How An ISO Certification Ensures Quality Healthcare
One of the best things about the country of Australia is its healthcare services. It offers one of the best healthcare systems in the world. Australia’s medical care services are safe and affordable for all. The healthcare workers are above par, and the hospitals’ medical equipment is ISO certified.
It is important to have safe and quality medical devices, which is why it is good for medical devices to be certified with ISO 13485 certification. An ISO certification demonstrates that the equipment is made in compliance with all the regulations set and following the stringent quality requirement set.
What is it for?
It is used to certify any medical device intended to diagnose, treat, and prevent diseases and other medical conditions that meet the quality requirements for its design and manufacturing.
Who is it for?
The certification is designed for organisations who are involved in the design and production of medical devices. Those that install and service these devices also use them. In addition, external and internal parties can use it in their auditing processes.
Is it required?
It is not required to be certified to this ISO standard. There are even organisations that benefit from its standards without undergoing certification. However, being certified can demonstrate to regulators that the requirements of the standard have been met.
What are its key elements?
There are five key elements to this ISO standard. These are:
- Quality management system
This section is all about the general quality management system requirements that will ensure the quality of the product. This section also includes the documentation process.
- Management responsibility
This section is all about the management’s role in ensuring that quality products are produced. It includes regulatory management requirements, quality policy, reviews, and management resources.
- Resource management
This section includes the needed resources to meet regulatory and customer requirements. It includes the provision of resources, work environment, human resources, infrastructure, and contamination control.
- Product realisation
This section looks at the planning stage of your product. It provides your product’s quality requirements. It also defines the required processes you have to undergo. Under this section, your employees’ qualifications and training requirements are defined. It is the section where your processes for validation, verification, monitoring, inspection, handling, distribution, storage, and tracing are defined.
- Measurement, analysis, improvement
An organisation shall plan, monitor, measure, and analyse its management system and products. The working and effectiveness of the quality management system must, in fact, be maintained.
What does it mean to be ISO 13485 certified?
A certification means that the organisation has met all the ISO requirements and has implemented ISO Quality Management System. The ISO certifies the safety and efficacy of medical devices.
Why is it important?
Australian businesses that are into medical devices are subject to stringent requirements. Australian regulations also require businesses to comply with this standard if they intend to supply medical devices. Also, an ISO certification will indicate to consumers that all the quality requirements are met in making the medical device.
If you are a business which is looking to enter the medical device industry, make sure that you are ISO compliant. There are companies that offer ISO consulting services that can help you with your business.