Overview of OP19 

Planning for Product / Service Realisation
1.0 Purpose
1.1 To describe how management, using a product quality plan, plans and develops operating and support processes for the processes, test and delivery of products that meet quality management system, regulatory and customer requirements as well as provide resources for effective implementation.
2.0 Associated Documents
2.1 ISO 9001:2000 Clause 7.5
2.2 Product Quality Plan
3.0

Scope

3.1

This process includes current and new products provided by the company. The planning process considers, where appropriate, product requirements, process documents, provision of resources, inspection or test activities, criteria for product acceptance and quality records.

4.0 Definition
4.1 A product quality plan is a document referencing product processes including function, specification, processing and inspection stages as well as inspection methods.
5.0 Responsibilities Defined
5.1 Quality Manager
5.2 Engineering Manager
5.3 Department managers
5.4 Engineers
6.0 Contents Include
6.1 Assessing the Product Process Flows
6.2 Preparing the Product Quality Plan
6.3 Approval and use of Product Quality Plan
6.4 Filing of the Documentation
6.5 Flowcharts - Product Quality Planning Process
6.6 Plans - Product Quality Plan