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BS EN ISO 13485:2003
Medical
devices - Quality management systems - Requirements for
regulatory purposes
This Standard is
aimed at companies that design, develop, produce, install or
service medical devices and 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 and regulatory requirements.
The newly published
BS EN IS013485: 2003 Medical Devices. Quality Management
Systems. Requirements for Regulatory Purposes now includes a
requirement for senior management "buy-in" as specified in ISO
9001:2000. However the primary objective 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 BS EN ISO 9001 that are not appropriate as
regulatory requirements. Therefore, while BS EN ISO 13485:2003
has the same format as BS EN ISO 9001:2000 and most of the same
requirements, compliance with BS EN ISO 13485:2003 does not
provide conformity with BS EN ISO 9001:2000.
BS EN ISO 13485:2003
supersedes BS EN ISO 13485:2001 and BS EN 1S0 13488:2001 which
was withdrawn in July 2006. To maintain their certified status
all organisations within the medical devices industry must adopt
BS EN 13485:2003
Major differences
between BS EN IS013485: 2003 and ISO 9001:2000 are the
requirement to maintain the effectiveness of the system rather
than improve it; emphasis on meeting customer and regulatory
requirements as against increasing customer satisfaction and a
greater requirement for documented procedures which include:
- Those
documents required by regulation
-
Responsibility and authority
- Training
procedure, if required
- Maintenance
requirements
- Health,
cleanliness, clothing
-
Environmental conditions
- Control of
contaminated product
- Risk
management
- Customer
requirements
- Design and
development
- Purchasing
process including traceability records and records of
verification
- Reference
materials and reference measurement procedures
- Labelling
and packaging
- Installation
and verification
-
Sterilization process validation
-
Identification and validation
- Preserving
product including shelf life
- Monitoring,
measurement and measuring devices
-
Sterilization records, servicing records, batch records,
validation
Differences in
research and development activities:
- Determine
design transfer activities
- Document
design planning outputs
- Include risk
management in input
- Approve
inputs
- Document
design outputs
- Include
specialist as needed in design review
- Complete
validation before delivery
- Include
clinical trial as required
Added programs to
consider:
- Clinical
evaluation
- Risk
management
- Clinical
trials
- Cleanliness
of product and contamination control
- Requirements
for implantable devices
-
Communication of advisory notices
Lewis Conquer
Consultancy Services specialise in putting in simple
uncomplicated quality management systems, that meet the
requirements of the BS EN ISO 13485 medical devices standard,
without unnecessary administration.
changes to BS EN ISO 13485:2003
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