ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence

[Sidney Vianna]

Looking for some guidance on the requirement for independence within clause 5.5.1

The independence and authority for personnel performing work affecting quality is part of the corporate culture. As for the means to "demonstrate" it to an external party, it could be as simple as having a 1-sentence statement in the quality policy to the effect of something along the lines of: "...irrespective of any employee's primary job, everybody in the organization is empowered to report quality concerns and take appropriate actions to prevent nonconforming products from further processing or shipment. Quality must never succumb to other priorities..."

Good luck.

 

[ThatSinc]

So with that in mind, the finding regarding independence of performing work affecting quality (device manufacture) and verifying quality (device release test) being performed by the same person should not bey a finding?

The quality policy does indeed state that quality is the responsibility of all personnel, and the quality manual states that there is overlap in functions and responsibility is delegated as per procedures.

The operator has the authority to perform both tasks as per their training, and advised that any issues identified during testing are raised to the technical director and NCRs raised by the op as necessary, with the technical director making the necessary disposition.

 

[Sidney Vianna]

So with that in mind, the finding regarding independence of performing work affecting quality (device manufacture) and verifying quality (device release test) being performed by the same person should not be a finding?

I guess you are asking if it would not be a nonconformity. The answer is NO; as long as you can demonstrate people are not compromising quality for delivery, costs, ethics, etc...the requirement is being complied with. Imagine a 1-man company complying with ISO 13485...there is no requirement/expectations for an "independent QA department".

 

[Tagin]

So with that in mind, the finding regarding independence of performing work affecting quality (device manufacture) and verifying quality (device release test) being performed by the same person should not bey a finding?

It's interesting that 'independence' is not defined anywhere (9000 or elsewhere) that I could find, so its unclear as to its exact intent. FDA 820.20 uses similar language, but doesn't define 'independence' either, it seems. Also, I can't find any 13485 equivalent to TS9002 for 9001 or similar APG docs as for 9001.

'Independent' means, in Merriam-Webster, "not dependent", where 'dependent' is defined as "determined or conditioned by another". So then 'independent' means 'not determined or conditioned by another". Perhaps, 'unhindered' is a fair synonym for 'independence' this clause.

If the same person performing the work and verifying quality is paid per-piece accepted, or they have a quota of accepted pieces/day, etc. then that person is now conditioned by that situation to accept as many pieces as possible. If they are hourly or salary, then that removes that condition.

So, I would ask it in terms of: what hinders this employee from performing objective quality verifications? If nothing, then they have adequate independence.