| Page 1; Page 2; Page 3||ISO 9001: 2008
The ISO 9000 family addresses “quality management”. This means what the organization does to fulfill: the customer’s quality requirements, and,applicable regulatory requirements, while aiming to enhance customer satisfaction, and,achieve continual improvement of its performance in pursuit of these objectives.
ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.
The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:
- No changes or minimum changes on user documents, including records
- No changes or minimum changes to existing processes of the organization
- No additional training required or minimal training required
- No effects on current certifications
The benefits identified for the ISO 9001:2008 edition fall into the following categories:
- Provides clarity
- Increases compatibility with ISO 14001.
- Maintains consistency with ISO 9000 family of standards.
- Improves translatability.
|Clauses Description: ISO 9001: 2000
1. Scope: Scope of the QMS, areas covered and any exclusions identified
2. Normative Reference: The normative reference ISO 9000:2000 (fundamentals/vocabulary) must be used in conjunction with the standard itself
3. Terms & Definitions: The terms and definitions given in ISO 9000 apply.
4.1 General Requirements: This clause covers the requirement of the organisation to actually set up a quality management system, and broadly sets out the activities associated with this. The organisation shall document, implement and maintain a quality management system (QMS) and continually improve its effectiveness in accordance with the requirements of the standard.
4.2 Documentation Requirements: The important issue here is that people must have the information they need to do their job. The QMS must include quality policy, quality objectives, quality manual, documented procedures, documents to ensure the effective planning, operation and control of its processes, and records. All documents are required to be controlled. Also required is the control of records, i.e. identification, storage, protection, retrieval, retention time and disposition of records.
5. Management Responsibility: Specifically identifies the responsibility of top management and the need for effective leadership
5.1 Management Commitment: Top management shall provide evidence of its commitment to the development and implementation of the QMS and continually improving its effectiveness.
5.2 Customer Focus: Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction
5.3 Quality Policy: A Quality Policy establishes a commitment to quality, a commitment to continuous improvement, the context for quality objectives and how the objectives relate to customer requirements
5.4 Planning: Top management shall ensure that the planning of the QMS is carried out in order to meet the requirements of the standard as well as the quality objectives. The integrity of the QMS is maintained when changes to the QMS are planned and implemented.
5.5 Responsibility, Authority & Communication: Top management shall ensure that responsibility and authorities are defined and communicated within the organisation. Everybody should know what they are expected to do (responsibilities) and what they are allowed to do (authorities). They should understand how these responsibilities and authorities relate to each other. A Management representative needs to be appointed who has responsibility for the QMS. Appropriate communication processes need to be established, and the effectiveness of the QMS must be communicated to the organisation.
5.6 Management Review: The QMS must be reviewed at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. Records from the review must be maintained. The review inputs and outputs must be clearly stated.
6. Resource Management: To ensure that the resources needed to both maintain and improve the QMS are available, and also to carry out the work required in a manner that will satisfy customer requirements.
6.1 Provision of Resources: The organisation shall determine and provide resources needed to implement and maintain the QMS and continually improve its effectiveness, and to enhance customer satisfaction by meeting customer requirements
6.2 Human Resources: Personnel performing work affecting quality of service, shall be competent on the basis of appropriate education, training, skill and experience. The organisation must determine the necessary competence and provide training to satisfy these. They must evaluate the effectiveness of the training and maintain appropriate records. They must also ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.
6.3 Infrastructure: The organisation shall determine, provide and maintain the infrastructure needed to perform work. Infrastructure includes buildings, workspace, utilities, equipment and supporting services. This means determining and providing for current infrastructure requirements and planning for expected future needs.
6.4 Work Environment: The organisation shall determine and manage the work environment needed to achieve conformity of service.
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