Documents Needed for ISO 9000
by Ron Kurtus (revised 29 November 2005)
There are four tiers of documentation recommended for satisfying ISO 9000 requirements. These documents are: the Quality Policy Manual, Procedures, Work Instructions, and Records.
Questions you may have include:
- Who needs to know about these documents?
- What are the characteristics of each?
- How do they relate to ISO 9000 compliance?
This lesson will answer those questions.
Who needs to know?
A number of people within a company should be familiar with these documents and their requirements.
Since ISO 9000 starts with upper management, they should be aware of what types of documentation is needed to assist in keeping their business well organized.
Head of Quality
The Head of Quality in a company is often in charge of controlling these documents and specifying the requirements for them, so obviously that person needs to be familiar with what they are about.
The technical writers or others who are assigned to write these documents and manuals need to be fully aware of their significance.
Finally, the workers who may use the documents as guides, or who may have to fill in records, must know about the ideas behind these ISO 9000 documents, as well as the significance of them to the company and their jobs.
Four tiers of documents
The four tiers of ISO 9000 documentation are the Quality Policy Manual, Procedures, Work Instructions, and Records.
Quality Policy Manual
The Quality Policy Manual (also simply called Quality Manual) is a top-level document that states the company philosophy toward providing quality product and work. It states what you plan to do. Since it states the company philosophy and outlines how the business is to be run, it should be written in direct coordination with top management.
Doomed to failure
Companies that do not have direct involvement of their executive officers in the drafting of the Quality Policy Manual are doomed to failureat least in the proper implementation of ISO 9000.
The Quality Policy Manual usually includes the policy toward each of the ISO 9000 requirements. This goes beyond simply re-stating the requirement. Instead it needs a mission and vision from management.
Rationale or belief
Our approach toward the Quality Policy Manual is to add the rationale for each policy in the manual. In other words, we believe you should include the reason for a given policy in order to show how it will benefit the company, its operations, and its profits.
A Procedure Manual should state how you plan to implement the policies stated in the Quality Policy Manual. It also states who is responsible for each ISO 9000 section.
Procedures often involve several departments or work areas within a company. They often outline the work flow between departments, suppliers, and the customer.
Work Instructions involve the details of how an individual or group is to perform a specific task or job. This is very important to maintain uniformity, as well as to ensure that the job can still be done if a key employee is unavailable.
Record keeping is certainly important to track design, costs, work, and product. The records should be value-added. Some poorly run companies are careless in keeping records, while others keep unnecessary records.
Relation to compliance
If a company is well organized, it is less likely to be involved in foolish mistakes or to have dysfunctional areas within the company. Thus there is a great need for some standards of organization.
By following the ISO 9000 standards, along with having a good company policy toward quality, procedures that tell what will be done and who will do it, work instructions to assure consistency of operations, and solid record-keeping, a company can enhance its chances for success.
The documentation required to effectively operate a business and to satisfy ISO 9000 requirements consist of a Quality Policy Manual, Procedures, Work Instructions, and Records. A company that fulfills these requirements enhance chances for success in their business operations.
Express yourself clearly
Resources and references
ISO Online - International Organization for Standardization website
ISO Standards Translated in Plain English - Extensive listing
ISO 9000 Certification Information - Good listing of ISO 9000 resources
Questions and comments
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Documents Needed for ISO 9000