ISO 13485:2003 & BS EN 13485: 2012 Quality Standard for Medical Devices
Medical - ISO 13485:2003
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
ISO 13485 requirements
In order to achieve ISO 13485 certification, you must develop written policies for the following functions:
- Document and record controls
- Internal auditing procedures
- Controls for non-conformance
- Corrective and preventative actions
- Process and design controls
- Record retention
- Accountability and traceability
As you implement ISO 13485, it is important to bear in mind that ISO standards are updated periodically — revisions and updates do occur and ISO 13485 is due for an update in the next few years. As quality system standards are updated, you must ensure that your own QMS keeps up with those updates in order to remain in compliance.
ISO 13485 benefits
Here is what medical device manufacturers can hope to gain from having an ISO 13485 certification:
- Access to markets that recognize or require the certification including Canada and Europe.
- Reduce operational costs by highlighting process deficiencies and improving efficiency
- Increase customer satisfaction by consistently delivering quality products and systematically addressing complaints
- Proven commitment to quality through an internationally recognized standard
- Adds transparency to the way complaints, surveillance or product recalls are handled
- From 1 July 2013, under the Construction Products Regulation (CPR), it became mandatory for manufacturers to apply CE marking to any of their products covered by a harmonised European standard (hEN) or a European Technical Assessment (ETA). This was a major change in the United Kingdom as affixing of CE marking under the old Construction Products Directive (CPD) had been voluntary. This, coupled with other changes introduced by the CPR, left the construction industry facing its most significant change for a decade in the way in which construction products were to be sold in Europe. - See more at: Click Here .
- ISO 9001 is being updated! ISO 9001 Quality Management Systems is under review, with the draft version now available for purchase. The final updated version is expected by the end of 2015. Learn more about the changes and how you can contribute to or purchase the draft version of ISO 9001:2015
- On 13 November, leaders from the European and Japanese standardization organizations have signed a joint Cooperation Agreement in Tokyo. The Cooperation Agreement between CEN, CENELEC and JISC provides a new framework for closer collaboration on various aspects of standardization, which will facilitate trade in goods and services between Europe and Japan.
- On July 11, 2014 the European Commission has published an updated list of European harmonized standards that pertain to the Machinery Directive (2006/42/EC) in the Official Journal of the European Union. Besides updates to existing standards, this list (2014/C 220/01) also contains 16 new standards
