This ISO 13485:2016 accreditation is unique for the fact that it relates to process rather than product standard, specifically pertaining to medical devices. It relates to design, process and distribution, rather than testing the product as many ISO standards tend to, it shows organisations that the medical device manufacturer has a quality management system in place and that it has the capacity to ensure that the end product meets the necessary standard.
Whilst it is not a requirement of the standard, ISO 13485:2016 certification acts as insurance, via a third party, that manufacturing processes meet the industry requirements. The requirements for the standard are updated every five years to stay abreast of technological and regulatory developments. By measuring the appropriateness and effectiveness of a process, whilst assessing safety and efficacy at all stages of the process, the standard ensures that medical devices produced under the certification are ready to manufacture.
Who is it for?
ISO 13485:2016 is designed for medical device manufacturing organisations, not individuals, to have their production process accredited. As the certification only requires that the manufacturer proves the quality system is effective and updated through checks every three years, a medical device manufacturer can be accredited for a single part of the processor every stage. The process doesn’t need to be ongoing, as with some other accreditations of this nature, however, it provides insurance as it validates the safety of a manufacturer’s risk management and process.
What it means for manufacturers to be ISO 13485:2016 accredited
As a major player in the medical device manufacturing industry, here at Europlaz, we use an established, ISO-accredited quality management system which we regularly review. We update all staff on the expectation to adhere to the system and go above and beyond to provide the best results for our customers.
This accreditation essentially follows the lines of pre-existing industry standards. Furthermore, the stringent checks on process mean that we and the consumer can be confident inconsistent compliance with regulatory requirements throughout production.
The criteria for ISO 13485:2016 mean that extensive risk assessment and pre-planning become part of our process. For this reason, it minimises the opportunity for unwanted surprises and failures at all stages of the process, reducing risk to patient safety and subsequent damage to reputation.
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