Does your registrar have Specific Requirements outside those of the standard?

Does your registrar have any requirements outside those of the standard?

  • Yes

    Votes: 5 50.0%
  • No

    Votes: 5 50.0%

  • Total voters
    10
Elsmar Forum Sponsor

SteelMaiden

Super Moderator
Super Moderator
#3
Each of the registrars I have worked with have had some requirements above the standard. Most of them deal with administrative type issues, nothing "big" but sometimes annoying. One required that we keep a documented list of how each of our records was filed (date - filed newest to oldest or oldest to newest, customer - alphanumeric or by customer number) this was kind of a pain...most of the time it is immediately apparent how things are filed when you open the draw, but oh well, we knew the answers and it took so little time and resources that it wasn't worth fighting over.
 
B

Bob_M

#4
Minor Issue

Registrar requires us to have a 2nd or deputy Management Rep assigned within our company. No big deal. Doesn't mean much unless I'm out sick during a surviellance audit. I have not found any other "special" requirments yet...
 
R

RosieA

#5
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.
 

Randy

Super Moderator
#6
RosieA said:
Registrar #1: Required by contract a stockist checklist. What was not in the contract was the requirement to have the quality policy memorized.
Anybody that requires people to memorize the QP is a boob (nothing to do with body parts).

Deputy mgmt rep....just a good common sense practice anyway

Signed mgmnt review minutes....I ain't gonna go back down this trail, that's in another thread, but I figured as much.
 
#7
Our registrar required a 3 page "custome rrequiremnts profile" tied to each clause of TS2. Also required a spreadsheet identifying COP's, inputs, outputs, measures, process owners, procedures and work instructions.
Note: COP's are not required by TS2.
 
E

energy

#8
Just desserts

RosieA said:
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.
And registrar #5 may want his/her own office with a lockable door, a telephone and, of course, a window. Preferrably yours.That's where the problem is. If the MR/QA Mgr did their Registrar interview correctly, they would sniff out these overbearing pompous bottom feeders at the very beginning. You get what you deserve because you didn't do your homework. If you inherited the mess, my condolences. Somebody dropped the ball. I interviewed three potential Registrars and two of them didn't have a chance. I got tired of staring up into those arrogant nostrils and they were cordially sent on their way. The one selected was extremely candid and very likable. When I posted this some time ago, I was told that I should be on the lookout for Charlatans in the industry. Why? Because, in some minds, no Registrar worth their salt should be likable. I say, If you expect crap, you will get it. If you take crap, you will get more of it! JMHO. :smokin:
 
A

Aaron Lupo

#9
Our former Registrar/Notified body had a special requirment that they did not convey. When we left them they were holding one of our customers cert. hostage becuase we went with an American Registrar and they siad that the EU Notified bodies have an unwritten agreement that in order for our cert to be valid it had to be done by someone in their little circle, so being that we didnt want to lose our largest customer we had to do what they said. Ohh those German Registrars! :mad:
 
A

Aaron Lupo

#10
RosieA said:
Registrar #1: Required by contract a stockist checklist. What was not in the contract was the requirement to have the quality policy memorized.
Was it the Registrar that required the QP to be memorized or the auditor there is a big difference. I have never heard anyone requiring the QP be memorized. I do audits for two Registrars and only ask the people to explain it to me in their own words, what it means to them and how they help support it in their function. Having a second/backup mgmt rep is pretty common most functions in a company do have backups!

No additional comments on Registrar#4, I think the point has been made in another thread. :truce:
 
Thread starter Similar threads Forum Replies Date
N Does anyone know a registrar that offers both ISO 9001 and ISO 17020? Registrars and Notified Bodies 6
A How does your registrar handle 2 certificates, one for AS9100 and one for ISO9001? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
R How long does it take for registrar to issue certificate? Registrars and Notified Bodies 8
Sidney Vianna Does your Registrar have a high Auditor Turnover Rate? Registrars and Notified Bodies 15
A Does your Registrar ask folks "Who's the Management Representative"? General Auditing Discussions 58
T How much does an accreditation body charge a registrar for auditing? Registrars and Notified Bodies 5
A Does anyone have any experience in changing their certification body (registrar)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
Watchcat Does "Similar Device" = "Predicate"? EU Medical Device Regulations 7
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
M Definition Open Audit - What does an Open Audit mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
I Does training have to be written? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P What does UPH/m² mean? Quality Tools, Improvement and Analysis 3
L "IATF-Compliant" IATF 16949:2016 certification? What does this mean? IATF 16949 - Automotive Quality Systems Standard 13
D Why does Official Journal list superseded standards? EU Medical Device Regulations 6
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
R Does any here use an internal auditing tool that works on different platforms? Internal Auditing 3
Sidney Vianna IAQG SCMH explains "positive risk"..........but does it? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 29
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1

Similar threads

Top Bottom