ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

7.1 Planning of Product Realization- Cont'd  

ISO 9001 Training - Key Explanation Points and Tips: - Continued:

Focus on defect prevention in planning the controls for product realization. 

The notes to 7.1 also permit you to use other project management tools or clause 7.3 product design and development requirements to plan for product realization processes.

Quality objectives may include - defect rates; scrap rates, etc. Requirements or criteria for the product may include - physical; dimensional; functional, etc, and their related measurements, tolerances and acceptance levels.

In many instances, depending on the nature of the product, the customer may specify objectives and requirements /criteria for the product realization processes as well.

Clause 7.1 does not require a ‘documented’ procedure. However, you must identify and document all processes addressing this clause as part of your QMS (see clause 4.1). For these processes, you must also identify what specific documents are needed for effective planning, operation and control of production processes (see clause 4.2.1d).

These documents may include - contracts; specifications; orders; product quality plans; work instructions; a documented procedure; etc., combined with unwritten practices, procedures and methods.

Look at the risks related to your product, processes and resources in determining the nature and extent of documented controls you need to have (also see clause 4.2.1 notes).

Where any of the product realization processes are done off-site (e.g. at head-office), your QMS must include the off-site processes within your QMS and ensure that such processes comply with ISO 9001 requirements.

Evidence of the off-site facility’s compliance may include - a copy of their ISO 9001 certification; results of their internal audits to ISO 9001; auditing the outsourced facility; etc.

The expectation is to flow down to the off-site facility, the relevant ISO 9001 requirements that you would have to implement, had you carried out the process at your own facility.

Performance indicators, (to measure the effectiveness of product realization in meeting requirements and achieving quality objectives), will be specific to each realization process and focus on reducing variation and waste in realization processes and related use of resources.

Objectives may be used to monitor and improve process - productivity; reduction of cycle time, errors, omissions and failures; etc.

You must also consider indicators to measure product performance such as - reduction in defect rates, PPM’s (defective parts per million), scrap rates, waste and rework; improvement in on time delivery (see clause 7.1a); product returns from customers; etc.