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).

(from BS EN ISO 9001:2000)

Much of Clause 7 was taken from various sections of the 1994 version, including 7.1. However, there is a greater focus on the process approach within the three paragraphs of 7.1, especially the planning aspects of product realization, which makes it one of the most critical clauses in the standard.

Perhaps the first thing organizations should do regarding Clause 7.1 is define what it is they produce, which is what "product realization" means. (Note: Service organizations "produce" a service, so they might not necessarily be excluded in this section.) In other words, this is the point at which your organization uses raw materials and converts it into something that can be sold or used in some way. You also should be aware of the definition of "product" as it relates to ISO 9001:2000:

"…results of a set of interrelated or interacting activities which transforms inputs into outputs."

Product realization is typically defined in the quality manual, usually in a section on definitions.

As in the 1994 standard, organizations must plan the control and production of all processes/activities that affect the quality of products or services. These process controls are particularly important where their absence adversely affect quality. Control should include:

• documented procedures-The detail of these procedures is dependent upon the training/experience of people carrying out the tasks.
• a suitable working environment-Can the product be affected by an adverse environment? i.e., special clean rooms are needed in some industries.
• following appropriate industry codes of practice/standards, quality plans (if applicable) and/or documented procedures.
• monitoring processes using suitable parameters and characteristics, i.e., using statistical techniques.
• an authorized person who can approve all processes and equipment used.
• workmanship criteria-Do the people carrying out the tasks know what is expected of them, how the product should look when they've finished?
• suitably maintained equipment-All equipment used must be suitably maintained to ensure the processes will not be interrupted (also covered in Clause 6.3).

Some processes cannot be tested fully until in final use, (new technology being used might not yet have established any test precedents, i.e., a new paint being developed to withstand 10 years of extreme weather conditions).

In such cases, qualified personnel should carry out all stages of the production process and/or continual monitoring should take place to ensure compliance to procedures. The qualification requirements shall be specified and records will be kept of the processes, equipment used for them and personnel carrying them out-these should be classified as records.

Additionally, as with the 1994 standard, final inspections will need to be carried out according to planned arrangements, (this could be a defined process or documented procedure). No products should be dispatched until all the test stages in your procedures have been satisfactorily completed and all documentation completed and authorized.

Also, this clause has two notes that are important for organizations implementing ISO 9001:2000 - but they are not requirements. The first note explains the quality plan concept, which can be used as an easier way to document product realization processes. It is also something that already might be being done.

The second note is also a good piece of advice from TC 176. It states that an organization should consider utilizing similar approaches to planning as those outlined in Clause 7.3 Design and Development. Doing so can strengthen and streamline operational planning on a number of levels.