Validation of Processes

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

Quality Policy

Clause 4.2.1 of ISO 9001:2008 QMS standard includes documented statement of quality policy as part of the organization's QMS documentation. Clause 5.3 of ISO 9001:2008 QMS standard mentions requirements for quality policy. It is the responsibility of the top management of the organization to ensure framing of quality policy of the organization.

What is in a quality policy?

Quality policy is a QMS documentation that provides a commitment to comply with requirements and continually improve the effectiveness of the quality management system and also to have a framework for establishing and reviewing quality policy. ISO 9000:2005 standard defines quality policy as overall intentions and direction of an organization related to quality that is formally expressed by the top management of the organization.

What are the requirements related to quality policy in ISO 9001:2008 QMS standard?

As per requirements mentioned in clause 5.3 of ISO 9001:2008 QMS standard the top management of the organization must ensure that:
(i) - the quality policy is appropriate to the purpose of the organization
(ii)- a commitment to comply with requirements of the quality management system is included in the quality policy
(iii)- a commitment to continually improve the effectiveness of the quality management system is included in the quality policy
(iv)- a framework for establishing quality objectives is provided in the quality policy
(v) - a framework for reviewing quality objectives is provided in the quality policy
(vi)- the quality policy is communicated within the organization
(vii)- the quality policy is understood within the organization
(viii)- the quality policy is reviewed for continuing suitability

The requirements as mentioned in (i) to (v) above are useful in developing or framing a quality policy.

First Sample 'Quality Policy'

"Our organization is committed to enhance customer satisfaction by achieving our organization's quality objectives through the effective application, review and continual improvement of our quality management system."

Second Sample 'Quality Policy'

"We, the employees of ABC Organization, are committed to meet customer requirements as well as applicable legal requirements by achieving our quality objectives through the application, review and continual improvement of our management systems."

With best wishes,

Keshav Ram Singhal

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With best wishes,

Keshav Ram Singhal