ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

7.3.2 Design & Development Outputs  

ISO 9001 Training - Key Explanation Points and Tips:

D & d output may be product or documentation or both. Product may be prototype or finished product and documentation could be a computerized or hardcopy drawing or specification.

Check d & d output against the input requirements specified in 7.3.2, before you use it any further. Express product design output in any or all the forms specified in 7.3.3.1. 

Provide appropriate d & d output information to:

- purchasing (material or service specifications);

- production (product specifications, special characteristics, drawings, diagnostics, etc.);

- service (product specifications; performance reliability and maintenance criteria).

- Initially, this information may be used for trials and validation, before being firmed up.

Many documents are created from the d & d output stage (drawings, quality plans, work instructions, etc). These documents must be controlled as per clause 4.2.3 of this standard (approval; revision control, distribution, etc).

Where any sophisticated d & d tools (e.g.  AutoCAD) are used requiring specific competency or training, ensure you provide and keep appropriate records of competency and training of personnel performing d & d activities and use of these tools.

7.3.4 Design & Development Review  

 Key Explanation Points and Tips:

Do design reviews at one or more milestones of the d & d project, depending on customer requirements, the size, complexity and risks involved. The purpose of these reviews is to evaluate results to requirements, check project progress and costs to plan (see 7.3.1) and take actions on any problems encountered.

You must take a multi-disciplinary approach for doing these reviews and keep appropriate records of issues discussed, actions to be taken, responsibilities and timeline for completion.

All d & d reviews must be included in your d & d plan.