| Quality Manual
This first step in building a Quality Management System is the creation of a
"Quality Manual". This is a separate and distinct step from developing quality procedures.
The purpose is to state in a concise and brief format, the policies and objectives of the
company required to achieve a desired level of quality for the organisation or division.
More than likely the input for the Quality Manual will come from your customers.
It is the customer that drives the Quality Process. Their requirements, needs and future
desires are the basis for implementing an ISO 9000 quality system in the first place.
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. ISO
9001:2000 is the focus of this manual. But, you may need to expand the scope to include
EMS 14001, QS-9000, AS-9000, or other industry specific quality requirements.
Each area that is written should include, at a minimum, 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.
ISO 9000 does not require a specific format for the Quality Manual.
Eight Quality Management Principles
1. Customer Focus -
Organisations depend on their customers and therefore have to understand their current and
future customer needs, meet their customers' requirements and strive to exceed their customers'
expectations.
2. Leadership -
Leaders establish a unity of purpose and the direction of the organisation. They need to create
and maintain an internal environment in which people can become fully involved in achieving the
organization's objectives.
3. People Involvement -
People at all levels are the essence of an organisation. Their full involvement creates
opportunities for their abilities to be used for the organisation's benefit.
4. Process Approach -
A desired result is achieved more efficiently when activities and related resources are managed
as a process.
5. Systems Approach to Management -
Identifying, understanding and managing interrelated processes as a system define the
organization's effectiveness at achieving its objectives.
6. Continual Improvement -
Continuous overall performance improvement is the objective of a successful long-term
organization.
7. Factual Approach to Decision-making -
Effective decisions are based on solid information and objective data analysis.
8. Mutually Beneficial Supplier Relationship -
An organisation and its suppliers are interdependent and a mutually beneficial relationship
enhances the ability of both to create value.
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Quality System 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
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Quality System 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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