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- Keshav Ram Singhal
Blog on 'Quality Concepts and ISO 9001: 2008 Awareness' at http://iso9001-2008awareness.blogspot.in

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Tuesday, December 20, 2016



Operation is the action of functioning of the organization to achieve its objectives.

Clause 8.1 of the standard stipulates requirements to plan, implement and control the operation processes necessary to meet the requirements for organization's products and services, and also consider the actions determined while addressing risks and opportunities, quality objectives and planning of changes as mentioned in clause 6 . Clause 4.4 of the standard also states to determine and implement processes needed for the quality management system. Most of the requirements mentioned in clause 4.4 of the standard support the requirements of clause 8.1.

In order to meet the requirements of clause 8.1, organizations are required to
- plan, implement and control processes,
- implement actions determined (i) to address risks and opportunities, (ii) to achieve quality objectives, and (iii) need for changes,
- determine requirements for products and services,
- establish the criteria for evaluating the processes in order to ensure that organization's processes are performing as expected and producing the intended outputs,
- establish the criteria for acceptance of products and services, so that products and services produced are further checked for meeting requirements for products and services,
- determine the resources needed in order to support operation,
- implement control as per established criteria (during in-process monitoring and measurement and final inspection, monitoring and measurement of the output of the process that may include inspection, test activities etc.,
- control changes planned and outsource processes, if any,
- review consequences of unintended changes and take necessary action to mitigate any adverse effect,
- determine documented information to maintain and retain to the extent necessary, maintain as determined and retained as determined.

What documented information can be determined to maintain?

Although the standard has left this on the organization to determine, however it is suggested to maintain documented information for organization's operational processes, procedures, product/service specifications, work instructions, monitoring and measurement criteria, workflow chart etc., to ensure desired results.

Outsourced processes

Outsourced processes needs to be controlled. In this regard requirements mentioned in clause 8.4 are relevant.

- Keshav Ram Singhal

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