrar's contract say? Is there anything in there to suggest that the registrar has/may have requirements outside of the minimum requirements of the standard?

I may be going through this soon, and Randy's point has made me add a question to my interview questions. But had I interviewed the registrar a week ago I would never have thought to ask it. I assumed (yeah, I know what happens when you assume) that the standard was what everyone (registrars included) went by, and I thought db’s mantra of “show me the shall” to challenge any registrar who added requirements would be an effective one. For example, if the registrar told me I had to maintain my final test quality records for 3 years, and my internal procedure said 1 year, I’d say “where is the shall?” From what Randy says, the registrar can require that and there’s nothing I can do about it (if I don’t address it prior to hiring them) if I want their cert. That doesn’t seem right, but legally it may be.

I’d like to see this question addressed directly by ISO or the RAB or someone at a level of authority higher than the individual registrar.

And I wonder if the answer is different depending on whether we’re talking ISO 9001-2000 or TS-16949 or ISO 14000.

...and I thought db’s mantra of “show me the shall” to challenge any registrar who added requirements would be an effective one. For example, if the registrar told me I had to maintain my final test quality records for 3 years, and my internal procedure said 1 year, I’d say “where is the shall?” ...

Looks like I'm finally getten through. This is a scary thought! :bonk:

Well, now, let's see what the scoop is. See http://elsmar.com/Forums/showthread.php?t=6661

I’d like to see this question addressed directly by ISO or the RAB or someone at a level of authority higher than the individual registrar.

And I wonder if the answer is different depending on whether we’re talking ISO 9001-2000 or TS-16949 or ISO 14000.

It already has been Mike and guess what....as long as there is no conflict between IAF guidance to ISO Guide 62 (QMS) or 66 (EMS) and the accreditation requirements the registrars basically have a blank check.

Remember, an organization when it approaches a registrar is ASKING permission to display a certificate with the REGISTRARS LOGO on it. The cert belongs to the registrar, organizations just rent or pay for the privilage to display them, so to speak. When an organization enters into a contract with a registrar it is no different than any other contract the organization has. In a contractural arrangement each party declares specifics for whatever renumeration is agreed to. The problem here is that many times these arrangements are left to folks who may not have been or are not adequately prepared to enter into them and many times fail to completely read the instrument (contract) for all the wherefore's and how-so-ever's. This is not their fault. The fault lies in how FSP's have been developed in their particular fields of endeavor by the organizations they work for and the educational processes used to develop FSP's. The focus is always on the function and seldom on those issues along the periphery (one of the leading causes of Tunopia).

You are on the right track Mike. Go for it!!

It already has been Mike and guess what....as long as there is no conflict between IAF guidance to ISO Guide 62 (QMS) or 66 (EMS) and the accreditation requirements the registrars basically have a blank check. ...........

See, now that was much more pleasantly stated than your previous posts. If you'd been this professional before I wouldn't have placed you in contention for this year's RUDE award. As it is now, you'll really have to work to get off the list. :eek:

I guess I'm in for a lot of sleep loss now!!!

Yeah, right. :rolleyes:

Is there anything else you'd like to comment on? Contract language maybe?

Maybe some of our skins are just a little thin and our feathers get ruffled too easy.

It already has been Mike and guess what....as long as there is no conflict between IAF guidance to ISO Guide 62 (QMS) or 66 (EMS) and the accreditation requirements the registrars basically have a blank check.

Remember, an organization when it approaches a registrar is ASKING permission to display a certificate with the REGISTRARS LOGO on it. The cert belongs to the registrar, organizations just rent or pay for the privilage to display them, so to speak.

With due respect, I guess it has not been proven to my personal satisfaction.

By your explanation, why could the registrar not make the cert. easier to get than the ISO 9001 standard since, as you said, "the cert belongs to the registrar"?

I can see wiggle room and grey areas for registrars to decide for themselves how long they should take to audit, or with how many auditors, or what level of proof or evidence they may require to verify to their satisfaction that a certain "shall" is met. I get that.

But I am not satisfied that it is kosher for the registrar to be effectively adding their own "shalls" such as the one I mentioned (the registrar telling me I have to maintain my final test quality records for 3 years even if my procedure says 1 year). Or let's say the registrar tells me I cannot do any in-house cal's. and the longest allowed cal. interval is 6 months. That is not an issue of interpretation or level of evidence -- it the addition of a "registrar shall" for lack of a better term.

I'm not saying you are wrong, Randy, I am saying I have not seen evidence that this is "legal" for the registrars to do as allowed by their governing bodies. Your posts do not show me this (or else I am not seeing it).

I guess I'm in for a lot of sleep loss now!!!

Yeah, right. :rolleyes:

Is there anything else you'd like to comment on? Contract language maybe?

Maybe some of our skins are just a little thin and our feathers get ruffled too easy.

And maybe some of us could use a few charm school lessons... :D At some point, Marc is going to break and and tell us we're behaving badly. So I'll just leave it here and let you know if you win the award in December. ;)

And maybe some of us could use a few charm school lessons... :D At some point, Marc is going to break and and tell us we're behaving badly. So I'll just leave it here and let you know if you win the award in December. ;)

I took and successfully completed a Dale Carnegie course many years ago. As for an award...machts nichts

Hey Mike.....

Let the auditors come in and find a failure to properly manage the Registrars Mark/Logo and see how exciting things get. The "MARK" is not mentioned in the standard, but the use of it is reviewed an nearly every surveillance by the auditors.

Legal, smeagle...if you sign a contract and agree to the terms guess who has the leverage?

I just show them the door and say "see ya". Then call the account manager and ask for a new auditor. I refuse to let an auditor, or consultant for that matter, tell the company how it should operate. We meet the requirments of the standards, their personal wants have no merit or place in the system.

As for the "mark", as far as this company is concerned it may as well be 666. We have our certificates posted and provide electronic copies as needed for our suppliers and customers. That is the only use of logos we have. It is not on our documentation and we do not use brochures etc. It is just another file that sits on my pc. If you don't use it you can't misuse it.

With due respect, I guess it has not been proven to my personal satisfaction.

By your explanation, why could the registrar not make the cert. easier to get than the ISO 9001 standard since, as you said, "the cert belongs to the registrar"? ........................

An auditor should not be telling you how to do things or that you should be doing cal's every 6 months etc.. However, with that being said the auditor may be looking at the REGULATORY requirements for your company and if the REGULATORY requirments say you need to keep the records for 3 years and you are only keeping them for a year guess who is right, not ISO, not your procedure but the REGULATORY requirements. Now if that is the case the auditor should let you know this as well. Just another angle to look at. :truce:

I refuse to let an auditor, or consultant for that matter, tell the company how it should operate. We meet the requirments of the standards, their personal wants have no merit or place in the system.

I'll work for you guys as a consultant....no sweat. You apparently don't expect much. ;)

BTW...Rosie stated in another thread that she had found the contract language requiring the Management Review to be signed. Apparently the auditor/registrar was correct in this case.

BTW...Rosie stated in another thread that she had found the contract language requiring the Management Review to be signed. Apparently the auditor/registrar was correct in this case.



....Hello? I never said that...maybe you have me confused with some other thin skinned subscriber?

http://elsmar.com/Forums/showthread.php?t=6661&page=1&pp=20

I think you stated you found the requirement in this thread. The again, I may be misunderstanding you. If so, forgive me.

Registrar #1: Required by contract a stockist checklist. What was not in the contract was the requirement to have the quality policy memorized. Also, we wanted to have a deputy management rep and they said no. Oddly, registrar #2 required a deputy management rep.

Registrar #2: contracturally required a deputy mgmt rep. no other issues. Auditor said he'd be fired if he required us to memorize the quality policy.

Registrar # 3: Nothing outside the standard

Registrar #4: nothing in the contract, but I've discovered the signed mgmt review minutes issue, and there may be more...I've only just started looking.

http://www.elsmar.com/Forums/showthread.php?t=6661&page=1&pp=20

I think you stated you found the requirement in this thread.

Ummm Randy, I think she was saying she found the signed contract, and the fact that that the registrar requires signed minutes. Not that it is in the contract. :o

I'll work for you guys as a consultant....no sweat. You apparently don't expect much.
Just the opposite Randy, we expect a great deal. We just won't take any bull! Besides, they don't need a consultant, they have me! :rolleyes:

Some of the stuff these auditors want does not fit in some systems. Our QS/TS auditor accepts our paperless system and works within it but our Environmental auditor wants a book with the master list date stamped. They are the only printed copies of our procedures we have. It's these little stupid things that get me.
The first 14000 auditor we had gave me a NC because the CA/PA process didn't specifically mention the EMS. I told him it didn't "specifically" mention the QMS provided examples that the system was used for both & showed him the door. A couple years ago we went through 3 BSI auditors before we changed registrars!
I look at like choosing a mechanic for your car. You rip me off or make me feel uncomfortable and I'll go else where. Like the guy at the tire shop I went to a couple weeks ago, he told me I needed new tie rods. I told him that was interesting as I showed him the bill of having them replaced 3 days earlier. Needless to say, I spent my money in another store.

I think you stated you found the requirement in this thread.

What I meant was that I had just discovered the "requirement" from the Registrar, not that I'd found the citation requiring signatures in the standard.

I can't find the citation in the standard and neither could my auditor's technical Help Desk. That's because it isn't there.

I hope that clarifies things.

We're in agreement as we usually are. The CA/PA thing? The dude was smokin' something.

BTW....how's the boy (man actually)? Tired?

What I meant was that I had just discovered the "requirement" from the Registrar, not that I'd found the citation requiring signatures in the standard.

I can't find the citation in the standard and neither could my auditor's technical Help Desk. That's because it isn't there.

I hope that clarifies things.

Was the requirement in the contract with the registrar or any other agreed to document? If it is, the registrar is not wrong. They are looking out for their interests as well as yours. This is one way of doing so in their eyes.

RosieA said "Registrar #4: nothing in contract, but I've discovered the signed management review minutes issue, and there may be more... I've only just started looking."

My interpretation (correct me if I'm wrong Rosie)

Although there is nothing in the contract, she discovered the signed management review minutes issues during a surveillance audit. The auditor stated this - she looked in the contract and could not find the requirement. Since this one was not in the contract, there may be other unstated requirements.

I just wanted to reply to Randy real quick.
BTW....how's the boy (man actually)? Tired?
It's good to have him stateside again, my cousin just went to Saudi last week though.
He's in good health but his eyes have aged Randy, it breaks my heart. I know he's 22 now and no longer my little boy, but that bright flash of mischieviousness is gone. There is a closer bond between us, you can see and feel it. The only thing he said about being there was "I know why you got out now". nuff said.

Thanks for asking, ooh raa!

Maybe some of our skins are just a little thin and our feathers get ruffled too easy.
This is NOT aimed at Randy - he just had the right sentence.

We've gone through the 'personal' aspects many times before. Folks, let's keep posts from becoming personal. It ruins the whole debate / discussion.

I have not seen evidence that this is "legal" for the registrars to do as allowed by their governing bodies.
Good point. Anyone have any details of comments specific to 'legal' issues?

I just figured a registrar could ask for anything as long as agreed to in the contract.

Good point. Anyone have any details of comments specific to 'legal' issues?

I just figured a registrar could ask for anything as long as agreed to in the contract.

You're right on target Marc. The key word that seems to slip by is CONTRACT.

If the contract stipulates that all documentation is to be on pink paper, size 40 Cotillion font and written backwards and it is agreed to and signed...guess what? The requirement is valid.

Realistically any extra requirements should be reasonable and make sense, but never the less, if you sign it, it's binding.

Both parties in a contract should actually read it occasionally.

As for "personal aspects", it's always sticks-and-stones with me.

Since I was looking at Guide 62 in response to another thread, I thought I'd post what it says about the discussion that's been going on here.3.2.1 Before proceeding with the assessment, the certification/registration body shall conduct, and maintain records of, a review of the request for certification/registration to ensure that
a) the requirements for certification/registration are clearly defined, documented and understood;
b) any difference in understanding between the certification/registration body and the applicant is resolved;

I think a) and b) above pretty well sum it up. The registrar must document and make clear to the organization what the requirements for certification are.

It's true. different registrar had so many understanding on implementation of quality management system.
It was very important to select registrar. what they focused on? audit logic etc.
They could have thousands of reason on explaining their question/requirement on your system.
My opinion is to consider what's points? If you thought you could not get any value-added services, it's better to switch another registrar.
you do not have many times/energy to do useless work.

One thing I gorgot to mention is that if you are FDA registered, guess what it is a requirement that your management reviews are signed or initialed by all in attendance. So if you are FDA registered your registrar would have every right to say that your mgmt reviews be signed or initialed as it falls under regulatory requirements.

One thing I gorgot to mention is that if you are FDA registered, guess what it is a requirement that your management reviews are signed or initialed by all in attendance. So if you are FDA registered your registrar would have every right to say that your mgmt reviews be signed or initialed as it falls under regulatory requirements.

ISO Guy, is that a new requirement of 13485? ? I left a medical devices company 3.5 years ago, led them through ISO, MDD, and several FDA audits. Mgmt Reviews were never signed and I never received a finding for it from either the Registrar/Notified Body or the FDA. Typed attendee listings were accepted.

ISO Guy, is that a new requirement of 13485? ? I left a medical devices company 3.5 years ago, led them through ISO, MDD, and several FDA audits. Mgmt Reviews were never signed and I never received a finding for it from either the Registrar/Notified Body or the FDA. Typed attendee listings were accepted.

Rosie, no it is not a new requirement for 13485. We recently had a client audit and the auditor was a former FDA inspector, she noticed that we did not have a signatures on one of our reviews (why o don't know all other reviews had initials of who attended) and made mention that the Inspectors like to see signatures/initials of those who attended the meeting. I am still trying to find in the QSR's where it states signatures are required but have been unable to locate it, not that I don't think it is a good idea, but if it keeps an FDA inspector happy and out of my hair I am all for it, heck we are doing it anway (well excpet for that one time) so no biggie.

Signatures for management review attendence...

It is interesting for an external auditor to be so formal with requiring an actual signature for proving attendence. Some are more "strict" than others, that's for sure.

I simply created a table at the top of our MR Minutes Form and have my recorder place an X by each individual's name. It shows that they were present or not present at the briefing. It is a simple approach and uses an objective party (recorder) to document attendence. Here is a simple example:

Present Name Role

X John Smith Management Representative
X Jeff Doe CEO
X COO
X CFO
X VP
VP
X Space Programs Manager

Rosie, no it is not a new requirement for 13485. We recently had a client audit and the auditor was a former FDA inspector, she noticed that we did not have a signatures on one of our reviews (why o don't know all other reviews had initials of who attended) and made mention that the Inspectors like to see signatures/initials of those who attended the meeting. I am still trying to find in the QSR's where it states signatures are required but have been unable to locate it, not that I don't think it is a good idea, but if it keeps an FDA inspector happy and out of my hair I am all for it, heck we are doing it anway (well excpet for that one time) so no biggie.Not only are signatures not required (only dates and results ref: 21cfr820.20(c)) but, FDA does not have the authority to view the results (ref: 21cfr820.180 Records (c) exceptions). You are only required to provide a certification that the reviews have taken place. This also applies to Internal Audits as well as Supplier Audits.

We use the attendence list and titles and date for TS16949. No signing by anyone has been required and we have been through 2 CB audits.