ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

7.3.2 Design & Development Inputs  

ISO 9001 Training - Key Explanation Points and Tips:

You must identify, document and review design inputs requirements for function, performance, safety, regulatory, quality, reliability, durability, life, timing,  maintainability, cost, identification, traceability, packaging, special or safety characteristics (from the customer or regulatory body), and other requirements essential to the product. 

You must have a process (should be part of your d & d plan) to deploy (identify, document, review and use) design input information (documents) coming from various sources such as - customer contracts, drawings and specifications; your own organization’s database of previous d & d projects; competitor analysis; industry standards; feedback from suppliers; field data.

D & D usually requires the input and involvement of many other functions and processes (e.g. contract review; product realization; purchasing, top management; etc.) within the organization and your process must manage this interaction by defining responsibilities and means of communications. Inclusion of these controls in your d & d plan is one of many effective ways to achieve this.  Such a multi-disciplinary approach has the benefit of applying the collective and relevant knowledge and skills of these different functions to carry out or review d & d activities.

You must identify and include any special and safety characteristics in your process control documents such as - quality plans; product drawings; operator instructions and other documents used to make or verify product. Note that special requirements can also include process parameters such as temperature, timing, concentrations, etc.

You must review all input requirements; review d & d progress; verify product design and validate developed product at various stages of your d & d process. The nature, frequency and scope of these controls must be defined in your d & d plan or other document. You must carry out these controls according to your plan and keep appropriate records (see record requirements in clauses 7.3.4; 7.3.5; 7.3.6 and 7.3.7).