ISO 9001:2008 QMS standard requires validation of processes only where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequent deficiencies (incompleteness or inadequacy) in the product become apparent (known) only after the product is in use or the service has been delivered. The relevant clause in this regard is clause 7.5.2 of ISO 9001:2008 QMS standard that mentions requirements. This clause is for those processes where an organization is not able to easily measure the resulting output. The normal example is how do you test a gun-bullet or tear-shell? If you try and test a gun-bullet or tear-shell, then you will destroy the gun-bullet or tear-shell. So there is a need of the system for validating the processes that the gun-bullet or tear-shell was manufactured correctly and the gun-bullet or tear-shell will not fail.
Validation must demonstrate the ability of such process to achieve planned results. An organization must establish effective arrangements, for such process, including:
- Defining acceptance criteria for review and approval of the process
- Approval of appropriate equipment
- Approval of qualification of personnel, so that trained and qualified personnel are able to handle the process
- Use of specific methods and procedures
- Requirements for records
- Requirements for re-validation
So an organization needs a standard operating procedure (SOP) for that process where the organization is not able to measure the resulting output. And the organization needs to establish effective arrangements, how the organization validates such processes and what records will be kept. Keeping a documented procedure for such standard operating procedure (SOP) is not a mandatory requirement, however the organization may think of determining a documented procedure for such SOP to ensure the effective planning, operation and control of the process included in the SOP. Without having a documented procedure for such SOP, the organization has to prove that the organization has such processes in place.
Please post your comments. With best wishes,
Keshav Ram Singhal
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