What is ISO ?

Stands for International Organisation for Standardization ISO is not an acronym, it is derived from the Greek word ISOS, meaning equal It is an NGO, founded in Feb 23, 1947 Prime focus on worldwide proprietary, industrial and commercial standards Has its headquarters in Geneva, Switzerland A network of the national standards institutes of 163 countries with one member per country

ISO

Its members

Presently 163 members out of 204 countries in the world

ISO

Its History

Began in 1926, as the International Federation of the National Standardizing Associations Disbanded in 1942 during the second World War Re-organized under the name ISO, in 1947

ISO

Its products

Main products are the International Standards Technical Reports

(e.g., ISO/IEC TR 19791:2006) (e.g., ISO/TS 16949:2009)

(ISO 9000)

Technical Specifications Technical Corrigenda

standards)

(e.g., ISO/IEC 13818-1:2007/Cor 1:2008)

Guidelines (a guidance to technical committees for the preparation of

ISO

Its family of standards & Portfolio

 Developed over 18500 international standards on wide variety of subjects  About 1100 new standards are published every year  The ISO Portfolio
Agriculture Building construction Environmental protection Food technology Health technologies Oil & Gas Plastics Ship building

ISO 9000

Quality management system

ISO 9000 family of standards deals with the fundamentals of quality management system

It is based on the eight quality management principles

Principle 1: Principle 2: Principle 3: Principle 4: Principle 5: Principle 6: Principle 7: Principle 8: Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships

 

Describes the use of process approach for continual improvement Deals with the requirements that organizations wishing to meet the standard have to fulfill

ISO 9000

Quality management system

The ISO 9000 family addresses "Quality management". This means what the organization does to fulfill: The customer's quality requirements, Applicable regulatory requirements, while aiming to Enhance customer satisfaction, and

Achieve continual improvement of its performance in pursuit of these objectives

ISO 9000

Quality management system

ISO 9000

Quality management system

 ISO 9000 is composed of 5 different, but related parts ISO 9000, 9001, 9002, 9003 and 9004  ISO 9000 and 9004 are guidelines, while ISO 9001, 9002, and 9003 are the categories in which a company may apply for certification.  ISO 9000: Quality Management and Quality Assurance Standards Guidelines for Selection and Use . Written in order to determine which category your organization should apply for.  ISO 9001: Quality Systems Model for Quality Assurance in Design/Development, Production, Installation, and Servicing. This is the category for companies which are involved in manufacturing or the creation and delivery of a service.  ISO 9002: Quality Systems Model for Quality Assurance in Production and Installation. Companies who perform many functions, with the exception of design and development, may apply to this category.

ISO 9000

Quality management system

 ISO 9003: Quality Systems Model for Quality Assurance in Final Inspection and Test.This category is useful for outside of the manufacturing sector, such as in distributors ISO 9003 is being used less and may be dropped in the future.  ISO 9004: Quality Management and Quality System Elements Guidelines. Used in order to help interpret the categories included in ISO 9000 certification.  The most widely used standards are the latest version of 9000 series, i.e. ISO 9001:2008 and ISO 14001

ISO 9000

The 8 management principles

ISO 9000

The Process Approach

Plan Act

check Do

ISO 9000

The Documentation Pyramid

ISO 9000

Audit & Certification Process

 Auditing Process
Internal audit by trained staffs or hired consultants External audit by certification bodies (bureau veritus)

 Auditing findings
Major Non-Compliances (to be rectified before recommendation) Minor Non-Compliances (does not affect the recommendation)

 Certification (valid only for 3 years)  Surveillance (audits will be conducted every year)  Re-certification (at the end of 3rd year)

ISO 9000

Steps for implementation

1. Get the Big Picture 2. Evaluate Your Quality System and Start The Implementation Project 3. Develop The Implementation Plan And Quality Goals 4. Create The Documentation Control Procedures 5. Create The Corrective and Preventive Actions System 6. Generate A Quality Manual 7. Start Training Employees and Maintaining Training Records 8. Inventory and Customer Fulfillment Documentation 9. Purchasing Control Documentation 10. Maintaining Nonconforming Materials 11. Design Control 12. Calibration And Maintenance Of Equipment 13. Detailed Work Instructions 14. Management Review 15. Internal Audit And Closure 16. The Certification Audit 17. Continuous Improvement

ISO 9000

Its benefits

 Creates a more efficient, effective operation  Increases customer satisfaction and retention  Reduces audits  Enhances marketing  Improves employee motivation, awareness, and morale  Promotes international trade  Increases profit  Reduces waste and increases productivity.

ISO 9000

Pitfalls

 Common criticism of ISO 9001 is the amount of money, time, and paperwork required for registration  Only for documentation  ISO 9001 promotes specification, control, and procedures rather than understanding and improvement  ISO 9000 is effective as a guideline, but that promoting it as a standard "helps to mislead companies into thinking that certification means better quality  Prone to failure when a company is interested in certification before quality  Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality  Certificate on the wall, chances are you will create a paper system that doesn't have much to do with the way you actually run your business

ISO 9000

A case study of TVS Motor Company

1. Management decides to go for QMS for the reasons of achieving the business results in a more systematic manner. 2. Top management decides on the QMS model, i.e. ISO or EFQM or etc.. 3. It decides on the certification bodies, i.e. BVCI, BSI etc.. 4. Appointing an ISO consultant for grooming the industry. It is done by evaluation of background, history etc.. 5. Conduct top management awareness program on QMS, TS 16949 6. Formation of task force, MR appointment and kick-off is done. Representative from each department. 7. Fix the target date for certification 8. Chalk out a milestone on a broader perspective. 9. Derive mission, Q policy, business objectives and cascading matrix for all functions of the company. 10. Prepare Quality manual for the company. 11. Prepare process maps for all process functions in all departments(process approach) 12. Derive Quality System Procedure(QSP) for all departments. 13. Prepare Quality system work instructions, guidelines. 14. Measure the current status of output and make records of it with respect to the standards

ISO 9000

A case study of TVS Motor Company

15. Align to company's objectives and confirm with the respective departments. 16. Once system is created, TS training is conducted across the company at all levels 17. Conduct self-audit and compare with respect to the standards created. 18. If there is a gap, try to bridge it by improving the standard or the process. 19. Conduct audit by 2nd party, i.e. Internal auditors 20. Conduct friendly audit by auditors from the certification body 21. Understand the audit findings and fill the gap if any 22. Apply for the certification body for final certification 23. Fix the dates for audit 24. Followed by Preliminary audit 25. Fill the gap by the timelines given by the certifying authority 26. Followed by the final audit 27. Findings of final audit will be in the form of Major & Minor NCR and observations/guidelines 28. Disposition of NCRs and call for verification. 29. Certification (valid only for 3 years) ISO/TS 16949, ISO 14001 30. Surveillance audit (once in a year) 31. Recertification at the end of 3rd year and so the cycle continues..

ISO 9000

A case study of TVS Motor Company

 Time lines for implementation

Started the TS process in 2002 ISO/TS 16949 Certification done in 2006 Re-certification in 2009 Due for re-certification in 2012

 Cost of the certification process

Initial cost was 10 lakhs INR/year Subsequently 3-4 lakhs INR/year Towards certifications fees, auditor s expenses etc..

ISO 9000

Sample minor NCR

NON CONFORMITY REPORT (SF 02E)

The independent certification body of Bureau Veritas

DATE

ORGANIZATION

FILE REF

REPORT NO

TVS MOTOR COMPANY LIMITED 21-Aug-07 Corporate scheme - Manufacturing site 2

NON CONFORMITY OBSERVED DURING NON CONFORMITY OBSERVED IN PROCESS FINDING (NONCONFORMITY)

177.46 RKS 05/08

SURVEILLANCE AUDIT 1 PED

It is observed that 53 dimensions out of 86 identified dimensions are not capable in relation to project U 86 requirements of process capability of 1.67. There is no evidence of a strategic action plan to achieve the capability requirements
ISO/TS 16949:2002 - SECTION AND REQUIREMENT 8.2.3.1 - Monitoring and measurement of manufacturing processes: The organization shall maintain manufacturing process capability or performance as specified by the customer part approval process requirements. The organization shall ensure that the control plan and process flow diagram are implemented, including adherence to the specified measurement techniques, sampling plans, acceptance criteria, and reaction plans when acceptance criteria are not met. Significant process events, such as tool change or machine repair, shall be recorded.

DESCRIPTION OF OBJECTIVE EVIDENCE

GRADE

LEAD ASSESSOR

ASSESSOR

ORGANIZATION REP.

minor nonconformity
TO BE COMPLETED BEFORE (max. 80 days)

Rajendra Kumar Sharma

Rajendra Kumar Sharma

Mr. Raghavendra

09-Nov-07

ISO 9000

Sample minor NCR

INCIDENT SPECIFIC CORRECTIVE ACTION (What is done to solve this problem)

TO BE COMPLETED BY THE ORGANIZATION

ROOT CAUSE ANALYSIS. Determine what caused the failure in the system to allow this nonconformity to occur. Ask yourself 5 times: "Why". (Multiple causes may exist - do not reword the auditor's nonconformity description)

CORRECTIVE ACTION (What is done to prevent recurrence)

DATE OF COMPLETION VERIFICATION OF CORRECTIVE ACTION

ORGANIZATION REPRESENTATI VE

Mr. Raghavendra

TO BE COMPLETED BY BVQI

RESULT VERIFICATION OF THE CORRECTIVE ACTIONS VERIFICATION OF CORRECTIVE ACTION ASSESSOR DATE

RESULT EFFECTIVENESS OF THE CORRECTIVE ACTIONS

VERIFICATION EFFECTIVENESS OF THE CORRECTIVE ACTIONS

ASSESSOR

DATE
ISO/TS 16949:2002 SF B02/15.01.06