ISO 13485 Why and How
Uploaded by
Marlin PohlmanISO 13485 Why and How
Uploaded by
Marlin PohlmanISO 13485:2016 Why and
How
June, 2019
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Content
• What is ISO 13485?
• What is medical devices QMS?
• PDCA approach
• Quality Policy
• Quality Objectives
• ISO 13485 myths
• Keys to success
• Benefits
• Steps to
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What is ISO 13485?
• International Standard published by ISO
• Applicable to companies in medical device industry
and any size
• The number of companies that have implemented ISO
13485 shows a general positive trend worldwide
• Provides a practical foundation for manufacturers to
address the directives, regulations, and responsibilities
• Demonstrates a commitment to the safety and quality
of medical devices
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What is medical devices QMS?
Quality Management System (QMS) is a collection of:
• Policies
• Processes
• Documented procedures
• Records
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PDCA approach
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Quality Policy
• Must be appropriate to the context of the company
and its purpose
• Includes a commitment to the requirements and
continual improvement
• It must be consistent with the quality objectives
• It is communicated and understood within the
organization
• It is periodically reviewed
• It is maintained as documented information
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Quality Objectives
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Myths of ISO 13485
• It says we always have to do it this way
• It belongs to the quality department alone
• It does not apply to my business
• Everything needs to be documented
• It is expensive to implement and maintain
• You need to spend lot of money on a consultant
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Keys to success
• Top management commitment
• Assigned roles, responsibilities, and authorities
• Appropriate resources
• Participation at all levels
• A structured and documented implementation plan
• Correct training, education, and awareness
• Adequate procedures and documentation
• Effective audit
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Reasons for implementation (1/3)
• Improvement of our credibility and image
• Improvement of customer satisfaction
• Fully integrated processes
• Use evidence-based decision making
• Creation of a continual improvement culture
• Engagement of employees
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Reasons for implementation (2/3)
Primary reasons:
• Improve image and credibility by attaining
certification to ISO 13485
• Ensure compliance with relevant legal and other
requirements
• Integrate processes for better alignment
• Improve decisions by basing them on data from
the Quality Management System
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Reasons for implementation (3/3)
Secondary reasons:
• Create a culture of continual improvement of
the processes
• Improve employee engagement towards process
improvement
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Purpose of the Project (1/2)
What do we want to achieve?
• Gain ISO 13485 certification
• Increase quality of product or service using the
process approach
• Ensure compliance by meeting legal and other
requirements
• Increase competitiveness of [organization name]
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Purpose of the Project (2/2)
What do we want to achieve?
• Better management of processes, activities and
functions
• Reduce costs through continual improvements
attained through the ISO 13485 Quality
Management System
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Milestones
Milestone Due date
Initiation
Planning
Assessment
Implementation
Internal Audit
Management Review
Corrective Actions
Certification Audit
Continual Improvement Setup
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Resources (1/2)
Human Internal resources – [list internal
resources resources, e.g., group name]
External resources – [list external
resources, e.g., consulting
company]
Technical Tool – [Tool name]
resources Equipment – [list equipment
needed]
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Resources (2/2)
Financial Amount: [define amount of money
resources needed to finish the project]
Cost types: [split costs according to the
cost type and include all resources
listed here, e.g., human resources –
internal and external, technical and
other resources]
Other Documentation
resources
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Deliverables
• QMS general requirements & related documents
• Definition of product realization processes
• Measurement, analysis, and improvement
processes
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What the Project Sponsor must do
to facilitate the project?
• Learn the Quality Policy
• Understand the quality objectives and how to
contribute to their achievement through your activities
• Meet the requirements of ISO 13485 - comply with
policies and procedures
• If you are aware of a non-conformity, report it
• Share your ideas and feedback in order to improve the
QMS
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ISO 13485 is a means for the company
to take a more systematic approach to
fulfill its objectives and, therefore, to
achieve such improvements.
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How is the ISO 13485 Standard Organized?
• Sections one through three describe the purpose and
harmonization for use of the standard. Sections four
through eight contain the conformance conditions of
the standard, i.e., the requirements necessary for
compliance, so they would be examined individually
and collectively as an integrated system
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Section Four (Systemic Requirements):
• This section defines the general documentation
requirements for compliance. It explains how to
implement and maintain a QMS for devices; prepare a
quality manual, quality policy, and quality objectives;
control QMS documents and records; and maintain
document integrity.
• Important to note is the new EDMS requirement for
storing and handling of documentation.
•
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Section Five (Management Requirements)::
• This section defines management’s role in the planning
(risk based), establishment, maintenance and
performance of an ISO 13485 QMS. It requires upper
management to actively participate in quality planning,
and to ensure that the quality policy is understood
throughout the organization.
• Specific requirements for carrying out periodic (risk
established) management reviews of the QMS,
including how often reviews should take place with
defined roles; what to cover; and expected outputs to
planned objectives, are also covered in section five.
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Section Six (Resource Requirements):
• This section defines the requirements for the provision
of resources, including physical resources (e.g, the
need for adequate space, tools and equipment);
environmental resources (e.g, the environment must
suit the type of device being made); and human
resources (e.g, how to train and maintain competent
personnel).
• Key topics covered in section six include the
importance of defining employee job requirements
(like software) and how to keep good training records
that verify and validate usability conditions.
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Section Seven (Product Realization
Requirements):
• The most extensive section covers everything that is
required in order to produce a product, from customer
requirements and communication to creating (designing
and manufacturing), installing, and supporting a medical
device through post-market surveillance.
• Requirements are given for how to correctly perform the
most basic tasks (e.g,processing maintenance; all risk
management planning and analysis phases),are also
covered in section seven. New items such as rigorous
technical design transfer, risk based reviews, deployed
change control and the formality of design and
development files (i.e. parent/child DHFs) that should be
audited during the design control process..
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Section Eight (Remedial Requirements):
• This final (but explicit) section defines the remedial
processes necessary in order to maintain the
effectiveness of the QMS. Key topics covered in section
eight include handling adverse events and customer
complaints; conducting risk-based internal audits;
formalities for monitoring and measuring processes
and product, including nonconforming product;
analyzing data for effectiveness (in management and
design reviews);and taking corrective and preventive
actions based on explicit risk and opportunity analyses
using rigorous statistically developed tools..
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The Financial Benefits of ISO 13485?
• Many device companies fail to realize how much
money they could save (or even generate) by
developing and implementing a quality management
system that adheres to ISO 13485. Although the
standard is not designed to make every medical device
company equal in talent or ability, it is designed to help
management understand how company processes
correspond to ISO 13485, and why those processes
work in the way that they do. In other words, the
standard is designed to make the quality system
transparent for business and now betweenregulatory
bodies (MDSAP)..
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The MDSAP (Med Device Single Audit
Program): How Does It Relate to ISO 13485?
• The MDSAP offers medical device companies the
opportunity to audit against a single set of
conformance standards. Participating regulatory
bodies are the U.S., Japan, Australia, Brazil, EU, China
and CAMCAS. Other countries are participating in the
program as observers and may require medical device
companies to participate in the program in the future
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