Healthcare and Medical Related Standards

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 9001 Certification for Your Business

What is ISO 9001 Certification?

An acknowledged international standard for quality management systems (QMS) is ISO 9001. It offers a systematic method for managing your company's operations to guarantee consistent product or service quality, client happiness, and ongoing improvement.

Key Elements of ISO 9001

  1. Quality Policy: Developing a clear quality policy that aligns with your organization's goals is crucial. It serves as the foundation for your QMS.

ISO 27001

Information Security  Management System 

ISO 27001 Information security systems help all enterprises and manufacturers to manage their information security management and later to the customer needs most aptly and efficiently. It has given the business an edge over others in the competitive business world. It is based on ISO 9001. In particular, the requirements for customer satisfaction and continual improvement have been modified to make them more appropriate for regulatory purposes.

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.

GSP

WHAT IS GSP?

Good Storage Practice (GSP) is a system for ensuring that products are consistently produced and being stored ccording to national & international guideliness or standards. It is designed to minimize the risks involved in any food and pharmaceutical production that cannot be eliminated through testing the final product.

CGMP ISO 22716

WHAT IS CGMP?

CGMP Certification confirms the product's identity, composition, quality, purity, and strength which they represent in the market. In the United States (US), Current Good Manufacturing (cGMP) Practices Regulated by the Food and Drug Administration (FDA) concerning the designing, monitoring, measuring, controlling, Processing, and maintenance of manufacturing processes, Operational environment, and infrastructure facilities.

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.

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