A Guide on Writing Quality Management System Documents

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How to Write Quality Management System Documents
By M.L. Browne, eHow Contributor
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Quality Management System Documentation
Documentation is at the heart of every company's quality management system (QMS). The creation, approval, effectivity, revision control and auditing of the QMS documents provide the company with a road map for continuous process improvement, increased customer loyalty and satisfaction, and in-depth understanding of all the things that contribute to the quality of design, creation, manufacture and support of its products and services. 

The QMS document hierarchy includes the policy statement, operating procedures, work instructions, audit records and change orders. Once approved and effective, copies of these documents are filed together in the company's quality management system manual. QMS documents, especially work instructions, are often written by the people who are primarily responsible for the things the documents describe. Difficulty:

 
Challenging
Instructions
Things You'll Need
* External regulatory standard
1. Policy Statement and Operating Procedures
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Create a QMS outline that includes a framework for your policy statement and operating procedures. * 2
Measure the Documentation Scope
Determine the scope of your QMS. For example, it can be for design, production and manufacture of products and services, or a subset of one or more of these things. You can also indicate whether the QMS must adhere to an externally regulated standard, such as those created by the International Organization of Standardization (ISO). Only operating procedures and work instructions that fall within the scope of the QMS need to be written. * 3

Meet with the people who have authority and responsibility for the areas of the company that fall within the QMS scope to decide what each person is...
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