ISO Standards

Standards

We specialise in ISO 13485, ISO 9001, ISO 22301, ISO 17025 and now ISO 15189 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. 

Please note: We can also assist with SAHPRA registrations and other regulatory requirements as applicable to medical devices.

ISO 22301

ISO 22301 provides a framework to plan, manage and maintain a business continuity management plan.

If it is set up correctly, it will help companies protect against, prepare for, respond to and recover from major disruptive events such as power outages, computer crashes, natural disasters, workplace violence, etc.

Your recovery is directly related to how much detail you include in your Disaster Recovery Planning Process. More is better.
If you spend the time and money now, it will help you in the future.

ISO 13485

All medical device companies 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 future purchases and tenders by companies.

The advantages of being ISO 13485 compliant 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.

ISO 14971

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.

ISO 9001

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 fewer 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.

ISO 17025

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 are already certified, we can use these documents as a starting point.

ISO 15189

ISO 15189 specifies the requirements for both quality and competence in medical laboratories. With more small independent laboratories being set up in South Africa we are now able to assist with this standard and help you ensure you offer the best service.

Being certified to this standard will help you stand out and give your patients and clients confidence in the services you offer.