ISO 9001:2000

Details about iso 9001:2000, objectives, global adoption, quality management process, quality manuaal, benifits

1. Presented by…….. TANMAY SAHA Roll no.- 17162020 M.Pharm 2 nd Semester Pharmaceutical Engineering & Technology

2. ISO 9001:2000 Published in 1951

3. ISO = The International Organization for Standardization (ISO) is an international standard-setting body composed of representatives from various national standards organizations. ISO 9000 = deals with the fundamentals of quality management systems. ISO 9001 =   deals with the requirements that organizations wishing to meet the standard must fulfill .

4. ISO 9001:2000 OBJECTIVES

5. IN ORDER TO ACHIEVE OBJECTIVES: The ISO 9001:2000 standard is based on eight principles:

6. GLOBAL ADOPTION: ISO Survey 2010.

7. GLOBAL ADOPTION: The ISO Survey of Management System Standard Certifications – 2014

8. Quality Management System Process:

9. QUALITY PROCEDURE CRITERIA: Quality procedures & policies, need to be Defined Documented Communicated Quality procedures should be, Attainable Up-to-date with revisions & releases

10. QMS- Documentation: Records Quality plans Specifications Quality manual Procedures, work instructions & drawing. Quality manual: Firm’s documented quality policy & quality management system. Authoritative Collection of procedures describing how to perform the quality task. ISO 9001:2000, Chapter 2, “A Practical Quality Manual Explained” serves as a guideline for compiling this document.

11. BENEFITS: The main benefits of the implementation of a QMS based on ISO 9001:2000 requirements are:

12. CONCLUSION: Model for Quality Assurance in Design, Development, Production, Installation and Services. ISO 9001 indicates “what to do” in a quality management system but not “how to do” it. This will replace the current series of ISO 9001/9002/9003. The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system. Avoid delegation of quality functions to junior administrators.

13. REFERENCES: Rogério Rabelo , Daniel Marques Périgo , ISO-2: ISO 9001:2000 and Quality Management Systems, Tools, Technologies and Training for Healthcare Laboratories. https://www.iso.org/standard/21823.html A guide to the contents of ISO 9001 : 2000 Quality Management Systems Requirements, BSIA Form No. 137, BRITISH SECURITY INDUSTRY ASSOCIATION, 1-9. The ISO Survey of Management System Standard Certifications – 2014 (data table), International Organization for Standardization, retrieved 16 September 2016. ISO Survey 2010.

14. ISO 9001:2000 STAY FIT & HEALTHY Thanking You………..