Module-1-ISO 13485-Document

ISO 13485-MEDICAL DEVICE
MODULE-1
Prepared by
SRIMANTH J
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CONTEXT
ISO13485 Pg.no: 3
QMS 3
Structure of ISO13485 3
KEY PRINCIPLES OF QUALITY 4
MANAGEMENT
KEY INTERESTED PARTIES IN ISO 13485 5
IMPLEMENTING ISO13485 USINF THE 6

PDCA PROCESS
DIFFERENCE BETWEEN ISO (9001 & 7
13485) CLAUSES
ISO13485?
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ISO is an international organization of standards and ISO13485 it internationally recognizes quality
standards for medical devices, these standards specifies the requirements for establishing,
implementing & maintain QMS in the year 2016 the standards was implemented and released in the
market.
QMS?
Quality Management System it is an systematic approach for quality management and enhancing
customer satisfaction. The QMS represents set of POLICIES PROCEDURES & INSTRUCTIONS firstly we
should make understand the needs and expectation of customer later establish the controls for your
process enhance delivery to the customer satisfaction.
The controls are not only technical, it may have combination of different types of control
 Documenting is organizational control

 Implementing new technology or change in the process is engineering control
 Training is HR-Related control
Structure of ISO13485?
ISO 13485 it has 9 clauses from clause 0-3 it represents about medical devices.
0.Introduction
1.Scope: how organizations are responsible for the effective management of all process specified in the
standards, if certain process are not carried out they can be excluded with justification.
2.Normative reference: it refers to the ISO9000 as a standard where terms & definition are given.
3.Terms & definition: here, we can have a specific definitions of medical devices.
And clause 4-8 represents about
4.Quality management system: provides the standard requirements for the structure of quality system
documentation requirements, such as quality manual and medical device file document and record
control.
5.Management responsibility: defines what is required for management commitment a focus on

customers, content of quality policy and objectives planning ,roles and responsibilities and the
management review meeting.
6.Resource management: defines the requirement for the availability of resources competences
infrastructure, work environment and contamination control.
7.Product realization: defines for requirements of operational planning, customer related process,
communication, design &development purchasing production and service provision and control of
monitoring and measuring equipment.
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8.Measurement analysis and improvement: defines the requirements for monitoring, measurement
analysis, evaluation, feedback, customer complaints non-conformances, corrective actions and
preventive actions internal audits, and improvements.
ANNEX A: it provides a comparison to an earlier 2003 revision of the standards.
ANNEX B: this is comparison of ISO 13485 & ISO 9001
KEY PRINCIPLES OF QUALITY MANAGEMENT?

The quality management system that represents the foundations for ISO13485 & ISO9001 and all other
ISO quality, Management standards they can be used to enhance company performance to achieve
success
There are 7 principles:
1.Customer Focus: the primary focus of quality management is to meet customer requirements(like on
time delivery, zero defects, customer survey results)
2.Management: managers at all level establish unity of purpose and direction and create conditions in
which people are engaged in achieving the quality objectives of the organization.
3.Engagement of People: all its employees are competent, empowered engaged in delivering value,
thereby enhancing the organization’s capabilities as a team.
4.Process approach: consistent and predictable results are achieved more effectively and efficiently
when activities are understood and managed as interrelated processes that function a coherent system.
5.Improvement: successful organization have an ongoing focus on improvement.
6.Evidence-based Decision Making: decision based on the analysis and evaluation of data and
information are more likely to produce the desired results.
7.Relationship Management: for sustained success, organizations manage their relationships with
interested parties(suppliers).
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KEY INTERESTED PARTIES IN ISO 13485?
IMPLEMENTING ISO13485 USINF THE PDCA PROCESS?
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PDCA are done all the time, personally as well as I business to the point where you are not even aware
you are doing it.
PDCA helps the implementation of your QMS.
PLAN: planning is done to define the quality system and documents required to support the system
ensure everyone from management to employees have specified roles and authorities and are
competent in these positions, to determine processes with associated monitoring & measuring system
and to provides resource as required .
The quality policy and objectives should be established and risk assessments completed.
DO: performing the tasks and activities throughout the operations from the request for quote through
to delivery and post delivery activities these requires following procedures and recording the activity
and results required in the system to deliver good quality products that are safe and effective.
CHECK: reviewing all the data from monitoring & measuring system, analyzing them, and determining
whether they are meeting the goals defined in the planning phase.
ACT: taking appropriate actions to improve performance or correct issues these can accomplish the
corrective action, preventive action and improvement action processes. The corrective action process is
used to resolve issues through root cause analysis and the preventive action process is done to prevent
negative events from occurring.
DIFFERENCE BETWEEN ISO (9001 & 13485) CLAUSES?
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ISO 9001 ISO 13485
1.SCOPE 1.SCOPE
2.TERMS & DEFINITION 2.NORMATIVE REFERENCE
3.NORMATIVE REFERENCE 3.TERMS & DEFINITION
4.CONTEXT OF ORGANIZATION 4.QUALITY MANAGEMENT
5.LEADERSHIP 5.MANAGEMENT RESPONSIBILITY
6.PLANNING 6.RESOURCE MANAGEMENT
7.SUPPORT 7.PRODUCT REALIZATION
8.OPERATION 8.MEASUREMENT ANALYSIS IMPROVEMENT
9.IMPROVEMENT
10.PERFORMANCE EVALUATION
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ISO 13485-MEDICAL DEVICE

IMPLEMENTING ISO13485 USINF THE 6

 Documenting is organizational control

And clause 4-8 represents about

5.Management responsibility: defines what is required for management commitment a focus on

ANNEX A: it provides a comparison to an earlier 2003 revision of the standards.

ANNEX B: this is comparison of ISO 13485 & ISO 9001

KEY PRINCIPLES OF QUALITY MANAGEMENT?

There are 7 principles:

5.Improvement: successful organization have an ongoing focus on improvement.

IMPLEMENTING ISO13485 USINF THE PDCA PROCESS?

PDCA helps the implementation of your QMS.

DIFFERENCE BETWEEN ISO (9001 & 13485) CLAUSES?

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