I am interested in hearing from folks who have solicited quotes from registrars and the quality of responses that they received.

In particular, I am interested in responses that have one or more of the following characteristics:

1. Quotes with confusing, ambiguous, or missing terms
2. Contractual reference to policies, procedures or other documents not provided with proposal.
3. Failure to match specifications (response to different terms, e.g. annual surveillances versus semi-monthly)
4. Significant spelling and grammatical errors or mistakes due to lack of attention, including;
a. Wrong company name
b. Wrong proposal submitted (belonging to another company)
c. Misspellings of words such as "registrar."
5. Absence of indicating days on site (for estimated traveling costs)
6. Wrong calculations of cost, including adding errors
7. Redundant, duplicate and/or conflicting responses from different offices of the same registrar
8. No response at all
9. Onerous terms (e.g. $100 charge for each travel receipt to support a claim for travel reimbursement)
10. Unlimited charges (e.g. $150 per hour travel charge)
11. Proposals not signed by a representative of the registrar
12. Unusual closeness of numbers presented by the other "competing" registrars.

What other "defects" have you encountered?

I have encountered all of these conditions over the past few years soliciting quotes for my clients. I usually canvas five or six top tier registrars and without disappointment most of the registrars respond with one or more of the above defects.

Thanks in advance for your input.

As an aside, have you by chance looked at the 'Registrars' comparison sheets in the pdf_files directory?

Look for:

Registrar_Interviewing.pdf
It will tell you what to look for, what to ask, and - of course - there are spreadsheets you can use to 'rate' registrars. I have seen every combination of what you state in your post. It's a company by company thing. I can't imagine charging for travel time, for example, but some registrars do. Some registrars charge full travel expenses, others have a 'cap' where (for example) they will charge no more than US$100 a day for food and hotel.

Registrars are popping up like rabbits. It's only a US$20K investment. Some are good, some are bad.

One thing I have noticed using the comparison sheets is that local registrars usually charge a bit more per auditor hour which often off-sets predicted travel savings of out-of-town registrars.

Yup - They're all different!

> I have encountered all of these conditions over the past
> few years soliciting quotes for my clients. I usually
> canvas five or six top tier registrars and without
> disappointment most of the registrars respond with one or
> more of the above defects.

Not unusual. Not at all.

And I typically require my clients to do the choosing - I only give some suggestions. I won't solicit a quote for them. I don't want a conflict of interest and I believe they should interview at least 3 registrars visit my client's facility to give their sales pitch before they quote. That way the client actually gets to meet a rep of the company. That alone can make or break consideration. If they send you a 'know nothing' sales or account rep - they're probably not a good choice.

I have came across all you stated. The most confusing usually involve the quote. Misc fees for copying, paper use, stamps, phone calls (yearly fee). auditor travel time, charges for use of marks, termination charge, schedule adjustment charges, charges for extra certificates.

Originally posted by gpainter

I have came across all you stated. The most confusing usually involve the quote. Misc fees for copying, paper use, stamps, phone calls (yearly fee). auditor travel time, charges for use of marks, termination charge, schedule adjustment charges, charges for extra certificates.I call this "...Nickel and Dimeing..." clients. That's why I made up the comparison spreadsheets and comparison presentation I listed above.

I do thank you for adding a couple (phone calls and stamps for example) that I haven't thought of. I'll have to update the files now... :thedeal:

Actually, we preferred to send an assessor out to do the sales visit, although he would not be the one to do the contracting he/she could answer the technical questions better than someone like me. Actually, I knew the technical information about approvals, I just didn't know about the actual audit.

But not all inquiries warranted a personal visit. A registrar has to look at the costs (taking an assessor out of the field to do a visit plus travel costs) weighed against the value of the contract and the liklihood of getting the contract. And a successful registrar isn't going to have someone available at the drop of the hat just sitting around not working,so there may not even be someone available to visit a "potential" client. Don't base your choice on whether they can send someone out to see you and if you approve of their choice. They have to use whoever they can sometimes, if at all.

I did many contracts. The costs were not hidden (although I know the registrars who do hide costs and what they were because keeping up with the competitors moves was important). The days onsite were spelled out, as well as any travel time that might be charged.

Marc, it is not unreasonable to charge to get an assessor to your facility. It is a fee-earning day and if he spends one day to get to you and one more day to fly back,that is two days that he is utilized on your behalf. For a local assessor, time may be charged by the hour (usually this is only if a subcontractor is used and that is what his contract with the registrar says). For other assessors, travel time may not be charged (depending on how specialized your industry is - medical device assessors are extremely costly and hard to come by so their time is almost always charged) but travel costs are. My registrar did not charge an add-on like 10% for "handling" the travel costs, jusst actual costs and the administrative time was just something we "ate".

Charges for extra accreditation marks are valid! These are pass-through expenses. The registrar doesn't make money on it. The accreditation bodies are paid for each time the mark is issued. So if you want the mark, you need to pay for it.

We had NO extra fees, beyond the time spent on-site, any travel time (which was extremely flexible), actual travel expenses, and extra accreditation marks beyond the complementary one. Nothing else. Well, there was an "additional certificate" charge beyond the first two that were provided, but we always told the client that there was no copyright on the cert and they could make as many Xerox or Kinko color copies as they wanted. If they insisted that they need another original, the extra charge was just to cover the special cert paper, of course the administrative time to print and package it, and the FedEx charges (because we could never send it anything but FedEx for tracking purposes).

The price would always look high to start with to a "prospect" because the initial comparison was always to the day rate. But total expenses over the 3 year period is what counts.

That is why I've maintained that the "top tier" registrars are not that much more than the others! Look beyond the day rate.

> Marc, it is not unreasonable to charge to get an assessor
> to your facility. It is a fee-earning day and if he spends
> one day to get to you and one more day to fly back,that is
> two days that he is utilized on your behalf. For a local
> assessor, time may be charged by the hour (usually this is
> only if a subcontractor is used and that is what his
> contract with the registrar says). For other assessors,
> travel time may not be charged (depending on how
> specialized your industry is - medical device assessors
> are extremely costly and hard to come by so their time is
> almost always charged) but travel costs are. My registrar
> did not charge an add-on like 10% for "handling" the
> travel costs, jusst actual costs and the administrative
> time was just something we "ate".

I've done this long enough to understand this and in general I agree with what you are saying. If I have a client in Tampa and go for 3 days it is 5 days to me (a day to get there and a day to return). If I'm at a facility for 5 hours, it's usualy 2 or more back in the hotel room 'filling in the details', etc.

My point is there are registrars who do 'hide' costs (as you agree) and/or 'Nickel and Dime' (multiple little charges for this and that) and this is something one should look at. I don't see it as an issue of whether the charges are valid or not - let's assume they all are vaild - give me something I can understand rather than an Enron contract. And if I ask a prospective registrar to send an auditor for an interview prior to 'signing on' and they refuse because the account isn't worth it, they're not gonna help me out anywhere else, either - so they'd be off my list immediately. I do agree that asking for an auditor is of little value as it's a game of switcheroo with auditors these days - used to be you could get registrars to agree to send the same auditor to audit each time but auditors are like truck drivers any more - registrars don't have the control over auditors they once had. Many wil only do contract work.

I will say this is sad. With one major client we had an audit in Singapore and then one somewhere else (I forget now). Same product and processes just different countries. There were so many inconsistencies between the auditors at the different plants that we stopped the process and demanded ONE specific, non-changing (the same person) auditor be assigned as lead auditor at EVERY audit at every facility. We could only audit one facility at a time - which slowed things down - but the inconsistencies between the auditors and their various interpretations of the standard would have cost more. Luckily my client was a very large multi-national whose account was worth kissing :ca: to keep.

Yes - company size (read $) counts. Alot. Money talks. When I worked with Motorola, we had a lot of clout with the registrar. We got many things we literally demanded and because the account was worth so much money the registrar did 'what was necessary'.

I know what you said about FedEx and their registration and I've accepted the sampling explaination. However, as Phyllis pointed out early on in the listserve discussion, if you ask a FedEx driver about ISO and get a blank stare and a "I don't know what an ISO is" - that tells me something. Having personally asked this and gotten the answer above, what am I to think?

> That is why I've maintained that the "top tier" registrars
> are not that much more than the others! Look beyond the
> day rate.

I have more often found local registrars are just as expensive, if not moreso, in the long run as 'top tier' registrars - so to me this isn't an issue.

As I said before, one can assess the registrars one is interested in and from there on out - as far as I'm concerned - it becomes a personal matter between the client and the registrar. To me such a thorough assessment of the registrar (and their contract) is nothing less than Contract Review on the part of the company seeking a registrar. If they do it poorly, shame on them. That's why I provide clients with comparison spreadsheets and a presentation on what to ask. :thedeal:

Marc,

Back to the personal sales visit by an assessor.......If an assessor can be made available to do a sales visit (which is extremely difficult), the vast odds are that they are not the assessor who is going to be doing the audit. They are only there to answer audit type questions that the company may have. They aren't there for a personal interview.

Why is it that people are willing to wait two months for a dentist appt. with a good dentist, or a month for a cabinet contractor, but find it unacceptable that a good registrar is also busy and doesn't have people standing around not working, much less the one out of 15 who are coded for your industry? (because the registrars and the accreditation bodies DO care about industry experience even if you don't).

Trying to free up (read: take off of a confirmed job with an existing client who wants the same assessor each time, thus pi$$ing them off to get a last minute substitute instead so that their regular assessor can jog off to see someone who may or may not actually sign a contract that will be worth perhaps 3 times over a three year period what the loss of fee-earning time plus walk-up airfare, car hire, etc. will cost for the visit...) the EXACT assessor that is proposed is quite difficult.

It is quite possible to arrange a telephone "interview" with the assessor that the registrar would most likely use. I would encourage everyone to consider this option. In this day and age, where people are scattered here there and everywhere and timing a meeting (even within an office) is a major feat, it accomplishes what you want and is more accommodating for both parties.

My comment regarding not being critical of whoever the registrar is able to send you for the sales visit, was just about the sales visit, not the continuity of registration. For the audit and surveillance visits, you should expect the same assessor primarily for each visit. Sometimes things happen and a substitution has to be made, but it is not unreasonable to ask for the same assessor to return each time. It is the first thing that a registrar tries to do - believe me, it makes long-term scheduling a whole lot easier to use the same assessor!

However, after a certain number of visits, a fresh pair of eyes is needed for the benefit of the client and for the benefit of the registrar. We had some clients who insisted that a new assessor be used after awhile, and there were some who resisted when we had to insist on sending out someone new after a period of several years.

I know the women (and the key assessor) who have managed the Motorola account for the last 5 years, so I am aware of the Motorola req's. and you are correct that the sheer volume of the business is what makes it possible. And their willingness to provide travel comforts for the assigned assessor who travels worldwide. I could name other large clients who were equally as willing to shell out the money to make it possible to use the same assessor world-wide.

I wouldn't expect the FedEx driver to know a darn thing about ISO!! Gosh, most people would look at you blankly! Even my boss! What is important is that he was hired based on established criteria, was trained as appropriate, has his authorities and responsibilities adequately communicated, and he knows how to perform his job and how his job impacts the process flow. He should also know how to find out how to do a task if he doesn't know how ( where procedures are kept, or the person to ask), and whatever else I'm missing. But the point is, all he needs to know is that FedEx cares about quality, what FedEx considers to be quality (or where he can find this info out) and how his job contributes. He doesn't have to know about ISO being the backbone of their QMS.

Keep in mind, some FedEx workers are temp staff and an organization usually has different req's for the degree of participation/information in QMS for temp staff.

I have "no proof" of the following but have been told it happens.

What does everyone think about a Registrar that may be charging Full Fair round trip air-flight... to EACH client.

When the schedule being followed is a continous weekly loop from client to client? - sometimes by short hop plane - other times by automobile? Justifying the charge by verbally stating - If you were our only client - that's what it should have cost?

Jim,

Do you mean charging two clients the same round-trip airfare? That would be very wrong. And I wonder how the registrar's finance dept. balances its books?? What would they possibly code the extra income? WF for Windfall?

But there are circumstances when a round-trip is the smarter and cheaper thing to do:

Usually an assessor will have his whole week planned out to fly to one city, then from that city to the next, and then to the next city, and then home (this would be the scenario for three one-day surveillance visits). It may end up being cheaper to book roundtrips on parts of that, than single one-ways - even if the return leg isn't used. This is especially true for the larger gateway airports. Or it may be necessary to book a roundtrip to get the flight time that is required to make it to the next client, even if the return leg isn't used.

Also, an assessor may have booked a ticket well in advance (to get the advance discount for the client) and there was only one client that week to start with. Now he is informed that there is a second job added on and he has to make travel arrangements. The first ticket stays as a roundtrip because it's cheaper than changing it at this point to a one-way. The second ticket ends up being a round trip from the first airport to the second destination, and back again to catch the second leg home. This is very taxing on the assessor and not what he would prefer to do but is cheaper for the client.

With two clients within driving distance of each other, they should share the airfare and car hire cost, not both pay for the full airfare.

I have booked "open jaw" roundtrip tickets for assessors returning to the same state within the month. They leave NY (for ex.) and fly to CA on the first leg of one round trip and return to NY on the first leg of a second round trip for the first trip to CA; then go back out to CA for more clients a few weeks later on the return leg of the second round trip, and back home again finally on the return leg of the first roundtrip. This could be done for two weeks back to back too so that every ticket had a Saturday stay and was significantly cheaper. The client may not understand the ticket dates and want to argue, but there is very good reasoning behind the actions.

A conscientious registrar will make the effort to keep your costs down. If you prefer, you can ask to make the arrangements yourself, although be prepared to accommodate the rest of the assessor's week and whatever changes come about (like a last-minute sales visit to Marc's client :biglaugh: :cool: )

The registrar should spend your money for you as if it were their own. If they don't, have them use the travel agency that you trust. We had clients who requested this, and it was accommodated.

> Back to the personal sales visit by an assessor.......If
> an assessor can be made available to do a sales visit
> (which is extremely difficult), the vast odds are that
> they are not the assessor who is going to be doing the
> audit. They are only there to answer audit type questions
> that the company may have. They aren't there for a
> personal interview.

As I said, I don't see this as an issue (the actual auditor visiting) as since about 1996 there were few if any registrars who will guarantee the same assessor. So - that's moot. Let's drop the assesor visit, but many times I still want a personal visit from a member of the company. That's my 'expectation' - like it or not.

You bring up a time issue - about assessors not sitting around doing nothing. That's a smoke screen. If IBM called a registrar for an interview which could lead to an IBM wide contract, the registrar would dig one up pronto! IBM = $

> It is quite possible to arrange a telephone "interview"
> with the assessor that the registrar would most likely
> use. I would encourage everyone to consider this option.
> In this day and age, where people are scattered here there
> and everywhere and timing a meeting (even within an
> office) is a major feat, it accomplishes what you want and
> is more accommodating for both parties.

Sometimes this is OK - but typically I want to meet the people (or at least their representative) and talk face to face. How many people are hired for jobs over the phone? Companies always asked me for a face to face interview. There is a reason for this. Registrars are no different.

I can't remember a contract I ever got that I was not required to first go and meet them (which I pay for). They want to interview me - then they check references. If I'm interested in the contract I go. And I pay my own way, pay for presentation materials, etc. Some contracts I win and some I lose. But all have wanted to interview me - in person.

> For the audit and surveillance visits, you should expect
> the same assessor primarily for each visit.

That doesn't happen anymore unless you get a small registrar or you're a big company and demand it. I - to this day - get complaints from former clients about a different auditor or set of auditors at each audit. Having a 'dedicated' auditor is seldom a reality anymore. The calls I get are almost always the same - different auditor telling them there is a problem where several earlier auditors who looked at 'it' before (yes - in detail) said they were compliant. Having the same auditor at every visit is for most, I would bet, a pipe dream (one of which I prsonally feel coming on right now...) I have several small clients who are with large registrars (one registered since 1996) and they have not ever (not once) had the same auditor. So to me asking for the same auditor is typically a good laugh - unless your company is big enough.

> I wouldn't expect the FedEx driver to know a darn thing
> about ISO!! Gosh, most people would look at you blankly!
> Even my boss!

This is my basic disagreement. Why are line personnel asked about the quality policy and what ISO is in a 'normal' registration? If FedEx drivers are employees (temporary or full-time) why are they exempt while at all my clients even the janitor is open to be interviewed and expected to know the company quality policy (or what it means to them), what ISO is to them and other such odds and ends. Is the FedEx driver not a part of the FedEx company? Are FedEx drivers 'better' in some way than line personnel in a manufacturing facility that they don't have to know a dang thing about it? Why do FedEx drivers get a pass?

Using your arguement only a select few in any company has to know anything about ISO - or that their company even IS ISO registered. That isn't what happened in any registration - large or small - that I have ever been involved in. Registrars are now even looking for ISO training for everyone - even line personnel and temporary workers. At harlewy-Davidson it took us 2 days and nights leading every employee through a basic ISO 'training' course.

Don't start me on Customer Complaints with FedEx. I admit I used to swear by FedEx - I sang their praises - but over the last couple of years UPS has won back all my business.

> I know the women (and the key assessor) who have managed
> the Motorola account for the last 5 years, so I am aware
> of the Motorola req's. and you are correct that the sheer
> volume of the business is what makes it possible. And
> their willingness to provide travel comforts for the
> assigned assessor who travels worldwide. I could name
> other large clients who were equally as willing to shell
> out the money to make it possible to use the same assessor
> world-wide.

Which tells us what? It tells us if your account is big enough you can get what you want. Oh, but for the rest of the companies... Motorola did this because of the differences in auditor interpretations - damning of the ISO/QS documents in and of its self. I was there. It wasn't Motorola's:
> willingness to provide travel comforts for the
It was differences in auditor interpretations which Motorola could not endure.

Even worse.... This is an indictment of ISO 9001 its self - if you have to have one auditor to ensure repeatability of interpretations at each location, what does that tell us? It tells me ISO 9001 is so vague and auditors are so different in their interpretations that registration is questionable. One company passes and another fails - everything being the same except the auditor(s) who did the audit.

> Do you mean charging two clients the same round-trip
> airfare? That would be very wrong.

Yup - I've seen this as well - and I've taken registrars to task over the practice. But not every registrar does this. Entela is one that 'groups' visits when possible and travel costs are split up between all the clients. That'as one reason I like Entela - I think they're basically honest.

Just my 2 cents. :thedeal:

Originally posted by Marc

I've done this long enough to understand this and in general I agree with what you are saying. If I have a client in Tampa and go for 3 days it is 5 days to me (a day to get there and a day to return). If I'm at a facility for 5 hours, it's usualy 2 or more back in the hotel room 'filling in the details', etc.

I think charging for traveling time is a joke espically at $150 an hour! That is what our registrar charged us 150x9hours= $1350 that is a bunch of BS!! These "charges" should be built into their system rather than charging for travel time. I guess travel time would no bother me so much if we were not being charged $1400 for on-site reports $1250 for a final report, $600 for a copy of our Certificate what a &^@*( joke!! After all is said and done 20K for a visit and why, becuase they are big enough to be able to do this. I have suggested switching (quote for 1/3 the cost) but the owners say no. We get terrible customer service from them it has been over 2 months since our audit and yet to see our new cert. I have e-mailed called etc.. and no response. I know this is off the topic a bit but it just makes me so mad when I think about it!
:mad: :mad:

Try making a formal complaint and request an 8-D corrective action. :biglaugh:

Happy holidays.

Dave

Personally I charge for travel, etc. - in a sense. It's all built in. I don't charge for travel costs or travel time, meals, hotel or anything individually. I figure out what it will cost me and give a quote - a number - which includes all the 'details'. No muss, no fuss, no confusion. The daily rate I quote includes everything.

Even when I do training for an implementation client - it's at the daily rate, independent of the number of trainees. This is, however, the one exception - I charge a per attendee fee for manuals and materials in addition to my daily rate - but I make this very clear at the beginning (except for Internal Auditor training, this is typically only a QS or TS issue - not an ISO issue, as it's typically FMEA, APQP or other specialized training).

If you're near me (like in northern Cincinnati) my daily rate is much, much cheaper than if you're in New Mexico. :thedeal:

Originally posted by ISO GUY

I think charging for traveling time is a joke espically at $150 an hour!Is this for an ISO 9001 audit or are we talking FDA here? If you're talking straight ISO 9001, you need to find a reasonable registrar. :thedeal:

Originally posted by D.Scott

Try making a formal complaint and request an 8-D corrective action. :biglaugh:If you're talking FedEx, that's the big reason I went back to UPS. I didn't ask for an 8-D, but about a year ago I got the run around with FedEx over a screwup on their end and the complaint person basicaly told me to buzz off and use another provider. Of course, I'm a small, infrequent user so it didn't surprise me. I will say now when I shop by catalogue or on the internet, I specifically look to see who provides their carrier services. If it's FedEx, I request UPS. If that's a no-go I have gone so far as ordering from another company.

Only a big company, such as Ford, would dare request a corrective action from FedEx.

Ah yes. FedEx. Mr. Smith brought a great company into the world but it has disintegrated into mediocrity. :thedeal:

Originally posted by Marc
Is this for an ISO 9001 audit or are we talking FDA here? If you're talking straight ISO 9001, you need to find a reasonable registrar. :thedeal:

Marc this was for an ISO/EN audit. I have given the owners of the company I work for quotes from other Registrars for about 1/3 of what our current Ripoffastrar is charging us. They do not want to switch because, " Some of our clients have use the same Registrar so if we are certified by them they they know we are good." I say BS you people are idiots, they don't care who we use as long as we have our certification, these companies come in and audit us every year anyways. All I can do is say hey I gave them the information it is up to them to make the money decision.

Well, it boils down to an upper management decision - good or bad. A lot of companies hire companies like Arthur Anderson based upon reputation despite the high fees. The recent Enron debacle is evidence that the big, well know, supposed 'super experts' aren't all they're cracked up to be. :thedeal:

Part of the problem with registrars, IMHO, is that their auditors often don’t know the rules. For example:

An auditor told a client of mine that flowcharts cannot be used for procedures. Procedures must be in narrative form, with paragraphs numbered.

An auditor told a die maker (TE) that he had to perform a complete PPAP, including the 300 part run. The die maker stated that this was performed during the 20 hour test, but was told that he had to make 300 die sets! (the customer only ordered two sets).

An auditor told a manufacturer that because their customer sends back nonconforming parts, that servicing applies.

An auditor wrote a major nonconformance during a surveillance audit because the company did not have all the requirements from the Big 3. The company does not any of the big three as their customers. When informed about Note 5, the auditor stated that if it was not in the body of the document, it doesn’t apply.

Perhaps we should start a new thread on registrar horror stories (or even consultant horror stories)

Dave B (the other Dave)

> Perhaps we should start a new thread on registrar horror
> stories (or even consultant horror stories)

Start with http://Elsmar.com/Forums/showthread.php?t=3865 for a recent one. Sadly, there are horror stories about auditors, registrars and consultants in many, many threads here. :thedeal:

Marc-

You mentioned the FDA and travel expenses above. Just to clarify this, the FDA doesn't charge companies for any of their expenses. All of their money comes from the taxpayers (e.g; you and me).

Alf

Yes - I understand that. I was really thinking of 'independent' auditors and consultants which deal with companies who are making products where the FDA is involved. Those folks are expensive. I apologise for the misunderstanding.

I guess it's now two weeks ago I was in Boston interviewing for a position with the Arthur D Little company. I was interested and was willing to join up cheap (well, what I thought was cheap) for the FDA experience I would gain (it was with the food and drug group). The main part of the postion was as their ISO Coordinator. They said no early this week - that I am "over qualified and over priced". So it goes... :thedeal:

Marc,

You are correct that the medical device consultants are very expensive. And so then are the assessors who the registrars use for EN and CE. Because these are the same folks! We are feeding from the same trough as someone (was it Randy?) pointed out earlier.

These folks can make all the money they want because becoming approved is a long and hard road. For a registrar to offer EN and CE marking services as a notified body, they have to present sterling credentials for their assessors, which includes actual manufacturing experience as well as quality for the specific categories of medical device.

The assessors can make mega bucks on their own either within the medical industry or as a consultant. Or a registrar can pony up and convince them to be an assessor.

These qualified assessors are located hit and miss around the globe. To get the one with the blood experience, long term contact, etc. etc. for your industry may very well involve flying them in from another country. The registrar can either charge you a $5000 day rate for each day on site, or they can charge you a normal day rate, plus the actual travel time. Either way, that assessor's time has to be paid for. The registration business is not a charity.

I can't disagree with a thing you're saying. That's why I really wanted in at AD Little. I figured if I could get 5 or 10 years in with ADL my 'senior' years (when I'm in my sixties) would be much more comfortable with FDA experience credentials. But, I lost out. :( Getting FDA credentials is about as hard as getting credentialled in nuclear auditing and consulting.

Originally posted by Lucinda



For a registrar to offer EN and CE marking services as a notified body, they have to present sterling credentials for their assessors, which includes actual manufacturing experience as well as quality for the specific categories of medical device.



Lucinda I am sure you are right about that, however, I have to question the auditors our Registrar/Notified body have been sending us. The company I am currently with right now has had 2 survveillance and one re-certification audit since I have been here and I just laugh to myself how little they know and how much I can spoon feed them things I want them to see. Makes you wonder a little.

This is an old thread, but I'll throw in my 2 cents, since the topic is still quite relevant.

I have done this ISO stuff for 10 years in 3 different industries, using 3 different Registrars. My best experience was with BSI, who is a not for profit and charges a flat fee. No haggling over airfare, no arguments about expenses. It was wonderful. :D

I used them when I was working for a medical devices manufacturer and was working for initial ISO, EN and CE marks. I found them to be extremely helpful, and very fair. On my first sterilization validation, their Microbiologist walked me through the process and taught me what no seminar, or book could. They were enablers.

I have not had the same experience with my other two Registrars, both of whom are internationally recognized names. My present Registrar has done such a bad job that several managers in my company are wondering if ISO is still worth it. Three MONTHS after my 3 year renewal and 2000 upgrade, I still don't have a contract. If I could convince my boss, I'd change Registrars in a nanosecond.

This just happened to me three weeks ago. I got a bill for a surveillance audit where the guy flew up from Mississippi, but charged $1300 for airfare. Now I know it doesn't cost that kind of money from Mississippi (on second thought, it might cost that much to leave Mississippi). Anyway, I thought that was outrageous.:thedeal:

Good Lord, Jim, where do I begin? :frust:

We've been registered for 9 years, and used the same Registrar for that whole period.

We did our 3 year renewal and 2000 upgrade, along with a scope extension in April.

1. The Registrar's office didn't process my scope extension request, and the lead auditor arrived on site telling me it couldn't be done on "short notice". (he was persuded to change his mind) However, 5 hours of the audit was dedicated to unraveling what went wrong and what had to be done.

2. The schedule I got from the office was totally wrong. Wrong arrival dates, wrong auditor names. I set an agenda for my internal people that had to be revised 3 times in the last 48 hours before the audit.

3. The lead auditor asked to see my contract, which I had been expediting but had not received, (and STILL don't have) and then suggested that he couldn't do the audit without the contract. Excuse me?? Who's responsible for getting it to me??

4. Because of the hold-up with #1, both auditors got very behind schedule and we had no closing meetings. When I had a chance to sit down and absorb the improvement notes written, at least three of the seven were in error. (EX: the auditor wrote us up for unlabeled NC material, when what he was looking at was an incoming RMA in the process of being received. I suppose this is partly my fault for having an escort assigned to him who wasn't paying attention)

5. Both auditors were confrontational and really POed a number of my managers. These are people who are used to being audited and whom I find easy to work with.

6. The Lead Auditor, because he was in a rush to make an airplane, asked me to buy a money order for him and mail in a speeding ticket fine he got while he was here. (He isn't US based) I've never had an auditor ask me to do a personal errand for him/her before, especially after such a disasterous audit. I might be inclined to do this for an auditor I worked with regularly and had a relationship with, but I'd never met this guy before.

7. The audit cost us $1200. more than we'd budgeted for (based on 9 years of history) because of a last minute scheduling conflict that caused the agency to substitute auditors and fly someone in from another country.

We got through it, but I requested that these two gentlemen be banned from returning to my company in perpetuity. Further, like many companies, my company is going through lean times and management is questioning the value of the money they spend on this ISO cert, especially after the $1200. "surprise".

Rosie

You can select your auditors, dont accept that you have to take what you are given.

Jim

There are good and bad auditors within all the certification bodies, you can ask your body for another auditor if you do not agree with their approach. An ex-boss of mine used to bring his auditor with him when he moved from job to job, even if the new company was already certified under the same body.

Jim, I don't think that having ISO certification gets us new business, but I do think it has become a base expectation of our customers. I believe that our competitors would just LOVE us to terminate our certificate so they could use this as leverage with customers. I know I'd do that if one of my competitors terminated theirs.

I am a believer in ISO 9001. I've been around long enough to remember what life was like with antique standards like 45208. But we do have to weigh needs/benefits these days, and if Registrars are difficult to work with, that just adds fuel to the fire of those who think it's a lot of BS.