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Workshop on Accreditation of
Bodies Certifying Medical Devices
Kiev,
17 - 18 November 2014
ISO 13485
Quality management system
Dr. Simona Pârvu
Ministry of Health
Romania
ISO 13485
 Was written to support medical device manufacturers in designing
quality management systems that establish and maintain the
effectiveness of their processes
 It ensures the consistent design, development, production,
installation, and delivery of medical devices that are safe for their
intended purpose
 The application of the quality system:
 Must ensure that the products conform to the provisions of the
Medical Devices Directive (MDD)
THE PRIMARY OBJECTIVE OF
ISO 13485:
 To facilitate harmonized medical device regulatory requirements
for QMS
 As a result, it includes some particular requirements for medical
devices and excludes some of the requirements of ISO 9001 that
are not appropriate as regulatory requirements
 Because of these exclusions, organizations whose QMS conform to
this International Standard cannot claim conformity to ISO 9001
unless their QMS conform to all the requirements of ISO 9001
WHAT IS A QUALITY SYSTEM?
 The QMS consists of the organizational structure, responsibilities,
procedures, specifications, processes, and resources that work
together to comply with the company’s quality policy and meet the
requirements of our customers and applicable regulatory
requirements
 Quality is the degree to which a set of inherent characteristics
fulfils requirements
SCOPE
 A QMS is designed to mitigate business risk through a
systematic, statistical and factual based approach to
creating and maintaining the process which delivers the
customer required product or service / business
objectives
But
 it is just part of an organizations internal control system
IS ISO 13485 = ISO 9001?
More emphasis in 13485 on:
1. Records meeting medical device requirements
2. Risk management
3. Work environment and cleanliness
4. Complaint handling and corrective action
Less on customer satisfaction and continual improvement
STRUCTURE OF QMS
 1. General Requirements
 2. Documentation requirements
a) General
b) Quality Manual
c) Control of Documents
d) Control of Records
1. GENERAL REQUIREMENTS
 Describe the scope of the QMS:
1. organization and locations
2. products
3. compliance (Regulations and Standards)
 Describe the document structure and types of documents
 To help auditors, include trace from requirements to quality manual
or procedures
 Requirements for documents and records
ORGANIZATIONS WORKING IN
THE FIELD OF MD
 Must establish, document, implement and maintain a
QMS and maintain its effectiveness in accordance with
this standard
 In this context the organization must:
1. identify the processes needed for QMS
2. if regulatory requirements permit exclusions of
design and development controls, this can be used as
justification for their exclusion from the QMS
If any of the requirements for the design and
development is not applicable for the medical
device for which the system is applied, the
organization does not need to include that
requirement in the system !
2. DOCUMENTATION
REQUIREMENTS:
 What is to be done and by whom, when, where and how
it is to be done, what materials, equipment and
documents are to be used
 How an activity is to be monitored and measured
 Design History File, Technical File, Complaint File,
device records, etc.
Any exclusions? (Section 7 only!)
Product Realization-Exclusions
 Exclusions of design and development (7.3) from the
QMS is allowed only if allowed by regulation.
See NOTE 2 of 7.1: The organization MAY also apply
the requirements given in 7.3 to the development of
product realization processes
Product Realization-Exclusions
 Organizations whose quality management systems exclude design and
development control (7.3 of ISO 13485), are still required to comply
with the product verification and validation requirements as specified
in 7.1 of ISO 13485 dealing with product realization
 In such organizations, the controls included in 7.3 should be
considered for all changes made to the product.
 Such changes will require objective evidence (e.g., product
verifications and validations, inspection and test specifications, revised
procedures, etc.) of the results of the activities described in 7.3 of ISO
13485
Product Realization – Non
applicability
of product realization
requirements is allowed if those functions are
not required by the nature of the medical
device being provided by the organization.
 “Non-inclusion”
For example, an organization providing singleuse, sterile medical devices may not need to
include within its quality management system
elements related to installation and servicing.
THE DOCUMENTATION MUST
INCLUDE:
 documented declarations regarding the policies regarding to quality
objectives
 a quality manual
 documented procedures required by this international standard
 documents required by the organization to ensure the effectiveness of
its planning, operations and the control of its processes
 records : legible, identifiable and easily retrievable
 records : established and maintained to provide evidence of compliance
with the requirements and effective operation of the QMS
 a documented procedure
 any other document specified by national or regional reglementations.
THE SCOPE OF QMS DOCUMENTATION
a) Can differ from one organization to another
depending :
 On the size of the organization and the type of its
activities
 Complexyti of processes
 Staff competence.
b) QUALITY MANUAL
Role:
Describes the QMS
Sets policy for the organization based on:
1. external regulations
2. company business practices and plans
3. company culture
THE QUALITY MANUAL WHICH MUST BE
ESTABLISHED AND DEVELOPED BY THE
ORGANIZATION
MUST INCLUDE:
1. the scope of QMS
2. documented procedures established for the
QMS
3. a description of the interaction between
quality management processes
QUALITY SYSTEM
c) PROCEDURES
Implement policy through
 definition of processes
 assignment of responsibility and authority
 identification of review and approval mechanisms
maintenance of records
Should be referred to in the quality manual or
otherwise summarized
Quality manual can be a collection of the high level
procedures
d) CONTROL OF DOCUMENTS
Changes only with approval by same persons or
functions as original
 record of changes
Communicate changes and documents
Use only latest revision
 define if it is paper or electronic version
Control over standards and other documents of external
origin
CONTROL OF RECORDS
 “Record”
is a document that furnishes objective
evidence of activities performed or results
achieved
Quality record is one that relates to the quality
management system
BENEFITS OF QMS FOR
MEDICAL DEVICES:
• customer satisfaction, business partners and legal
requirements
• providing the authorities with proofs that the laws and
regulations are respected
• minimize and control the risks
• preventing errors before they correct
• improved quality performance
• transparency and clarity of internal processes
• saving time and costs
TO WHOM IS THIS QUALITY
ASSESSMENT SYSTEM ADDRESSED
 to private companies that manufacture on a
regular basis medical devices for medical
laboratories
 to companies that produce medical
components
 to consultants who design, manufacture and
assemble medical instruments for medical
laboratories
All the elements, requirements and
provisions adopted by the manufacturer for
his quality system must be documented :
Written policies and procedures such as :
1.
2.
3.
4.
quality programs
quality plans
quality manuals
quality records
THE MEDICAL DEVICES
DIRECTIVE (MDD) :
 the manufacturer of medical devices keeps a productrelated, adequate and efficacious quality system.
 the MDD gives more flexibility to the device
manufacturer in organizing his company according to
size, social environment, culture of countries, and nature
of the devices than the ISO 9001 standard.
 On the other hand even ISO 9001 in combination with
the additional requirements of EN ISO 13485, DOES
NOT FULLY COVER the requirements of the MDD.
ADDITIONAL ASPECTS TO BE
COVERED BY THE QMS
• the technical documentation
• reference to the essential requirements according to Annex I of the
MDD
• information about harmonized standards and medical device
regulations
• risk analysis
• labeling and instructions for use
• different languages
• post-marketing surveillance
• reporting under the vigilance system
• retention of certain documents
IT IS NO SECRET
that a suitable quality system, which is
implemented in all relevant stages, may
be an important factor for maintaining
and improving product safety and
performance.
THE TASK OF THE NOTIFIED
BODY (NB):
to understand the culture of the
manufacturer and to evaluate whether or
not the QMS meets the minimum
requirements of the MDD, and to give
advice where deficiencies are detected
ISO 9001 & ISO 13485 for CEMARK - QUALITY SYSTEMS
 To believe that a QMS according to ISO 9001 is the key
to CE-marking it is completely wrong !!!
 The ISO 9001 of standards is the most popular way for
the proper organization of a quality management
system.
 ISO 13485 it is another preferable possibility
 But harmonized standards are not the only way to
demonstrate compliance with the MDD !!!
Conclusion
It is important to bear in mind that:
 ISO standards are updated periodically revisions and updates do occur and
 ISO 13485 is due for an update in the next few
years.
As quality system standards are updated, you must
ensure that QMS must keeps up with those updates
in order the manufactures remain in compliance.
Thank you !