ISO 9001 Training
Understanding ISO 9001:2008
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ISO 9001 TrainingUnderstanding ISO 9001:2008
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7 Product Realization 7.1 Planning of Product Realization The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1). In planning product realization, the organization shall determine the following, as appropriate: a) quality objectives and requirements for the product; b) the need to establish processes and documents, and to provide resources specific to the product; c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance; d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4). The output of this planning shall be in a form suitable for the organization's method of operations. NOTE 1: A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract can be referred to as a quality plan. NOTE 2: The organization may also apply the requirements given in 7.3 to the development of product realization processes. |
ISO 9001 Training - Key Explanation
Points and Tips:
Clause 7.1 is
essentially a repeat of clause 4.1, but applied specifically to
product realization processes
(see clause 4.1 explanation points - COP’s). The focus is on controls governing
the making of product to meet customer requirements and all the QMS
processes that, directly or indirectly, make this happen.
Product realization processes may include - customer related processes (sales and marketing);
design and development; production; shipping; receiving; packaging; measurement and monitoring of product and
processes, etc., whether performed onsite or off-site.
Some of the
support processes that come to bear on product realization include- document control; record control; human
resources; infrastructure provision and maintenance; IT; purchasing and materials management; laboratory services
and control of monitoring and measuring devices, business planning; etc.
The
output of product realization planning may be implemented in many different ways. It does not necessarily have to
be all in one document, but may sometimes include several documents (drawings; machine set-up; inspection criteria;
process sheets; etc.). These must be readily available to those performing realization
processes.
You may also consider using specific product,
contract or project quality plans to accomplish this. Your quality plans should include the processes needed;
process sequence and control parameters; specific resources needed to make, verify and deliver product; product
acceptance criteria and quality objectives; product and process monitoring and measurement controls; plans to
control and correct any product or process nonconformities; reference to support processes; documents needed (such
as work instructions or engineering specifications, etc.) and details of records to be
kept.