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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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Friday, December 2, 2016


Article - Creating and developing a procedure


ISO 9000:2015 standard defines the term 'procedure'. A procedure is a specified way to: (i) carry out an activity, or (ii) carry out a process that means carry out a set of interrelated or interacting activities that use inputs to deliver an intended result.

A procedure can be written (documented) or not. When a procedure is written (documented), it is usually referred to as a 'documented procedure'.

A documented procedure usually has the following description:
- Title,
- Document number,
- Reference,
- Cross-reference,
- Purpose,
- Scope,
- Responsibility - Who will do what,
- Procedure details - When, where and how to do,
- What resources (materials, equipment, document) will be used,
- How the activity or process will be controlled,
- How to retain documented information for the activity or process carried out

Steps to create and develop a procedure

Step 1 - Determine the need to create and develop a procedure.
Step 2 - Assign responsibility to someone to develop and write the procedure.
Step 3 - The author should - (i) establish the scope of the procedure, (ii) collect and document (write) all relevant information.
Step 4 - The author should prepare a draft by using a simple and easily understood language.
Step 5 - The author or QMSC should circulate the draft to persons concerned to obtain their comments.
Step 6 - The author should incorporate changes (modifications and additions) to the draft and prepare a final draft.
Step 7 - The author or QMSC should submit the final draft to the authority for approval for adequacy prior to issue.
Step 8 - The QMSC should issue the documented procedure for implementation.
Step 9 - Review of the procedure should be done after its implementation for some time (say three to six months) and amend/revise the procedure.
Step 10 - When you observe that the procedure is no longer useful, withdraw the procedure with information to persons and departments concerned.

QMSC = QMS Coordinator
QMS = Quality management system

- Keshav Ram Singhal

For details on the Training Handbook on 'ISO 9001:2015 QMS Awareness', please CLICK HERE.

For details on 'Checklist for ISO 9001:2015 QMS', please CLICK HERE.

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