Medical Devices

ISO 37001 Anti-bribery Management System

WHAT IS ISO 37001?

ISO 37001 certification makes you bring your organization toward a better business environment. It makes your organization be capable of complying with globally recognized anti-bribery best practices and proves your competence toward implementing and managing an Anti-bribery Management System.

The Anti-bribery Management System which is based on ISO 37001, helps your organization prevent, detect, and address bribery towards a better ethical business culture.

ISO 45001 Occupational Health & Safety

 Occupational Health and Safety 

ISO 45001 | Compliance with Health and Safety legislation and regulations is a critical requirement for all businesses. Implementing a structured Occupational Health and Safety Management System (OHSMS) based on recognized standards can provide significant benefits, including improved compliance, reductions in illness and injury statistics, and cost savings. The OHSAS 18001 standard is the most widely recognized Occupational Health &Safety Management System standard globally.

ISO 14001|EMS

Environment Management System

With the alarm of global warming and its consequences, human society has become serious about ecology and its preservation. ISO 14001 is an international standard developed by the International Organization for Standardization (ISO) through dedicated technical committees representing approximately 173 countries around the world. Its purpose is to enable an organization of any type or size to develop and implement a policy committing it to the prevention of pollution, compliance with legal and other requirements, and continual improvement.

ISO 50001 | Energy Management

Energy Management systems | EMS

Requirements with guidance for use, is a voluntary International Standard developed by ISO (International Organization for Standardization). ISO 50001 gives organizations the requirements for energy management systems (EnMS). ISO 50001 benefits organizations large and small, in both public and private sectors, in manufacturing and services, in all regions of the world. ISO 50001 will establish a framework for industrial plants, commercial, institutional, and governmental facilities, and entire organizations to manage energy.

GDPMD for Medical Devices

WHAT IS GDPMD?

GDPMD specifies the requirements for a quality management system to be established, implemented, and maintained by an established of medical device importer/distributor/ authorized representative to comply with the Malaysian Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012.

ISO 28000

WHAT IS ISO 28000?

This standard identifies the requirements for a supply chain security management system, relating security management to many other aspects of business management. These include all activities controlled or influenced by organizations that impact supply chain security, which includes the transportation of these goods along the supply chain.

ISO 15189

WHY ISO 15189?

Competence in any field is crucial, but it’s even more pertinent in the medical sphere where the patient’s system is compromised by disease or injury. ISO 15189 is a mark of confidence awarded to medical laboratories – an accreditation that proves you are dedicated to delivering a proficient and quality service across all aspects of your operation.

ISO 13485

WHAT IS ISO 13485?

ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485 contains requirements essential for organizations operating at any tier in the medical devices and pharmaceutical supply chain. The primary objective of the standard is to facilitate harmonized medical device regulatory requirements and as a result, it includes some particular requirements for manufacture, installation, and servicing such as added requirements on record-control, sterilization, and risk management.

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