ISO 13485:2003 specifies requirements for a quality management system where an organization
needs to demonstrate its ability to provide medical devices and related services
that consistently meet customer requirements and regulatory requirements applicable
to medical devices and related services.
The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory
requirements for quality management systems. As a result, it includes some particular
requirements for medical devices and excludes some of the requirements of ISO 9001
that are not appropriate as regulatory requirements. Because of these exclusions,
organizations whose quality management systems conform to this International Standard
cannot claim conformity to ISO 9001 unless their quality management systems conform
to all the requirements of ISO 9001.
All requirements of ISO 13485 are specific to organizations providing medical devices,
regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls,
this can be used as a justification for their exclusion from the quality management
system. These regulations can provide alternative arrangements that are to be addressed
in the quality management system. It is the responsibility of the organization to
ensure that claims of conformity with ISO 13485 reflect exclusion of design and
ISO 13485 Management Systems of Medical Devices.
Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for:
Implementation of a Quality Management System with several enhancements
Risk Management approach to product development and product realization
Validation of processes
Compliance with statutory and regulatory requirements
Effective product traceability and recall systems.
A manufactured product is defined as a medical device if it is used to:
Cope with human disease.
Prevent human disease.
Diagnose human disease.
Treat human disease.
Alleviate human disease.
Monitor human disease.
Care for human injuries.
Diagnose human injuries.
Treat human injuries.
Alleviate human injuries.
Monitor human injuries.
Compensate for human injuries.
Meet human anatomical needs.
Investigate human anatomical issues.
Replace human anatomical structures.
Modify human anatomical structures.
Support human anatomical structures.
Maintain human physiological functions.
Investigate human physiological issues.
Replace human physiological structures.
Modify human physiological structures.
Support human physiological structures.
Support or sustain human life
Control human conception
Disinfect human medical devices
Examine specimens taken from human bodies.
Medical devices can include:
Instruments, Appliances, Implants, Machines, Software, Materials, Calibrators, Apparatuses,
In vitro reagents, Related articles.
Manufactured products that achieve results by pharmacological, immunological, or
metabolic means are not medical devices. However, the results achieved by medical
devices may be assisted by these means.
The benefits of certification
Customer satisfaction through delivery of products that consistently meet customer
requirements as well as quality, safety and legal requirements.
Reduced operating costs - through continual improvement of processes and resulting
Improved stakeholder relationships - including staff, customers and suppliers.
Legal compliance - by understanding how statutory and regulatory requirements impact
the organization and its customers
Improved risk management - through greater consistency and traceability of products
and use of risk management techniques
Proven business credentials - through independent verification against recognized
Ability to win more business - particularly where procurement specifications require
certification as a condition to supply in a highly regulated sector.
Who can apply for ISO 13485
ISO 13485 contains requirements that are essential for any organization operating
at any tier in the medical device and pharmaceutical supply chain. It is especially
relevant to manufacturers that wish to demonstrate applicable regulatory requirements,
and by organizations whose services support medical device manufacturers.
The process of registration follows three simple steps:
Application for registration is made by completing the application questionnaire
Assessment to ISO 13485 is undertaken by recognized accreditation bodies - the organisation must be able to
demonstrate that its quality management system has been fully operative for a minimum
of three months and has been subject of a full cycle of internal audits
Registration is granted by NQA and maintained by the organisation. Maintenance is
confirmed through a programme of annual surveillance visits and a three yearly re-certification
Initial Certification Audit
The assessment process for achieving certification consists of a two stage Initial
Certification Audit as follows:
Stage 1 - the purpose of this visit is to confirm the readiness of the organisation
for full assessment. The assessor will:
Confirm that the quality manual conforms to the requirements of ISO 13485
Confirm its implementation status
Confirm the scope of certification
Check legislative compliance
Produce a report that identifies any non-compliance or potential for non-compliance
and agree a corrective action plan if required.
Produce an assessment plan and confirm a date for the Stage 2 assessment visit.
Stage 2 - The purpose of this visit is to confirm that the quality management system
fully conforms to the requirements of ISO 13485 in practice. The assessor will:
Undertake sample audits of the processes and activities defined in the scope of
Document how the system complies with the standard
Report any non-compliances or potential for non-compliance
Produce a surveillance plan and confirm a date for the first surveillance visit
If the assessor identifies any major non-conformance, the organisation cannot be
certified until corrective action is taken and verified.