How Standards are Developed...
Information & Training. | Quality Assurance. Quality Management.
The International Standards Organization (ISO) is the primary international body responsible for development worldwide standards in quality, environmental, safety, regulatory environment. Within the ISO body, technical committees (TC’s) are set-up to focus on specific areas where standards are to be developed. The Technical Committees are staffed by experts in their area, who come from industry, academia, government and non-government bodies from around the world. The TC’s draft new or revised standards, which are then circulated for comment, feedback and recommendation. It takes approximately 3 years to develop a standard from initial draft to final approved publication.
ISO Standards Development (source: ISO International Standards Organization)
There are four principles upon which the ISO base their standards development process. First, the standard must respond to a need in the market, second the standard must be based on global expert opinion, third the standards are developed and progressed through a multi-stakeholder process, i.e. members of the relevant TC must represent the brood range on interested parties, e.g. industry, academia, government, voluntary sectors, etc. and finally the new standard needs to be based on consensus.
Information & Training. | Quality Assurance. Quality Management.
- The Principles of Quality Management
- The Quality Manual
- Quality Standards and Specifications
- The Quality Management System
- Revised requirements of ISO 9001: 2015
- Design Quality – Products & Processes
- Good Manufacturing Practice (GMP)
- Documentation
- CAPA – Corrective And Preventative Action
- Calibration Certification
- Change Management and Control
- Quality Management Training
- Product and Process Validation
- Supplier Quality Assurance
- Audits & Auditing
- Ensuring the Quality Management System is Risk based
- Etc. …. Etc. …. Etc. …
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