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 31000 is the international standard for risk management. By providing comprehensive principles and guidelines, this standard helps organizations with their risk analysis and risk assessments. Whether you work in a public, private or community enterprise, you can benefit from BS ISO 31000, because it applies to most business activities including planning, management operations and communication processes.
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 22301 is the international standard for business continuity management and builds on the success of British Standard BS 25999 and other regional standards. It’s designed to protect your business from potential disruption. This includes extreme weather, fire, flood, natural disaster, theft, IT outage, staff illness, or terrorist attack.
This globally recognized Information Technology Service Management Standard was inspired by the British Standard BS 15000 model and aligned with the process approach defined by the Office of Government Commerce (OGC)’s IT Infrastructure Library (ITIL). ISO 20000 has been designed to shape consistency in the management of IT services and infrastructure, either internal or outsourced, benefiting employees and clients.
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.
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