TRAINING & CONSULTING
We specialize in all aspect of International Management System Standards training and consultancy
services such as ISO9001, ISO17025, ISO14971, ISO14001, ISO22000, ISO 13485, ISO15189, ISO50001, ISO29001, ISO/TS 16949,etc.
We also provide training and consultancy support for other International Standards such as British Retail Consortium Global Standard (BRC), HACCP, International Food Standard (IFS), GMP Standards, CE Mark and Medical Device Regulation by country such as US Food and Drug Administration (FDA), Canadian Medical Device Conformity Assessment (CMDCAS), Japan Phamaceutical Affairs Law (JPAL) and etc.
We provide consultants with various industrial knowledge who has an extensive experience in leading
your organization to implement the Management System successfully. All of our clients have passed the ISO registration on the first certification audit.
GAP ANALYSIS
The very first step in implementing an effective Management System is to conduct a gap analysis to
determine what needs to be done by the company in order to comply with the International Management System Standard requirements. Some of the activities carried out during the assessment are as follows:
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To carry out a comprehensive assessment of your operation and any available documentation |
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Identify Strengths, Weaknesses, Opportunities,Threats of the company |
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Preparation of Gap Analysis report |
MAINTENANCE PROGRAM
We provide a full range of support to maintain your Management System after having achieved the
Certification. We customize all our Maintenance Program based on your company’s needs.
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Review and Improve Current Documentation
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Internal Audit prior to Surveillance Audits /Certification Audit |
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Technical support during Surveillance Audits /Certification Audit |
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Advice on Corrective Action to be taken in response Nonconformity Reports |
MALAYSIA MEDICAL REGULATION 
In view of the Malaysia Medical Device Act 2012 (Act 737) that came into effect on 30th June 2013,all
Manufacturers, Local Authorised Representative (LAR), Importers and Distributors of medical devices are required to obtain Establishment License and register the medical devices/products with the Malaysian Medical Device Authority (MDA).
Establishment License
We provide consultancy support in obtaining Establishment License in compliance with the Malaysia
Medical Device Regulation 2012.
Our support will also include the development and implementation of ISO13485:2003 and/or GDPMD as specified in the Regulation.
Medical Device Registration
Our consultancy support will include preparation of the relevant documentation for submission to the
Medical Device Authority (MDA).
We also provide consultancy support on Medical Devices Product Registration submission.
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