ISO 13485 is an international standard that defines quality management system requirements for Designing and manufacturing of Medical Devices. ISO 13485 was published by ISO (International Organization for Standardization) in year 2003. Before ISO 13485:2003 documents such as EN 46001 and EN 46002 were effective. ISO 13485 & ISO 13488 was first published 1996.
This ISO 13485 is based on the ISO 9001 standard with specific requirements to meet regulatory needs. ISO 13485 addresses most or all of the quality system requirements in markets including Europe, Australia, Japan and Canada. The US Food and Drug Administration does not formally recognize ISO 13485 certification, but US Good Manufacturing Practices quality system requirements overlap with the standard in many areas. ISO 13485 is also the basis for quality system regulations in a markets such as South Korea and Brazil.
The ISO 13485 standard, officially known as EN ISO 13485:2003, cant only be used by organizations in the design, development and production process for medical devices but also for the related services.
Why ISO 13485?
Objective of the ISO 13485 was to harmonize the regulatory requirement to ease the access of the global market, many country who are member of European Union like Austria , Belgium , Bulgaria , Croatia , Cyprus , Czech Republic , Denmark , Estonia , Finland , France , Germany , Greece , Hungary , , Ireland, Italy , , Latvia , Lithuania , Luxembourg, Malta , Netherlands , Poland , Portugal , Romania , Slovakia , Slovenia , Spain , Sweden , United Kingdom have adopted ISO 13485 into their regulatory compliance requirement and made ISO 13485 mandatory to export the medical devices in these countries. Implementation of the ISO 13485 supports the compliance of the regulatory requirement for European Union.
ISO 13485 with ISO 9001:
ISO 13485 is stand alone document; ISO 23485 is generally harmonized with ISO 9001; Main difference in ISO 9001:2008 & ISO 13485:2003 is that where ISO 9001 requires for Continual improvement; ISO 13485 requires the institutions / company / orgasniation to demonstrate that quality management system is effectively implemented and maintained, but ISO 13485 does not consider customer satisfaction like ISO 9001;2008.
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:
· Faster and easier market access to countries that recognize the certification: Canada, Japan, South Korea, Brazil, Australia & New Zealand.
· 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
How to Apply for ISO 13485 Certification in India - TNV provides assessment and certification to ISO 13485, simultaneously organisation may opt to choose with ISO 9001 Certificate. Download Application form from the website from the portal http://isoindia.org/iso_downloads.php