Thanks for given documents

1. Quality Management
Systems
CO5: execute the various ISO standards and quality systems to improve the quality in organisation

2. Learning Objectives
• Understand the ISO 9000 series of standards, namely,
– ISO 9000,
– ISO 9001 and
– ISO 9004
• Brief overview of sector specific standards, namely,
– AS 9100
– ISO/TC 16946 and
– TL 9000
• Understand the ISO 9001 requirements
• Overview of ISO 9001 implementation
• Detailed & analysis on registration requirements

3. The ISO Survey of Management
System Standard Certifications 2020
ISO 9001 QMS 916,842
ISO 14001 EMS 348,473
ISO 45001 OHS 190,481
ISO/IEC 27001 INFORMATION SECURITY 44,499
ISO 22000 FOOD SAFETY 33,741
ISO 13485 QMS FOR MEDICAL DEVICES 25,656
ISO 50001 ENERGY 19,731
ISO 20000-1 IT SERVICE 7,846
ISO 22301 SOCIETAL SECURITY 2,205
ISO 37001 ANTI-BRIBERY 2,065
ISO 39001 ROAD TRAFFIC SAFETY 972
ISO 28000 SUPPLY CHAIN SECURITY 520

4. The timeline of ISO 9001
revisions
1980
TC176 formed
1987
First edition
1994
First Minor revision
2000
First major revision
2008
Second minor
revision
2015
Second Major
revision

5. ISO 9001 Certifications: Top 10
countries in 2016

6. ISO 9001 certifications in Indian
Subcontinent in 2016

7. Benefits of ISO Registration
There are various reasons for implementing a quality system that conforms to an
ISO standard.
• The primary reason is that customers or marketing are suggesting or
demanding compliance to a quality system.
• Other reasons are needed improvement in processes or systems and a desire
for global deployment of products and services
• A study of manufacturing firms was undertaken to determine if there
was any improvement in performance after registration. Significant
improvement was noted in:
– Internal quality as measured by the percent of scrap, rework, and
nonconformities at final inspection.
– Production reliability as measured by the number of breakdowns per month,
percent of time dedicated to emergencies, and percent of downtime per shift.
– External quality as measured by product accepted by customers without
inspection, claims of nonconforming product, and returned product.
– Time performance as measured by time to market, on-time delivery, and
throughput time.
– Cost of poor quality as measured by external nonconformities, scrap, and
rework.

8. ISO 9000 Series of Standards
• ISO 9000:2015—Quality Management Systems
(QMS)—fundamentals and vocabulary discusses the
fundamental concepts related to the QMS and provides
the terminology used in the other two standards.
• ISO 9001:2015—Quality Management Systems
(QMS)—requirements is the standard used for
registration by demonstrating conformity of the QMS to
customers, regulatory, and the organization’s own
requirements.
• ISO 9004:2009—Quality Management Systems
(QMS)—Managing for the Sustained Success of an
Organization provides guidelines that an organization can
use to establish a QMS focused on improving
performance.

9. Sector-specific Standards
The ISO 9000 system is designed as a simple system that could be used by any
industry. Other systems have been developed that are specific to a particular
industry. One of the problems with sector-specific standards is the need for
suppliers with customers in different industries to set up quality systems to meet
each sector’s requirements.
• AS9100: This aerospace industry quality system was officially released by the
Society of Automotive Engineers in May 1997. In March 2001, the International
Aerospace Quality Group (IAQG) aligned AS9100 with ISO 9001:2000.
Industry-specific interpretations and methodologies are identified in italics and bold
type. These additions are accepted aerospace approaches to quality practices and
general requirements.
– This International Standard specifies requirements for a quality management system
where an organization (a) needs to demonstrate its ability to consistently provide
product that meets customer and applicable statutory and regulatory requirements,
and (b) aims to enhance customer satisfaction through the effective application of the
system, including processes for continual improvement of the system and the assurance
of conformity to customer and applicable statutory and regulatory requirements

10. Sector-specific Standards: IATF 16949: 2016
• Automotive quality management system ISO/TS 16949 standard has
been upgraded to IATF 16949.
• In 2016, IATF 16949:2016 was published by the IATF. This literature
supersedes and replaces the ISO/TS 16949, defining the
requirements of a quality management system for organizations in
the automotive industry.
• The IATF or International Automotive Task Force is an “ad hoc”
group of automotive manufacturers and their respective trade
associations, formed to provide improved quality products to
automotive customers worldwide.
• This standard is entitled Quality Systems Automotive
Suppliers—Particular Requirements for the Application of ISO 9001.
It harmonizes the supplier quality requirements of the U.S. big
three as provided in QS 9000 Third Edition with the French, German
and Italian automakers.

11. Sector-specific Standards: IATF 16949: 2016
• The goal of this technical specification is the development of
fundamental quality systems that provide for continuous
improvement, emphasizing defect prevention, and the reduction
of variation and waste in the supply chain.
Three basic
levels:
•ISO 9001 Requirements
•Industry Specific Requirements
•Company Specific Requirements

12. Sector-specific Standards
• TL 9000 is a specific set of requirements based on ISO
9001 that defines the design, development, production,
delivery, installation and maintenance of
telecommunications products and services.
Structure of TL 9000

13. Schematic representation of the elements of a single process

14. ISO 9001:2015 Requirements
The standard has ten clauses:
1. Scope,
2. Normative References,
3. Terms and Definitions,
4. Context of the Organization,
5. Leadership,
6. Planning,
7. Support,
8. Operation,
9. Performance Evaluation, and
10. Improvement.

15. ISO 9001 Requirements
• Scope: All the requirements of this International Standard are generic and
are intended to be applicable to any organization, regardless of its type or
size, or the products and services it provides.
• 4. Context of the Organization
– Understanding the organization and its context
• Quality Management System (QMS): The organization shall establish,
document, implement, and maintain a QMS and continually improve its
effectiveness.
• Management Responsibility: There are several aspects of management
responsibility
– Management commitment
– Customer Focus
– Quality Policy
– Planning
– Responsibility, authority and commitment
• Resource management: The organization shall determine and provide the
resources needed (a) to implement and maintain the QMS and continually
improve its effectiveness, and (b) to enhance customer satisfaction by
meeting customer requirements. Resources include human resource,
infrastructure and work environment

16. •5
• Leadership and Commitment
•7 Support
•8. Operation
•9.
•Performance Evaluation
•10 Improvement
•4 Context of Organization
•6 Planning
ISO 9001:2015 clauses overview

17. •4 Context of 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
•7 Support
•7.1 resources
•7.2 competence
•7.3 awareness
•7.4 Communication
•7.5 documented information
ISO 9001:2015 clauses overview

18. •8 Operation
•8.1 operational planning and control
•8.2 requirements for products and services
•8.3 design and development of products and services
•8.4 control of externally provided processes, products and services
•8.6 release of products and services
•8.7 control of nonconforming outputs
•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
ISO 9001:2015 clauses overview (continued)

19. The Documentation Pyramid

20. Top
Management
Commitment
Appoint the
Management
Representativ
e
Create
Awareness
Appoint an
Implementatio
n Team
Provide
Training
Plan and
Schedule
Select Element
Owners
Review
present system
Write the
documents
Install the new
system
Internal Audit
Management
Review
Preassessment
Final Audit and
Registration
Implementation
Process

21. Internal Audits
After the policies, procedures, and work instructions have been developed and
implemented, checks must be made to ensure that the system is being followed
and the expected results are being obtained. This activity is accomplished through
the internal audit, which is one of the key elements of the ISO 9000 standard.
• Objectives- There are 5 objectives namely, (1) Determine that actual performance conforms
to the documented QMS. (2) Initiate corrective action activities in response to deficiencies.
(3) Follow up on noncompliance items from previous audits. (4) Provide continued
improvement in the system through feedback to management. (5) Cause the auditee to think
about the process, thereby encouraging possible improvements.
• Auditor: Audits should be performed by qualified individuals who have received training in
auditing principles and procedures
• Techniques: During the actual audit, there are a number of techniques that the auditor
should employ. The objective is to collect evidence, and there are three methods:
examination of documents, observation of activities, and interviews.
• Procedure: Key elements of audit procedure are: plan and checklists, schedules, audit
meetings (pre, during audit and post meetings) and audit reports

22. Registration
Quality system registration is the assessment and audit of a
quality system by a third party, known as a registrar. There
are two parts:
– Selecting a registrar: In the United States, Registrar Accreditation
Board (RAB) maintains a list of approved registrars. In India,
Quality Council of India (QCI), carries out assessment of
certification bodies. This is done under the National Accreditation
Board for Certification Bodies (NABCB) scheme
– Registration process: It has six basic steps: application for
registration, document review, pre-assessment, assessment,
registration, and follow-up surveillance.
Registrars require a completed application to begin the
registration process

23. ISO/ IEC 17025: 2017
• ISO/ IEC 17025:2017 specifies ‘General requirements for the
competence of testing and calibration laboratories’ was prepared by
the International Organization for Standardization (ISO) Committee on
Conformity Assessment (CASCO).
• Conformity of the quality management system within which the
laboratory operates to the requirements of ISO 9001 does not of itself
demonstrate the competence of the laboratory to produce technically
valid data and results. Nor does demonstrated conformity to this
international Standard imply conformity of the quality management
system within which the laboratory operates to all the requirements of
ISO 9001.
• Accreditation bodies that recognize the competence of testing and
calibration laboratories are expected to use this International Standard
as the basis for their accreditation.

24. ISO/ IEC 17025: 2017
• In India, accreditation of laboratories as per ISO/ IEC 17025 is
done by National Accreditation Board for Testing and Calibration
Laboratories (NABL).
• NABL is an autonomous body under the aegis of Department of
Science and Technology, Government of India.
• NABL is a signatory to Asia Pacific Laboratory Accreditation
Cooperation (APLAC) Mutual Recognition Agreement (MRA) and
International Laboratory Accreditation Cooperation (ILAC)
Arrangement. Thus the test results and measurement data
produced by Indian accredited laboratories are acceptable
amongst 64 economies worldwide.

25. ISO 15189: 2012
• This standard specifies requirements for quality and competence
in medical laboratories. ISO 15189 can be used by medical
laboratories in developing their quality management system and
assessing their own competence. It can also be used for
conforming or recognising the laboratory by their customers,
regulatory authorities and accreditation bodies.
• In India NABL acts as an accreditation body as per ISO 15189.

26. Summary
• Worldwide emphasis on quality and economic competitiveness
resulted into wider acceptance of ISO 9000 series of standards.
Most countries have adopted this series in their national
standards.
• These standards are written for contractual situations between
a customer and supplier.
• There are several benefits of ISO 9000 registration. There is an
increasing trend to adopt ISO 9000 quality system standard
worldwide.
• The standard is generic in scope and can be tailored to fit into
any organization’s needs.
• The third-party registration system often gives a very
cost-effective alternative to the two-party multiple audit
systems.
• In addition to this generic series, there are other sector specific
quality system standards, such as automotive or aerospace.
These standards often use ISO 9000 requirements as the basic
framework.