Lack of Registration Body Consistency in Transitioning

RoxaneB

RoxaneB

Super Moderator
Super Moderator
#1
#1
Registrar's Consistency in Transitioning

Originally, I had the angry icon for this post, but I think the unhappy is more apt. The lack of consistency with Registration bodies has once again reared its ugly head with one of my friends in the ISO world.

His company, a well-known company who shall remain nameless, is ISO 9001:1994 registered and just beginning to transition to ISO 9001:2000. The Registrar, who shall also remain nameless, was brought in to help explain what was required for the new Standard. It wasn't a Gap Analysis, but was basically a summary of the new requirements. Lo and behold, the following requirements exist according to this enlightened Registrar:

- a Quality Manual is not required;
- all documentation can be scrapped except for the six required procedures;
- the remaining procedures must be renumbered to correspond to the new Standard; and,
- anything in draft form can potentially be pitched into the nearest airlock and jettisoned.

But the whole lack of a Quality Manual is what has me steaming made. Followed with the fact that the Registrar is saying that the Organization can put off transitioning until January 2004...and maybe even March 2004 (whatever is convenient for the organization). :confused:

Has anyone else heard about Registrars providing such skewed information or am I just blowing all of this out of proportion?

Thanks!
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
R

Russ

Quite Involved in Discussions
#2
#2
Well we go through our first "transition" audit on Thursday. I have had no such information that a QM isn't needed. This guy is waaaaay out in left field. What has management at this place said about this registrar? If they don't give him his walking papers, well that tells a lot doesn't it! I hope he can show them where this guy is dead wrong.
 
R

Raul Rovirosa

#3
#3
Hello RC

I have never heard anything of this sort. Our company is also transitioning to the new standard. As far I know the Quality manual is the most important part of the documentation that needs to be revised when making the transition from 1994 to 2000. This has been told to me by our registrar.

All I can say everyday it seems to get a bit more confusing and the waters keep getting muddier.

:bigwave:

Regards
 
D

db

#4
#4
More

Jim Wade said:

We need to tell them what interpretation we intend to use, not ask them!
Click to expand...
Jim, I'm not sure I agree that the new standard is badly written. I guess it all depends on one's point of view. Your statement above is absolutely right on!!!!! This is why I don't think it is all that bad of a document. If we (hereinafter called the organization) determine the interpretations, then I think the document can't be all that bad. I am glad that I don't audit for a living. :smokin:
 
G

gpainter

Quite Involved in Discussions
#5
#5
After reading this and other post, the same problems arise as with the 87 & 94 versions. Read the introduction to the 00 standard 0.1, this may explain the confusion or make more so. I think it boils down to a generic standard that works for all. Is there such a thing (cure all)???? I think many of the problems go to:
the way business conducts itself in regard to registration ( if you register to improve or just to get the bottom wrung registration)
the registrars (auditors) for their shortfalls (lack Of consistancy)
the TC that writes the document for not saying what they mean
( no fuzzy language, no terms that need defination, an approved standard that needs no interpretation documents)
There needs to be a partnership with all these groups ( 1 of the 8 QMPs )when standards are written. I think they have attempted this on the new standard. So, I have some hope that future revisions will only improve. Its all big money: training, books, magazines, consultants, registrars,auditors,etc.
 
RoxaneB

RoxaneB

Super Moderator
Super Moderator
#6
#6
Ahhh...I've got more information on the situation. My friend is the ISO 14001 Mgmt Rep and was asked to sit in on this meeting. His coworker, the ISO 9001 Mgmt Rep was chairing this meeting and, by the sounds of it, has not done his homework with the new Standard. Top Management for this organization then has had no exposure to ISO 9001:2000, as well. Everything that this Registrar told them was taken at face value. *faint*

I learned early on in my ISO-life (around 1993) to take everything my Registrar says with a grain of salt...followed with "Show me where it says I *must* do that."

With my Registrar, rather that tell them what our plans are in detail, we ask them what they would accept when it comes to addressing items such as Customer Focus, Continual Improvement, etc. If their answer does not match ours, we simply state "That's nice, but here's what we're doing as per our interpretation."

The kicker is when we first did our Gap Analysis last summer, the consultant doing it was our former auditor from our Registrar. For every gap he found, he stated "Formalize it!" When questioned what he meant by formalize, his response was "Document it!" Folks, one of his gaps was how we use a newsletter to communicate to our employees about our Customer's requirements. He wants us to formlize (i.e., document) how we develop the newsletter!!! From arranging articles, to the approval process, to the editing process, etc. :frust:

Of course, not knowing much about the new standard, we blindly agreed to his "suggestions" and thus began the panic attack. The same thing is happening with my friend's organization.

Moral of the story?....before taking a Registrar's comments at face value, become familiar with the Standard!

Having since taken an ISO 9001:2000 Lead Auditor course and a Transition from ISO 9001:1994 to ISO 9001:2000 course, I've returned to the Gap Analysis performed by our consultant and tossed it. I've done my own and, while I'm potentially more biased towards our system than our consultant, our gaps are not quite as large as what he made them out to be.

I'm somewhat confused though by how my friend's Registar stated that they could successfully hold off on their Transition until January or even March 2004. I thought the date had to be by Dec 13, 2003...no if's, and's, or but's. Granted, my friend's company is a large, well-known, multi-national organization (up there with the Nike's and Coca-Cola's of the world). Is the Registrar just providing them with an extension in order to keep the business? :confused:

Sometimes I feel like the wonderful world of ISO should win an Emmy for all the soap opera sagas it has. :)
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Informational From RAPS – 27% Will be Compliant? Survey Highlights Lack of Readiness for EU MDR Medical Device and FDA Regulations and Standards News 0
C Neglect or legitimate deferral? Is excessive workload or lack of resources in a department or a team a valid root cause for a non-conformance? Problem Solving, Root Cause Fault and Failure Analysis 12
K FAA Audit - Major nonconformity for lack of timely calibration of two devices EASA and JAA Aviation Standards and Requirements 5
Q Lack of Awareness in ISO 9001 - Share a Presentation for Employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K Minitab Lack-of-Fit Test in DOE (Design of Experiments) Using Minitab Software 4
S Minor Nonconformity for Lack of Job Descriptions in ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 62
V Lack of Fit vs Pred-R-Square. Using Minitab Software 3
L Audit NC - Lack of Effective Corrective Action Process ISO 13485:2016 - Medical Device Quality Management Systems 4
S Corrective Action for Customers Lack/Delays in Payment Misc. Quality Assurance and Business Systems Related Topics 6
J Lack of Measureables in our Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
AnaMariaVR2 Warning letter addresses lack of training/education 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 22
S Lack of Will & Empowerment of Employees Human Factors and Ergonomics in Engineering 15
C Internal Auditor lack of Competence Internal Auditing 76
Jim Wynne Forklift Safety, or Lack Thereof Coffee Break and Water Cooler Discussions 4
P United Break Guitars - Customer (Lack of) Care Coffee Break and Water Cooler Discussions 2
J Measurement Uncertainty (MU) - Genetic Testing Lab - Lack of suitable CRM - ISO 17025 ISO 17025 related Discussions 6
Q Meeting behavior and lack of cooperation of attendees to manager ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
P Lack of 3rd Shift Internal Audit - Major or Minor NC (Nonconformance)? Internal Auditing 17
N Lack of Management Commitment? Surveillance audit is next month General Auditing Discussions 6
A Lack of Quality Presence in Strategic Meetings ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Lack of Management Commitment and Cooperation in Implementation of QMS! Quality Manager and Management Related Issues 36
N Raising a Nonconformance for Lack of Competency of Contractor ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
H Identifying the 7 Wastes and Adding "Lack of Creativity" as the 8th Waste Manufacturing and Related Processes 16
T NC: Lack of efficiency measurement for scheduling/shipping: clause 5.1.1 IATF 16949 - Automotive Quality Systems Standard 20
B Consequences for repeat nonconformances - Carelessness, lack of focus Nonconformance and Corrective Action 9
Jim Wynne Americans Love Science But... There is a lack of basic knowledge World News 14
M Broken Gages - Lack of Accountability General Measurement Device and Calibration Topics 11
M Lack of Training vs. Laziness: Failure to Complete Forms and Tags AFTER Training Training - Internal, External, Online and Distance Learning 68
J Problems with our internal auditors having a lack of motivation Internal Auditing 1
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 4
M Establishment Registration US Food and Drug Administration (FDA) 3
R Importers - For the FDA Registration/ Listing, is the CMO the importer? Medical Device and FDA Regulations and Standards News 6
A Registration requirements for custom branded device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
E Adding models to an approved Russian Registration Certificate Other Medical Device Regulations World-Wide 1
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
J Brazil Registration Holder Other Medical Device Regulations World-Wide 0
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
G ITAR Registration for Metrology Laboratory? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
A 510(k) registration and listing US Food and Drug Administration (FDA) 1
A GMDN Registration Basic preliminary Information EU Medical Device Regulations 0
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
F UDI Registration - Who is responsible for Registration of the Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
P Establishment Registration and Device listing - Wording of 807.20 (a) (6) Medical Device and FDA Regulations and Standards News 3
J Medical Device Registration in the UAE MoH Other Medical Device Regulations World-Wide 2
O Cancellation of Registration from ARTG - Sponsor Unresponsive Other Medical Device Regulations World-Wide 0
M Mexico Medical Device Registration Requirements Other Medical Device Regulations World-Wide 1
JoCam False information provided for Medical Device Registration - What are the implications? Other Medical Device Related Standards 3
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
T Reaction Plan To Drive suppliers to IATF 16949 registration IATF 16949 - Automotive Quality Systems Standard 4

Similar threads

Top Bottom