ISO 9001 - Understanding ISO 9001 Requirements

7 PRODUCT REALIZATION
7.1 Planning of Product Realization
Your organization must plan and develop the processes needed for product realization
This planning must be consistent with the requirements of other processes of your QMS (see 4.1)

In planning product realization, you organization must determine, as appropriate:

a)Product quality objectives and product requirements

b)The processes, documents and resources specific to the product

c)Specific product verification, validation, monitoring, inspection, and test activities; and criteria for product acceptance

d)Records needed as evidence that realization processes and resulting product meet requirements (see 4.2.4)

ÞKeep such planning output in a form suitable to your organization’s method of operations

Note 1: A quality plan is a document that specifies the QMS processes (including product realization processes) and resources applied to a specific product, project, or contract.

Note 2: An organization may also apply the requirements of 7.3 to the development of the product realization processes

Key Explanation Points and Tips:

ÞClause 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.

ÞProduct 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.

ÞSome 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.

ÞThe 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.

ÞYou 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;