ISO 13485:2003

Richard Rush
Quality Management Consulting
www.qualitymanagementconsulting.com

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Management Consulting
 Objectives

„ Discuss European regulatory scheme

„ Background/history of ISO 13485
„ Compare and contrast 9001 and 13485
„ Identify implementation challenges for
ISO 13485
„ Answer your questions

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 The European Regulatory Scheme

„ Medical Device Directive is the European

parliament’s legal objectives which are agreed to
and transposed into national law.
„ The Directives harmonize controls on product
design and safety requirements throughout
Europe.
„ You can download directives free of charge from
the European Union website.

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 The European Regulatory Scheme

„ Competent Authority – the administrative

agency within a European country as
designated in that country’s national law

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 The European Regulatory Scheme

„ Notified Body – a government-sanctioned

agency in a member state of the European
Union that carries out conformity assessment
procedures for medical devices.
„ The Notified Body provides services for
conformity assessment of the quality system and
to the essential requirements listed in the
medical device directive.

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 The European Regulatory Scheme

„ The Notified Body may be utilized to certify the

quality system to ISO 13485
„ The Notified Body may be required to review
Technical File documentation, to assure
conformance with “essential requirements” from
the directives
„ Ultimately, the notified body certifies the
application of the CE Mark for class 2 and 3
devices
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 The European Regulatory Scheme

„ The Notified Body is regulated and

overseen by the Competent Authority
„ Decisions made by the notified body are
recognized by all European countries
„ Certain requirements may be additionally
placed by other countries (e.g., national
language requirements for labels,
reporting adverse events)
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The Medical Device Quality System
Standard
„ Formerly EN 46001
„ Later ISO 13485:1996
„ Currently ISO 13485:2003
„ Full Quality Assurance is one route to a CE
Mark

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 Procedure Requirements

„ ISO 9001:1994 18
„ ISO 13485:1996 18
„ ISO 9001:2000 6
„ ISO 13485:2003 17
„ 21 CFR Part 820 (QSR) 36

Source: Medical Product Outsourcing Magazine - Mar/Apr 2004

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Differences from ISO 9001:2000

„ 13485 does not require continual

improvement or customer satisfaction, but
rather maintaining them (4.1)

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Differences from ISO 9001:2000

„ Medical device companies must also

comply with local and national
requirements (4.2) and commit to
regulatory compliance (5.3)

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Differences from ISO 9001:2000

„ More prescriptive requirements for

documented procedures and records
retention
„ Align more closely to FDA’s Quality System
Regulation (21 CFR 820)

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Differences from ISO 9001:2000

„ Additional requirements for sterile and

implanted devices, for example

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 Additional Documentation
„ Responsibilities and authorities
„ Training procedures
„ Health, cleanliness, and
clothing
„ Environmental conditions
„ Maintenance
„ Control of contaminated
products
„ Risk management
„ Customer requirements
„ Design and development
„ Purchasing control
„ Labeling and packaging
„ Installation and verification
„ Process and sterilization
validation
„ Identification
„ Preservation of product (shelf
life)
„ Feedback and
„ Analysis of data

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Changes from ISO 13485:1996

„ Restructured similar to ISO 9001

„ Follows the process approach
„ Allows exclusions and non-application for
areas where permitted

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 Implementation Challenges

„ Exclusions/non-application/justifications
often missed
„ Design control may be excluded
„ Processes that do not apply must be justified
in the Quality Manual

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 Implementation Challenges

„ Process approach and the description of

processes in the Quality Manual is not well
understood
„ Not Plan-Do-Check-Act
„ Describe key business activities which add
value
„ Involve inputs and outputs that feed to and
from other processes
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 Implementation Challenges

„ Audits not performed using process model

„ Auditors not well-trained
„ Business processes not well-defined

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 Implementation Challenges

„ Objectives tied to the Quality Policy have

not been determined
„ Quality policies may not lend themselves to
tangible objectives
„ Appropriate, measurable and time-based

„ Implementation plans

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 Implementation Challenges
„ Risk management has not been established or is
not documented throughout the product
realization process
„ Design control
„ Supplier selection
„ Nonconformances
„ ECOs
„ etc.
„ ISO 14971 may be used; not required
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 Implementation Challenges

„ CAPA process is weak

„ Root cause analysis not rigorous
„ Poor application/understanding of preventive
action

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 Implementation Challenges

„ Feedback processes are too limited

„ Complaints
„ Reportable events

„ Customer surveys

„ Journal reviews

„ Internet searches

„ Market research

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 Implementation Challenges
„ Analysis of data is too limited
„ Complaint rates
„ Acceptance rates

„ Process controls

„ Supplier performance

Not all data need be reviewed in the

management review
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 A Useful Resource

ISO/TR 14969:2004 – Medical devices –

Quality management systems – Guidance
on the application of ISO 13485:2003

Contains the full standard and discussion

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