ACB-MDQMS Issue 1, XX June 2012

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1 DEPARTMENT OF STANDARDS MALAYSIA SCHEME FOR THE ACCREDITATION OF CERTIFICATION BODIES (The ACB Scheme) ACB-MDQMS Issue 1, XX June 2012 SUPPLEMENTARY REQUIREMENTS FOR BODIES OPERATING MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS CERTIFICATION Authority To Issue Director General Department of Standards Malaysia

2 QUALITY MANAGEMENT SYSTEM CERTIFICATION Table of Content Page Section 1: Introduction 1 Section 2 : Reference 2 Section 3: Academic Qualification For Lead Auditors, Auditors and Technical Experts 2 Section 4: Training For Lead Auditors and Auditors 2 Section 5: Work Experience For Lead Auditors, Auditors And Technical Experts 3 Section 6: Auditing Experience For Lead Auditors And Auditors 3 Section 7 : Medical Devices Technical Areas 4 Section 8: Witnessing 5

3 Section 1: Introduction This document outlines the supplementary requirements for conformity assessment bodies (CAB) seeking accreditation on certification of Medical Devices Quality Management Systems from STANDARDS MALAYSIA. It is important to understand that these are the requirements that have to be met by CAB. They are not applicable to the organizations that are being audited by the CAB. The requirements that must be met by the organizations can be found in the ISO The term shall is used throughout this document to indicate those provisions which, reflecting the requirements of MS ISO/IEC and IAF MD9, are mandatory. The term should is used to indicate guidance which, although not mandatory, is provided as a recognised means of meeting the requirements. CAB whose systems do not follow these requirements in any respect will only be eligible for accreditation if they can demonstrate to the Department of Standards Malaysia (STANDARDS MALAYSIA) that their solutions meet the relevant clause of MS ISO/IEC and IAF MD9 in an equivalent way. Issue 1, XX June 2012 Page 1 of 5

4 Section 2 : Reference MS ISO/IEC Conformity assessment Requirements for bodies providing audit and certification of management systems IAF MD9 - IAF Mandatory Document for the Application of ISO/IEC in Medical Device Quality Management Systems (ISO 13485) GD-XX - Guidance on the classification of Medical Devices GD-XX - Guidance on the classification of IVD Medical Devices ACB 7 The conduct of accreditation assessments Section 3: Academic Qualification For Lead Auditors, Auditors and Technical Experts The CAB shall ensure that auditors and technical experts have the knowledge corresponding to tertiary education ( minimum degree level ) in relevant or equivalent fields as in Annex C C.1 of IAF MD9 Section 4: Training For Lead Auditors and Auditors The lead auditors and auditors : 4.1 shall have undergone a minimum 2 days course on the medical device quality management systems standard ( ISO ) ; 4.2 shall have undergone a minimum 2 days course on the application of risk management to medical devices standard ( ISO ) and its related assessment procedures ; 4.3 shall have undergone a recognised training course on national law / regulatory requirements for medical devices ; Issue 1, XX June 2012 Page 2 of 5

5 4.4 shall have undergone 40 hours of recognised lead assessor course in ISO 9001 or ISO Note : in the case of auditors who have undergone ISO lead assessor course, the requirement in 4.1 is optional provided the lead assessor course content has included elements of 4.1 Section 5: Work Experience For Lead Auditors, Auditors And Technical Experts 5.1 In addition to Annex C C.2 of IAF MD9, the work experience acquire from conducting conformity assessments and regulatory inspection works in medical devices related industry are also acceptable. 5.2 The technical expert shall have a minimum of ten years work experience in medical devices related industry as in 4.1 above. 5.3 The number of years for total work experience may be reduced by one year if the auditor has completed appropriate post-tertiary education. 5.4 For technical expert, the reduction shall be as follow in the relevant technical area : a) Masters 2 years b) PhD 3 years Section 6 : Auditing Experience For Lead Auditors And Auditors 6.1 For initial qualification, the auditor shall perform at least twelve MDQMS audit days in four organizations within the last three years under the leadership of qualified auditor. The audits shall cover the entire process from preparation to reporting. Note : Stage 1 audit days is excluded Issue 1, XX June 2012 Page 3 of 5

6 6.2 Extension to a new product categories only applicable to class A and B as specify in documents GD-XX : Guidance on the classification of Medical Devices and GD-XX : Guidance on the classification of IVD Medical Devices. The auditor shall has competence through relevant education and training in the new product categories, and either : a) six month work experience in the new product categories; or b) MDQMS audits in four organizations under the supervision of a qualified auditor in the new product categories 6.3 For maintaining the qualification of the auditor, the auditor shall has performed a minimum of five external audits ( 3 rd party audit) per year, including at least two MDQMS audits Section 7 : Medical Devices Technical Areas Addition to Annex A of IAF MD 9 Table A NON-ACTIVE MEDICAL DEVICES Main Technical Areas Non-active Medical Devices Technical Areas General non-active, non-implantable medical devices Products Categories Covered by the Technical Areas Non-active devices for injection, infusion, transfusion and dialysis (includes dialysis solution) Non-active medical devices other than specified above Rubber base products Polymer base products Issue 1, XX June 2012 Page 4 of 5

7 Section 8: Witnessing 8.1 The following guidance document applies for medical devices classification a) GD-XX : Guidance on the classification of Medical Devices b) GD-XX : Guidance on the classification of IVD Medical Devices 8.2 For low risk devices, number of witnessing shall follow Table 1 of ACB For each high risk devices under Class D, witnessing is mandatory for every cycle. 8.4 For Class C devices, which may fall under the high risk devices depending on the application, then the witnessing is mandatory as in 8.3 Issue 1, XX June 2012 Page 5 of 5

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