How to set quality objectives of R&D outsourcing - Examples please

P

Pauling

Dear all,

Nice to meet you!:)
We got the ISO 13485 certificate including design and development, production and distribution.However we only play the role of distributor and R&D Outsourcing.We strongly want to keep the D&D scope of certificate,so we keep R&D Dept..
But how to set the quality objectives of R&D outsourcing to make it reasonable and implemented?
Forgive my poor english and pls help to comment!
Thanks in advance!
 

Coury Ferguson

Moderator here to help
Trusted Information Resource
Re: how to set quality objectives of R&D outsourcing

Dear all,

Nice to meet you!:)
We got the ISO 13485 certificate including design and development, production and distribution.However we only play the role of distributor and R&D Outsourcing.We strongly want to keep the D&D scope of certificate,so we keep R&D Dept..
But how to set the quality objectives of R&D outsourcing to make it reasonable and implemented?
Forgive my poor english and pls help to comment!
Thanks in advance!

Welcome to the Cove. ;)

I am not an expert on ISO 13485, but I would think that the objectives would need to be determined by the Organization. They also need to be measurable, in my opinion.

Look at the Objectives as a Goals for the Organization to accomplish and lines up with the Policy of the organization.
 
S

SteveK

Re: How to set quality objectives of R&D outsourcing-Examples please

Hi Pauling,

One example could be (as used by our company):
“That all manufactured products meet the required customer specification and that they comply in accordance with the relevant Regulatory and/or International Standards.”
Measures of this can be any complaint feedback, customer questionnaires, auditing etc.

Even if you are 'just' a distributor you will be the contact point for (dis)satisfied customers.
 
D

Duke Okes

Re: How to set quality objectives of R&D outsourcing-Examples please

Who are the customers of the R&D process and what would they measure about it? Who owns the R&D group and what measures of performance do they care about? What should the R&D group be doing in the future?

Once you know the performance measures that are applicable then you can better decide what objectives/targets would be useful.
 

Colin

Quite Involved in Discussions
Re: How to set quality objectives of R&D outsourcing-Examples please

I think it is worth evaluating why objectives are required (other than because the standard says so) before deciding what they should be.

Objectives are often used to drive improvement (or at least conformance) so what do you want to improve? Is it time taken to fulfill a design, adherence to requirements, reduction in required design changes, etc. Once you have identified what needs improving you can set an objective.

The next step is to evaluate current performance, decide by how much you can/want to improve and attach a value to your objective. Then establish a strategy to achieve the objective. Continue to monitor and measure which will tell you if you are on track or not.
 

Coury Ferguson

Moderator here to help
Trusted Information Resource
Re: How to set quality objectives of R&D outsourcing-Examples please

Here is ISO9000 definition of Quality Objective:

ISO9000 said:
quality objective

something sought, or aimed for, related to quality (3.1.1)

NOTE 1 Quality objectives are generally based on the organization's quality policy (3.2.4).

NOTE 2 Quality objectives are generally specified for relevant functions and levels in the organization (3.3.1).
 
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