Process planning is central to ISO 9001:2008. It is a general requirement (4.1).
Process planning requires the organisation to:
Most organisations include a flow chart (process map) to show the sequence and interaction of work (4.1b). To do this, walk a job through from start to finish and draw a process map of the core processes.
A typical process may look like this:
Enquiry and Quotation › Order Receipt › Design › Sample approval › Specification › Purchasing › Goods Receipt › Goods-In Stores › Manufacture › Test › Goods-out Stores › Despatch
Around these core processes, there will be various support processes e.g. training, maintenance, calibration, internal audit, etc.
These support processes enable the core processes to function.
No. Production processes (or as ISO 9001:2008 calls it, "product realization processes") are just a subset of your normal business processes.
Think of "production" as "creation". If your organisation designs training courses or provides cleaning services, your production processes are how you develop a course or how you plan and deliver your service – all just part of "running the business".
There is more to a process than just the tasks and decisions which define the flow of information or material. You also need to define the materials, hardware and skills required and the environmental influences (e.g. light, hygiene, humidity) which could affect the operation of the process.
As little as you need in order to demonstrate consistency and control. Be clear about why are you doing it and who will use the resultant definitions. But do it for yourself and your staff – a QMS is not solely for your external auditor.
Two pages of a flowchart should be sufficient for a process. Assume your people are competent – or train them if they're not.
Your organisation’s quality management system is that part of your overall management system which establishes, documents and implements your quality policy, and related processes for providing products and services which meet or exceed customer requirements, and which satisfies quality management system requirements of ISO 9001:2008.
Your organisation should adopt the process approach advocated by ISO 9000:2005, by defining and managing:
If your organisation outsources processes, you must be able to demonstrate sufficient control over each outsourced process. This is to ensure that those processes are performed according to the relevant requirements of ISO 9001:2008.
Outsourced processes may be controlled in any number of ways; either by providing suppliers or subcontractors with product specifications or by requesting inspection and test results or certificates of compliance or by conducting product and quality management system audits of your supplier/subcontractor.
The expectation here is that your quality management system flows down to your supplier/subcontractor, the relevant ISO 9001 requirements that you would have to implement had the process been performed in-house under your quality management system control.
Process planning is documented and explained in our Quality Manual Template and guidance document.