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ISO
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Discussion Points
ISO 9001 Basics
Implementation Issues
Documentation
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Introduction to QMS
What is Quality Management System ?
management system to direct and control an
Organization with regard to quality.
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STANDARD
What is Standard?
A standard is a document that provides requirements, specifications,
guidelines or characteristics that can be used consistently to ensure that
materials, products, processes and services are fit for their purpose.
What is an International Standard?
An International Standard is a document, established by consensus. It
describes how to achieve an optimal outcome time after time by using an
agreed and consistent approach.
ISO Standards help:
Make products compatible, so they fit and work well with each other/
Identify safety issues of products and services / Share good ideas and
solutions, technological know-how and best management practices
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Examples of Standards
Standards for paper sizes (A4 family) make life
easier for printer, photocopiers and office
supplies manufacturers, because they know their
products will work with available paper formats
More goods can travel the world smoothly by air,
sea and land thanks to containers defined in
International Standards, boosting the global
economy.
Credit cards can be used anywhere because they
meet standards that specify dimensions,
technology and communication protocols to work
with dispensers and payment systems.
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Introduction to QMS
How a Standard helps in Improving the Quality?
International Standards are the backbone of our society,
ensuring the safety and quality of products and services,
facilitating international trade and improving the
environment in which we live in.
Conformity to International Standards helps reassure
consumers that products, systems and organizations are
safe, reliable and good for the environment.
The process approach says a desired result is achieved
more efficiently when activities and related resources are
managed as a process. (Hence Process Standard)
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Introduction to QMS
1946: 65 delegates from
25 countries meet to
discuss the future of
International
Standardization.
1947: ISO officially
comes into existence
with 67 technical
committees
1949, ISO Geneva with
Central Secretariat has 5
members of staff.
In 1951, the first ISO
standard (called
Recommendations at this
time)
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Introduction to QMS
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History of ISO 9000 Standards
NASA was the first to produce a set of procedures,
specifications and requirements known as Military
Specifications (Mil Specs).
British Ministry of Defence (MOD) as the Defence
Standard (DEF STAN) 05 series of procedures
British Standards Institution (BSI) formally adapted the
DEF STAN 05 series into a virtually identical set of
documents known as the BS 5750 series.
This standard was then copied by other nations and a
common series of recommendations known as the ISO
9000:1994 series of ‘Standards for Quality Assurance’
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ISO 9000 TIMELINE
ISO 9000:1987 (heavily based on BS 5750 Parts 1–
3.)
ISO 9001:1994 (Model for QA in design,
development,
production, installation and servicing)
ISO 9002:1994 (Model for QA in production,
installation and servicing)
ISO 9003:1994 (Model for QA in final inspection and
test)]
ISO 9001:2000
ISO 9001:2008
ISO 9001:2015
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PRESENT STATUS
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Stake Holders in ISO 9001
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ISO Terminologies
Conformity assessment/ Compliance assessment: Is
any activity to determine, directly or indirectly, that a
process, product, or service meets relevant technical
standards and fulfils relevant requirements.
Accreditation – the formal recognition by an
independent body, generally known as an accreditation
body, that a certification body it operates according to
international standards.
Certification – the provision by an independent body
of written assurance (a certificate) that the product,
service or system in question meets specific
requirements.
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PROCESS OF CERTIFICATION
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STAKEHOLDERS
International Accreditation Forum : The IAF is the
world association of Conformity Assessment
Accreditation Bodies and other bodies interested in
conformity assessment in the fields of management
systems, products, services, personnel and other
similar programmes of conformity assessment.
Accreditation Body in India:
National Accreditation Board for Certification Bodies
(NABCB)
Certification Body :
35 Certification Bodies Registered in NABCB
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Number of Certificates
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SECTOR SPECIFIC DERIVATIVES
Aerospace Industry: AS9100
Automotive Industry: TS 16949
Computer Software: IEC 12207
Food and Drink Industry: ISO 15161:2001
Medical Devices: ISO 13485:2003
Telecommunications Industry: TL 9000
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Typical Project Approach
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Typical Registration Process
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Approaches to Quality Assurance
3rd Party
Audit For
Certification 3rd Party for 2nd Party
Audit
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QUALITY MANAGEMENT PRINCIPLES
Seven Principles of QMS
QMP 1 – Customer focus
QMP 2 – Leadership
QMP 3 – Engagement of people
QMP 4 – Process approach
QMP 5 – Improvement
QMP 6 – Evidence-based decision making
QMP 7 – Relationship management
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Customer Focus
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Process Approach
The quality management system consists of
interrelated processes. Understanding how
results are produced by this system enables
an organization to optimize the system and
its performance.
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Improvement
Successful organizations have an ongoing focus on
improvement. Improvement is essential for an
organization to maintain current levels of performance,
to react to changes in its internal and external conditions
and to create new opportunities.
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Evidence Based Decision Making
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Types of Documents used in QMS
Quality Manual: Documents that provide consistent
information , both internally and externally , about the
organization's quality management system.
Quality Plans: Documents that describe how the QM is
applied to a specific product, project or contracts
Work instructions: Work instructions: Documents that
provide information about how to perform activities and
processes consistently
Records: Documents that provide objective evidence of
activities performed or results achieved
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Four Tier Operational Pyramid
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Continual Improvement of QMS
Management
Responsibility Customers
Customers
Resource Measurement
Management Analysis and Satisfaction
Improvement
Product Product
Requirements Realization Output
Input
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Clauses of ISO 9001: 2015
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REPRESENTATION OF THE STRUCTURE
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Structure of ISO 9001:2015
(1/3)
1 Scope 2 Normative references 3 Terms and
definitions
4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of
interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
5 Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve
them
6.3 Planning of changes 35
Structure of ISO 9001:2015
(2/3)
7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8 Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and
services
8.4Control of externally provided processes, products
and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
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Structure of ISO 9001:2015
(3/3)
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
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The common structure and ISO 9001:2015 additions
4 Context of 9 Performance
5 Leadership 6 Planning 7 Support 8 Operation 10 Improvement
organization Evaluation
7.2
4.2 5.2 Comp 9.2 10.2
6.2
Interested Poli etenc Inte Nonconformity
Planning
parties cy e rnal and corrective
audi action
7.3 t
5.3 Aware 9.3
4.3 ness 10.3
Org Man
Scope Continual
aniz age
improvement
atio 7.4 me
nal Com nt
role munic revi
4.4 s, ation ew
QMS resp
7.5
onsi
Docu
biliti
ment
ISO/TC 176/SC 2/ N1282
es
ed
and
infor
aut
matio
hori
n
ties
38 3
The common structure and ISO 9001:2015 additions
8 Operation
39 3
Plan Do Check Act
4 9
5 6 7 8 10
Context of Performance
Leadership Planning Support Operation Improvement
organization and Evaluation
7.1.5 9.2
Monitoring and Internal audit
ISO/TC 176/SC 2/ N1282
measuring
resources
9.3
7.1.6 Management
Organizational review
knowledge
7.2
Competence
7.3
Awareness
7.4
Communication
7.5
Documented
information 40 4
Audit schedule
An audit schedule should specify:
•The auditee
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