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 55001(or ISO 55001:2014) enables organizations to implement Asset Management System necessary to manage their assets and optimize their lifetime value effectively and efficiently. With the advent of Publicly Available Specification (PAS 55), ISO 55001 standard is being widely adopted in various industries (utilities, transport, mining, process and manufacturing) over the globe and is seen as the blueprint for any organization focused on management and in maximizing their value.
The ISO 55000 family comprises of three standards:
BS ISO 39001 sets out the minimum requirements for a Road Traffic Safety Management System. Governments, road authorities, safety groups, and private companies were keen to develop such a standard due to the rising number of people killed or injured on the road each year.
ISO 29001 (published in 2003) defines the quality management system requirements for the design, development, production, installation, and service of products for the petroleum, petrochemical, and natural gas industries. Developed as a direct result of a partnership between ISO and the international oil and gas industry (led by the American Petroleum Institute - API), ISO 29001 specifically focuses on the oil and gas supply chain.
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 18788 provides a framework for establishing, implementing, operating, monitoring, reviewing, maintaining, and improving the management of security operations. It provides the principles and requirements for a security operations management system (SOMS).
ISO 18788 provides a business and risk management framework for organizations conducting or contracting security operations and related activities and functions while demonstrating:
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.
Hazard Analysis Critical Control Points (HACCP) is defined to be the food detrimental elements major control points by the food and drug administrative agent. HACCP is composed as hazard analysis (HA) and critical control points (CCP). HA is to search for the hazard elements and analyze the hazard structure. HACCP is to decide the sanitation control points to control the major hazard control points after identifying the hazard elements from material supply, manufacture, processing, preservation and distribution to the end user consumption.
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.
AS9100 (BS EN 9100) is the single common quality management standard for the aerospace industry. It is used and supported by the world's leading aerospace companies and throughout their supply chains. AS9100 can be used by organizations across the aerospace sector, including design, manufacturing, maintenance and distributing companies. If you certify to the standard you can be confident that you have an effective quality management system in place. AS9100 may also be essential to achieving your trade license, making it essential now and in the future.
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