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 .
T

Trek1

#1
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.
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
I'm sorta disagree in that if you do not have a copy of a specific standard, and do not have access to that standard, the question is going to be how do you know what the requirements are?

I think Jan is right in the sense that there is no stated requirement that you buy and/or possess the standard, but I have seen auditors ask to see a company's copy of various standards in their document control database (or however they were tracking external documents).

Since you do state *compliance*, there is no actual requirement.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
for CE marking our notified body absolutely insists we own every standard we reference.
 

jkuil

Quite Involved in Discussions
#5
Probably this notified body also has a standards shop.:)

Basically you need to have continuous direct access to referenced standards and have methods to assure that you are up-to-date with the latest revision of the standard. If you can do that by other means that buying the standard that is fine. But, in most cases this is a violation of the the copyright of the standard and therefore also not allowable.
 

Ajit Basrur

Staff member
Admin
#6
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.
By "medical company", is it a Pharmaceutical, Medical device or drug distributor ? Can you pl elaborate the nature of business ?
 

Al Rosen

Staff member
Super Moderator
#7
4.2 Documentation requirements
4.2.1 General
The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures and records required by this International Standard, and
d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.
A referenced document within a procedure should be available and controlled.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
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)?
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.
 
A

arios

#9
A referenced document within a procedure should be available and controlled.
Dear Al Rosen

You bring an insteresting approach, however where would could we draw the line between the ¨Should¨ and the ¨Must¨?

I have worked the Medical Device sector for various years and I must admit this is still a gray area for me. How you approached the subject is interesting and I appreciate the recommendation. I still hope further guidance can be provided by more cove members to see what they think.

Alberto
 

howste

Thaumaturge
Super Moderator
#10
I agree with Al and Sidney, and would reference one more clause:
ISO 9001:2008 said:
4.2.3 Control of documents
Documents required by the quality management system shall be controlled...
A documented procedure shall be established to define the controls needed... d) to ensure that relevant versions of applicable documents are available at points of use...
It's not just a "should", the standard "shall" be controlled and available. Your organization has no control over a copy at the library, and it may not be available when you need it.
 
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