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Transitioning from ISO 9001:2008 to ISO 13485:2003


TRANSITIONING FROM ISO 9001:2008 TO ISO 13485:2003 GOING ... * Emphasis on effectiveness of quality management system as opposed to improvement More ... – PowerPoint PPT presentation

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Title: Transitioning from ISO 9001:2008 to ISO 13485:2003

Transitioning from ISO 90012008 to ISO
134852003Going After Medical Device Business
  • ASQ Las Vegas section 705
  • December 16, 2009
  • Presented by Michelle M. Johnston, RAC
  • Advanced Quality System Solutions

The Medical Device Sector
  • 100B industry
  • More recession-proof than other sectors but hit
    in 2008/2009
  • Ageing US population (baby boomers)
  • Growth in the following segments
  • Cardiac
  • Orthopedic (record level of private equity)
  • Neurotechnology (electronic devices interact with
    the nervous system)
  • 15k medical device companies
  • gt400k jobs

What the Heck is EN ISO 134852003?
  • Quality system standard intended for medical
    device industry
  • Format based on ISO 9001, process approach
  • Intended to promote harmonization in the global
  • Regulators dont recognize ISO 9001

What the Heck is EN ISO 134852003?
  • Emphasis on effectiveness of quality management
    system as opposed to improvement
  • More controls than ISO 9001
  • Higher the risk of the devicemore controls
  • However, if you dont manufacture the finished
    device, not all requirements are applicable

What the Heck is EN ISO 134852003?
  • It is the medical device manufacturers
    responsibility to define and implement the
  • As applicable, they will pass along the
    requirements to their suppliers, usually in the
    form of a purchase spec or Supplier Agreement

From A Manufacturers Perspective
  • Assurance that their suppliers have adequate
    controls in place
  • Selecting a supplier who is registered to ISO
    13485 can mean reduced monitoring by the
  • From a regulatory perspective, much greater
    scrutiny on how manufacturers evaluate and
    monitor their suppliers. High visibility recalls
    where problems originated at the supplier.

What are the Differences?
  • Lets examine some of the important differences
    between ISO 9001 and ISO 13485

What are the Differences?
  • The biggest difference is the intent of the
    standard. In the regulatory world, customer
    satisfaction and continuous improvement are
    superseded by the safety and effectiveness of
    medical devices.

1.2 Application
  • Can only exclude section 7.3, Design and
    Developmenthowever, other regulations may
    preclude this
  • Other requirements in section 7 may be
    non-applicable based on the nature of the medical
    device (sterilization, implants) or activities
    performed by the organization
  • Exclusions/non-applications to be justified

4.1 General Requirements
  • The organization shall establish, document,
    implement and maintain a quality management
    system and maintain its effectiveness in
    accordance with the requirements of this
    International Standard.

4.2 Documentation Requirements
  • The quality management system documentation
    shall include
  • Any other documentation requirements specified
    by national or regional regulations.

4.2 Documentation Requirements
  • There is a requirement or a particular type of
    document, commonly referred to as a Device Master
  • The organization shall establish and maintain a
    file containing documents defining for each type
    / model of medical device product specifications
    and quality system requirements (process and
    quality assurance) for
  • complete manufacturing, and
  • installation and servicing, if appropriate

4.2 Documentation Requirements
  • The Quality Manual must outline the structure of
    the documentation used in the quality management
  • Typically 4-tier structure
  • Quality manual
  • SOPs
  • Work instructions
  • Forms/records

4.2.4 Records
  • The importance of records in the medical device
    industry cannot be overstated.
  • Universal rule If it isnt documented, it
    wasnt done.
  • Documentation, documentation, documentation
  • Stringent rules regarding recording of
  • Blue or black ink only
  • No crossouts, write overs
  • Most organizations have a Good Documentation
    Practices procedure and intensive training.

4.2.4 Records
  • Retention requirements based on the lifetime of
    the device
  • Retention equivalent to lifetime of device or not
    less than 2 years from date of release for
  • Other regulations have more stringent
  • Most medical device manufacturers do not often
    destroy records
  • Records specific to the medical device industry
  • Device History Record (traveler, work order)
  • Adverse event reports to regulatory agencies

5Management Responsibility
  • Management must maintain the effectiveness of the
    quality management system
  • Independence and authority of those who perform
    tasks affecting quality
  • Management rep promotes customer and regulatory
    requirements throughout the organization
  • Management review must include new or revised
    regulatory requirements

6Resource Management
  • Determine and provide resources to implement the
    QMS and maintain its effectiveness
  • And to meet customer and regulatory requirements
  • May need a documented procedure to satisfy other
    regulatory requirements

6.3 Infrastructure
  • Preventive Maintenance
  • Documented requirements for maintenance
  • Records maintained

6.4 Work Environment
  • Can be very critical, dependent on the device
  • Controls must be established if the environment
    could adversely impact the medical device
    (concern for devices intended to be sterilized)
  • Cleanroom or environmentally controlled
  • Gowning
  • Documented procedure for environmental controls
    and monitoring
  • No food and drink

6.4 Work Environment
  • Controls for used (returned) product to prevent
  • Personnel who work under special environmental
    conditions must be trained

6.4 Work Environment
  • Can also include ESD controls
  • Designated ESD work areas
  • Wrist/ankle straps
  • Daily testing or continuous monitoring
  • Handling and storage of ESD sensitive devices
  • Records

7.1 Planning of Product Realization
  • Specific reference to ISO 14971Medical Devices
    Risk Management
  • Medical device manufacturers would expect
    suppliers to have a documented pFMEA in place.

7.3 Design and Development
  • A documented procedure is required.
  • More records are required
  • Design inputs must include safety and performance
  • Design inputs must be approved
  • Records of design outputs are required
  • Independent person required at design review
  • Clinical evaluation as part of design validation

7.4 Purchasing
  • Documented procedure required
  • FDA requirement Where appropriate, purchasing
    documents will include an agreement that the
    supplier will notify the manufacturer of any
    changes to the product or service so that the
    manufacturer may assess the impact of the change
    on the finished device
  • Unauthorized changes can have a significant
    impact and result in recalls by the manufacturer
  • Evaluation of suppliers is typically risk-based

7.5 Production and Service Provision
  • The availability of documented procedures,
    requirements, work instructions, and reference
    materials and reference measurement procedures as
  • The implementation of defined operations for
    labelling and packaging
  • Record that shows manufacturing history including
    quantity. Record shall be reviewed and approved.

7.5 Production and Service Provision
  • Cleanliness of product and contamination control
  • A documented procedure is required
  • Intended for devices sold sterile or
  • Devices to be sterilized by the end user
  • Installation and servicing procedures and
  • Specific requirements for sterile and implantable

7.5 Production and Service Provision
  • Procedure for the validation of computer software
  • Records of these activities
  • Procedure for ID and traceabilitymore stringent
    controls or implantable devices
  • Procedure to distinguished returned product from
    conforming product
  • Status of productmust be known at all times
    throughout the product realization process
  • Procedure for the preservation of product
    conformityhandling, storage

7.5 Production and Service Provision
  • Procedure for devices with a limited shelf life
    or special storage conditions
  • Storage conditions will be controlled and
  • Procedure required for calibration activities

8.2 Monitoring and Measurement
  • Specific requirements for customer complaints as
    opposed to customer satisfaction
  • Some types of complaints must be reported to
    regulatory agencies

8.2.4 Monitoring and Measurement of Product
  • Documented procedure for inspection activities
  • Specific requirements for active implantable and
    implantable devices

8.3 Control of Nonconforming Product
  • UAI disposition only if regulatory requirements
    continue to be met
  • Must record person who authorizes UAI
  • Work instructions for rework activities
  • Determine and document any adverse impact of
    rework on the device

8.5.1 General (Improvement)
  • Customer complaints
  • Documented procedures for product recalls
  • Must record reason if a complaint is not followed
    by CAPA
  • Procedure for notification of complaints to
    regulatory agencies

8.5.2 CAPA
  • Record the results of any investigation
  • Determine the effectiveness of the corrective
    action taken
  • Same for preventive action

Industry Trade Shows
  • MDM showsannually
  • East coast
  • West coast
  • Midwest

  • Thanks for your time.
  • Michelle Johnston
  • Advanced Quality System Solutions
  • 858.722.4471