ISO 13485 - Supply Chain Requirements

Dear all,

Our company sells computers to hospitals and our company wants to be ISO 13485 certified.
The design of the computers is done elsewhere in a factory with ISO 13485, but we only add/change hard drive or RAM memory or wifi modules, but opening the device is necessary to perform this task.
Our computer systems (touch screen panel PC or Tablet like systems) are used in hospitals for basic use, but some are used in surgery operationg room and display heart rate and blood pressure.


My questions is:
Is there anything Supply Chain should do or know to comply with ISO 13485?


Please help and thanks in advance!

Do you have a copy of the standard? If not, get one!

There's a section on purchasing controls (7.4).

Dear Yodon,

Thanks for your reply.
We already have a copy of the ISO standard, but as vague as it sometimes can be, i would like to know if there are any examples of what's different from ISO 9001, because we already comply with that ISO standard

Matthies said:

Dear Yodon,

Thanks for your reply.
We already have a copy of the ISO standard, but as vague as it sometimes can be, i would like to know if there are any examples of what's different from ISO 9001, because we already comply with that ISO standard

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Refer our existing threads -

ISO 13485 Sec 7.4 - Supplier Selection, Evaluation and Re-evaluation

Purchasing Process Map for ISO 9001 and ISO 13485 - Example wanted

You can also take a look at this article -
Supplier Controls in a ISO 13485:2003 Environment

Matthies said:

Dear Yodon,

Thanks for your reply.
We already have a copy of the ISO standard, but as vague as it sometimes can be, i would like to know if there are any examples of what's different from ISO 9001, because we already comply with that ISO standard

Click to expand...

I am working with a company implementing ISO 13485 and the very first activity we performed was to sit down with a copy of 13485 and 9001 and highlighted the actual differences between the two standards. Medical device additional requirements are in blue text but in many cases the change was only minor. A good example is the Purchasing Process, Clause 7.4.1. The only additional requirement for this clause is the addition of the requirement to have a documented procedure.

Jeff Frost said:

I am working with a company implementing ISO 13485 and the very first activity we performed was to sit down with a copy of 13485 and 9001 and highlighted the actual differences between the two standards. Medical device additional requirements are in blue text but in many cases the change was only minor. A good example is the Purchasing Process, Clause 7.4.1. The only additional requirement for this clause is the addition of the requirement to have a documented procedure.

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2 comments:

1. Even more user-friendly than the blue Italics, is ISO 13485:2003 annex B, which tabulates / discusses the differences.

2. Adding a requirement to have a documented procedure is not "minor" IMO. Where such a requirement is absent, it suffices to demonstrate that the existing process / practice is generally aligned with the standard's requirements; while a requirement for a documented procedure forces the organization to be much more systematic and consistent + it allows much closer audit scrutiny.

Cheers,
Ronen.

Ronen E

Though you may not like the word minor, most changes to ISO 13485 are business operation based and are usually present within the organizations. One must remember that under 9001 the organization must establish process methods such as purchasing. Everyone performing the process (purchasing in this case) must understand the company’s method for meeting Standards requirement and must adhere to established process methods when performing the function. If employees are not following the established process method, then there is a finding of nonconformity. So in the case of my example the assessment of the purchasing process per 13485 becomes (1) has the business established a process for purchasing product, (2) is it documented in a procedure and (3) are the employees performing this process following the established and documented methods.

Thanks all for the useful information!

Matthies said:

Thanks all for the useful information!

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Hi Matthies,

Sorry, I had to delete the video as its against the ToS.

Appreciate your understanding.