ISO 9001 Training
Understanding ISO 9001:2008
Delicious
Digg
Reddit
Stumbleupon
Ma.gnolia
Facebook
Newsvine
BlinkList
Spurl
ISO 9001 TrainingUnderstanding ISO 9001:2008
|
|
7 Product Realization 7.3.5 Design and Development Verification Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4). 7.3.6 Design and Development Validation Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4). 7.3.7 Control of Design and Development Changes Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4). |
ISO 9001 Training - Key
Explanation Points and Tips:
Product design
Verification includes - design reviews (see 7.3.4); comparing the new design to a similar proven
design if available; performing alternate calculations; performing tests and simulations; reviewing the
design documents before release, etc.
Verification is
checking product or process to input requirements, whereas validation is checking product or process is suitable
for its intended use - does it perform/function in the way intended by your customer or your
organization.
Manufacturing
process design verification include - design review (see 7.3.4); process capability studies; testing various
process parameters; performing tests and trials; reviewing the manufacturing process design documents before
release, etc.
Product
and manufacturing process validation includes - design reviews; comparison between customer requirements
and internal development plans; d & d validation against customer requirements and d & D input
requirements; corrective action and lessons learned from documented process failures and product
nonconformities
If you
outsource any part of your d & d activity, then you must exercise the same controls required by clause 7.3 on
the outsourced work and the organization doing the work, had it been done internally.
You must keep records for both verification
and validation activities.
Make sure your process for d & d changes follow
appropriate steps of clause 7.3 (define plan, have inputs and outputs, verify and validate) to the extent
necessary to meet customer requirements and control product, quality and business
risks.
Changes may come from internal,
customer or regulatory sources. Get all requests for product or manufacturing process design changes in
writing from your customer!
Impact of the change must be evaluated
on - materials used; design process; manufacturing process; characteristics and use of developed product;
regulatory compliance; cost; etc.