Q: Does clause 7 Product Realization in ISO 9001:2008 Quality management systems–Requirements apply to the design and development of manufacturing processes?
We have four facilities that are ISO 9001 certified under one certificate. One location designs the product, and the other facilities manufacture it. In the “design facility” we follow the requirements of clause 7. In the manufacturing facilities, we currently do not apply clause 7 for the process of developing the manufacturing processes.
A: ISO 9001 clause 7.3 is applicable to the design and development characteristics of a product.
ISO 9001:2008 clause 7.1 (Planning of Product Realization) and its reference to clause 4.1 (General Requirements) is more specific to product planning to ensure that the product quality objectives and the processes/resources are available to produce a product that will meet defined quality requirements as specified during design and development in clause 7.3.
Clause 7.1 requires that the planning process include identification of the inter-related processes (i.e., monitoring, inspection, product quality objectives, testing, records of conformity needed to verify the product requirements have been achieved.
The bottom line: the product characteristics, quality objectives and inter-related processes must be documented. If this is not fully achieved in the design and development process (clause 7.3), it must be included in the product planning process (clause 7.1). Please see clause 4.1.
Please keep in mind that your company’s ISO registrar will require evidence of conformity (records/documentation) to verify the requirements of clauses 4.1, 7.1 and 7.3 have been met.
ASQ Senior Member
Managing Director of Aston Technical Consulting Services
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