ISO9001 top

ISO-9001 is the specification standard for quality management systems developed by the International Organization for Standardization. As of December 2003, organizations that voluntarily subscribe to this standard must conform with the current version, referred to as ISO-9000: 2000, in order to achieve an accredited verification of conformance.

The basic elements of ISO-9001:2000 are listed below. For guidance in developing an effective QMS to meet requirements of these elements click here.

The ISO-9001 standard includes requirements in the following areas. Please contact us for a detailed description of the requirements of each element.

4.1 General Requirements
4.2 Documentation Requirements	4.2.1 General 4.2.2 Quality manual 4.2.3 Control of documents 4.2.4 Control of quality records
5. Management Responsibility 5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning	5.4.1 Quality objectives 5.4.2 Quality management system planning
5.5 Responsibility, authority and communication	5.5.1 Responsibility & authority 5.5.2 Management representative 5.5.3 Internal communication
5.6 Management review	5.6.1 General 5.6.2 Review input 5.6.3 Review output
6. Resource Management 6.1 Provision of resources
6.2 Human resources	6.2.1 Assignment of personnel 6.2.2 Training, awareness and competency
6.3 Infrastructure
6.4 Work environment
7. Product Realization 7.1 Planning of product realization
7.2 Customer-related processes	7.2.1 Determination of requirements related to product 7.2.2 Review of requirements related to product 7.2.3 Customer communication
7.3 Design and development	7.3.1 Design and development planning 7.3.2 Design and development inputs 7.3.3 Design and development outputs 7.3.4 Design and development review 7.3.5 Design and development verification 7.3.6 Design and development validation 7.3.7 Control of design and development changes
7.4 Purchasing	7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product
7.5 Production & service provision	7.5.1 Control of production and service provision 7.5.2 Validation of processes for production and service provision 7.5.3 Identification and traceability 7.5.4 Customer property 7.5.5 Preservation of product
7.6 Control of monitoring and measuring devices
8. Measurement, Analysis & Improvement 8.1 General
8.2 Monitoring & measurement	8.2.1 Customer satisfaction 8.2.2 Internal audit 8.2.3 Measurement & monitoring of processes 8.2.4 Measurement & monitoring of product
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement	8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 Preventive action