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WELCOME TO ALL IN ISO/TS AWARENESS PROGRAM
PRAGATI COATINGS PVT. LTD.
CONDUCTED BY :-
VIKRAM SINGH
ISO/TS AWARENESS PROGRAM
INTERNATIONAL STANDARDS
DEFINITION :-
International standards are standards developed by international standards organizations. International
standards are available for consideration and use worldwide. The most prominent organization is the
International Organization for Standardization (ISO).
PURPOSE :-
International standards may be used either by direct application or by a process of modifying an international
standard to suit local conditions. The adoption of international standards results in the creation of equivalent,
national standards that are substantially the same as international standards in technical content, but may have
(i) editorial differences as to appearance, use of symbols and measurement units, substitution of a point for a
comma as the decimal marker, and
(ii) differences resulting from conflicts in governmental regulations or industry-specific requirements caused by
fundamental climatic, geographical, technological, or infrastructural factors, or the stringency of safety
requirements that a given standard authority considers appropriate.
International standards are one way of overcoming technical barriers in international commerce caused by
differences among technical regulations and standards developed independently and separately by each nation,
national standards organization, or company. Technical barriers arise when different groups come together, each
with a large user base, doing some well established thing that between them is mutually incompatible.
Establishing international standards is one way of preventing or overcoming this problem.
HISTORY :-
Standardization -
The implementation of standards in industry and commerce became highly important with the onset of the
Industrial Revolution and the need for high-precision machine tools and interchangeable
parts. Henry Maudslay developed the first industrially practical screw cutting lathe in
1800, which allowed for the standardisation of screw thread sizes for the first time.
Maudslay's work, as well as the contributions of other engineers, accomplished a
modest amount of industry standardization; some companies' in-house standards spread a
bit within their industries. Joseph Whitworth's screw thread measurements were adopted
as the first (unofficial) national standard by companies around the country in 1841. It
came to be known as the British Standard Whitworth, and was widely adopted in other
countries. By the end of the 19th century differences in standards between companies
were making trade increasingly difficult and strained. The Engineering Standards
Committee was established in London in 1901 as the world's first national standards
body. After the First World War, similar national bodies were established in other countries. The Deutsches
Institut für Normung (DIN) was set up in Germany in 1917, followed by its counterparts, the American National
Standard Institute and the French Commission Permanente de Standardisation, both in 1918.
ISO/TS AWARENESS PROGRAM
INTERNATIONAL STANDARDS
International Organisations : -
By the mid to late 19th century, efforts were being made to standardize electrical
measurement. An important figure was R. E. B. Crompton, who became concerned
by the large range of different standards and systems used by electrical engineering
companies and scientists in the early 20th century. Many companies had entered the
market in the 1890s and all chose their own settings for voltage, frequency, current
and even the symbols used on circuit diagrams. Adjacent buildings would have
totally incompatible electrical systems simply because they had been fitted out by
different companies. Crompton could see the lack of efficiency in this system and
began to consider proposals for an international standard for electric engineering.
In 1904, Crompton represented Britain at the Louisiana Purchase Exposition in Saint
Louis as part of a delegation by the Institute of Electrical Engineers. He presented a
paper on standardisation, which was so well received that he was asked to look into the
formation of a commission to oversee the process.[6] By 1906 his work was complete
and he drew up a permanent constitution for the first international standards
organization, the International Electro-technical Commission. The body held its first
meeting that year in London, with representatives from 14 countries. In honour of his
contribution to electrical standardisation, Lord Kelvin was elected as the body's first
President.
The International Federation of the
National Standardizing Associations
(ISA) was founded in 1926 with a
broader remit to enhance international
cooperation for all technical standards
and specifications. The body was
suspended in 1942 during World War II.
After the war, ISA was approached by the recently formed United Nations Standards Coordinating Committee
(UNSCC) with a proposal to form a new global standards body. In October 1946, ISA and UNSCC delegates from 25
countries met in London and agreed to join forces to create the new International Organization for
Standardization (ISO); the new organization officially began operations in February 1947.
LIST OF STANDARDS :-
List of International Common Standards.
List of Technical Standard Organisations.
ISO/TS AWARENESS PROGRAM
INTERNATIONAL STANDARDS
International Organization for Standardization
DEFINITION :-
The International Organization for Standardization (ISO) is an
international standard-setting body composed of representatives from
various national standards organizations. Founded on 23 February 1947,
the organization promotes worldwide proprietary, industrial and
commercial standards.
It is headquartered in Geneva, Switzerland, and as of March 2017
Works in 162 countries. It was one of the first organizations granted
general consultative status with the United Nations Economic and
Social Council.
OVERVIEW :-
ISO, the International Organization for Standardization, is an independent, non
governmental organization, the members of which are the standards organizations of the
163 member countries. It is the world's largest developer of voluntary international
standards and facilitates world trade by providing common standards between nations.
Over twenty thousand standards have been set covering everything from manufactured
products and technology to food safety, agriculture and healthcare.
STRUCTURE :-
ISO is a voluntary organization whose members are recognized authorities on standards,
each one representing one country. Members meet annually at a General Assembly to
discuss ISO's strategic objectives. The organization is coordinated by a Central Secretariat
based in Geneva.
A Council with a rotating membership of 20 member bodies provides guidance and
governance, including setting the Central Secretariat's annual budget.
The Technical Management Board is responsible for over 250 technical committees, who
developed ISO standards. ISO has 168 national members.
ISO/TS AWARENESS PROGRAM
1.0 BASIC DETAILS
 FULL NAME :
i)- ISO – INTERNATIONAL ORGANISATION FOR STANDARDIZATION.
ii)- TS – TECHNICAL STANDARD/SPECIFICATION.
iii)- IATF – INTERNATIONAL AUTOMOTIVE TASK FORCE.
 DEFINITION :
ISO/TS/IATF is an technical specification aimed at the development of a quality management system that
provides for continual improvement , emphasizing defect prevention and the reduction of variation and
waste in the automotive industry supply chain.
 ISO 9000 SERIES EDITION DETAILS :
FIRST EDITION – ISO 9000 : 1987
SECOND EDITION – ISO 9000 : 1994
THIRD EDITION – ISO 9001 : 2000
FOURTH EDITION – ISO 9001 : 2008 (Valid Till Sept’2018)
FIFTH EDITION - ISO 9001 : 2015
 ISO/TS 16949 SERIES EDITION DETAILS :
FIRST EDITION – ISO/TS 16949 : 1999
SECOND EDITION – ISO/TS 16949 : 2002
THIRD EDITION – ISO/TS 16949 : 2009
FOURTH EDITION – ISO/TS 16949 : 2014
FIFTH EDITION – IATF 16949 : 2016
• Released by ISO (International Organization for Standardization)
• Prepared by IATF with JAMA (International Automotive Task force and Japanese Automotive
Manufacturers Association)
2.0 Three Goals of ISO/TS:
1. Continual Improvement
2. Emphasizing defect Prevention
3. Reduction of variation and waste across the supplier chain.
Eight Management Principles deployed through ISO/TS :
• 1- Customer Focus
• 2- Leadership
• 3- Engagement/Involvement of people
• 4- Process approach
• 5- Systems Approach to management
• 6- Continual Improvement
• 7- Evidence based decision making
• 8- Relationship Management
Principle 1 – Customer focus
Organizations depend on their customers and therefore should understand current and future
customer needs, should meet customer requirements and strive to exceed customer
expectations.
Principle 2 – Leadership
Leaders establish unity of purpose and direction of the organization. They should create and
maintain the internal environment in which people can become fully involved in achieving the
organization's objectives.
Principle 3 – Involvement of people
People at all levels are the essence of an organization and their full involvement enables their
abilities to be used for the organization's benefit.
Principle 4 – Process approach
A desired result is achieved more efficiently when activities and related resources are
managed as a process.
Principle 5 – System approach to management
Identifying, understanding and managing interrelated processes as a system contributes to the
organization's effectiveness and efficiency in achieving its objectives.
Principle 6 – Continual improvement
Continual improvement of the organization's overall performance should be a permanent
objective of the organization.
Principle 7 – Factual approach to decision making
Effective decisions are based on the analysis of data and information.
Principle 8 – Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a mutually beneficial relationship
enhances the ability of both to create value.
DIFFERENCE BETWEEN ISO 9000/9001/9004
ISO 9000 – Fundamentals and Vocabulary, which introduces the basic principles underlying
management systems and explains the terminology .
ISO 9001 – Requirements, which specifies the criteria for certification.
ISO 9004 – Guidelines for performance improvements goes beyond ISO 9001 by identifying
how ISO 9001 can be used as a springboard for improving the efficiency and effectiveness of a
quality management system.
ISO/TS AWARENESS PROGRAM
ISO/TS AWARENESS PROGRAM
Evolution of ISO 9000 standards :-
The ISO 9000 standard is continually being revised by standing technical committees and
advisory groups, who receive feedback from those professionals who are implementing the
standard.
1987 Version :-
ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three "models"
for quality management systems, the selection of which was based on the scope of
activities of the organization:
ISO 9001:1987 - Model for quality assurance in design, development, production,
installation, and servicing was for companies and organizations whose activities included
the creation of new products.
ISO 9002:1987 - Model for quality assurance in production, installation, and servicing had
basically the same material as ISO 9001 but without covering the creation of new products.
ISO 9003:1987 - Model for quality assurance in final inspection and test covered only the
final inspection of finished product, with no concern for how the product was produced.
ISO 9000:1987 was also influenced by existing U.S. and other Defence Standards ("MIL
SPECS"), and so was well-suited to manufacturing. The emphasis tended to be placed on
conformance with procedures rather than the overall process of management,
which was likely the actual intent.
1994 version :-
ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just
checking final product, and continued to require evidence of compliance with documented
procedures. As with the first edition, the down-side was that companies tended to
implement its requirements by creating shelf-loads of procedure manuals, and becoming
burdened with an ISO bureaucracy. In some companies, adapting and improving processes
could actually be impeded by the quality system.
ISO/TS AWARENESS PROGRAM
2000 Version :-
ISO 9001:2000 replaced all three former standards of 1994 issue, ISO 9001, ISO 9002 and
ISO 9003. Design and development procedures were required only if a company does in fact
engage in the creation of new products. The 2000 version sought to make a radical change
in thinking by actually placing front and centre the concept of process management (the
monitoring and optimisation of a company's tasks and activities, instead of just inspection of
the final product). The 2000 version also demanded involvement by upper executives in
order to integrate quality into the business system and avoid delegation of quality functions
to junior administrators. Another goal was to improve effectiveness via process performance
metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of
continual process improvement and tracking customer satisfaction were made explicit.
ISO 9000 Requirements include:
• Approve documents before distribution;
• Provide correct version of documents at points of use;
• Use your records to prove that requirements have been met; and
• Develop a procedure to control your records.
2008 Version :-
ISO 9001:2008 in essence re-narrates ISO 9001:2000. The 2008 version only introduced
clarifications to the existing requirements of
ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004.
There were no new requirements. For example, in ISO 9001:2008, a quality management
system being upgraded just needs to be checked to see if it is following the clarifications
introduced in the amended version.
ISO 9001 is supplemented directly by two other standards of the family:
ISO 9000:2005 "Quality management systems. Fundamentals and vocabulary"
ISO 9004:2009 "Managing for the sustained success of an organization. A quality
management approach"
Other standards, like ISO 19011 and the ISO 10000 series, may also be used for specific parts
of the quality system.
ISO/TS AWARENESS PROGRAM
ISO9001-2015 Version :-
In 2012, ISO TC 176 - responsible for ISO 9001 development - celebrated 25 years of
implementing ISO 9001, and concluded that it is necessary to create a new QMS model for the
next 25 years. This is why they commenced the official work on creating a revision of ISO
9001, starting with the new QM principles. This moment was considered by important
specialists in the field as "beginning of a new era in the development of quality management
systems. "As a result of the intensive work from this technical committee, the revised standard
ISO 9001:2015 was published by ISO on 23 September 2015. The scope of the standard has
not changed; however, the structure and core terms were modified to allow the standard to
integrate more easily with other international management systems standards.
The 2015 version is also less prescriptive than its predecessors and focuses on performance.
This was achieved by combining the process approach with risk-based thinking, and employing
the Plan-Do-Check-Act cycle at all levels in the organization.
Some of the key changes include:
• High Level Structure of 10 clauses is implemented. Now all new standard released by ISO
will have this High level structure.
• Greater emphasis on building a management system suited to each organization's
particular needs
• A requirement that those at the top of an organization be involved and accountable,
aligning quality with wider business strategy
• Risk-based thinking throughout the standard makes the whole management system a
preventive tool and encourages continuous improvement
• Less prescriptive requirements for documentation: the organization can now decide what
documented information it needs and what format it should be in
• Alignment with other key management system standards through the use of a common
structure and core text Inclusion of Knowledge Management principles
• Quality Manual & Management representative is now not mandatory requirements.
ISO/TS AWARENESS PROGRAM
Certification :-
ISO does not certify organizations itself. Numerous certification bodies exist, which audit
organizations and, upon success, issue ISO 9001 compliance certificates. Although
commonly referred to as "ISO 9000“ certification, the actual standard to which an
organization's quality management system can be certified is ISO 9001:2015 (ISO 9001:2008
will expire by around September 2018). Many countries have formed accreditation bodies to
authorize ("accredit") the certification bodies. Both the accreditation bodies and the
certification bodies charge fees for their services. The various accreditation bodies have
mutual agreements with each other to ensure that certificates issued by one of the
accredited certification bodies (CB) are accepted worldwide. Certification bodies themselves
operate under another quality standard, ISO/IEC 17021, while accreditation bodies operate
under ISO/IEC 17011.
An organization applying for ISO 9001 certification is audited based on an extensive sample
of its sites, functions, products, services and processes. The auditor presents a list of
problems (defined as "nonconformities", "observations", or "opportunities for
improvement") to management. If there are no major nonconformities, the certification
body will issue a certificate. Where major nonconformities are identified, the organization
will present an improvement plan to the certification body (e.g., corrective action reports
showing how the problems will be resolved); once the certification body is satisfied that the
organization has carried out sufficient corrective action, it will issue a certificate. The
certificate is limited by a certain scope (e.g., production of golf balls) and will display the
addresses to which the certificate refers.
An ISO 9001 certificate is not a once-and-for-all award, but must be renewed at regular
intervals recommended by the certification body, usually once every three years. There are
no grades of competence within ISO 9001: either a company is certified (meaning that it is
committed to the method and model of quality management described in the standard) or
it is not. In this respect, ISO 9001 certification contrasts with measurement-based quality
systems.
ISO/TS AWARENESS PROGRAM
ELEMENTS OF ISO 9000 CERTIFICATION :-
• Management Responsibility.
• Quality System.
• Contract Review.
• Design Control.
• Document & Data Control.
• Purchasing.
• Customer Supplied Product.
• Product Identification and Traceability.
• Process Control.
• Inspection and Test Status.
• Control of Inspection, Measuring and Test Equipment .
• Inspection and Test Status.
• Control of Nonconforming Product.
• Corrective & Preventive Action.
• Handling , Storage, Packaging, Preservation and Delivery.
• Control of Quality Records.
• Quality Audits.
• Training.
• Servicing.
• Statistical Techniques.
GENERIC PRODUCT CATEGORIES NEEDS ISO CERTIFICATION :-
• HARDWARE.
• SOFTWARE.
• PROCESSED MATERIALS.
• SERVICE.
ISO/TS AWARENESS PROGRAM
STAGES FOR ISO 9000 CERTIFICATION :-
• Setting up Steering Committee.
• Design of Management System.
• Training all Employees.
• Setting up documentation system.
• Implementation.
• Monitoring & Evaluation.
• Internal Audit & Pre-assessment audit.
• Certification Audit by ISO accredit body.
• ISO Registration.
• Maintenance of the system.
• Internal Quality Audit.
• Surveillance Visit.
ISO/TS AWARENESS PROGRAM
Contents of ISO 9001:2015 :-
ISO 9001:2015 Quality management systems — Requirements is a document of
approximately 30 pages which is available from the national standards organization in each
country. Only ISO 9001 is directly audited against for third party assessment purposes.
Contents of ISO 9001:2015 are as follows:
Section 1: Scope
Section 2: Normative references
Section 3: Terms and definitions
Section 4: Context of the organization
Section 5: Leadership
Section 6: Planning
Section 7: Support
Section 8: Operation
Section 9: Performance evaluation
Section 10: Improvement
Essentially the layout of the standard is similar to the previous ISO 9001:2008 standard in
that it follows the Plan, Do, Check, Act cycle in a process based approach, but is now
further encouraging this to have risk based thinking. (section 0.3.3 of the introduction) The
purpose of the quality objectives is to determine the conformity of the requirements
(customers and organizations), facilitate effective deployment and improve the quality
management system.
Before the certification body can issue or renew a certificate, the auditor must be satisfied
that the company being assessed has implemented the requirements of sections 4 to 10.
Sections 1 to 3 are not directly audited against, but because they provide context and
definitions for the rest of the standard, not that of the organization, their contents must be
taken into account.
The standard no longer specifies that the organization shall issue and maintain
documented procedures, however ISO 9001:2015 requires the organization to document
any other procedures required for its effective operation. The standard also requires the
organization to issue and communicate a documented quality policy, a quality
management system scope, and quality objectives. The standard no longer requires
compliant organizations to issue a formal Quality Manual. The standard does require
retention of numerous records, as specified throughout the standard. New for the 2015
release is a requirement for an organization to assess risks and opportunities (section 6.1)
and to determine internal and external issues relevant to its purpose and strategic
direction (section 4.1). The organization must demonstrate how the standard’s
requirements are being met, while the external auditor’s role is to determine the quality
management system's effectiveness. More detailed interpretation and implementation
examples are often sought by organizations seeking more information in what can be a
very technical area.
ISO/TS AWARENESS PROGRAM
Auditing :-
Two types of auditing are required to become registered to the standard: auditing by an
external certification body (external audit) and audits by internal staff trained for this
process (internal audits). The aim is a continual process of review and assessment to verify
that the system is working as it is supposed to; to find out where it can improve; and to
correct or prevent problems identified. It is considered healthier for internal auditors to
audit outside their usual management line, so as to bring a degree of independence to
their judgments.
Under the 1994 standard, the auditing process could be adequately addressed by
performing "conformance auditing":
• Tell me what you do (describe the business process)
• Show me where it says that (reference the procedure manuals)
• Prove that this is what happened (exhibit evidence in documented records)
The 2000 standard uses a different approach. Auditors are expected to go beyond mere
auditing for rote conformance by focusing on risk, status, and importance. This means they
are expected to make more judgments on what is effective, rather than merely adhering
to what is formally prescribed. The difference from the previous standard can be explained
thus:
Under the 1994 version, the question was broad: "Are you doing what the manual says you
should be doing?", whereas under the 2000 version, the questions are more specific: "Will
this process help you achieve your stated objectives? Is it a good process or is there a way
to do it better?“
Advantages :-
Proper quality management can improve business, often having a positive effect on
investment, market share, sales growth, sales margins, competitive advantage, and
avoidance of litigation.
According to ISO the 2015 version of the standard brings the following benefits:
1. By assessing their context, organizations can define who is affected by their work and
what they expect. This enables clearly stated business objectives and the identification of
new business opportunities.
2. Organizations can identify and address the risks associated with their organization.
3. By putting customers first organizations can make sure they consistently meet customer
needs and enhance customer satisfaction. This can lead to more repeat custom, new
clients and increased business for the organization.
ISO/TS AWARENESS PROGRAM
4. Organizations work in a more efficient way as all their processes are aligned and
understood by everyone. This increases productivity and efficiency, bringing internal costs
down.
5. Organizations will meet necessary statutory and regulatory requirements.
6. Organizations can expand into new markets, as some sectors and clients require ISO
9001 before doing business.
7. Become more cost efficient.
8. Increased credibility and competitiveness.
9. Lower costs and shorter cycle times through effective use of resources.
10. Enhanced customer satisfaction and improved customer loyalty leading to repeat
business.
11. Increased revenue and market share obtained through flexible and fast responses to
market opportunities.
12. Integration and alignment of internal processes which will lead to increased
productivity and results.
13. Consistency in the delivery of your product or service.
14. Improved communication, planning and administration processes.
SOME OTHER BENEFITS :-
• Suitable for both small and large organisations.
• Better internal management.
• Less wastage.
• Increase in efficiency, productivity and profit.
• Improved customer retention and acquisition.
• Consistent outcomes, measured and monitored.
• Globally recognised standard.
• Compatible with other ISO / Non – ISO standards.
• Minimize mistakes.
• Improves reporting & communication.
• Better quality products & services.
• Standards maintained by annual assessments.
ISO/TS AWARENESS PROGRAM
Disadvantages :-
• Any employee in the organisation doesn’t make any system in their department, which
cannot fulfil the requirements of ISO/TS.
• Every employee bound to work under the ISO/TS guidelines.
• Paper work or Evidence based work become higher.
• Numerous training to be conducted for better understanding of work.
IMPORTANT TERMS/ABBREVIATIONS:
S.No Acronym FULL FORM
01 APQP ADVANCED PRODUCT QUALITY PLANNING
02 PAP PART APPROVAL PROCESS
03 FMEA FAILURE MODES & EFFECTS ANALYSIS
04 SPC STATISTICAL PROCESS CONTROL
05 MSA MEASUREMENTS SYSTEM ANALYSIS
06 RPN RISK PRIORITY NUMBER
07 CPM CRITICAL PATH METHOD
08 MTBF MEAN TIME BETWEEN FAILURES
09 MTTR MEAN TIME TO REPAIR
10 PSW PART SUBMISSION WARRANT
11 CSR CUSTOMER SPECIFIC REQUIREMENTS
12 ITR INVENTORY TURN OVER RATIO
13 GRR GAGE REPEATABILITY & REPRODUCIBILITY
14 CFT CROSS FUNCTIONAL TEAM
15 MDT MULTI-DISCIPLINARY TEAM
16 ISO INTERNATIONAL ORGANISATION FOR STANDARDISATION
17 IATF INTERNATIONAL AUTOMOTIVE TASK FORCE
18 JAMA JAPANESE AUTOMOTIVE MANUFACTURERS ASSOCIATION
19 SOP STANDARD OPERATING PROCEDURES
20 GD & T GEOMETRIC DIMENSIONING & TOLERANCING
21 IQA INTERNAL QUALITY AUDIT
22 NCR NON CONFORMITY REPORT
23 OEE OVERALL EQUIPMENT EFFECTIVENESS
24 WP WORK PROCEDURE
25 WI WORK INSTRUCTION
26 nDC NUMBER OF DISTINCT CATEGORIES
27 TS TECHNICAL SPECIFICATION
28 CA &PA CORRECTIVE ACTION & PREVENTIVE ACTIONS
29 QMS QUALITY MANAGEMENT SYSTEM
30 EMS ENVIRONMENTAL MANAGEMENT SYSTEM
31 MR MANAGEMENT REPRESENTATTIVE
32 MRM MANAGEMENT REVIEW MEETING
33 IQA INTERNAL QUALITY AUDIT
34 PDCA PLAN DO CHECK ACT
ISO/TS AWARENESS PROGRAM
Any audit leads to improvement only.
Suggestions for the Auditee: (the person who is going to be audited ):
A. Must have the following with you at the time of audit:
1. The turtle chart for the process for which you are getting audited.
2. The work Instructions of your function.
3. The quality records (Properly completed with date, signature )
B. Remember that the auditor is going to follow the process –approach.
So better first cross check yourself whether you have the right answers for upstream
and down stream processes. ( i.e. towards the input side and the output side of
your process.)
C. TS means understanding & implementing the TS requirements and also the
customer requirements . So, better study the same before auditing.
D. The loop must be closed. (Plan-Do-Check-Act )
E. In TS audit ,auditor can verify the compliance through any of the following
methods:
a. Through records and documents.
b. By observing the work( actual process)
c. Through cross checking with other information.
F. If there are any NC’s to your function in the internal audit, you must know the
corrective actions taken by you.
G. It is expected that you know the customer complaints and actions taken on the
same.
H. You are also expected to have complete data regarding the quality objectives of
your function . ( Target/Actual status)
Types of audit Non Conformities( NC or NCR)
Major NC Minor NC
System does not exist.
There is no awareness about the work
instructions of own area.
There are isolated cases of
non compliance to the
system.
System not implemented at all. Not affecting the product
quality.
More number of minor non
conformities under the same
clause.
General Suggestions:
1.It is the system audit and not your audit. Any non- conformity raised
is towards the system and not to auditee in specific.
2.Auditor’s main role is to verify the conformance of the system and
notfinding out your faults/mistakes.
3.It is always better to be open than to hide any thing from the
auditor.
4.Please be specific in answering the questions.
5.If you have not understood the question correctly, please
request the auditor to repeat the question.
6. Please do not start telling “stories” to the auditors.
7.Be just a good human being.
8.Auditor is always happy when you show him the objective
evidence (proof) of what you are saying or claiming what you
are doing.
9. Keep a writing pad and pen handy for writing any suggestions given
by the auditor.
10.If possible , switch off your mobile when your audit starts.
11.If auditor asks some information which is not in your area of
responsibility, better tell him/her accordingly rather than giving a
wrong answer.
Suggestions for preparation for the external audit:
1. Do cross auditing( inter-functional) with one of your
colleagues.
2. Carry out a self-examination by the following method: A
.Take the process manual
B.Verify the records as mentioned in the “list of records”
C.Verify all documents as mentioned in the “list of
documents”
D. Ensure that on the shop floor:
a.All control plans/process sheets/work
instructions/safety instructions are properly
displayed
b. All fire-extinguishers are in ok condition.
c.rejection is identified and kept with proper
identification.
d. No parts in the gang-ways(aisles)
e. shop floor persons are neat/clean.
f.Quality policy is displayed and known to people.
THANK YOU SO MUCH
ALL THE BEST.
PRAGATI COATINGS PVT. LTD.

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ISO/TS Awareness Program

  • 1. WELCOME TO ALL IN ISO/TS AWARENESS PROGRAM PRAGATI COATINGS PVT. LTD. CONDUCTED BY :- VIKRAM SINGH
  • 2. ISO/TS AWARENESS PROGRAM INTERNATIONAL STANDARDS DEFINITION :- International standards are standards developed by international standards organizations. International standards are available for consideration and use worldwide. The most prominent organization is the International Organization for Standardization (ISO). PURPOSE :- International standards may be used either by direct application or by a process of modifying an international standard to suit local conditions. The adoption of international standards results in the creation of equivalent, national standards that are substantially the same as international standards in technical content, but may have (i) editorial differences as to appearance, use of symbols and measurement units, substitution of a point for a comma as the decimal marker, and (ii) differences resulting from conflicts in governmental regulations or industry-specific requirements caused by fundamental climatic, geographical, technological, or infrastructural factors, or the stringency of safety requirements that a given standard authority considers appropriate. International standards are one way of overcoming technical barriers in international commerce caused by differences among technical regulations and standards developed independently and separately by each nation, national standards organization, or company. Technical barriers arise when different groups come together, each with a large user base, doing some well established thing that between them is mutually incompatible. Establishing international standards is one way of preventing or overcoming this problem. HISTORY :- Standardization - The implementation of standards in industry and commerce became highly important with the onset of the Industrial Revolution and the need for high-precision machine tools and interchangeable parts. Henry Maudslay developed the first industrially practical screw cutting lathe in 1800, which allowed for the standardisation of screw thread sizes for the first time. Maudslay's work, as well as the contributions of other engineers, accomplished a modest amount of industry standardization; some companies' in-house standards spread a bit within their industries. Joseph Whitworth's screw thread measurements were adopted as the first (unofficial) national standard by companies around the country in 1841. It came to be known as the British Standard Whitworth, and was widely adopted in other countries. By the end of the 19th century differences in standards between companies were making trade increasingly difficult and strained. The Engineering Standards Committee was established in London in 1901 as the world's first national standards body. After the First World War, similar national bodies were established in other countries. The Deutsches Institut für Normung (DIN) was set up in Germany in 1917, followed by its counterparts, the American National Standard Institute and the French Commission Permanente de Standardisation, both in 1918.
  • 3. ISO/TS AWARENESS PROGRAM INTERNATIONAL STANDARDS International Organisations : - By the mid to late 19th century, efforts were being made to standardize electrical measurement. An important figure was R. E. B. Crompton, who became concerned by the large range of different standards and systems used by electrical engineering companies and scientists in the early 20th century. Many companies had entered the market in the 1890s and all chose their own settings for voltage, frequency, current and even the symbols used on circuit diagrams. Adjacent buildings would have totally incompatible electrical systems simply because they had been fitted out by different companies. Crompton could see the lack of efficiency in this system and began to consider proposals for an international standard for electric engineering. In 1904, Crompton represented Britain at the Louisiana Purchase Exposition in Saint Louis as part of a delegation by the Institute of Electrical Engineers. He presented a paper on standardisation, which was so well received that he was asked to look into the formation of a commission to oversee the process.[6] By 1906 his work was complete and he drew up a permanent constitution for the first international standards organization, the International Electro-technical Commission. The body held its first meeting that year in London, with representatives from 14 countries. In honour of his contribution to electrical standardisation, Lord Kelvin was elected as the body's first President. The International Federation of the National Standardizing Associations (ISA) was founded in 1926 with a broader remit to enhance international cooperation for all technical standards and specifications. The body was suspended in 1942 during World War II. After the war, ISA was approached by the recently formed United Nations Standards Coordinating Committee (UNSCC) with a proposal to form a new global standards body. In October 1946, ISA and UNSCC delegates from 25 countries met in London and agreed to join forces to create the new International Organization for Standardization (ISO); the new organization officially began operations in February 1947. LIST OF STANDARDS :- List of International Common Standards. List of Technical Standard Organisations.
  • 4. ISO/TS AWARENESS PROGRAM INTERNATIONAL STANDARDS International Organization for Standardization DEFINITION :- The International Organization for Standardization (ISO) is an international standard-setting body composed of representatives from various national standards organizations. Founded on 23 February 1947, the organization promotes worldwide proprietary, industrial and commercial standards. It is headquartered in Geneva, Switzerland, and as of March 2017 Works in 162 countries. It was one of the first organizations granted general consultative status with the United Nations Economic and Social Council. OVERVIEW :- ISO, the International Organization for Standardization, is an independent, non governmental organization, the members of which are the standards organizations of the 163 member countries. It is the world's largest developer of voluntary international standards and facilitates world trade by providing common standards between nations. Over twenty thousand standards have been set covering everything from manufactured products and technology to food safety, agriculture and healthcare. STRUCTURE :- ISO is a voluntary organization whose members are recognized authorities on standards, each one representing one country. Members meet annually at a General Assembly to discuss ISO's strategic objectives. The organization is coordinated by a Central Secretariat based in Geneva. A Council with a rotating membership of 20 member bodies provides guidance and governance, including setting the Central Secretariat's annual budget. The Technical Management Board is responsible for over 250 technical committees, who developed ISO standards. ISO has 168 national members.
  • 5. ISO/TS AWARENESS PROGRAM 1.0 BASIC DETAILS  FULL NAME : i)- ISO – INTERNATIONAL ORGANISATION FOR STANDARDIZATION. ii)- TS – TECHNICAL STANDARD/SPECIFICATION. iii)- IATF – INTERNATIONAL AUTOMOTIVE TASK FORCE.  DEFINITION : ISO/TS/IATF is an technical specification aimed at the development of a quality management system that provides for continual improvement , emphasizing defect prevention and the reduction of variation and waste in the automotive industry supply chain.  ISO 9000 SERIES EDITION DETAILS : FIRST EDITION – ISO 9000 : 1987 SECOND EDITION – ISO 9000 : 1994 THIRD EDITION – ISO 9001 : 2000 FOURTH EDITION – ISO 9001 : 2008 (Valid Till Sept’2018) FIFTH EDITION - ISO 9001 : 2015  ISO/TS 16949 SERIES EDITION DETAILS : FIRST EDITION – ISO/TS 16949 : 1999 SECOND EDITION – ISO/TS 16949 : 2002 THIRD EDITION – ISO/TS 16949 : 2009 FOURTH EDITION – ISO/TS 16949 : 2014 FIFTH EDITION – IATF 16949 : 2016 • Released by ISO (International Organization for Standardization) • Prepared by IATF with JAMA (International Automotive Task force and Japanese Automotive Manufacturers Association) 2.0 Three Goals of ISO/TS: 1. Continual Improvement 2. Emphasizing defect Prevention 3. Reduction of variation and waste across the supplier chain. Eight Management Principles deployed through ISO/TS : • 1- Customer Focus • 2- Leadership • 3- Engagement/Involvement of people • 4- Process approach • 5- Systems Approach to management • 6- Continual Improvement • 7- Evidence based decision making • 8- Relationship Management
  • 6. Principle 1 – Customer focus Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations. Principle 2 – Leadership Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives. Principle 3 – Involvement of people People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit. Principle 4 – Process approach A desired result is achieved more efficiently when activities and related resources are managed as a process. Principle 5 – System approach to management Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives. Principle 6 – Continual improvement Continual improvement of the organization's overall performance should be a permanent objective of the organization. Principle 7 – Factual approach to decision making Effective decisions are based on the analysis of data and information. Principle 8 – Mutually beneficial supplier relationships An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. DIFFERENCE BETWEEN ISO 9000/9001/9004 ISO 9000 – Fundamentals and Vocabulary, which introduces the basic principles underlying management systems and explains the terminology . ISO 9001 – Requirements, which specifies the criteria for certification. ISO 9004 – Guidelines for performance improvements goes beyond ISO 9001 by identifying how ISO 9001 can be used as a springboard for improving the efficiency and effectiveness of a quality management system. ISO/TS AWARENESS PROGRAM
  • 7. ISO/TS AWARENESS PROGRAM Evolution of ISO 9000 standards :- The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard. 1987 Version :- ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three "models" for quality management systems, the selection of which was based on the scope of activities of the organization: ISO 9001:1987 - Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products. ISO 9002:1987 - Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products. ISO 9003:1987 - Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced. ISO 9000:1987 was also influenced by existing U.S. and other Defence Standards ("MIL SPECS"), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management, which was likely the actual intent. 1994 version :- ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system.
  • 8. ISO/TS AWARENESS PROGRAM 2000 Version :- ISO 9001:2000 replaced all three former standards of 1994 issue, ISO 9001, ISO 9002 and ISO 9003. Design and development procedures were required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing front and centre the concept of process management (the monitoring and optimisation of a company's tasks and activities, instead of just inspection of the final product). The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit. ISO 9000 Requirements include: • Approve documents before distribution; • Provide correct version of documents at points of use; • Use your records to prove that requirements have been met; and • Develop a procedure to control your records. 2008 Version :- ISO 9001:2008 in essence re-narrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version. ISO 9001 is supplemented directly by two other standards of the family: ISO 9000:2005 "Quality management systems. Fundamentals and vocabulary" ISO 9004:2009 "Managing for the sustained success of an organization. A quality management approach" Other standards, like ISO 19011 and the ISO 10000 series, may also be used for specific parts of the quality system.
  • 9. ISO/TS AWARENESS PROGRAM ISO9001-2015 Version :- In 2012, ISO TC 176 - responsible for ISO 9001 development - celebrated 25 years of implementing ISO 9001, and concluded that it is necessary to create a new QMS model for the next 25 years. This is why they commenced the official work on creating a revision of ISO 9001, starting with the new QM principles. This moment was considered by important specialists in the field as "beginning of a new era in the development of quality management systems. "As a result of the intensive work from this technical committee, the revised standard ISO 9001:2015 was published by ISO on 23 September 2015. The scope of the standard has not changed; however, the structure and core terms were modified to allow the standard to integrate more easily with other international management systems standards. The 2015 version is also less prescriptive than its predecessors and focuses on performance. This was achieved by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization. Some of the key changes include: • High Level Structure of 10 clauses is implemented. Now all new standard released by ISO will have this High level structure. • Greater emphasis on building a management system suited to each organization's particular needs • A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy • Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement • Less prescriptive requirements for documentation: the organization can now decide what documented information it needs and what format it should be in • Alignment with other key management system standards through the use of a common structure and core text Inclusion of Knowledge Management principles • Quality Manual & Management representative is now not mandatory requirements.
  • 10. ISO/TS AWARENESS PROGRAM Certification :- ISO does not certify organizations itself. Numerous certification bodies exist, which audit organizations and, upon success, issue ISO 9001 compliance certificates. Although commonly referred to as "ISO 9000“ certification, the actual standard to which an organization's quality management system can be certified is ISO 9001:2015 (ISO 9001:2008 will expire by around September 2018). Many countries have formed accreditation bodies to authorize ("accredit") the certification bodies. Both the accreditation bodies and the certification bodies charge fees for their services. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the accredited certification bodies (CB) are accepted worldwide. Certification bodies themselves operate under another quality standard, ISO/IEC 17021, while accreditation bodies operate under ISO/IEC 17011. An organization applying for ISO 9001 certification is audited based on an extensive sample of its sites, functions, products, services and processes. The auditor presents a list of problems (defined as "nonconformities", "observations", or "opportunities for improvement") to management. If there are no major nonconformities, the certification body will issue a certificate. Where major nonconformities are identified, the organization will present an improvement plan to the certification body (e.g., corrective action reports showing how the problems will be resolved); once the certification body is satisfied that the organization has carried out sufficient corrective action, it will issue a certificate. The certificate is limited by a certain scope (e.g., production of golf balls) and will display the addresses to which the certificate refers. An ISO 9001 certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body, usually once every three years. There are no grades of competence within ISO 9001: either a company is certified (meaning that it is committed to the method and model of quality management described in the standard) or it is not. In this respect, ISO 9001 certification contrasts with measurement-based quality systems.
  • 11. ISO/TS AWARENESS PROGRAM ELEMENTS OF ISO 9000 CERTIFICATION :- • Management Responsibility. • Quality System. • Contract Review. • Design Control. • Document & Data Control. • Purchasing. • Customer Supplied Product. • Product Identification and Traceability. • Process Control. • Inspection and Test Status. • Control of Inspection, Measuring and Test Equipment . • Inspection and Test Status. • Control of Nonconforming Product. • Corrective & Preventive Action. • Handling , Storage, Packaging, Preservation and Delivery. • Control of Quality Records. • Quality Audits. • Training. • Servicing. • Statistical Techniques. GENERIC PRODUCT CATEGORIES NEEDS ISO CERTIFICATION :- • HARDWARE. • SOFTWARE. • PROCESSED MATERIALS. • SERVICE.
  • 12. ISO/TS AWARENESS PROGRAM STAGES FOR ISO 9000 CERTIFICATION :- • Setting up Steering Committee. • Design of Management System. • Training all Employees. • Setting up documentation system. • Implementation. • Monitoring & Evaluation. • Internal Audit & Pre-assessment audit. • Certification Audit by ISO accredit body. • ISO Registration. • Maintenance of the system. • Internal Quality Audit. • Surveillance Visit.
  • 13. ISO/TS AWARENESS PROGRAM Contents of ISO 9001:2015 :- ISO 9001:2015 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. Only ISO 9001 is directly audited against for third party assessment purposes. Contents of ISO 9001:2015 are as follows: Section 1: Scope Section 2: Normative references Section 3: Terms and definitions Section 4: Context of the organization Section 5: Leadership Section 6: Planning Section 7: Support Section 8: Operation Section 9: Performance evaluation Section 10: Improvement Essentially the layout of the standard is similar to the previous ISO 9001:2008 standard in that it follows the Plan, Do, Check, Act cycle in a process based approach, but is now further encouraging this to have risk based thinking. (section 0.3.3 of the introduction) The purpose of the quality objectives is to determine the conformity of the requirements (customers and organizations), facilitate effective deployment and improve the quality management system. Before the certification body can issue or renew a certificate, the auditor must be satisfied that the company being assessed has implemented the requirements of sections 4 to 10. Sections 1 to 3 are not directly audited against, but because they provide context and definitions for the rest of the standard, not that of the organization, their contents must be taken into account. The standard no longer specifies that the organization shall issue and maintain documented procedures, however ISO 9001:2015 requires the organization to document any other procedures required for its effective operation. The standard also requires the organization to issue and communicate a documented quality policy, a quality management system scope, and quality objectives. The standard no longer requires compliant organizations to issue a formal Quality Manual. The standard does require retention of numerous records, as specified throughout the standard. New for the 2015 release is a requirement for an organization to assess risks and opportunities (section 6.1) and to determine internal and external issues relevant to its purpose and strategic direction (section 4.1). The organization must demonstrate how the standard’s requirements are being met, while the external auditor’s role is to determine the quality management system's effectiveness. More detailed interpretation and implementation examples are often sought by organizations seeking more information in what can be a very technical area.
  • 14. ISO/TS AWARENESS PROGRAM Auditing :- Two types of auditing are required to become registered to the standard: auditing by an external certification body (external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual process of review and assessment to verify that the system is working as it is supposed to; to find out where it can improve; and to correct or prevent problems identified. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgments. Under the 1994 standard, the auditing process could be adequately addressed by performing "conformance auditing": • Tell me what you do (describe the business process) • Show me where it says that (reference the procedure manuals) • Prove that this is what happened (exhibit evidence in documented records) The 2000 standard uses a different approach. Auditors are expected to go beyond mere auditing for rote conformance by focusing on risk, status, and importance. This means they are expected to make more judgments on what is effective, rather than merely adhering to what is formally prescribed. The difference from the previous standard can be explained thus: Under the 1994 version, the question was broad: "Are you doing what the manual says you should be doing?", whereas under the 2000 version, the questions are more specific: "Will this process help you achieve your stated objectives? Is it a good process or is there a way to do it better?“ Advantages :- Proper quality management can improve business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. According to ISO the 2015 version of the standard brings the following benefits: 1. By assessing their context, organizations can define who is affected by their work and what they expect. This enables clearly stated business objectives and the identification of new business opportunities. 2. Organizations can identify and address the risks associated with their organization. 3. By putting customers first organizations can make sure they consistently meet customer needs and enhance customer satisfaction. This can lead to more repeat custom, new clients and increased business for the organization.
  • 15. ISO/TS AWARENESS PROGRAM 4. Organizations work in a more efficient way as all their processes are aligned and understood by everyone. This increases productivity and efficiency, bringing internal costs down. 5. Organizations will meet necessary statutory and regulatory requirements. 6. Organizations can expand into new markets, as some sectors and clients require ISO 9001 before doing business. 7. Become more cost efficient. 8. Increased credibility and competitiveness. 9. Lower costs and shorter cycle times through effective use of resources. 10. Enhanced customer satisfaction and improved customer loyalty leading to repeat business. 11. Increased revenue and market share obtained through flexible and fast responses to market opportunities. 12. Integration and alignment of internal processes which will lead to increased productivity and results. 13. Consistency in the delivery of your product or service. 14. Improved communication, planning and administration processes. SOME OTHER BENEFITS :- • Suitable for both small and large organisations. • Better internal management. • Less wastage. • Increase in efficiency, productivity and profit. • Improved customer retention and acquisition. • Consistent outcomes, measured and monitored. • Globally recognised standard. • Compatible with other ISO / Non – ISO standards. • Minimize mistakes. • Improves reporting & communication. • Better quality products & services. • Standards maintained by annual assessments.
  • 16. ISO/TS AWARENESS PROGRAM Disadvantages :- • Any employee in the organisation doesn’t make any system in their department, which cannot fulfil the requirements of ISO/TS. • Every employee bound to work under the ISO/TS guidelines. • Paper work or Evidence based work become higher. • Numerous training to be conducted for better understanding of work.
  • 17. IMPORTANT TERMS/ABBREVIATIONS: S.No Acronym FULL FORM 01 APQP ADVANCED PRODUCT QUALITY PLANNING 02 PAP PART APPROVAL PROCESS 03 FMEA FAILURE MODES & EFFECTS ANALYSIS 04 SPC STATISTICAL PROCESS CONTROL 05 MSA MEASUREMENTS SYSTEM ANALYSIS 06 RPN RISK PRIORITY NUMBER 07 CPM CRITICAL PATH METHOD 08 MTBF MEAN TIME BETWEEN FAILURES 09 MTTR MEAN TIME TO REPAIR 10 PSW PART SUBMISSION WARRANT 11 CSR CUSTOMER SPECIFIC REQUIREMENTS 12 ITR INVENTORY TURN OVER RATIO 13 GRR GAGE REPEATABILITY & REPRODUCIBILITY 14 CFT CROSS FUNCTIONAL TEAM 15 MDT MULTI-DISCIPLINARY TEAM 16 ISO INTERNATIONAL ORGANISATION FOR STANDARDISATION 17 IATF INTERNATIONAL AUTOMOTIVE TASK FORCE 18 JAMA JAPANESE AUTOMOTIVE MANUFACTURERS ASSOCIATION 19 SOP STANDARD OPERATING PROCEDURES 20 GD & T GEOMETRIC DIMENSIONING & TOLERANCING 21 IQA INTERNAL QUALITY AUDIT 22 NCR NON CONFORMITY REPORT 23 OEE OVERALL EQUIPMENT EFFECTIVENESS 24 WP WORK PROCEDURE 25 WI WORK INSTRUCTION 26 nDC NUMBER OF DISTINCT CATEGORIES 27 TS TECHNICAL SPECIFICATION 28 CA &PA CORRECTIVE ACTION & PREVENTIVE ACTIONS 29 QMS QUALITY MANAGEMENT SYSTEM 30 EMS ENVIRONMENTAL MANAGEMENT SYSTEM 31 MR MANAGEMENT REPRESENTATTIVE 32 MRM MANAGEMENT REVIEW MEETING 33 IQA INTERNAL QUALITY AUDIT 34 PDCA PLAN DO CHECK ACT ISO/TS AWARENESS PROGRAM
  • 18. Any audit leads to improvement only. Suggestions for the Auditee: (the person who is going to be audited ): A. Must have the following with you at the time of audit: 1. The turtle chart for the process for which you are getting audited. 2. The work Instructions of your function. 3. The quality records (Properly completed with date, signature ) B. Remember that the auditor is going to follow the process –approach. So better first cross check yourself whether you have the right answers for upstream and down stream processes. ( i.e. towards the input side and the output side of your process.) C. TS means understanding & implementing the TS requirements and also the customer requirements . So, better study the same before auditing. D. The loop must be closed. (Plan-Do-Check-Act ) E. In TS audit ,auditor can verify the compliance through any of the following methods: a. Through records and documents. b. By observing the work( actual process) c. Through cross checking with other information. F. If there are any NC’s to your function in the internal audit, you must know the corrective actions taken by you. G. It is expected that you know the customer complaints and actions taken on the same. H. You are also expected to have complete data regarding the quality objectives of your function . ( Target/Actual status)
  • 19. Types of audit Non Conformities( NC or NCR) Major NC Minor NC System does not exist. There is no awareness about the work instructions of own area. There are isolated cases of non compliance to the system. System not implemented at all. Not affecting the product quality. More number of minor non conformities under the same clause. General Suggestions: 1.It is the system audit and not your audit. Any non- conformity raised is towards the system and not to auditee in specific. 2.Auditor’s main role is to verify the conformance of the system and notfinding out your faults/mistakes. 3.It is always better to be open than to hide any thing from the auditor. 4.Please be specific in answering the questions. 5.If you have not understood the question correctly, please request the auditor to repeat the question. 6. Please do not start telling “stories” to the auditors. 7.Be just a good human being. 8.Auditor is always happy when you show him the objective evidence (proof) of what you are saying or claiming what you are doing. 9. Keep a writing pad and pen handy for writing any suggestions given by the auditor. 10.If possible , switch off your mobile when your audit starts. 11.If auditor asks some information which is not in your area of responsibility, better tell him/her accordingly rather than giving a wrong answer.
  • 20. Suggestions for preparation for the external audit: 1. Do cross auditing( inter-functional) with one of your colleagues. 2. Carry out a self-examination by the following method: A .Take the process manual B.Verify the records as mentioned in the “list of records” C.Verify all documents as mentioned in the “list of documents” D. Ensure that on the shop floor: a.All control plans/process sheets/work instructions/safety instructions are properly displayed b. All fire-extinguishers are in ok condition. c.rejection is identified and kept with proper identification. d. No parts in the gang-ways(aisles) e. shop floor persons are neat/clean. f.Quality policy is displayed and known to people.
  • 21. THANK YOU SO MUCH ALL THE BEST. PRAGATI COATINGS PVT. LTD.