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TRANSITIONING FROM ISO 9001:2008 TO ISO 13485:2003—GOING 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 2
$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 >400k jobs
What the Heck is EN ISO 13485:2003?
3
Quality system standard intended for medical device industry
Format based on ISO 9001, process approach
Intended to promote harmonization in the global market
Regulators don’t recognize ISO 9001
What the Heck is EN ISO 13485:2003?
4
Emphasis on effectiveness of quality management system as opposed to improvement
More controls than ISO 9001
Higher the risk of the device=more controls
However, if you don’t manufacture the finished device, not all requirements are applicable
What the Heck is EN ISO 13485:2003?
5
It is the medical device manufacturer’s responsibility to define and implement the requirements.
As applicable, they will pass along the requirements to their suppliers, usually in the form of a purchase spec or Supplier Agreement
From A Manufacturer’s Perspective
6
Assurance that their suppliers have adequate controls in place
Selecting a supplier who is registered to ISO 13485 can mean reduced monitoring by the manufacturer
From a regulatory perspective, much greater scrutiny on how manufacturer’s evaluate and monitor their suppliers. High visibility recalls where problems originated at the supplier.
What are the Differences?7
Let’s examine some of the important differences between ISO 9001 and ISO 13485
What are the Differences?8
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 In the regulatory world, customer satisfaction and continuous improvement are superseded by the safety and effectiveness of medical devices.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 9
Can only exclude section 7.3, Design and Development—however, 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 Requirements10
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
11
The quality management system documentation shall include:
Any other documentation requirements specified by national or regional regulations.
4.2 Documentation Requirements
12
There is a requirement or a particular type of document, commonly referred to as a Device Master Record.
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
13
The Quality Manual must outline the structure of the documentation used in the quality management system.
Typically 4-tier structure: Quality manual SOPs Work instructions Forms/records
4.2.4 Records14
The importance of records in the medical device industry cannot be overstated.
Universal rule: If it isn’t documented, it wasn’t done.
Documentation, documentation, documentation
Stringent rules regarding recording of information Blue or black ink only No crossouts, write overs
Most organizations have a Good Documentation Practices procedure and intensive training.
4.2.4 Records15
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 distribution
Other regulations have more stringent requirements
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
5—Management Responsibility
16
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
6—Resource Management17
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 18
Preventive Maintenance
Documented requirements for maintenance
Records maintained
6.4 Work Environment19
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 manufacturing Gowning Documented procedure for environmental
controls and monitoring No food and drink
6.4 Work Environment20
Controls for used (returned) product to prevent contamination
Personnel who work under special environmental conditions must be trained
6.4 Work Environment21
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
22
Specific reference to ISO 14971—Medical Devices Risk Management
Medical device manufacturers would expect suppliers to have a documented pFMEA in place.
7.3 Design and Development
23
A documented procedure is required. More records are required Design inputs must include safety and
performance requirements 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
24
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
25
The availability of documented procedures, requirements, work instructions, and reference materials and reference measurement procedures as necessary
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
26
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 controls
Specific requirements for sterile and implantable devices
7.5 Production and Service Provision
27
Procedure for the validation of computer software
Records of these activities Procedure for ID and traceability—more
stringent controls or implantable devices Procedure to distinguished returned product
from conforming product Status of product—must be known at all times
throughout the product realization process Procedure for the preservation of product
conformity—handling, storage
7.5 Production and Service Provision
28
Procedure for devices with a limited shelf life or special storage conditions
Storage conditions will be controlled and recorded.
Procedure required for calibration activities
8.2 Monitoring and Measurement29
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
30
Documented procedure for inspection activities
Specific requirements for active implantable and implantable devices
8.3 Control of Nonconforming Product
31
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)32
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 33
Record the results of any investigation Determine the effectiveness of the
corrective action taken Same for preventive action
Industry Trade Shows34
MD&M shows—annually East coast West coast Midwest
