The standard is based on ISO 9001, but includes additional requirements specific to this business sector. In addition, important terms have been defined including: medical device, active medical device, active implanted medical device, sterile medical device, and many more.
ISO 13485 supports the reduction of unexpected risks with regard to the devices and enhances their management. This applies not only to companies that construct, produce and service medical devices, but also to organizations distributing and using them. The standard aims to increase the organization’s reputation in the eyes of customers and authorities.
ISO 13485 benefits include:
- Evidence of adherence to legal and regulatory or contractual requirements
- Minimize and manage risks
- Emphasize competence
- Error prevention instead of error correction
- Improved performance quality
- Customer and employee satisfaction
- Transparency and clarity of internal processes
- Time and cost savings
ISO 13485 under CMDCAS
DQS Medizinprodukte GmbH, a part of DQS GmbH (the holding company of DQS Inc.,) is one the recognized certification bodies worldwide. Together DQS Medizinprodukte GmbH and DQS Inc. have the ability to issue certificates to ISO 13485 according to the requirements of the Canadian Medical Devices Conformity Assessment System. Since October 2003, DQS Medizinprodukte GmbH has been accredited and listed by the Canadian authorities, Health Canada and SCC, as a CMDCAS recognized registrar.
With a CMDCAS certificate recognized by the Canadian authorities, organizations manufacturing medical devices of the risk classes II, III and IV according to the Canadian MDR (Medical Devices Regulations) can receive approval for the Canadian market.
ISO 13485:2016 the long anticipated revision of the standard used by medical device manufacturers worldwide has finally been published. The standard is now based on ISO 9001:2008.
DQS Inc. now accredited to the new version of ISO 13485 and able to perform upgrade audits. DQS is also able to offer gap assessment services for organizations.
Gap Assessments to ISO 13485:2016 benefits include:
- Early identification of missing requirements
- Early evaluation of the organizations risk based approach
- Minimize and manage risks for upgrade activities
- Evaluation of process based approach in your QMS
- Evaluation of incorporation with ISO 9001:2015