ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

8.2.4 Monitoring and Measurement of Product

ISO 9001 Training - Key Explanation Points and Tips:

You must identify, monitor and measure product characteristics to verify conformity to requirements. Product characteristics may include - dimensional; functional; performance; reliability; durability; maintainability; life; cost; etc. We had previously established that requirements may come from your customer, your own organization, regulatory and industry sources.

You must plan (see clause 7.1) - what product characteristic(s) to measure; type of measurements; what measurement device to use; how often to measure; sample size; acceptance criteria; and records needed - for each product or product type. Use your product quality plan to document these controls.

Your product, project or contract quality plan must define the stages at which various monitoring and measurement will be carried out - incoming receipt of materials from suppliers or outsourced work; storage; internal production processes; finished product; packaging; at time of shipping; and post installation.

Monitoring and measurement may be done by your personnel, subcontracted or outsourced labor or by the customer. You must ensure that all personnel performing monitoring and measurement of product are trained and competent.

If you plan on releasing (during any stage of production) or shipping finished product, where all planned inspections and measurements to that stage have not been completed, ensure that you obtain prior written approval/waiver from a relevant internal authority or the customer (see clause 8.3.4). Where practical, consider completing all missed planned inspections and measurements before product delivery.

Clause 8.2.4 does not require a ‘documented’ procedure. However, you must identify and document all product realization processes that may address this clause, as part of your QMS (see clause 4.1), e.g. receiving, production, shipping, etc.. For such processes, you must also identify what specific documents are needed (see clause 4.2.1d. and 7.1b.) for effective planning, operation and control.

You could use a product quality plan; documented procedure or other combination of specific practices, procedures, documents and methods. Look at the risks related to your product, processes and resources in determining the extent of documented controls you need to have (also see clause 4.2.1 notes).

Performance indicators to measure product conformity - reduction in defect rates, PPM’s (defective parts per million), scrap rates, waste, rework; improvement in on time delivery (see clause 7.1a); product returns from customer; etc.

Performance indicators to measure the effectiveness of product realization processes in achieving product conformity include - productivity; reduction of cycle time, errors, omissions and failures; etc. (see clause 7 processes).