What is ISO?
ISO is the International Organisation for Standardisation and exists to bring consistency and quality across international markets and industries in the fields of terminology, compatibility, interoperability, health, safety and the environment.
ISO’s origins reach back to 1926 when the International Federation of National Standardising Associations was established to create standards in the field of engineering. This organisation was dissolved during the Second World War.
With the need for standardisation already recognized, 25 countries met in London in 1946 to discuss and develop a new iteration of the organisation to create international standards. ISO (the name has its roots in the Greek ISOS meaning equal), therefore, the organisation became official in 1947 and today has a membership of 165 national standards bodies. It is non-governmental and independent with headquarters now based in Geneva, Switzerland. For the first 40 years of its existence, the development of technical standards for products and technologies was the key focus. Since the 1980’s, the development of process standards has been main activity.
Why would a company seek to become ISO accredited?
At any stage in its growth and evolution, becoming an ISO accredited organisation is a significant and valuable step for a business. It requires investment financially and time to establish and maintain the standard relevant to the business type. For instance, TriMedika is an ISO13485 accredited organisation which enables the company to design, develop, manufacture, and distribute medical devices.
The benefits are far reaching and resoundingly positive:
- The introduction of process to each of the business activities bringing consistency across the organisation, reducing, or eliminating error and ensuring quality.
- The processes and procedures enable excellent levels of traceability, record keeping and control.
- For employees of an accredited company, the processes relative to the standard give employees high levels of what is required to carry out their specific role. They receive appropriate training, regular training reviews and therefore, are both confident and competent in carrying out their activities.
- External partners, whether customers or suppliers also gain confidence in contracting with an ISO company. In the case of applying for tenders, having an ISO certification will improve the organisation’s likelihood of success as it confirms that the company works to a specific standard, is highly professional and run by a qualified team. Having ISO accreditation is therefore good for business!
- TriMedika must also carry out audits of every new supplier with which it contracts for components, products and services, ensuring that standards are never compromised, and traceability is ensured. This audit will examine what accreditations the potential suppler holds.
- Regular auditing (usually annual) means that the processes and tested and reviewed so that goal of achieving continuous improvement across all activities is easier to meet
ISO 13485:2016
It specifies the requirements for a quality management system for organisations that manufacture medical devices. It must demonstrate its ability to establish and maintain quality in the production of medical devices and support functions so that it consistently meets customers’ expectations and meets the applicable regulatory requirements.
TriMedika is an ISO 13485:2016 accredited; the company adheres to the standard in everything it does, consistently looking to identify areas for improvement and execute upon these. It is everyone’s responsibility in the organization to work to the standard, be vigilant and seek improvement.
