Medical Device_Quality Management (2) (1) (2).pptx

EN ISO 13485:2016
Quality Management
System for Medical
Devices
1

QMS
A QUA LİTY MANAGEMENT SYSTEM
(QMS) İS A SET OF POLİCİES,
PROCESSES AND PROCEDURES
REQUİRED FOR PLANNİNG A ND
EXECUTİON OF AN ORGA NİZATİON'S
CORE BUSİNESS (PRO DUCTİON /
DESİG N A ND DEVELOPMENT /
SERVİCE / A SSEMBLY / TESTING).
QUALİTY MANAGEMENT SYSTEM =
GOOD BUSİNESS SENSE
2

• QMS integrates various internal processes
within the organization and aims to provide a
process approach to the execution of the
system.
• Process-based QMS enables organizations to
identify, measure, control and improve or
develop various core processes that will lead
to better business performance.
3

EN ISO 13485
MEDICAL DEVICE
MANUFACTURERS MUST OPERATE
A QUALITY MANAGEMENT SYSTEM
TO ACHIEVE THE SAFETY AND
EFFECTIVENESS TARGETS OF THE
PRODUCT(S) THEY PRODUCE.
4

EN ISO 13485:2016
1. Scope: It is a standard that can be applied to all
organizations that play a role in one or more stages of the
medical device life cycle or the medical device supply chain.
Basic information about the scope of the companies is
explained by taking into account their activities.
It defines the steps and ways of operating the processes
carried out within the scope of the company.
5

EN ISO
13485:2016
6
2. Prescriptive References: ISO 9000, Quality
management systems — Fundamentals and
vocabulary
3. Terms and Definitions: It specifies the application of
the terms and definitions given in ISO 9000: 2015 and
ISO 13485. (There are a total of 19 terms and
definitions from 3.1-3.19. 14 of them are new or have
been clarified compared to the previous version.)

4. Quality
Management
System
4.1. General
Requirements
7
4.1.1 Explains the general framework of the QMS and the way it
is controlled. The organization must determine, implement and
maintain the QMS requirements by understanding its role under
the applicable legislative requirements. The organization must
create the requirements it determines for all locations it has. The
organization must determine the requirements arising from the
legislative requirements and document them.
4.1.2 This is the section where the process-oriented approach is
explained. This is the section where the activities the
organization performs, the relationship between these activities
and the legislative requirements in the activities are determined.
The section clearly defines that the risk-oriented approach should
be used in the processes.
4.1.3 Requests requirements for QMS processes, how they are
implemented and evidence of compliance.

4. Quality Management System
4.1. General Requirements
4.1.4 In cases where there is a change, the requirements to
ensure control of the QMS and the medical device are
specified. It requests the evaluation of the effect of the
change on the QMS and the medical device. In addition, the
control of the compliance of the change with international
standards and legislative requirements is defined in this
article.
8

4. Quality
Management
System
4.1. General
Requirements
4.1.5 In activities performed by an external source on behalf
of the organization, it is requested to define the
organization's responsibility and the requirements for
controlling these external activities. The organization should
take into account the related risks when controlling external
activities. The supplier performing the external activity
should also meet the requirements of Article 7.4 of the
standard. 4.1.6 This newly added section of the standard
requests that the software used in the QMS be verified in a
manner compatible with product software, process control
software and software used for monitoring and
measurement.
9

4.2.
Documentation
Requirements
10
4.2.1 GENERAL: IT SPECİFİES THE
DOCUMENTATİON STRUCTURE
THAT MUST BE ESTABLİSHED FOR
THE QUALİTY MANAGEMENT
SYSTEM. (QUALİTY POLİCY,
QUALİTY OBJECTİVES, QUALİTY
MANUAL, PROCEDURES AND
RECORDS, DOCUMENTS
ORİGİNATİNG FROM LEGİSLATİVE
REQUİREMENTS)
4.2.2 QUALİTY MANUAL: IT
SPECİFİES THE CONTENT OF THE
KEK DOCUMENT THAT MUST BE
CREATED (SCOPE, OUT-OF-SCOPE
İTEMS AND JUSTİFİCATİONS,
DOCUMENTED PROCEDURES OR
REFERENCES, PROCESS
İNTERACTİON AND OUTLİNES OF
THE DOCUMENTATİON STRUCTURE
İN THE QMS SYSTEM)
4.2.3 MEDİCAL DEVİCE FİLE: IT
SPECİFİES THE DOCUMENTS THAT
THE MEDİCAL DEVİCE FİLE MUST
PROVİDE DEPENDİNG ON LEGAL
REGULATORY REQUİREMENTS.
(PRODUCT DESCRİPTİON,
İNTENDED USE, LABEL, USER
MANUAL, PRODUCT FEATURES,
PRODUCTİON-PACKAGİNG-
STORAGE-PROCESSİNG-
DİSTRİBUTİON
FEATURES/PROCEDURES,
MONİTORİNG AND MEASUREMENT
PROCEDURES, İNSTALLATİON
REQUİREMENTS AND SERVİCE
PROCEDURE İF APPROPRİATE)

11
4.2. Documentation Requirements
4.2.4 Control of Documents: It is requested to define
the requirements related to the preparation,
publication, revision, prevention of deterioration and
loss of documents within the quality management
system, prevention of their incorrect use, tracking
and distribution of external documents. It is a
mandatory procedure. **
4.2.5 Control of Records: It is requested to define
special requirements for the control of records that
demonstrate compliance with the requirements and
effective operation of the QMS. It is a mandatory
procedure. ** The procedure content should define
the controls required for the identification, storage,
security and integrity of records, retrieval, retention
period and organization of records. The organization
will define and implement methods to protect
confidential health information.

5. Management
Responsibility
5.1 Management commitment
Top management should provide evidence of its commitment to the
development and implementation of the QMS and its continued
effectiveness. (Quality policy, quality objectives, resource requirements,
internal adoption of regulatory requirements, management review)
5.2. Customer Focus
Top management should identify and implement customer requirements
and applicable regulatory requirements.
5.3. Quality Policy
The quality policy should emphasize top management commitment to the
suitability and continued effectiveness of the QMS to meet customer
demands and regulatory requirements.
HAZIRLAYAN: Z.NİHAN Y.YEŞİLDAL 12

5.4 Planning
13
5.4.1 QUALİTY OBJECTİVES TOP MANAGEMENT SHOULD
ESTABLİSH REALİSTİC, MEASURABLE
OBJECTİVES CONSİSTENT WİTH THE
QUALİTY POLİCY. THESE OBJECTİVES
SHOULD BE DETERMİNED FOR
EACH STAGE OF THE
ORGANİZATİON. IT İS İMPORTANT
THAT THE DETERMİNED OBJECTİVES
MEET THE LEGİSLATİVE AND
PRODUCT REQUİREMENTS.
5.4.2 PLANNİNG OF THE QUALİTY
MANAGEMENT SYSTEM
GENERALLY ADDRESSES PLANNİNG
RELATED TO THE QMS. ARTİCLE 4.1
AND SHOULD BE AİMED AT
MEETİNG THE QUALİTY
OBJECTİVES. WHEN CHANGES İN
THE QUALİTY MANAGEMENT
SYSTEM ARE PLANNED AND
İMPLEMENTED, THE QMS SHOULD
MAİNTAİN İTS İNTEGRİTY.

5.5
Responsibility,
Authority and
Communication
14
5.5.1. Responsibility and
Authority
5.5.2. Management
Representative
5.5.3. Internal Communication
Top management should
determine, document and
announce the responsibilities
and authorities within the
organization (for all personnel
at all levels involved in the
processes)
Top management should
appoint one of its members as
the Management
Representative, separate from
its other responsibilities.
For the effective operation of
the QMS, it should determine
and use the communication
channels within the
organization.

5.6
Management
Review
15
5.6.1 General
5.6.2 Review input
5.6.3 Review output
** The procedure is a mandatory article to be documented.
Top management must carry out a planned review activity at certain intervals.
In the input section, articles on reporting to legal authorities, complaint
management, monitoring and measurement of processes, and changes that
will affect the QMS have been added. The outputs should include information
on changes resulting from new or revised legislative requirements.

6. Resource Management
16
6.1. Provision of Resources 6.2. Human Resources
The organization should plan and
document the process to ensure
adequate resources for the
effective initiation, maintenance
and management of the QMS
and its processes. The
organization should determine
the competence and training
requirements for personnel who
affect product quality. It should
plan to increase the competence
of personnel. It should keep
activity records as evidence.
6.3. Infrastructure - Maintenance
The organization should determine and document the maintenance activities to be
carried out to ensure product requirements. It should take precautions to prevent the
mixing of the processing order of products. Maintenance activities include the building
- work environment and all related areas, equipment and software subject to
maintenance.

6.4. Working Environment
and Contamination Control
6.4.1. Work environment
The organization shall determine and manage the work environment required to ensure
compliance with product requirements.
The factors that may affect product quality within the work environment shall be determined
- Process equipment,
- Established work environment,
- Personnel in this work environment.
The work environment shall be qualified and quantified limit values

shall be determined in order to
ensure that the work environment is of the desired quality.
6.4.2. Contamination Control
The organization shall provide a suitable work environment to meet the production requirements
of the products and to prevent contamination.
The organization shall determine and document the requirements to prevent contamination of
personnel or product. A requirement shall be determined for the control of contamination caused by
microorganisms or particles for sterile medical devices.
17

18
7. Product Realization
7.1 Planning Product Realization The importance of planning for
product realization and the
requirements of these planning
activities should be documented.
It is important to document the risk
management processes used in
product realization.
In addition to the activities related
to product realization, the
organization's product processing,
storage, distribution and
traceability activities should also be
considered during planning.

19
7.2. Customer-related Processes
7.2.1 Determination of product/service-related requirements
The need for any user training for the desired performance and safe use of the medical device, user-specific
requirements should be determined
7.2.2 Review of product/service-related requirements
Control of compliance of the device to be sold with legal requirements
7.2.3 Communication
The requirements for product supply specified by the customer or in accordance with regulatory requirements
should be documented. These requirements should be taken into account in product shipment and post-shipment
activities when determining them. The need for user training to ensure the performance of the medical device
should also be determined.
In cases where the customer does not specify the requirements, the product requirements determined by the
organization should be mutually approved. Re-approval should be obtained in case of a change in the requirement.
In addition to communication with the customer, the organization may contact the legal authority regarding
regulatory requirements.

7.3. Design and
Development
7.3.1 General
7.3.2 Design and Development Planning
7.3.3 Design and Development Inputs
7.3.4 Design and Development Outputs
7.3.5 Design and Development Review
7.3.6 Design and Development Verification
7.3.7 Design and Development Approval
7.3.8 Design and Development Transfer
7.3.9 Control of Design and Development Changes
7.3.10 Design and Development Files
*** This is a mandatory procedure item.
20

7.3. Design and Development
21
Legislative requirements and risk analysis outputs should be taken into consideration.
During the design and development stages, the product's operation, performance, usability and safety parameters should be
taken into consideration. In case of a change, the impact on these issues should be evaluated.
It is necessary to document the activities carried out at every stage of product design and development.
If the medical device is intended to be used with another device, this activity should be validated.
The organization should create a design and development file that includes records of changes for the product or product family.
It has become important to transfer the design and development process to the manufacturing environment in an appropriate
manner. Before the final product is manufactured, production specifications and their availability should be verified.

7.4. Purchase
7.4.1
Purchasing
process
7.4.2
Purchasing
information
7.4.3
Verification of
purchased
product
***This is a mandatory
procedure.
The purchasing process required
to meet the requirements for the
purchased product must be
determined. Typical steps in the
purchasing process are related to
supplier selection, qualification
and monitoring.
All information and requirements
related to the purchased product,
and changes when necessary,
must be defined and reported in
writing.
When verifying the purchased
product, the supplier's
performance and risks originating
from the supplier must be taken
into account.
When there is a change in the
product requirements, the
organization must determine the
impact of this change on the
product realization processes or
the impact on the medical device.
22

23
7.5. Provision of Products and Services
7.5.1 Control of Product and Service Provision
Methods and procedures for control of production should be documented.
Infrastructure requirements for production
Implementation of monitoring and measurement of process parameters and product properties
7.5.2 Product Cleanliness
Requirements for cleaning activities to be applied to the product should be defined. If the product cannot be cleaned before use or before sterilization, cleaning during use is important.
7.5.3 Installation Activities
In cases where the installation is not done by the manufacturer, the documentation requirements for the installation should be provided and the installation should be approved.
7.5.4 Service Activities
The organization should document the requirements for service activities, define reference materials and reference measurements. The organization should keep all records related to the
service activity (including complaints) (even if performed by the supplier) and analyze them for improvement.

7.5. Provision of
Products and
Services
HAZIRLAYAN: Z.NİHAN Y.YEŞİLDAL 24
7.5.5 Special Requirements for Sterile Medical Devices
There is no addition to the article content. The organization must keep records related to
sterilization parameters for each lot. Traceability must be ensured.
7.5.6 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION
The organization is requested to determine the validation requirement related to the processes
providing products and services and to perform the validations.
***It is a procedure requirement.
The procedure to be created should include equipment and personnel qualifications, method
acceptance criteria, number of samples, revalidation conditions, record requirement, information
regarding process verification.
Requirements for validation and revalidation of software programs used in product or service
provision should be determined. (These software have an important effect on compliance with
product specifications)

7.5. Provision of
Products and Services
7.5.7 Specific requirements for the validation process of sterilization and sterile barrier
systems
***A procedural requirement.
The organization shall determine and implement the requirements for the validation of
sterilization and sterile barrier systems. The definition of the sterile barrier system is a
definition added to the current standard. Validation activities shall be performed prior
to the use of the sterilization and sterile barrier system and shall be repeated in case of
changes.
7.5.8 Determination
The product status shall be determined according to the monitoring and measurement
processes of the product during the product realization activity. It is important that
only products that comply with the specified product requirements are made available
for use.
26

7.5. Provision of
7.5.9 Traceability
7.5.9.1 General
7.5.9.2 Specific Requirements for Implantable Devices
Describes the requirements for traceability of the product throughout its production
and distribution.
Importers and distributors who supply products to the market or customer under
written agreements must meet the requirements for product traceability. The
manufacturer may request these records at any time.
7.5.10 Customer Property
Identify, verify, protect and secure customer property provided while the customer's
property is under the control of the organization or is used by the organization.
27

7.5. Provision of
7.5.11 Product Storage)
***It is a procedural requirement.
It must determine and document the conditions for the protection of the product in a
way that it continues to meet its requirements throughout its life.
The organization must determine and document the requirements for protection
against changes, contamination or damage to the product in processing, storage and
distribution conditions.
7.6 Control of Monitoring and Measuring Equipment
Conditions and requirements for the control of monitoring and measuring equipment
must be determined. If there is a software used during these activities, the software
must be validated and revalidated.
28

8. Measurement, Analysis
and Improvement
8.1 General
8.2 Monitoring and Measurement
8.2.1 Feedback
8.2.2 Complaint Processing/Management
8.2.3 Reporting to Competent Authority
8.2.4 Internal Audit
8.2.5 Monitoring and Measurement of Processes
8.2.6 Monitoring and Measurement of Product
29

8. Measurement, Analysis
and Improvement
• It is required to determine general requirements for planning and implementing processes related to
measurement, analysis and improvement.
• Requirements should be determined to measure and analyze whether customer requirements are met.
• Complaint management is a new concept and a procedure defining the conditions, requirements, records,
measures to be taken and corrections to be made related to this activity should be prepared. Records of this
activity should be kept.
• Situations where the competent authority should be informed as a result of complaint management should be
determined, and the documents to be used during this process should be determined. A procedure should be
established for activities related to notification to the competent authority.
• The organization should carry out internal audit activities at certain intervals. A procedure should be
established for the activities related to internal audit activities such as auditor selection, audit
frequency/planning, records to be created, etc.
• There is no change in the article related to monitoring and measuring processes, and monitoring and
measurement methods related to the processes that determine them, and relevant records should be defined.
• In product monitoring, the competence of the personnel who gives the approval for the release of the product
is emphasized. Records must be kept of personnel who perform all kinds of measurements and tests for implant
products.
30

8.3. Control of non-
conforming product
8.3.1 General
8.3.2 Activities in the event of nonconforming product detected before
shipment
8.3.3 Activities in the event of nonconforming product detected after shipment
8.3.4 Reprocessing
***This is an article that requires a procedure.
According to the old standard, the article was divided into 4 by detailing. It is
requested that the activities to be carried out are determined separately
according to the stage in which the nonconforming product status is detected.
In the event of reprocessing, it must be confirmed that the product meets the
requirements.
31

8.4 Analysis of data
Feedback, possibilities for developing product conformity
requirements, suppliers, audits, service report analysis are
requested. All processes included in the quality management
system (training, sales, purchasing, production, etc.) such as
parameters are evaluated and analyzed.
32

8.5. Improvement
8.5.1. General
Improvement activities covering changes in the product, process or QMS should be
determined to maintain the suitability, adequacy and effectiveness of the QMS.
The requirement to use information from post-market surveillance (as well as other
sources) to identify changes to the QMS, process or product has been added.
8.5.2 Corrective Action
Actions are requested to prevent recurrence of detected nonconformities.
8.5.3 Preventive Action
Requests that requirements be determined and measures be taken to prevent
potential nonconformities from becoming nonconformities by detecting them.
33

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