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GDPMD Good Distribution Practice for Medical Devices

(GDPMD) applies to all companies carrying out activities, as stated in the Medical Devices Act 2012 (Act 737). Malaysian Medical Devices Act 2012 (Act 737) requires all the medical devices manufactures, exporters, importers, distributors, and local authorized representatives to be certified to a Medical Device Quality Management System or Good Distribution Practices for Medical Devices (GDPMD) and register their products as part of the Medical Devices, effectively enforced on 1st July 2013
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Medical Devices Conformity Assessment

Section 10 of Medical Device Act ( Act 737 ) requires a medical device to undergo conformity assessment by a registered CAB prior to its registration. However, many medical devices have undergone conformity assessment and approved in countries recognized by Medical Device Authority (MDA).
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ISO 9001:2015 Quality Management System

ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS).consectetur ullamcorper.
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ISO 45001:2018 Occupational Health and Safety Management Systems

The goal of ISO 45001 is the reduction of occupational injuries and diseases, including promoting and protecting physical and mental health.
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FSSC 22000 Version 5.1 Food Safety Management System

The FSSC 22000 Scheme is founded on ISO standards and, just like ISO 22000, focuses on the continuous improvement of a Food Safety Management System.
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IATF 16949:2016 Automotive Quality Management System

IATF 16949:2016 is the International Standard for Automotive Quality Management Systems.
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Hazard Analysis Critical Control Point (HACCP)

Hazard Analysis and Critical Control Point (HACCP) is a systematic approach to identifying and controlling hazards (i.e. microbiological, chemical or physical) that could pose a danger to the preparation of safe food.
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MS 2530 Malaysian Sustainable Palm Oil (MSPO) Certification

The Malaysian Sustainable Palm Oil (MSPO) Certification Scheme is the national scheme in Malaysia for oil palm plantations, independent and organised smallholdings, and palm oil processing facilities to be certified against the requirements of the MSPO Standards.
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4R2S Standard (MS 2697, MS 2696)

MS 4R2S is a qualification and standardization of automotive parts and components to enhance and standardize the Reuse, Recycle, Remanufacturing, Repair, Services and Spare part sectors of the Automotive Industry.
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ISO 37001:2016 (ABMS) Anti Bribery Management system

ISO 37001/ MS ISO 37001 is a voluntary internal control system for organizations to manage, handle, enforce, evaluate as well as to improve anti-corruption measures effectively. It is a flexible instrument that can be adapted to decrease the corruption risks faced by any organizations.
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ISO 13485:2016 Medical Devices Quality Management System

ISO 13485 is an Internationally Recognized Quality Standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices.
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ISO 22000 Food Safety Management System

ISO 22000 is a globally recognised standard for food safety in all links of the food chain. It was developed by the International Organization for Standardization (ISO).
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Good Manufacturing Practice (GMP)

GMP describe the conditions and practices that are necessary for the manufacturing, processing, packing or storage of food to ensure its safety and wholesomeness.
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ISO 14001:2015 Environmental Management System

ISO 14001:2015 specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance.
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ISO50001:2018 Energy Management System

ISO 50001 Energy Management System is an international standard. The standard specifies the requirements for establishing, implementing, maintaining and improving an energy management system, whose purpose is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance, including energy efficiency, energy security, energy use and consumption.
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ISO 27001 Information Security Management System

The international standard ISO 27001 sets out the requirements for an information security management system (ISMS). With an ISMS, you can secure sensitive information using a systematic approach that covers people, processes and IT systems.

Kiwa International Certifications(M) Sdn Bhd

2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor

+603-3884 7813

info@kiwacert.com

Accredited to ISO/IC 17021:2015

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ACB QMS 28

ACB OSH 17

ACB EMS 20

ACB GMP 06

ACB FSMS 13

ACB HACCP 08

ACB MDMS 05

2022 © Kiwa International Certifications (M) Sdn Bhd. ALL Rights Reserved.

Kiwa International Certifications(M) Sdn Bhd

2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor

+603-3884 7813

info@kiwacert.com

Certification Status

Accredited to ISO/IC 17021:2015

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A Simple Image

ACB QMS 28

ACB OSH 17

ACB EMS 20

ACB GMP 06

ACB FSMS 13

ACB HACCP 08

ACB MDMS 05

2022 © Kiwa International Certifications (M) Sdn Bhd. ALL Rights Reserved.