View ISO9001 QMS
Procedures Manual Sections
- Introduction to ISO
- Manual Preparation
- QMS Quality Manual
- QMS Quality Procedures
- EMS Quality Procedures
- Reports and Forms
Weight: 5 pounds
ISO Quality
Management Systems
In this Section:
Other Introductory Sections:
- Introduction to ISO
- ISO Standards
- ISO 9000:2000 Standard
- ISO Quality Management Systems
- ISO Certification Process
- ISO Definitions
Quality Objectives
To assure that a company or division will meet the ISO 9000 requirements and receive certification, the following process should take place:
- Management Decision and Commitment
- Adequate Training and Evaluation
- Compliance with Appropriate Standards
- Audit and Registration
Quality Systems Implementation
Some of the obstacles that can interfere with successful implementation and that must be avoided can include, unrealistic time frames, resistance to change, lack of management commitment, insufficient training, or subjective interpretation of the standards.
The areas most frequently resulting in Non-Certification by companies to date have been in document control, design control, purchasing, inspection and testing, quality systems, process control and inspection, or measuring and test equipment. 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 procedures 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
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Quality Systems Documentation
Many professionals and consultants associated with ISO 9000 registration recommend organizing the documentation into four levels.
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 the procedures. 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: Scope, Policy and Responsibilities.
The Scope portion should simply state the purpose of the covered area.
The Policy portion should state the company policy regarding the applicable ISO clause.
The Responsibility portion should state who, in generic titles or positions, is responsible for the policy.
Although there is no standard format or requirement for the Quality Manual, a sample manual is provided in this guide for you to use as a template to create your own Quality Manual.
Level 2 - Procedures and Responsibilities
The second level of documentation should be more detailed and address the procedure(s) of an activity for a department or function and the personnel (generic titles or positions) responsible for accomplishing the procedure(s). These procedures can be organized on a departmental basis.
Samples of Level 2 type departmental procedures and responsibilities documentation are provided in the ISO Policies and Procedures System. The ABR ISO9000:2000 Quality Procedures start with the designation "QP" and may be used as a template to create your own procedures. They are not the only format or method to accomplish the requirements.
The procedures in this manual provide format and verbiage to describe tasks and activities that are typical for organizations that meet ISO 9001:2000 requirements. They certainly are not the only format nor functional descriptions of these tasks and activities. They are intended to provide a foundation for you to develop the procedures that work for your company. As you rewrite the procedures for your application, be sure to verify your modifications against the requirements of the ISO standard to ensure all requirements are still addressed.
An example of where you may want to change the format is the Effectiveness Criteria section of certain procedures. Section 4.1 c) of the ISO 9001:2000 standard requires that 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.
The primary reason this section was included in the procedures was to encourage thought in this area. Often times, effectiveness of a process, task, or activity is assumed to be known. The 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 significant improvement.
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 was 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 3 - 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.
Individual work instructions are very specific to an industry or company. Supplimental documentation may be used including User's Manuals, Engineering or Technical Manuals, Technical Support notes, Manufacturing Notes, etc., in order to create detailed work instructions. Samples of level 3 type work instructions are not provided in this guide.
Level 4 - Forms and other Documents
The last level of documentation can include forms, records, checklists, surveys, and other documents used in the production or delivery of a product or service.
Samples of quality level 4 type Reports and Forms and other documents are provided in this manual and may be used as a template to create your own forms. The forms provided should be used as guides, not necessarily as final documents. Again, they are there to provide examples and foundations for you to work from.
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Confidentiality Statements
A confidentiality statement in the footer is totally optional and strictly a recommendation to protect your company's interests. Normally, when customers request a copy of your Quality Manual, the top-level quality policy manual is what they are after. The implementing Quality Procedures usually contain proprietary details that are specific to your company and may be something you do not want to share, and usually are not meaningful to your customers.
