Guidance on conformity assessment standards order No. 1
Quality management systems and quality assurance techniques
8 April 2003
Conformity Assessment Standards Order No. 1 - Quality Management Systems and Quality Assurance Techniques (CASO 1) specifies relevant conformity assessment standards relevant to the implementation of the manufacturer's quality management system and particular quality assurance techniques.
Schedule 1 of this Order determines conformity assessment standards for Full Quality Assurance, Production Quality Assurance and Product Quality Assurance for the manufacture of all kinds of medical devices. The application of the conformity assessment standard will provide a presumption of compliance for the conformity assessment procedures relating to requirements of the quality management system, requirements of the production quality management system and requirements of the product quality management system, depending on which of these conformity assessment procedures is being applied.
Schedule 2 of this Order determines conformity assessment standards for quality assurance techniques relevant to particular manufacturing processes relating to the supply of medical devices in a sterile state. Different standards apply depending on the type of sterilisation procedure being used.
Background
The Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety and efficacy of therapeutic goods that are used in Australia or exported from Australia.
Section 41DC of the Act provides the Minister, or the Minister's delegate, with the power to determine conformity assessment standards and to also determine that quality management systems implemented by the manufacturer that comply with these standards are to be treated as having had applied to them the parts of the conformity assessment procedures specified in the Order.
The conformity assessment procedures set out the requirements relating to the application of quality management systems for the manufacture of medical devices and other requirements relating to the obligations of manufacturers of medical devices. Compliance with applicable conformity assessment standards is not required, but it is one way to establish compliance with the conformity assessment procedures set out in the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). If a manufacturer chooses to apply a conformity assessment standard, and this is applied correctly, the manufacturer's quality management system is presumed to comply with the parts of the conformity assessment procedures set out in the Order (section 41BI of the Act).