SBS - The best value in QMS software

Would you spend your own $$$ for ISO 9001 registration

Would you spend your own money for ISO 9001 registration?

  • Yes

    Votes: 11 27.5%
  • No

    Votes: 29 72.5%

  • Total voters
    40
C

Carl Keller

Boy, I picked the wrong days to have my office redecorated!

We could argue and give chapter and verse about teh standard and the associated guide till the cows come home, but in the end, ISO auditors should not be giving suggestions for anything related to the ISO standard, much less those things in your system that are not ISO related.

If you want your ISO system audited, get an ISO auditor.

If you want business or manufacturing related improvement suggestions, get a consultant that specializes in that area.

Industry is too competitive to put even a fraction of your company potential on the line by sharing even minor practices with soemone who may be in the competitors den in a week. Regardless of whether they are ethical or not.

I would say that those that do not see the problem with it are the very reason I would not want them in my facility.

Carl-
 
Elsmar Forum Sponsor
D

Don Palmer

JSW05 said:
:truce: I give up.
It APPEARS you may have been outclassed. After viewing Paul's website through the profile link, I had little doubt as to the outcome of this debate. :lmao:

JSW05, :applause: You're :agree1:
 

Jim Wynne

Staff member
Admin
Muleskinner said:
It APPEARS you may have been outclassed. After viewing Paul's website through the profile link, I had little doubt as to the outcome of this debate. :lmao:

JSW05, :applause: You're :agree1:
Thank you. It's kind of like drinking beer--I know my limit. Sometimes I don't stop there, but I know where it is.:lol:
 

Wes Bucey

Prophet of Profit
JSW05 said:
Whatever puts the fire out :biglaugh:
What do you say, Carl? Shall we let James drink out of the boot?
JSW05 said:
:truce: I give up.
Nooooooo! Say it isn't so!:lmao:
Muleskinner said:
It APPEARS you may have been outclassed. After viewing Paul's website through the profile link, I had little doubt as to the outcome of this debate. :lmao:
OUCH! 404 codes do NOT a website make!:rolleyes:
Carl Keller said:
I would say that those that do not see the problem with it are the very reason I would not want them in my facility.
Amen!
Perhaps on that note, we ought to close the thread. Any objections?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
Wes Bucey said:
Perhaps on that note, we ought to close the thread. Any objections?
Hi Wes. I am not a forum moderator. What is meant by closing a thread? Or do you mean closing the poll?
In my experience closing threads was something done only in case of extreme situations where things got way out of hand and personal attacks went much beyond the casual heated discussions. Personally I don't think this was the case in this thread. What purpose would serve "closing this thread"?
 

Wes Bucey

Prophet of Profit
Sidney Vianna said:
Hi Wes. I am not a forum moderator. What is meant by closing a thread? Or do you mean closing the poll?
In my experience closing threads was something done only in case of extreme situations where things got way out of hand and personal attacks went much beyond the casual heated discussions. Personally I don't think this was the case in this thread. What purpose would serve "closing this thread"?
There are several options to closing a thread:

  1. Delete entirely - not contemplated here
  2. Close and hide - usually a temporary measure while Moderators and Administrators debate about content
  3. Close to additional comment, but leave visible for reference purposes (contemplated here)
My reasoning (not firm, which is why I asked for opinion) is that two sides have a basic disagreement about interpreting a specific document (Guide 62) and have exhausted civil debate on the matter. I proposed to close it before emotions get out of hand. We have already devolved on one side to "displacement" (a term in comparative psychology where the subject transfers to a different topic in order to avoid a direct confrontation. Animals protecting territories often do this by stopping to preen themselves or appearing to lose interest instead of battling an encroacher.) The switch to humor, however crude or rude, is a prime example of human displacement.

If you have an interpretation of Guide 62 or a later version which resolves the issue, please post!
 

Sidney Vianna

Post Responsibly
Staff member
Admin
My take

Thanks for the explanation. Since you are asking for feedback, I don't think this thread should be closed. While there are two strongly opposing views to the subject, I believe that civility has been reinstated.

There are no new revisions to the IAF Guidance document. As I mentioned already, ISO 17021 is being developed to replace ISO Guide 62.
I suspect that this thread, if allowed to continue, will continue to receive a lot of attention (over 3750 views so far). And increasing traffic to the Cove is a good thing.
 
Last edited:
Thread starter Similar threads Forum Replies Date
M Justifying the Cost of Quality? Money that we spend on the quality system Misc. Quality Assurance and Business Systems Related Topics 24
Hershal How did you spend New Years? 2009 Coffee Break and Water Cooler Discussions 8
P To make money, You have to spend money Coffee Break and Water Cooler Discussions 13
G BillMyParents makes it easy for kids to spend parents' money After Work and Weekend Discussion Topics 5
BradM How much can you spend in a month? World News 9
K Calibration - Not willing to spend money in calibration/preventive maintenance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
A How much time do you spend on the factory floor? Philosophy, Gurus, Innovation and Evolution 18
S How will you spend your spare time? Hobbies? Coffee Break and Water Cooler Discussions 23
T How Much Time Do You Spend Training A New Internal Auditor? (Poll) Internal Auditing 56
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 4
M Who needs a MDEL? How to buy and sell medical devices on my own Canada Medical Device Regulations 14
J Create your own symbol? Other Medical Device Related Standards 7
L Contracted Manufacture Company wanting to be able to design and manufacture own product. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S 510k: What to include if your own device is the predicate US Food and Drug Administration (FDA) 5
M Software Development Company - Who would own the whole process and the certification afterwards? ISO 14001:2015 Specific Discussions 1
K ISO 17025:2017 clause 7.6.2 - Performing calibration of its own equipment shall evaluate the measurement uncertainty ISO 17025 related Discussions 6
C Can You Internally Audit a Process You Own? Internal Auditing 25
S Calibrating our own equipment, can we? Micrometers to calibrate vernier calipers General Measurement Device and Calibration Topics 13
A Validating my own application developed with Agile Qualification and Validation (including 21 CFR Part 11) 5
U Own Procedure was not effectively implemented Problem Solving, Root Cause Fault and Failure Analysis 3
V Who should define and own the Design and Development Plan and how to maintain the updates and revisions. ISO 13485:2016 - Medical Device Quality Management Systems 2
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 149
C Can we be our own EU authorised representative? EU Medical Device Regulations 34
N Own brand labelling/virtual manufacture of IVD's EU Medical Device Regulations 2
N How to obtain Own Brand Label (OBL) CE Marking? EU Medical Device Regulations 18
K Nonconformance on training - Not following own processes (IATF 16949) Internal Auditing 14
V Own foreign manufacturing facilities declared as sub-contractors ISO 13485:2016 - Medical Device Quality Management Systems 5
A 3D Printing concept in airline to manufacture its own aircraft cabin parts EASA and JAA Aviation Standards and Requirements 3
F AEMPS (Spain) Registration - Medical Devices - We do not own the products we make EU Medical Device Regulations 2
B Procedure Pack - KIT - Each has its own CE Mark CE Marking (Conformité Européene) / CB Scheme 6
S OBL (Own Brand Labeling) - Full Quality to Production Quality EU Medical Device Regulations 5
B Submit a Special 510(k) or "Documentation by our own" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A Selling our own class 1 (EU) devices worldwide - Who is responsible for registration? Other Medical Device Regulations World-Wide 7
B Own Brand Labelling and Distributors - Self Test IVD's EU Medical Device Regulations 3
L ISO 13485 and OBL (Own Brand Label) Agreement EU Medical Device Regulations 20
S Internal Auditors shall not audit their own work? Internal Auditing 21
L Build own Power Magnetic Field Test Equipment for IEC 61000-4-8 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
P OBL (Own Brand Labelling) - Technical Files/Risk Management ISO 13485:2016 - Medical Device Quality Management Systems 3
L Building your own Leakage Current Tester IEC60990 Other US Medical Device Regulations 4
P OBL (Own Brand Label) - Annex III ? EC Type Examination EU Medical Device Regulations 2
A EC Certification Process and Time Frame for Own Brand Labeling Medical Devices EU Medical Device Regulations 4
E "Internal" CAPA (Audit Nonconformance) Issuance to your own Department Nonconformance and Corrective Action 4
R Auditors can NOT audit their own work audit finding Internal Auditing 17
V Own Brand Labeling Agreement/Contract Review ISO 13485:2016 - Medical Device Quality Management Systems 5
M IEC 60601-1 testing for device with its own 2V battery power supply necessary? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D State Past Due on its own Meter Inspection ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Richard Regalado BYOD (Bring Your Own Device) Policy by UK Information Commissioner's Office IEC 27001 - Information Security Management Systems (ISMS) 0
T Can I approve my own Documentation per FDA QSR 21 CFR Part 820? ISO 13485:2016 - Medical Device Quality Management Systems 1
J Own Brand Labeling NB (Notified Body) requirements EU Medical Device Regulations 3

Similar threads

Top Bottom