Do I need to buy a standard to claim compliance to a standard?

Do you need to buy a standard to claim compliance to that standards ?

  • Yes

    Votes: 16 80.0%
  • No

    Votes: 4 20.0%

  • Total voters
    20
  • Poll closed .

Big Jim

Super Moderator
#21
The difference is that they're not certified to the external calibration document. They are not held accountable to the content of that document. If they wrote their own document and changed the calibration methods, there would be no repercussions.

However, if they wrote their manual to regurgitate the requirements of the standard and then used it as the requirements document, it still would need to be verified to ensure that it met the requirements of the standard. This would have to be done by comparing it against the standard. Every time they made a change to the manual, they would have to verify again that it still met the requirements of the standard.
Once again, this is the line from the standard that applies here. It is an external document.

4.2.3f "to ensure that the documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled."

May I stress "determined by the organization".

If they have determed that they don't need a copy of the standard, they don't. This is especially true if they have some other way to show they have met all the requirements.

Again, I don't feel this is the ideal situation. Ideally, every registered company would have a copy of the standard as good business practice.
 
Elsmar Forum Sponsor

suildur

Involved In Discussions
#22
Hi,

If a medical company claims compliance to a standard, does it need to buy the standard? Or is it sufficient to have access to the standard (such as having the standard available for consultation in a college library)?

Thanks.
Yes, of course, you "must" have the standard. I have read some of the discussion, and in fact, someone must have already told "external documents", but I haven't seen someone just talking about the meaning of external documents. The phrase says it all. If you were to free to decide to use or not to use "external documents", the standard shouldnot have talked about external documents. But the standard says something about external documents, which means that you must have some regarding to your scope, and those documents must be controlled. If you own the document, you can control it. If you don't own the document, you must prove that you control it (just like the way in outsourcing any process). How will you prove that the related standard is under your control when it is in the library? I even don't consider the accessability.

Also, remember the rule about instructions. An instruction must be accessable and must be found where it is needed; e.g. if you have some kind of machine and there needs to be an instruction to operate it, then the operation manual/instruction must be around/near the machine; not at the operator's house, or, at the HQ office. It's the same case.
 

howste

Thaumaturge
Super Moderator
#23
Once again, this is the line from the standard that applies here. It is an external document.

4.2.3f "to ensure that the documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled."
I agree.
May I stress "determined by the organization".

If they have determed that they don't need a copy of the standard, they don't. This is especially true if they have some other way to show they have met all the requirements.
If they're claiming compliance, and also claim they don't need the document, then they are talking out of both sides of their mouth. It's clearly conflicting. Essentially they're saying they need it, but they don't really need it.

These are the same kind of people who use a gage for final verification of product, then claim that the gage doesn't require calibration because it's "not necessary to ensure valid results."
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#24
If they're claiming compliance, and also claim they don't need the document, then they are talking out of both sides of their mouth. It's clearly conflicting. Essentially they're saying they need it, but they don't really need it.
They will not be in the position to answer the fundamental audit question "How do you know you are operating your system to the most recent requirements?" and its corollary "Show me. (Prove it.)" if they do not have a copy of them, or a system to ensure they have the most recent copy, on top of that!
 
G

Groo3

#25
I voted No because of the way the question was asked...

However, if you wish to successfully demonstrate compliance to a standard, I do believe you should at least have a copy of the appropriate standard handy at all times and be familiar with the requirements (some form of training to the standard requirements).
:2cents:
 
O

outoftown

#26
A standard such as this would normally fall under the concept of "document of external origin" which should be identified and have it's distribution controlled. As an external auditor, I would be very leery of an organization that claims compliance to a standard, while relying on a public library to access it. If you are going to be that stingy, I would be concerned with what other "expenditure shortcuts" is this organization doing to maximize it's profit.
My sentiments exactly. I am also an external auditor. Access at the library would not be considered an acceptable means of meeting the external document requirement. It's a similar response to "my consultant lets me borrow it when I need it" or "I can always order it online if I need it". Think of using your answer to justify why you don't have another external document like MSDS on location. It just won't fly.
 

Big Jim

Super Moderator
#27
My sentiments exactly. I am also an external auditor. Access at the library would not be considered an acceptable means of meeting the external document requirement. It's a similar response to "my consultant lets me borrow it when I need it" or "I can always order it online if I need it". Think of using your answer to justify why you don't have another external document like MSDS on location. It just won't fly.
The question is does the standard require a registered company to have a copy. It does not directly require it. Most all of these responses are rationalizations for trying to make it fit from some round-about way.

4.2.3 c does not directly address it.

4.2.3 f does not directly address it.

Why could a company not "borrow it from his consultant" when it is needed? Why would that not fly?
 
O

outoftown

#28
Not having a standard available is not simply a nonconformity on that basis. Justification for any documentation that is needed, other than that required by law, regulations, standards, corporate entities, customers, etc. must be proven by a failure due to lack of having the documentation. As the previous poster stated, I would also be leery of a situation where the standard to which a company is registered is not available at the company. When someone is cutting corners by not obtaining a copy of the standard, I would check to see if they cut corners elsewhere. e.g. How did the internal auditors get trained? What do they use for reference? Instead of not flying, maybe I should have said something is fishy. From experience, a situation where the consultant controls the copy of the standard and not the company, there is a good possibility the organization may be too dependent on that outside party for their QMS knowledge. It may also be limited to only what the consultant put in place to pass the registration audit. If the consultant is not actively involved, once changes to the business and/or QMS happens, and they do... (e.g. loss of internal auditors, skipped management reviews), without a standard, the company puts itself in a position of not knowing what actions would be acceptable.

Refer to 1.1 This International Standard specifies requirements....

I ask...Wouldn't anyone want a copy of the requirements they are being held accountable for? Would you put absolute trust in either your consultant's interpretation or your auditor's interpretation of the requirements?

I also refer you to 4.2.1 d (The quality management system shall include)...documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.

I also ask, wouldn't the process owner for some core management processes or quality processes want a copy of the standard to help manage those processes? e.g. Management Review, Internal Audits, CAPA...

Note that I am also taking the assumption the company did not copy the standard verbatim as part of their quality manual.
 
Last edited by a moderator:
S

samsung

#29
As the thread title goes, the answer is plain 'No' else the thread title should have been 'Do I need to 'have' a copy of the standard........'Buying' per se, is not necessary, it can be either borrowed from someone and, as Outoftown mentioned, can be copied "verbatim as part of their quality manual". It's also possible that some one may gift it to you.

It will be interesting to know if it constitutes a violation of the copyright laws if the standard is copied verbatim in the Quality Manual.
 
R

Richard Pike

#30
Hi,

If a medical company claims compliance to a standard, does it need to buy the standard? Or is it sufficient to have access to the standard (such as having the standard available for consultation in a college library)?

Thanks.


NO ! i.e.
There is a requirement when driving, to adhere to the laws of the road.

However. I do not need copies of the relevant legislation in my car to do this.

and YES ! i.e.

Your Operator is required to work in accordance to a Work Instruction, but has to go to the library to view that instruction. Would you consider this effective?

What happened to common sense in the quality industry?
No wonder the industry ha such an appalling reputation. (in general and of course excluding all Cove members)
 
Thread starter Similar threads Forum Replies Date
A I need the ISO 13485 Standard manual. Where can I buy it? ISO 13485:2016 - Medical Device Quality Management Systems 9
J Need to Train Management for Management buy-in for the QMS Training - Internal, External, Online and Distance Learning 6
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 0
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
J Need a contract monitoring Tool General Information Resources 0
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 0
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
W 17025 and NIST handbook relationship (need advice) ISO 17025 related Discussions 8
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
K Need procedure for D&D inputs? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
Ed Panek Immediate need for 80601-2-56 Consulting expert. PM me for details Career and Occupation Discussions 0
Tagin You're Gonna Need a Bigger Root Cause Coffee Break and Water Cooler Discussions 12
M PSA Suppliers - CSR matrix and need the quality manual of PSA APQP and PPAP 2
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
I Do I need to sign off my annual audit calendar? Internal Auditing 2
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
V Certified Auditor - Need of additional certification specific to industry ( GMPs) ASQ vs ECA vs others Professional Certifications and Degrees 1
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
K Do I need a "State of the art" plan? CE Marking (Conformité Européene) / CB Scheme 1
S Need advice for schooling Quality Manager and Management Related Issues 5
R What information do i need to get from the device manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Need guidance on project ISO 13485:2016 - Medical Device Quality Management Systems 2
H Need MSA 4th ed. compliant attribute MSA template General Measurement Device and Calibration Topics 4
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Countries with no need for FSC (Free sales certificate) Other Medical Device Regulations World-Wide 0
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
N IPC-A-630 - Is this free or do i really need to pay for it? Manufacturing and Related Processes 4
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
P Need a programmer for QVI's VMS software for optical inspection machine Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
silentmonkey How to decide what characteristics need to be verified during incoming inspection? ISO 13485:2016 - Medical Device Quality Management Systems 5
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T Do I need a qualified compiler for class B software? IEC 62304 - Medical Device Software Life Cycle Processes 3
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Proof of Concept Studies - Do we need to comply with SAE reporting? Medical Device and FDA Regulations and Standards News 3
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
A Demonstration of Equivalence - Need for comparing biological characteristics for an SamD EU Medical Device Regulations 1
G Need to change KPI we called NC parts (maximum 3%.) to FTQ (first time quality) IATF 16949 - Automotive Quality Systems Standard 4

Similar threads

Top Bottom