Quality is the real capital of medical and diagnostic laboratories around the world. It demands constant attention and a firm commitment to standards of quality, safety and integrity. By applying ISO standards, these organisations live up to the responsibility and trust placed in them directly by patients and commercially by doctors and medical institutions.
Medical laboratories apply quality and ISO standards to achieve several goals that sustain their customers’ trust:
- Better quality: by applying locally and internationally agreed standards that are regularly reviewed by internationally accredited quality auditors until the organisation qualifies for ISO certification such as ISO 9001 and ISO 14001.
- Greater trust: by publicising the standards the organisation complies with through a certificate from a certification body accredited locally by the Egyptian Accreditation Council (EGAC) and internationally by the International Accreditation Service (IAS), both signatories of the International Accreditation Forum (IAF) multilateral recognition arrangement, such as Team Quality
- Regulatory compliance: quality certificates assure consumers and customers that medical organisations comply with all applicable regulatory requirements.
- Greater operational efficiency: medical organisations and laboratories are only granted quality accreditation and ISO certification once the standards have been verified as applied and reviewed at more than one stage. This requires everyone in the organisation to follow all work instructions and regulations as well as possible and to strive for the highest standards of organisational quality and consumer trust.
- Access to global markets: ISO certification gives medical device manufacturers the opportunity to reach markets all over the world.
A tip from the Team Quality team: for medical organisations, ISO 13485 is the standard to look at. It is an important international standard for medical device management systems and manufacturing. You can find out more about it on our ISO 13485 page
Achieving ISO certification involves several steps
- Understanding the standard: the person managing the medical organisation must understand the standard to be implemented and assess its impact on the organisation and its reputation.
- Gap analysis: This involves assessing current systems and processes to identify where changes are needed to conform to the standard.
- Implementation: Once the gaps in your system have been identified, the next step is to establish the processes the standard requires and make sure they are effective.
- Internal audit: An internal audit is essential to verify that the processes implemented conform to the standard and to the organisation’s requirements.
- Management review: Management review meetings check that the system is ready for the certification audit and reinforce commitment to the standard’s continual improvement requirements.
- Certification audit: This is the final step, in which the certification body carries out the external audit.
How to choose an ISO and quality certification body
You need to choose your certification body carefully, regardless of differing pricing policies and tempting offers, because an ISO certificate from a certification body becomes part of your organisation’s reputation. You should therefore choose a company with strong, genuine authorisations and accreditations locally and internationally, a proven track record and real strengths that help your brand stand among prestigious brands and organisations. Team Quality offers you all of this and more.
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