SBS - The best value in QMS software

Companies stating ISO Compliant without ISO Certification

Randy

Super Moderator
#11
Moved from companies stating ISO Compliant..

This may not be a loophole in the strictest sense of the word, but I think it is an area that bares examination and clarification. It would be the same as a company saying that their measuring devices are compliant to NIST standards hoping that people would interpret it as traceable in an unbroken line to NIST.

Doug
No it's not the same. There is a greater lack of potential for litigation, civil or criminal, for claiming to having a system you manage your organizational processes by than claiming to use correct methods to insure products or materials meet legal or other requirements.

And your expertise in the ISO world is?
 
Elsmar Forum Sponsor

Helmut Jilling

Auditor / Consultant
#12
This may not be a loophole in the strictest sense of the word, but I think it is an area that bares examination and clarification. It would be the same as a company saying that their measuring devices are compliant to NIST standards hoping that people would interpret it as traceable in an unbroken line to NIST.

Doug

Perhaps, a few people may interpret it this way, if they are unfamiliar with the ISO and calibration worlds. And it is possible that a company management is hoping for that, since they also may be unfamiliar.

A greater probability would be that experienced customers would quickly surmise the company is ducking below the radar and unwilling to get certification. A wise buyer would quickly demand to see what this claim is based on. An uninformed buyer may get fooled. But, that may be what his lack of training and experience deserves.

I don't like companies that cheat, but I don't think that is cheating if they clearly state they are only "complying," not "certified."
 
S

silentrunning

#13
No it's not the same. There is a greater lack of potential for litigation, civil or criminal, for claiming to having a system you manage your organizational processes by than claiming to use correct methods to insure products or materials meet legal or other requirements.

And your expertise in the ISO world is?
My "expertise" is very limited. I am here to learn and share ideas. Since you seem to be bothered by anyone who feels differently than you, I will be sure to steer clear of any of your posts in the future.

Doug
 
D

Duke Okes

#14
When the ISO 9001 standard was first developed it was not for certification/registration purposes. That was just something that developed separately, likely driven by the EU Directives.

Companies claim compliance to standards, etc. all the time. For example, by default we expect companies to comply with GAAP, which Enron+ proved to be false.

There are obviously many problems with the 9001 registration process, including registrars who (under another name) will help you install the QMS, registration auditors who don't have a clue (and are imposing their narrow views), and the conflict of interest where registrars are being paid by their customers.

We could also point out problems with the drivers license process, medical/legal/engineering licenses, etc. The world is not, and never will be, perfect. That's why quality professionals have jobs!!!
 

Helmut Jilling

Auditor / Consultant
#15
My "expertise" is very limited. I am here to learn and share ideas. Since you seem to be bothered by anyone who feels differently than you, I will be sure to steer clear of any of your posts in the future.

Doug

Ahh, Doug, don't be too put off by Randy's comments sometimes...that is just part of his loveable and charming personality. :D His bark is worse than his bite. He really is a good guy and has lots of good insight.

You may even come to enjoy it at some point down the line... It keeps the Cove more interesting if we occasionally have some firecrackers. Many of us wrestle with each other from time to time. Keeps the place lively.

Welcome!
 

Randy

Super Moderator
#16
No, don't steer clear of anything. I'm honestly curious about your background. You have noted that you were seeking FDA information which is highly regulated and ISO systems are a bit different.

The ISO "Systems" community has understood for years that an organization can make a claim without 3rd party involvement...part of verifying that type of claim normally results in what is known as the 2nd Party or Supplier audit.

The 3rd party registration process helps to reduce or eliminate the need for those supplier audits and therefore (theoretically at least) add validity to everything.
 
D

Duke Okes

#17
My "expertise" is very limited. I am here to learn and share ideas. Since you seem to be bothered by anyone who feels differently than you, I will be sure to steer clear of any of your posts in the future. Doug
Don't pay any attention to Randy ... he can't even spell, as indicated by the quote after his posts "Our scars are reminders that out past is real – Hannibal Lecter" ('out' should be 'our').

That's just a poke, Randy! Don't shoot!
 
C

chaosweary

#19
Another example is not a curve ball, but a slider:D ... Some registrars are allowing companies to register certain products / product lines to a particular standard even though the standard is a management system standard and not a product standard. Then the companies go off and tell their customers that they are registered to that particular standard.:notme:
 
H

HSSE Auditor

#20
Don't pay any attention to Randy ... he can't even spell, as indicated by the quote after his posts "Our scars are reminders that out past is real – Hannibal Lecter" ('out' should be 'our').

That's just a poke, Randy! Don't shoot!
Here is another example. :truce::lol:

Originally Posted by Randy

It's not a loophole and never has been. This has been a well established fact for over 20 years now.

The risk is more to the claimant because they may be asked to actually prove thier claim.
 
Thread starter Similar threads Forum Replies Date
C In-process inspection - Tooling and assembly lines for automotive companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
V Sister companies selling same medical device under different names ISO 13485:2016 - Medical Device Quality Management Systems 3
D Big companies suffer from quality management system? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Who are the go to companies for non-destructive hardness testing? General Measurement Device and Calibration Topics 3
R Customer Satisfaction importance in companies with Government/Public Administration as main customer? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
K Submission of MDR File - Partner Companies - Computed Tomography (CT) CE Marking (Conformité Européene) / CB Scheme 10
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M ISO 13485 extended Site (Two companies) ISO 13485:2016 - Medical Device Quality Management Systems 2
D 3 Companies - Medical device parts and substances - Responsibilities EU Medical Device Regulations 4
F ISO Certified companies - Is there a list of certified companies that I can access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
Q How is Medical Device Number (MDL) assigned to companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Nicole Desouza Are Shipping Companies Suppliers? Manufacturing and Related Processes 4
S Companies that maintain your machine should be in ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
D Why are pharma companies automating QMS systems? Quality Management System (QMS) Manuals 2
M ISO 27001 ISMS scope for companies with subsidiaries IEC 27001 - Information Security Management Systems (ISMS) 0
M Informational From RAPS: Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance Medical Device and FDA Regulations and Standards News 0
R ISO 9001 versus ISO 13485 for Suppliers to Medical Device Companies ISO 13485:2016 - Medical Device Quality Management Systems 2
R Qualification of Distributors such as McMaster-Carr and Digikey to Medical Device Companies ISO 13485:2016 - Medical Device Quality Management Systems 3
N MDSAP Participants 2019 - How many companies are participating YTD? ISO 13485:2016 - Medical Device Quality Management Systems 20
T Why do most companies have Quality reporting to Engineering or Operations and not to CEO? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 45
T Series A ready company - Term for medical devices companies? Other Medical Device Regulations World-Wide 2
R How to keep track of all FDA rules and regulations for medical device companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Design Transfer between two companies with different QMS CE Marking (Conformité Européene) / CB Scheme 3
T QMS/MDD scope - Two companies located in different places work together Human Factors and Ergonomics in Engineering 10
J What my companies RoHS declaration should say 2011/65/EU, 2015/863, or 2017/2102 REACH and RoHS Conversations 3
K Outsourced Major Processes - Working for Two Sister Companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Y FDA PreCert Program for Software (Companies) - 2017 Other US Medical Device Regulations 1
A ISO 9001:2015 Implementation for Marketing and Sales Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J Recommendation for US Agent Services for Medical Device Companies EU Medical Device Regulations 6
T Register of TS 16949 Certified Companies IATF 16949 - Automotive Quality Systems Standard 2
H How Calibration Precision checks are implemented in medical device companies General Measurement Device and Calibration Topics 2
M Using a Complaint Management Software (Medical Device companies) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Transfer of AS9110 Certification between Companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
I FDA Medical Device Registration - Scenario - Two Companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Where to start to helping other companies to get ISO IEC 27000? Consultants and Consulting 1
S Elisa kits for poultry disease check up companies US Food and Drug Administration (FDA) 3
Marc What companies think climate change will have a material impact on their business? Sustainability, Green Initiatives and Ecology 11
E Should companies that perform calibration services be ISO 17025 accredited? ISO 17025 related Discussions 13
E CAPA Management Software Tool Recommendations for Small Companies Quality Assurance and Compliance Software Tools and Solutions 3
O List of ANVISA Registered Companies Other Medical Device Regulations World-Wide 1
Ajit Basrur FDA Loosens Pharmaceutical Regulations on 13 Companies Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
I Auditing Transport Service Companies Service Industry Specific Topics 5
T What type of industries or companies that should implement PAS 55? Other ISO and International Standards and European Regulations 2
D Documentation Control Software for small companies on a Budget Quality Assurance and Compliance Software Tools and Solutions 10
T ISO 9001 for a Holding Company which owns several Food Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Three Sub-Companies - Is One Quality Manual Enough? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B ISO 9001 Certified Company and acquisition of non-ISO 9001 Certified Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R How do companies measure QC Productivity? Quality Manager and Management Related Issues 3

Similar threads

Top Bottom