Sample of ASEAN Quality Manual - ABC COSMECTICS...

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ABC COSMECTICS MANUFACTURING Ref no : QM-001 Version No: 2 NOTE: This sample Quality Manual does not serve as a model manual. It is only intended to illustrate how a Quality Manual can be formatted and presented. The actual Quality Manual prepared by you should contain more specific and detailed description of the quality system which your company has adopted for its functions/ processes. QUALITY MANUAL FOR ABC COSMETICS MANUFACTURING Prepared by : ____________________ _________ Mr. Andrew Lim Date Quality Assurance & Quality Control Manager Approved by : _____________________ __________ Mr. Stanley Tan Date General Manager Authorised by: _____________________ __________ Mr. Benjamin Foo Date Managing Director Date of Authorisation : 31 December 2003 Effective Date : 1 January 2004 __________________________________________________________________ Health Sciences Authority Page 1 of 19
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REVISION HISTORY Ref No Date of Revision Reason for Amendment QM-001 /Version 2 1 May 2005 Annex 1 – New organization chart. Distribution List Controlled copy : Managing Director General Manager Human Resource Manager Material Management Manager W arehouse Manager Production Manager Quality Assurance & Quality Control Manager Finance Manager Purchasing Manager Master Copy: Document Controller __________________________________________________________________ Health Sciences Authority Page 2 of 19
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Contents 1. INTRODUCTION ................................................................................. 5 2. QUALITY POLICY AND SCOPE ............................................................ 5 3. ORGANISATION AND RESPONSIBILITIES ........................................... 6 4. MANAGEMENT REVIEW ..................................................................... 7 5. DOCUMENTATION CONTROL ............................................................. 8 6. PURCHASING .................................................................................. 10 7. PERSONNEL .................................................................................... 10 8. PREMISES ....................................................................................... 11 9. EQUIPMENT .................................................................................... 12 10. SANITATION & HYGIENE .................................................................. 12 11. PRODUCTION .................................................................................. 13 12. QUALITY CONTROL ......................................................................... 14 13. INTERNAL AUDIT ............................................................................. 16 14. STORAGE ........................................................................................ 16 15. CONTRACT MANUFACTURING AND ANALYSIS ................................. 17 16. PRODUCT COMPLAINT .................................................................... 17 17. PRODUCT RECALL ........................................................................... 18 DEFINITIONS/ABBREVIATIONS: __________________________________________________________________ Health Sciences Authority Page 3 of 19
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GM - General Manager GMP - Good Manufacturing Practice HR - Human Resource MD - Managing Director QA/QC - Quality Assurance & Quality Control SOP - Standard Operating Procedure QMS - Quality Management System __________________________________________________________________ Health Sciences Authority Page 4 of 19
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1. INTRODUCTION ABC Cosmetics Manufacturing was formed in Sep 2003 and had obtained Good Manufacturing Practice (GMP) Certification since Mar 2004. We specialize in formulation and manufacturing of cosmetic products. We have developed and manufactured our own brand of skin care products. Our products are marketed in Singapore, Japan, Taiwan and Hong Kong. We are also the contract manufacturer of a number of branded cosmetic products. 2. QUALITY POLICY AND SCOPE 2.1. Quality Policy The quality policy of ABC Cosmetics Manufacturing is to manufacture and deliver products of high and consistent quality that will meet the expectation of our customers as well as the regulatory authority. We are committed in maintaining an effective quality management system (QMS) that embraces all the essential requirements of Good Manufacturing Practice as well as in training our staff to be quality conscious. 2.2. Scope The QMS described in this quality manual covers the following functions i.e. purchasing, manufacture, quality control, storage and distribution which takes place at: ABC Cosmetics Manufacturing Pte Ltd Unit #01-01, 01-02 & 01-03 Kampung Ubi Industrial Park Singapore 123456 __________________________________________________________________ Health Sciences Authority Page 5 of 19
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  • Winter '16
  • Padmanathan
  • Management, ........., Quality management system, Health Sciences Authority

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