I had read through with the SCM handbook but I'm not sure if all the chapter in that handbook will be included in my CM Plan.
We are going for a certification on AS9100C and currently we are doing some revision to our ISO 13485 QMS to suit the AS9100C. My problem is that the product that will be going to be audited is a medical product. So I'm not sure how to do a CM plan on a medical product that will suit the AS requirements. To be able to produce an AS product we need to be certified first.
How about this from the IAQG Auditor Guidance Material
Planning of product realization
7.1.3 Configuration management
What to look for
Configuration planning management
? the configuration management planning scope and the objectives
? the product description subject of the management
? timetable planning for the significant actions of the configuration management
? the means used (IT system, for instance)
? the configuration management planning coming from the supplier
? the identification of the significant documents and their interrelation
Configuration identification
Evidence of the existence of:
? the tree of product, specification and other configuration
? the identification method of the product and documentation (drawing, spec, ...) and the identification of the change (status of the changes)
? the requirement to the traceability such as serial number, lot number, ....
? the method of communication to know the configuration status of the product
Change controls
Examples of objective evidence:
? the system of the management configuration changes to all steps of the design (for example : parts list at the different levels of design- development part list- to be certified part list- certified part list, ...)
? the configuration change method, the deviations
Configuration status accounting
Examples of objective evidence:
? the form of change identifying the data of the changes to be recorded
? the routing card, following sheet the serial number, batch number of the part, sub-assembly, assembly
? the production operations done by the operator
NOTE:
When traceability is a requirement, traceability level of the parts depends on the part category (e.g., the critical ones should be traceable from the raw material to the assembly, the part should always be with its SN during the production, in addition all the manufacturing history should be recorded). Also, see ISO 10007
