A Guide on Writing Quality Management System Documents

How to Write Quality Management System Documents
By M.L. Browne, eHow Contributor * * * * Print this article
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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 * 1
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 responsible for writing and in what form the documents must be produced. * 4
Create a project plan that identifies each documentation task, who owns it, the dates the documentation is due for review and the projected due date for management approval. * 5
Conduct periodic documentation progress reviews according to the project plan, and offer assistance and support when necessary to task owners who encounter difficulties in keeping to the schedule. * 6
Get Management Approvals
Conduct a management approval review on the policy statement and operating procedures to make them effective as of the date of signing. * 7
Store all quality management system policy statements and operating procedures in the central QMS document repository or manual. 2. Work Instructions * 1
Documenting the Work Instructions
Ask people whose work contributes to the quality of the products or services to write each task they perform in a logical, simple manner. These documents are called "work instructions," and they will be updated as the work changes over time. Work instructions provide support for the operating procedures. * 2
Collect and review the work instructions according to the project review dates, and have the supervisor or manager who is responsible for the work output approve them as they are finished. * 3
Collate and file the QMS work instructions with the operating procedures in the central QMS document repository. 3. Audit Records and Change Orders * 1
Periodic QMS Document Inspection and Audit
Periodically conduct a review of the quality management system documents to determine whether they are still effective. The scope, operating procedures and work instructions are considered effective if everyone still follows what is written in the documents. * 2
Write an audit report that clearly identifies what procedures or work instructions are or are not being followed, along with supporting dates, data and evidence of noncompliance. * 3
Submit the audit report to the company's designated quality management representative and the managers and supervisors whose areas are in noncompliance so they can take corrective action, and then file a copy of the report in the central QMS document repository. * 4
Decide what Change Orders are Necessary
Meet with the quality management representative and, if necessary, amend the QMS operating procedures or work instructions to reflect an accurate description of what is being done. These amendments are also known as "change orders." * 5
Ask the quality management representative to approve the change orders, file them in the central CMS document repository and then replace any copies of the operating procedures or work instructions that are out of date. * ISO 9001 registrationwww.cdgcertification.com
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Tips & Warnings * Simplicity and clarity of the writing are keys to implementing successful quality management system documents. Each document is a guideline for a functional area, and you should design the documents for ease of access and use. If they're too complex, nobody will pay attention to them.

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