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~ Quality Systems & Documentation ~
Objectives
To assure that a company or division will meet the ISO 9000 requirements and receive certification, the following process should take place:
1. Management Decision and Commitment 2. Adequate Training and Evaluation 3. Compliance with Appropriate Standards 4. Audits and Registration |
Implementation
Some of the obstacles that can interfere with successful implementation and that must be avoided can include:
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The areas most frequently resulting in Non-Certification by companies to date have been in:
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 Quality systems |
| Design control |
Process control |
| Measuring and test equipment |
Inspection |
| Inspection and testing |
Purchasing |
Although all areas of the company’s quality assurance program are required to be in compliance with the standard, management should perform extra reviews to ascertain compliance in these above areas.
The appropriate personnel under the direction of management should review the standards and develop, implement and maintain a minimum set of quality systems and methods to satisfy the ISO 9000 standard.
Further, these personnel will provide confidence to management that the intended quality is being achieved and is:
Documented / Demonstrable / Effective / Maintained 
Documentation
ISO 9000 recommendations typically suggest organizing the documentation into four levels:
Level I - Quality Policies and Objectives Level II - Departmental Procedures & Responsibilities Level III - Work Instructions Level IV - Forms and Related Documents. |
Level 1 - Quality Policies and Objectives
This first level of documentation is often referred to as a “Quality Manual” and is separate and distinct from other processes. The purpose of this level of documentation is to state in a concise and brief format, the policies and objectives of the company for achieving a desired level of quality for the organization or division.
At a minimum, the Quality Manual is required to address each one of the paragraphs of the applicable ISO Series that the company plans to become registered against.
Each area that is written should include three parts: Purpose, Scope, and Responsibilities.
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There is no standard format or requirement for the Quality Manual. It must however clarify points of policy, points of responsibility, and points of accountability.
Level II - Departmental Methods and Responsibilities
A broad “Big-Picture” view of a process or system, that may include sub processes or sub systems. The documentation can utilize a “Master Document” format for tight document control, substantially reducing the chances of using out-of-date documentation. Each Methods Overview document will contain all documents related to the Method being outlined. “Drill down” access is fast and easy, allowing anyone to start at the top and go to the most specific, detailed instructions in a matter of seconds.
Second level documentation provides management-level detail that defines the processes or activities within a department or function including the personnel (generic titles or positions) responsible for fulfillment of the associated requirements. These processes can be organized on a departmental or intra-departmental basis.
An example of where your company may want to modify its format is the Effectiveness Criteria section related to certain processes. Section 4.1 c) of the ISO 9001:2000 standard requires the criteria and methods to determine the operation and control of processes are effective to be determined. It does not require the methods and criteria to be defined in the procedures; other methods may be used.
Without clarity in this area, many assumptions may not be verbally expressed and frequently there is no agreement between departments or even between employees in the performing department. Defining these criteria and obtaining consensus among interested parties can result in several significant improvements.
When determining these criteria, a holistic approach as to what is best for the company should be used. An obvious example involves Purchasing. In the past, purchasing effectiveness may have been measured by the purchase price of materials. The obvious fallacy with this measure is that out of specification or marginal components result in increase costs downstream and may actually result in higher total costs.
Level III - Work Instructions
This level of documentation should be very detailed on “how” to accomplish a specific job, task or assignment.
For example, a work procedure could be developed for assembling the final housing of a product with step-by-step instructions including such detail as the torque requirements of the fastening screws.
Level IV - Forms and other Documents
The last level of documentation can include forms, records and other documents used in the production or delivery of a product or service.
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