International Organisation for standardization is the one and only world famous organisation which has authority to publish ISO standards and also to revise them in a certain time interval. It has published around 21500 + standards all of them have been in a successful, among these standards there are some of theĀ standards which can be implemented into an organisation by doing with the BF greater improvement in that particular organisation, there are some of the standards which are just guidelines. The beauty of this ISO standards is that there are beautifully crafted standards for different kinds of organisations and let us discuss one search specific standard for manufacturer of medical devices in this particular blog. ISO 13485 is a standard which is medical devices quality management system as the name suggests this standard is specifically drafted for the organisation who are manufacturers of any kind of medical equipment. ISO 13485 certification in England is similar to other generic standards but additional to that there are some other requirements in the standard like the regulatory requirement and also the customer requirement on satisfactorily achieving this to requirements one can complaint with ISO 13485 in England but also making sure that the quality management system also is in place. Some of the other important requirements are meeting the requirements of the medical devices, management, work environment and cleanliness and also complaint handling and corrective action. All the required document, management review, awareness, resource required to meet them extra have to be clearly defined and records has to be maintained to demonstrate the conformance of the ISO 13485 in Birmingham.
The beauty of this standard is that all the regulatory requirements from different countries like Australia, Europe, Canada, japan, South Korea,Brazil etc has been taken care thoroughly.
It has 8 number of clauses which are mentioned below
- First one is scope
- Normative reference
- Terms and definitions
- Quality management system requirements
- Management responsibilities
- Resource Management
- Product realisation
- Measurement, analysis and improvement
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