ISO 13485
Why is ISO 13485 Important?
ISO 13485 is crucial for medical device companies because it ensures the consistent quality and safety of their products, leading to increased customer trust, regulatory compliance, and overall operational efficiency. It establishes a framework for managing the design, development, production, and distribution of medical devices, ensuring they meet regulatory requirements and customer expectations.
ISO 13485 covers the implementation, documentation and maintenance of quality management by suppliers and producers of medical devices.
To implement a QMS with a higher level of control, focus on safety and tougher requirements and standards which can benefit the manufacture of medical devices or components for them.
No matter the challenge, we certify on what we know works and elevate your vision of success
Benefits of ISO 13485 Certification
Customer satisfaction
Deliver products that consistently meet customer requirements and a service that is dependable and can be relied on.
Reduced operating costs
Continual improvement of processes and resulting operational efficiencies mean money saved.
Improved stakeholder relationships
Improve the perception of your organization with staff, customers and suppliers.
Legal compliance
Understand how statutory and regulatory requirements impact your organisation and its customers.
Proven business credentials
Independent verification against a globally recognised industry standard speaks volumes.
Ability to win business in regulated sectors
Certification helps to win business – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.
Improved risk management
Greater consistency and traceability of products and services means problems are easier to avoid and rectify.
Steps to Certification
Step 1
Complete a Quote Request Form so we can understand you and your business. We will then use this to personally prepare a proposal for your certification and define what is known as your ‘scope of assessment’.
Step 2
We will then contact you to book your assessment with an NQA assessor. It consists of two mandatory visits that form the Initial Certification Audit. Please note that you must be able to demonstrate that your management system has been operational for a minimum of three months and has been subject to a management review and a full cycle of internal audits.
Step 3
Following a successful stage two audit, a decision is made. If positive, your certification will be issued by NQA, with both a hard and soft copy of the certificate awarded. Certification is valid for three years and maintained through surveillance audits (years one and two) and a recertification audit in year three.
Is ISO 13485 Certification Right For Me?
ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonised medical device regulatory requirements.
Annex B of the ISO 13485:2016 standard includes a comparison with ISO 9001 for reference. Importantly, neither can be used to make a QMS that is automatically compliant to the other and both need auditing.
Further, there are many terms in ISO 13485 unique to medical devices. ISO 13485 also retained the role of a quality representative to top management, where ISO 9001 removed this in many aspects. Interestingly, ISO 9001 has a lot more requirements for monitoring external providers for performance than the old version, and this is something always required by ISO 13485.
ISO 13485 is also ideal for companies that provide parts and services for medical device manufacturers. The standard has requirements for traceability, identification, risk assessment, cleanliness and documentation of procedures, all of which position these enterprises to be strong sources for medical components. Since there are many regulatory requirements by which medical device manufacturers must evaluate and monitor their suppliers, the presence of ISO 13485 certification will help medical device manufacturers feel confident about working with these parts and services providers.
Apart from medical devices, businesses in the aerospace industry seek to get certified to ISO 13485 to diversify. Those with AS9100 are already set up to achieve ISO 13485 easily.
