What are the Differences between QMS standard in ISO9001, Hong Kong GMP and ISO/IEC17025 (HOKLAS Accreditation)? (1)
The worldwide-recognized Quality Management System is ISO9000 family. ISO9001:2000 is a generic standard for quality management system applicable to all organizations irrespective of type, size or product / service provided. However, many technical requirements are not stated in this generic standard ISO9001:2000 specifically. For instance, Cheung H.Y. and Chan L.W. (1998) presented that plant design for the manufacture of Chinese herbal pills is one of the more challenging activities in pharmaceutical industry, as it is the prime factor affecting the quality of a drug. Therefore, GMP legislative requirements can upgrade TCM products in Hong Kong(2). The design and implementation of team-based quality improvement campaign to Laboratory are also rose by Chin K.S. et al. 1996(3). Both industries are very concern about quality. Therefore, GMP Guideline:1995 and ISO/IEC17025:1999 are developed for herbal medicine industries and laboratories, which emphasis for the technical competence of both industries. Lau Edward P. (1996) stated that ISO 9000 is not well accepted by the pharmaceutical industry in the US (same as HK) for conventional therapeutic products because the mandatory regulatory practice, designs specifically for the industry, is superior to the ISO standards in many cases(4). The main clause comparison between ISO9001:2000, HKGMP:1995 and ISO/IEC17025:1999 (HOKLAS Accreditation) are summarized in Table 1.
The fundamental differences in the processes used by accreditation bodies and certification bodies to establish compliance with ISO/IEC17025 (HOKLAS Accreditation) and ISO9001 are obviously. Laboratory accreditation aims to recognize specific technical competence, the assessments of laboratories are conducted by teams comprising relevant technical experts and assessors able to evaluate not only the compliance with the management systems requirements of ISO/IEC17025 (or ISO9001), but also determining the specific technical competence of personnel and the availability of all the technical resources need to produce reliable data and results for specific test methods(5).
The fundamental differences in the processes used by accreditation bodies and certification bodies to establish compliance with ISO/IEC17025 (HOKLAS Accreditation) and ISO9001 are obviously. Laboratory accreditation aims to recognize specific technical competence, the assessments of laboratories are conducted by teams comprising relevant technical experts and assessors able to evaluate not only the compliance with the management systems requirements of ISO/IEC17025 (or ISO9001), but also determining the specific technical competence of personnel and the availability of all the technical resources need to produce reliable data and results for specific test methods(5).
Reference:
1. Lai, Lotto K.H. and H.Y. Cheung (2003) “Laboratory accreditation has added-value for quality control of herbal medicine manufacturing but cannot replace implementation of good manufacturing practices.” Hong Kong Pharmaceutical Journal, 12(1), pp26-19.
2. Cheung H.Y. and L.W. Chan (1998), Planning and Designing a GMP Plant for the Manufacture of Chinese Herbal Pills, International Symposium on “The Worldwide Herbal Industry: Present and Future”, p16, July 15-17.
3. Chin K.S., K.V. Patri, K.F. Pun, W.H. Yeung, L.T. Poon and K.K. Poon (1996), Starting the Journey: Team-based QI in a University Laboratory, The TQM Magazine, 8(2), pp.20-25.
4. Lau Edward P. (1996), Pharmaceutical Quality Assurance and Quality Control Workshop, E.L. Associates, Inc., USA.
5. HKAS News, Hong Kong Accreditation Service, Issue No.33, January 2003.
沒有留言:
發佈留言