We specialise in ISO 13485, ISO 9001, ISO 22301 and ISO 17025 but can assist with a number of other related standards and have experts we can contact should we not be able to answer your questions. We constantly monitor the standards and any updates that are made. We can also assist with the SAHPRA and other regulatory requirements as applicable to medical devices.
Everyone should be compliant to ISO 13485:2016. This standard provides the basis for a comprehensive quality management system for handling medical devices, with particular focus on trace-ability and product risk identification.
Perhaps more than any other manufactured product, the quality of medical devices has a direct impact on their effectiveness as well as the safety of patients and users. For this reason, most countries require an independently audited and verified internal quality management system. Without it many products are unable to sell within the major markets. this is now being applied within South africa and will impact on future purchases and tenders by companies.
The advantages of being ISO 13485 complaint and/or certified include:
- An increase in efficiency and product quality because you are constantly measuring and checking your processes and products
- As a globally recognised standard your certificate increases your credibility
- Shows a commitment to quality and demonstrates compliance with international and industry standards.
To comply with ISO 13485, your company also needs to apply ISO 14971:2019 – application of risk management. While this is a requirement for ISO 13485, it can also be applied to the other standards as they all require a risk assessment to be done.
Implementing ISO 9001 should be seen as the development of a system which, apart from providing a recognisable quality system, also helps you to manage the operations within your company :
- Determining the needs and expectations of customers and clients. The less customer complaints the greater the customer satisfaction.
- Establish policies, objectives and a work environment necessary to meet these needs.
- Designing and managing the processes necessary to implement the policy and attain the objectives.
- Measuring and analysing the adequacy and effectiveness of the processes to fulfil their purpose and objective. This will mean a reduction in non-conformances.
- Continually improving the system by evaluating its performance.
ISO 9001 represents your commitment to quality and that you place customer satisfaction as a top priority.
If your company needs to demonstrate technical competence based on an efficient quality system, then ISO 17025 could be the appropriate standard.
ISO 17025 is applicable to testing and calibration laboratories and accreditation shows your company has demonstrated they are technically competent to perform specified tests, calibrations and measurements. (Note: you are not certified to this standard but are accredited).
Many of the principles are the same as ISO 9001 and should you already be certified we can use these documents as a starting point.