Quality Manual in ISO 9001:2015

QUALITY MANUAL importance in 9001:2015

Required or not?

This is only conflict due to new revision of ISO 9001.  Since Manual is not required in 2015 updation, but it keeps value in companies.

So, what is a quality manual?

A quality manual describe the company’s intentions for operating the process of Quality Management System. It can include policies for all areas of the business its affect the ability to make high quality products which meets customers and ISO These policies define how your department managers will implement procedures within the boundaries specified in the quality manual.

An important note

Many other quality management system standards based on ISO 9001 are still requiring a quality manual. If your standard requires one, then you must maintain a quality manual.

Here are some uses for a quality manual.

1. To communicate management’s expectations to employees
2. To demonstrate the company’s plan to conform to the requirements of ISO 9001:2015
3. To demonstrate the fulfillment of Clause 5.3, that organizational roles, responsibilities and authorities are assigned, communicated and understood
4. To provide a starting point for auditors:
   1. Internal
   2. Customer
   3. ISO Certification Body

Content

For users of ISO 9001:2015, the contents of your quality manual are completely up to you. But, remember that everything you say you do, you must show evidence that you really do it! So be careful what you include and make sure the policies reflect actual practices. Here are some common topics included in quality manuals:

• Quality policy
• Explanation of the company’s documentation structure
• Organizational chart
• Policy statements for each applicable ISO requirement
• Reference to operating procedures

Of course, your quality manual may not cover each of these, and it may include much more. The trick is to find a balance between all that could be in there and what really needs “to be”.

Development

To develop a quality manual, you might consider these steps:

1. List policies to be written (note any ISO requirements that do not apply).
2. Draft policies based on applicable ISO requirements.
3. List operating procedures or refer to them as appropriate.
4. Determine format and structure of the manual and make the first draft.
5. Circulate the draft manual for input from all departments and address inadequacies identified.
6. Attain a formal approval and release.

So many things are in Quality Manual. Its just a try to spread awareness for ISO