What is the ISO 13485 Standard?
ISO 13485 specifies requirements for a quality management system that can be used by an organisation involved in one or more stages of a medical device's lifecycle.
These include design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development or provision of associated activities.
The Standard can also be used by suppliers or external parties providing products such as raw materials, components, subassemblies, medical devices, sterilisation, calibration, distribution, and maintenance services.
Benefits of ISO 13485 Certification
Organisations in the medical manufacturing industry across the globe have experienced the benefits of attaining ISO 13485 certification. By assessing and improving internal quality management processes, your organisation will build a reputation for consistently and reliably manufacturing quality medical devices.
The ISO 13485 tick of quality publicly demonstrates your business’s certification, providing stakeholders and consumer with confidence, helping your organisation to stand out amongst competitors.
The benefits of an ISO 13485 certified quality management system can include:
Why certify your QMS with TQCSI?
TQCSI is an international organisation, with a network of offices across the globe. Each of our offices is operated by local experts. This allows us to provide a localised service at a competitive price. When you work with TQCSI, you can rest assured that the auditor speaks your language and understands your operating environment.
As the world’s largest JASANZ certification body, we have certified thousands of Quality Management Systems for businesses of all shapes and sizes. Whether transferring your ISO 13485 certification from another certification body or starting from scratch, we make the certification process easy.
Don’t wait, start your ISO 13485 Certification now
Reach out to your local TQCSI office today to experience a smooth path to ISO 13485 certification. Alternatively, tell us a bit about your business and your quality management objectives through our online form.
Start Certification ProcessPreparing for ISO13485 Certification of your Quality Management System
When our auditors undertake the ISO13485 certification process, they will be assessing your systems and documentation. Having your documentation organised before our auditors begin will allow for a smoother, simpler ISO13485 certification process.
Below is a checklist of typical items and systems documentation that a compliant ISO13485 Management System might have.
ISO 13485 Management Systems Requirements
An ISO 13485 quality management system requires organisations to:
- Understand their QMS related external & internal issues, and interested parties
- Have a Policy Statement describing senior management’s commitment to QMS improvement
- Assess potential QMS related risks
- Monitor controls identified during risk assessments to ensure their effectiveness
- Develop and monitor QMS objectives and targets
- Ensure staff are competent and understand the organisation’s QMS risks, as well as their roles and responsibilities within the quality management system
- Identify, report and rectify any QMS nonconformances
- Take corrective action for significant or repetitive QMS nonconformances
- Conduct internal audits of the QMS management system.
- Conduct Management Reviews at planned intervals to ensure ongoing suitability, adequacy and effectiveness of the QMS
- Established procedures for controlling QMS documentation and records to ensure integrity, confidentiality and availability.
Documentation Requirements for ISO 13485 Certification
To meet the ISO 13485 requirements, you will need to have the following documents:
- Quality Policy
- Quality or Management Manual
- Organisational structure – identifying who has functional QMS related roles, responsibilities and authorities
- Documentation specified by national or regional regulations
- Documents for each medical device including, but not limited to: general description, specifications for product, procedures for measuring and monitoring, requirements for installation, and procedures for servicing
- Records of product output
- Design inputs related to product requirements
- Records of design reviews
- Records of design verification and validation activities
- Records of design and development transfer
- Procedures for reporting QMS related issues and nonconformances, establishing management system objectives as well as the risk assessment process
- Records of management system objectives, nonconformances, risk assessments, reviewing goals, and corrective action, must all be retained
- Risk management plan
- Supplier evaluation & selection criteria
- Complaint handling procedure
ISO 13485 Certification Mark for Quality Management Systems
The certification mark can be used on all promotional material to promote your certification.
Other ISO Certifications
ISO 9001:2015
Certification of Quality Management Systems
ISO 55001:2018
Certification of Asset Management Systems
ISO 45001:2018
Certification of OHS Management Systems
ISO 14001:2015
Certification of Environmental Management Systems
View All Standards
Want to know more about ISO 13485 Certification?
Certification of Medical Device Manufacturers (QMS) ensures the safety and effectiveness of medical devices are enhanced by complying with the high standards in product quality and manufacturing processes.
Contact your local TQCSI office today to learn how certification to ISO 13485 can help your business, or email us at info@tqcsi.com