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Re: R&D 13485:2003 Clarification...
All excellent points, to be sure. Here's where I'm getting confused, though- ISO 13485:2003, 7.3 Design and Development states that "the organization shall plan and control the design and development of product.
During the design and development planning, the organization shall determine
a) the design and development stages,
b) the review, verification, validation and design transfer activities that are appropriate to each design and development stage, and
c) the responsibilities and authorities for design and development.
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
Planning output shall be documented, and updated as appropriate, as the design and development progresses (see ISO 13485:2003, 4.2.3 Control of Documents)."
So... having regulated documents IS necessary...
Tempus,
I've highlighted your words that indicate to me that you are trying to impose your will on your R&D team instead of listening to them.
I agree with Laura's advice on this in #7 and Somashekar's in #8.
To whom does the QMS belong? How is the QMS fulfilling the needs of the R&D team. To paraphrase Edision, many R&D failures may be necessary for their eventual success.
They may already realize the importance recording what does not work but see the recording methods mandated by your QMS as unhelpful.
Lastly, periodic multidisciplinary design reviews for resulting in effective design output may not be appropriate to the sand-box or skunk works activities at the front-end of truly innovative R&D.
John
I've highlighted your words that indicate to me that you are trying to impose your will on your R&D team instead of listening to them.
I agree with Laura's advice on this in #7 and Somashekar's in #8.
To whom does the QMS belong? How is the QMS fulfilling the needs of the R&D team. To paraphrase Edision, many R&D failures may be necessary for their eventual success.
They may already realize the importance recording what does not work but see the recording methods mandated by your QMS as unhelpful.
Lastly, periodic multidisciplinary design reviews for resulting in effective design output may not be appropriate to the sand-box or skunk works activities at the front-end of truly innovative R&D.
John
All excellent points, to be sure. Here's where I'm getting confused, though- ISO 13485:2003, 7.3 Design and Development states that "the organization shall plan and control the design and development of product.
During the design and development planning, the organization shall determine
a) the design and development stages,
b) the review, verification, validation and design transfer activities that are appropriate to each design and development stage, and
c) the responsibilities and authorities for design and development.
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
Planning output shall be documented, and updated as appropriate, as the design and development progresses (see ISO 13485:2003, 4.2.3 Control of Documents)."
So... having regulated documents IS necessary...
