LRQA Malaysia - Improving performance, reducing riskLRQA Malaysia - Improving performance, reducing risk


Healthcare & Medical

Standards, Schemes & Directives

Standards, Schemes & Directives in the Healthcare & Medical sector

Please find the relevant assessment contents on this sector

Healthcare & Medical Standards

  • BS 25999

    BS 25999 provides the framework for assessing, planning and testing your contingency plans which helps build organisational resilience.

  • ISO 50001

    Energy management is a fundamental area of focus across all sectors of industry. Implementing an ISO 50001 certified energy management system can save you money and reduce greenhouse gas (GHG) emissions.

  • HACCP

    HACCP is a preventative approach to food safety and pharmaceutical safety which addresses physical, chemical, and biological hazards as a means of prevention rather than finished product inspection.

  • ISO 13485

    ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices.

  • ISO 14064

    ISO 14064 is an international standard against which GHG emissions reports are voluntarily verified.

  • ISO 28000

    ISO 28000 is an international supply chain security management system standard.

  • ISO 9001

    The internationally recognised quality management system standard, and the preferred solution for over half a million organisations in 159 countries.

  • ISO/IEC 27001

    ISO/IEC 27001 aims to ensure that adequate controls addressing confidentiality, integrity and availability of information are in place to safeguard the information of interested parties. These include customers, employees, trading partners and the needs of society in general.

  • OHSAS 18001

    This standard provides a systematic approach to identifying helath and safety hazards, and then either eliminating the hazards or reducing their risks.

  • SA 8000

    Social Accountability 8000 is an assessment and certification standard; it is based on international human rights conventions that focus on improving working conditions. It was developed by Social Accountability International (SAI).

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Healthcare & Medical Directives

  • In Vitro Diagnostic Medical Devices Directive

    The In Vitro Diagnostic (IVD) Medical Devices Directive is relevant to you if you design, manufacture or distribute IVD medical devices within the European Economic Area.

  • Medical Devices Directive

    The directive covers all products which claim to have a medical purpose and which are used in and on the human body, from heart valves to scalpels, excluding in vitro diagnostics, which are covered in a separate directive.