Professional Documents
Culture Documents
Introduction
It is a requirement of the International Standards Organizations that standards are reviewed every 5 years Previous issues were in 1987 and 1994
ISO 9001:2000
Replaces ISO 9001 - 1994 ISO 9002 - 1994 ISO 9003 - 1994 with one standard
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ISO 9001:2000
QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
An Overview
4.0 Quality Management System 4.1 Requirements The organization Shall Establish, Document, Implement, Maintain Continually improve a Quality Management System
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Quality Management System To implement the QMS organisations shall a) identify processes b) determine the sequences and interaction of the processes c) determine criteria and methods to ensure effective operation and control of the processes
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Quality Management System To implement the QMS organisations shall d) ensure availability of resources and information to support operation and monitoring of processes e) monitor, measure, and analyze the processes f) implement actions necessary to achieve planned results and continuous improvement of the processes
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Procedures
Documented Procedures are required in this International Standard Documents are required by an organization to ensure effective operation and control of its processes.
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ISO 9001:2000
5 Management responsibility 5.1 Management Commitment 5.2 Customer focus 5.3 5.4 5.5 5.6 Quality Policy Planning
Responsibility, authority and communication
Management review
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Management Commitment
Top management shall provide evidence of its commitment to: the development of the QMS the implementation of the QMS continually improving the effectiveness of the QMS
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ISO 9001:2000
6. Resource Management 6.1 Provision Of Resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment
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ISO 9001:2000
7. Product Realization
7.1 Planning of product realization 7.2 Customer related processes 7.3 Design and Development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of Monitoring & Measuring Devices.
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Records of the review should be maintained Verbal contracts (with no documented statements of requirements) shall be confirmed before acceptance Where orders are changed, the relevant documents shall be amended accordingly and relevant personnel made aware of the changes
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Customer Communication
Determine and implement effective arrangements to communicate with customs on:
product information inquires, handling of contracts and orders customer feedback including customer complaints
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7.4 Purchasing
Purchasing process shall ensure that
purchased product conforms to specified requirements controls applied to supplier and purchased product shall be dependent upon the effect of the purchased product on subsequent product realization process or the final product. Evaluate and select supplies based on their ability to meet the specified requirements Establish criteria for selection and evaluation of supplies Maintain records of the results of evaluations and any necessary actions assuring thereof.
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Purchasing Information
The information should describe the product to be purchased including: requirements for approval of product, procedures, processes and equipment requirements for qualification of personnel QMS requirements
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ISO 9001:2000
7. Product realization Controlled Processes
Sales
Design
Purchasing
Production
Identification
Customer Property
Special Process
Note :- Exclusions to the scope of the quality management system are only permitted from these activities.
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ISO 9001:2000
8.0 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and Measurement 8.3 Control of Nonconforming Product 8.4 Analysis of data 8.5 Improvement
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Internal Audits
Conduct internal audits at planned intervals to determine whether the QMS: conforms to the planned arrangements conforms to this international standard conforms to QMS requirements established by the organization is effectively implemented and maintained
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Internal audits
Select auditors and conduct audits to ensure objectivity and impartiality Auditors not to audit their own work Establish procedure for internal audit specifying responsibilities and requirements for planning and conducting audits Management responsible for areas being audited shall ensure that actions are taken without delay to eliminate detected non-conformities and their causes Follow-up activities to include the verification of the actions taken and the reporting of verification results
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Improvement
Continually improve the effectiveness of the QMS through : quality policy quality objectives audit results analysis of data corrective and preventive actions Management review
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