SET-UP OF MANAGEMENT SYSTEM
We expertise in providing consultation services in design and development of management system, which includes documentation and operation set-up, according to applicable International Standards (ISO), regulatory or industrial requirements, such as:
ISO 9001 Quality Management System
ISO 14001 Environmental Management System
ISO 45001 Occupational Health and Safety
ISO 22000 Food Safety Management System, HACCP and GMP for food industry
ISO 13485 and GDPMD for medical device industry
ISO 17025 and GLP for testing and calibration laboratory
Malaysian Sustainable Palm Oil (MSPO)
Conducting a gaps analysis is the very first step in implementing an effective management system or necessary change in a company, as it helps to identify actions need to be carried out.
Gaps analysis is one of our complimentary services that we offer to our potential clients. Please contact with us for more information.
ESTABLISHMENT LICENSE APPLICATION AND MEDICAL DEVICE REGISTRATION IN MALAYSIA
We provide advise and assist manufacturers worldwide, local authorized representatives (LAR), importers and distributors of medical devices to obtain Establishment License and to register the medical devices or products with Malaysian Medical Device Authority (MDA).
COACHING AND TRAINING
It is crucial for company to develop and maintain necessary knowledge and competency of the workforce. To help our clients to achieve this purpose, we tailors coaching and training sessions to assist clients in interpreting requirements and implementing necessary plans effectively.
We offer a wide range of solutions in helping our clients to sustain their certifications. We customize the Maintenance Program which can include:-
review and improve current documentation or practice.
data analysis and continual improvement plan.
technical support during audit.
advise on corrective action to be taken in response to nonconformity report.
REGULATORY AFFAIRS COMPLIANCE ASSIST
We are committed to assist our clients to navigate confidently in the increasingly regulated world. We expertise in interpreting relevant regulatory requirements in different industries, such as medical device, pharmaceutical, food and manufacturing industry. We provide advise to assist our clients to comply with the requirements.