ISO 13485 is an internationally recognized quality standard which states the
requirements of the Quality Management System (QMS) for the design and
manufacture of Medical Devices. While it remains a stand-alone document, ISO
13485 is based on ISO 9001 with some additional clauses as well as the removal
of some requirements.
Overview of the ISO
Clause 1: Scope
- a quality management system for an organization that provides
medical devices and services that meets customer requirements and
harmonized medical device regulatory requirements
Clause 2: Normative Reference
- References ISO 9000:2005 which should be used along with the
standard. It outlines the
Management Systems-Fundamentals and Vocabulary
Clause 3: Terms and Definitions
- Gives definitions used in the standard, many of which are IN ADDITION to ISO 9001:
- Active Implantable Medical Device
- Active Medical Device
- Advisory Notice
- Customer Complaint
- Implantable Medical Device
- Medical Device
- Sterile Medical Device
Clause 4: General Requirements Gives requirements for the overall Quality Management System
Documentation Requirements, including:
Quality Manual with Scope of the QMS
- Required Procedures
- Required Forms & Records
- Control of Documents
- Control of Forms
Clause 5: Management Responsibility Gives requirements for Management's role in the QMS
- Management Responsibility
- Quality Policy & Objectives
- Customer Focus & Customer Satisfaction
- Management Review
Clause 6: Resource Management Gives requirements for resources including:
Personnel & Training
- Resource Management
Clause 7: Product Realization Gives requirements for:
- the production of the product or service
- customer related processes and Customer Feedback
- Process control
- Identification and Traceability
- Customer Property
NOTE: Much of Clause 7 is modified from ISO 9001
Clause 8: Measurement, Analysis and Improvement
- Gives requirements on monitoring processes and improving those
- Customer Satisfaction
- Internal Audits
- Control of Non-Conforming Product
- Corrective and Preventive Action
NOTE: Several items in Clause 8 are modified from ISO 9001
Here is a partial Sampling of some of the key Medical Device
Standards from around the world:
US FDA Medical Device Regulations
Design Control Guidance for Medical Device Manufacturers
Text related to FDA 21 CFR 820.30 and sub clause 4.4 of ISO 9001.
Labeling for Medical Devices
Guidance on medical device labeling from the FDA
Quality Systems Regulations (QSR)
US FDA 21 CFR Parts 808, 812, and 820
Medical Devices; Current Good Manufacturing Practice (CGMP); Final
Post Market Surveillance
Guidance on criteria and approaches for medical device post-market
Human Factors in Medical Device Design
Discusses the CDRH push to have manufacturers apply Human Factors
to device design.
European Medical Device
Regulations Directives (MEDDEV):
Active Implantable Medical Devices Directive (AIMDD)
Full text of European directive 90/385/EEC that governs active
implantable medical devices.
In-Vitro Diagnostic Devices Directive (IVDD)
Full text of the European IVD directive 98/79/EC that governs
Medical Device Directive, Full Text (MDD)
Full text of the European Medical Devices Directive 93/42/EEC.
Personal Protective Equipment Directive (PPE)
Full text of the European directive 89/686/EEC that governs
personal protective equipment.
Canadian Medical Device
Canadian Medical Devices Regulations
Full text of the Canadian MDR as part of the Food and Drugs Act of
Transition to ISO 13485:2003
Brief document that discusses timeline for transitioning to ISO
ISO 13485 Audit Guidelines
Guidance document that discusses ISO 13485 QS audits performed by
Officially Recognized Registrars
Listing of registrars recognized by Health Canada and standards to
which they may audit.
Health Canada Licensing Fees
Document detailing all medical device licensing and other fees for
Japanese Medical Device
Regulations & Guidelines
Japan's Pharmaceutical Affairs Law Ordinance 169
Japanese Requirements Review - January 2005
ISO 13485 Success Factors
Research into what makes a ISO 13485
implementation a success has revealed 11 Critical Success Factors. They
are, in order of importance:
- Leadership & commitment, preferably by Top
management but at least by somebody.
- A simple, comprehensive implementation plan
- Training & support for everyone involved or
affected by the implementation project
- Buy-in and voluntary support & commitment from
a critical mass of people (>1
person, building to 25% of employees)
- Early successes that clearly prove that ISO
13485 will benefit customers, suppliers, management, and especially
- Adequate resources and time to achieve all
that needs to be done
- Rapid and effective communication, feedback,
and recognition on efforts made, results achieved, and work to be done
- Expert, pre-experienced advice, coaching,
cheerleading, pre-warnings, and technical expertise on ISO 13485
- Auditing, training, and remedial assistance to
achieve consistent compliance to minimum requirements.
- Dress-rehearsal audit, final fixes, then formal
Registration Audit by Accredited Registrar
- Continuous assessment, improvement, and
re-registration of systems.
PQA help your ISO 13485 Implementation ?
PQA has developed an 7-step ISO 13485 implementation program. This 7-step program encompasses
all of the critical success factors:
Perform a Gap Analysis PQA
will perform a gap analysis of your current quality or environmental
management system to determine the frequency, consistency &
effectiveness of compliance to the requirements, the root causes of any
shortcomings, and what will have to be developed to meet your business
needs and the needs of the management system requirements.
Project Schedule PQA will work with
the Project Coordinator to prepare a project schedule. The schedule will
list the actions identified from the Strategy session and Gap Analysis,
the “Process Owners” responsible to perform the action, and a timeline.
Establish Implementation Teams
PQA will help you identify the personnel at all levels in the
organization who will be on the “Process Teams”. This ensures input,
involvement & buy-in throughout the organization.
Develop Process Maps PQA will assist the
“ProcessTeams” to develop Process Maps. There will be 2 levels of
Define the high-level processes and their
interactions. These would include, for example, Quotation, Design,
Purchasing, Manufacturing, etc.
Each block in the high-level map becomes a Process Map
of its own.
Develop Documentation PQA will
help the Process Teams identify and prepare the level of documentation
required. This will include:
Procedures to cover the ISO requirements for
documented procedures. For some processes, this may be just the
Process Maps. In other processes, explanatory step-by-step
instructions may be needed.
The numerous forms which may be needed for recording
the results of the process measurements that will be performed (where
possible, we will use existing forms as is, or modify them to meet the
Employee Training PQA will
help you identify the training needs of your employees so they will be
able to fulfil their responsibilities in the ISO system. PQA offers a
wide range of
Training Workshops to address most training needs.
Pre-Registration Internal Audit
PQA will provide pre-registration internal audit services as follows:
PQA will act as Lead Auditor, using your internal
audit team, to conduct a Dress Rehearsal Audit of the entire quality
system. Performing a Dress Rehearsal Audit that involves the your
Internal Quality Auditors serves three purposes.
Provide your internal auditors with practice in
Determine those elements of your ISO system which
need to be fine-tuned prior to the Registrar’s audit.
You will have completed an internal audit of your
entire ISO system prior to your registration audit - this is a
requirement to obtain your registration.
PQA will conduct a Post Audit Meeting, presenting the
results of the Dress Rehearsal Audit to your Management Review team,
and assist in identifying corrective actions needed.
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