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ISO 13485
What is ISO 13485 Overview of the ISO 13485 Requirements Medical Device Regulations
ISO 13485 Success Factors How can PQA help your ISO 13485 Implementation?

What is ISO 13485

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 13485 Requirements

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
    Quality 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
    • Labeling
    • 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
  • Planning
  • customer related processes and Customer Feedback
  • Design
  • Purchasing
  • 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 processes
  • Customer Satisfaction
  • Internal Audits
  • Control of Non-Conforming Product
  • Corrective and Preventive Action

NOTE: Several items in Clause 8 are modified from ISO 9001

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 Medical Device Regulations

Here is a partial Sampling of some of the key Medical Device Standards from around the world:

US FDA Medical Device Regulations & Guidelines

  1. Design Control Guidance for Medical Device Manufacturers
    Text related to FDA 21 CFR 820.30 and sub clause 4.4 of ISO 9001.
  2. Labeling for Medical Devices
    Guidance on medical device labeling from the FDA
  3. Quality Systems Regulations (QSR)
    US FDA 21 CFR Parts 808, 812, and 820 Medical Devices; Current Good Manufacturing Practice (CGMP); Final Rule.
  4. Post Market Surveillance
    Guidance on criteria and approaches for medical device post-market surveillance.
  5. Human Factors in Medical Device Design
    Discusses the CDRH push to have manufacturers apply Human Factors to device design.
  6. Additional Quality System Information

    Quality System (QS) Regulation

    21 CFR 8204  

    Medical Device Quality System Regulation and Preamble5 


    Quality System Regulation Guidance Documents

    Medical Device Quality Systems Manual- go to http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/default.htm

    Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff7



European Medical Device Regulations Directives (MEDDEV):

  1. Active Implantable Medical Devices Directive (AIMDD)
    Full text of European directive 90/385/EEC that governs active implantable medical devices.
  2. In-Vitro Diagnostic Devices Directive (IVDD)
    Full text of the European IVD directive 98/79/EC that governs in-vitro diagnostics.
  3. Medical Device Directive, Full Text (MDD)
    Full text of the European Medical Devices Directive 93/42/EEC.
  4. Personal Protective Equipment Directive (PPE)
    Full text of the European directive 89/686/EEC that governs personal protective equipment.

Canadian Medical Device Regulations (CMDR)

  1. Canadian Medical Devices Regulations
    Full text of the Canadian MDR as part of the Food and Drugs Act of 1998.
  2. Transition to ISO 13485:2003
    Brief document that discusses timeline for transitioning to ISO 13485:2003
  3. ISO 13485 Audit Guidelines
    Guidance document that discusses ISO 13485 QS audits performed by CMDCAS registrars.
  4. Officially Recognized Registrars
    Listing of registrars recognized by Health Canada and standards to which they may audit.
  5. Health Canada Licensing Fees
    Document detailing all medical device licensing and other fees for Canada.

Japanese Medical Device Regulations & Guidelines

  1. Japan's Pharmaceutical Affairs Law Ordinance 169
  2. Japanese Requirements Review - January 2005
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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:

  1. Leadership & commitment, preferably by Top management but at least by somebody.
  2. A simple, comprehensive implementation plan
  3. Training & support for everyone involved or affected by the implementation project
  4. Buy-in and voluntary support & commitment from a critical mass of people  (>1 person, building to 25% of employees)
  5. Early successes that clearly prove that ISO 13485 will benefit customers, suppliers, management, and especially workers
  6. Adequate resources and time to achieve all that needs to be done
  7. Rapid and effective communication, feedback, and recognition on efforts made, results achieved, and work to be done
  8. Expert, pre-experienced advice, coaching, cheerleading, pre-warnings, and technical expertise on ISO 13485 implementation.
  9. Auditing, training, and remedial assistance to achieve consistent compliance to minimum requirements.
  10. Dress-rehearsal audit, final fixes, then formal Registration Audit by Accredited Registrar
  11. Continuous assessment, improvement, and re-registration of systems.

How can 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:

  1. 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.

  2. 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.

  3. 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.

  4. Develop Process Maps   PQA will assist the “ProcessTeams” to develop Process Maps. There will be 2 levels of Process Maps:

    • 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.

  5. Develop Documentation   PQA will help the Process Teams identify and prepare the level of documentation required. This will include:

    • Policy Manual.

    • 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 new requirements).

  6. 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.

  7. Pre-Registration Internal Audit   PQA will provide pre-registration internal audit services as follows:

    • PQA will provide internal quality auditors with Internal Quality Audit Training, focusing on the process approach and the ISO requirements.

    • 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 performing audit

      • 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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