Management System Certification

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Management System Audits

Audit & Types of Audit?

An audit is a tool used to review a process or function to determine if it is fit for purpose. Audits examine and compare a process against the documented version of it to determine if it still meets its aims and goals. In this way, they are great simulators for change and growth within a business as they can highlight potential areas for improvement.

There are several types of audits related to ISO Certification and Management System Standards, which can be broadly categorized as follows:

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.

ISO 55001

WHAT IS ISO 55001?

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:

ISO 39001 Road Safety

WHAT IS ISO 39001?

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

Petroleum, Petrochemical & Natural Gas Industries

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.

ISO 31000

WHAT IS ISO 31000?

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 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.

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