Wawan Setyawan (2009) says that writing the ISO 9001 series 2008 on the last show of the revision, so the ISO 9001:2008 Quality Management System is ISO 9001 revised in 2008. While Stanley Sutrisno (2010) says that the number 2008 on the ISO 9001 series this is the year of issuance of the quality management system which is an improvement of the quality management system before the Quality Management System ISO 9001:2000.
Based on the above description can be concluded that the ISO 9001:2008 Quality Management System is ISO 9001 Quality Management System issued in 2008 as a revision of ISO 9001:2000 Quality Management System.
Middle East Quality Management Professionals (MEQMP) (2008) states that no additional clauses in the revised ISO 9001:2000 Quality Management System to ISO 9001:2008 Quality Management System. Changes from ISO 9001:2000 Quality Management System to ISO 9001:2008 Quality Management System is a minor change, which means there is little change in its content, and these changes aim to clarify or further explain the essence or substance of the previous ISO 9001 version, namely Management System Quality ISO 9001:2000 and to further improve compliance with ISO 14001:2004 Environmental Management System.
ISO 9001:2008 sets requirements and recommendations for the design and assessment of a quality management system. ISO 9001:2008 is not a product standard, because it did not state requirements - requirements that must be met by a product. ISO 9001:2008 is the only standard of quality management system, but nevertheless expected that the product resulting from an international quality management system will be of good quality. This is in line with the statement Perry L. Johnson (1997:6) "ISO 9000 is not a standard product, but a quality system standard. It APPLIES not to products or services, but to the process the which creates Them ". This means that ISO 9000 is not a standard for the product, but it is a standard quality system for the manufacture of such products.
Quality Management System ISO 9001:2008 has eight clauses. BSN (2008) states that the clauses contained in ISO 9001:2008 Quality Management System are as follows:
1) Clause 1. Scope
The scope of ISO 9001: 2008 has been developed or expanded. In this case the requirements of the standard has been stressed to meet customer satisfaction through the effectiveness of the application of quality system, including processes to continually improve and guarantee compliance.
2) Clause 2. Normative References
This clause contains only references from ISO 9001:2008.
3) Clause 3. Terminology and Definitions
This clause states that the terms and definitions given in ISO 9000:2008 (Quality Management Systems Fundamentals and Vocabulary).
4) Clause 4. Quality Management System
This clause is more emphasis on the need for continuous improvement (continual improvement). Management organization must establish measures for the implementation 9001:2008 quality management system.
5) Clause 5. Management Responsibility
This clause emphasizes the commitment of top management towards the development and improvement of the quality management system ISO 9001:2008. This clause also forced the involvement of top management with customer needs, establish policies for quality, setting quality goals, planning, quality management system, establish responsibilities and authority of the organization, raised formally a representative of management and ensure proper internal communication processes , and must conduct a review of the quality management system.
6) Clause 6. Human Resource Management
This clause states that an organization hasus determine and provide the resources needed are appropriate, personnel responsible for carrying out the task should be defined in the ISO 9001:2008 quality management system and has competencies related to the relevant education, training, skills and experience.
7) Clause 7. Product Realization
This clause states that the organization must ensure that the product realization process is under control in order to meet the product requirements.
8) Clause 8. Measurement, Analysis and Improvement
According to this clause of the organization shall establish plans and implement the processes of measuring, monitoring, analysis and improvement is needed in order to ensure the suitability of the product, ensure conformity of the quality management system and continually improve the effectiveness of quality management system.
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