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ISO Quality Systems

A TOOL FOR QUALITY IMPROVEMENT

S K Sharma, DGM(E) & MR ONGC Academy

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ISO Quality Systems

International Organization for Standardization (ISO)
Originated in 1926 as the International

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Federation of the National Standardizing Associations (ISA).

Focused heavily on Mechanical Engineering.

Disbanded in 1942 during the Second World War. Re-organized under the current name, ISO, in 1946 with delegates from 25 countries. ISO' is a Greek term meaning 'equal'.
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ISO Quality Systems

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Objective: To facilitate the international coordination and unification of industrial Standards Operations started Membership : 23 Feb.1947 in Geneva, Switzerland : voluntary, 164 Members out of 205 countries.

Indian representative : Bureau of Indian Standards (BIS)

Functioning Through Technical Committees (TCs)

TC/ 176 assigned for Quality Management Systems Official Languages : French, English and Russian
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ISO Quality Systems

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Members Correspondent Members Subscriber members Places with ISO 3166-1 code who are not members of ISO
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ISO Quality Systems

ISO has three membership categories:

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Member bodies : National Bodies that are considered to be the most representative standards body in each country. Only members of ISO having voting rights. Correspondent members: Countries having no standards organization, do not participate in standards promulgation. These members are informed about ISO's work. Subscriber members : Countries with small economies, pay reduced membership fees, can follow the development of standards. Participating members are called "P" members as opposed to observing members which are called "O" members.
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ISO Quality Systems

Features of the ISO 9000 family

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International consensus on good quality management practices.

Provides a set of standardized requirements for a quality management system.

Certification is not a compulsory requirement. Provides a Tried and Tested framework for a systematic approach to manage the organization's processes for consistently turning out product satisfying customers expectations Lays down what requirements ones quality system must meet, but does not dictate how it should be met
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ISO Quality Systems

Features of the ISO 9000 family

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Facilitates Organization in doing its business in an Orderly and Structured manner.

Efficient utilization of Time, Money and Other resources

Good management practices available to organizations of all sizes & sectors everywhere in the world

Integrates with the world economy

ISO Quality Systems Quality Perceptions Customer satisfaction/ delight Conformance to requirements (Crossby-1974) Fitness for use (JURAN-1974) Value for money Zero defects Guarantee of confidence Quality is what the customer wants Efficiency and productivity On time delivery Systematic approach to excellence 8 Excellence in output

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ISO Quality Systems Quality Perceptions

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Never-ending cycle of improvement Consistently producing conforming product Credibility Quality is the totality of features and characteristics of a product or service that bear on its ability to satisfy both stated and implied needs (ISO 9000-1994) Degree to which a set of inherent characteristics fulfils requirements (ISO 9000:2000)

Quality is all of the above

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ISO Quality Systems Customer Expect Quality Because They Want... Product or service that is reliable To meet their requirements Value for money No hassle Quality Provides... Work enjoyment/ Job satisfaction Respect Hassle and stress free environment Job security Pride for the organization

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Total quality is a marathon and not a sprint Total quality is a marathon and not a sprint

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Quality is an endless journey...

Quality is an endless journey...

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ISO Quality Systems

Features of the ISO 9000 family

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FIRST PUBLISHED FIRST REVISION SECOND REVISION THIRD REVISION

: 1987 : 1994 : 2000 : 2008

ISO 9001 and ISO 9004 are quality management system standards designed to compliment each other but can be used independently also. ISO 9001: specifies requirements for a QMS for internal application by organisations, or for certification or for contractual purposes. It focuses on the effectiveness of QMS in meeting customers requirements. ISO 9004: is under revision, provides wider focus on quality management than ISO9001 and provides guidance to management to achieve SUSTAINED success in a complex, ever changing and demanding environment
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ISO Quality Systems

Features of the ISO 9000 family

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ISO 9001:2008 :

Developed to introduce clarifications to the existing requirements of 9001:2000 and to improve compatibility with ISO 14001:2004. Does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.

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ISO Quality Systems

ISO 9001:2008 MAIN ASPECTS

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Quality Management is what an organization does to

fulfill: Customer's quality requirements Applicable regulatory requirements Enhance customer satisfaction and Achieve continual improvement of its performance in pursuit of these objectives. There is little directive in the series Each organization to establish its own procedures These are applicable, with only minimal interpretation to all types of industries
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ISO Quality Systems

QUALITY MANAGEMENT PRINCIPLES

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1. CUSTOMER FOCUSED ORGANIZATION Organization depends on their customers & therefore must understand their current & future needs , strive to meet and exceed their expectations. 2. LEADERSHIP Leadership establishes unity of purpose & direction of the Organization, create internal environment in which people involve themselves fully to achieve objectives of the Organization. 3. INVOLVEMENT OF PEOPLE People are the most important and prized resources of an Organization. Their full involvement enables their abilities to be used for the benefit and betterment of the Organization. 16

ISO Quality Systems

QUALITY MANAGEMENT PRINCIPLES

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4. PROCESS APPROACH
A desired result is achieved more efficiently when related Resources and Activities are managed as a process.

5. SYSTEM APPROACH TO MANAGEMENT

Identifying, Understanding & Managing a system of interrelated processes of a given Objective which contributes to the Effectiveness & Efficiency of the Organization. 6. CONTINUAL IMPROVEMENT Continual improvement should be a permanent Objective of the Organization.
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ISO Quality Systems

QUALITY MANAGEMENT PRINCIPLES

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7. FACTUAL APPROACH TO DECISION MAKING

Effective decisions should be based on the logical

& intuitive analysis of data and information.
8. MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIP

Mutually beneficial relationship between the Organization & its Suppliers enhances the ability of both the Organizations to create value.
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ISO Quality Systems

Advantages of Quality System implementation

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Marketing Advantage & International Acceptance.

Clarity of customer requirements. Edge over competitors who are not accredited. Clarity of roles and responsibilities. Effective Management Control. Increased Customer Confidence. Clear business objectives. Control over the quality of operations - Cutting the cost of poor quality. Measurement of processes & means for corrective action.
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ISO Quality Systems

Advantages of Quality System implementation

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Increased transparency and accountability

Assurance on the quality of suppliers and the

products and services they supply

Education and training of companys Personnel

Effective working methods A framework for improvement Employee Morale
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ISO Quality Systems

ISO Certification : The Five Steps

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INITIATION PLANNING DOCUMENTATION IMPLEMENTING ESTABLISHING

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ISO Quality Systems -Initiation

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General Requirements of Quality Management System

The organization shall establish, document, implement and maintain a Quality Management System and continually improve its effectiveness in accordance with the requirements of International Standards. The organization shall:
Determine the process needed for QMS Determine the sequence and their interaction Determine criteria and methods for effective operations and control Ensure availability of resources to support operation and monitoring of process Monitor, Measure and Analyse the processes for achieving continual improvements
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ISO Quality Systems

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Essential : Managements Commitment - Appointment of MR - Constitution of steering committee - Designing quality policy & objectives - MRM Awareness & Involvement of every Employee through orientation programs. Training of Personnel: Documentation, Internal & Lead auditors training & other trainings for knowledge up gradation and skill development.
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ISO Quality Systems-Planning

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Top management to ensure that : Quality objectives including those needed to meet requirements for the product are established at relevant functions and levels within the organisation. The quality objectives shall be measurable and consistent with the quality policy. QMS Planning is done to meet the requirements of QMS Integrity of QMS is maintained Responsibility, Authority and Communication is well defined Management Review (MRM): Review Input- Results of audit, customer feedback, process performance and product conformity, corrective/preventive actions, last MRM review, suggestions for further improvements and Review Outputimprovements of the effectiveness of the QMS and its processes Resource Management: Manpower competence, Trainings, awareness, Infrastructure, Work environment, Finance & purchase etc Customer related Processes: Determination and review of product related requirements, Design, development, customer feedback and review etc Measurement, Analysis and improvement : Customer satisfaction, Internal Audit, monitoring and measurement of process and product, control of non conforming product, Analysis of data, corrective and preventive actions for improvement
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ISO Quality Systems-DOCUMENTATION

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Documentation in quality management is a set of quality

management policies, plans & procedures needed to have a system dependent organization instead of person dependent organization. Quality Management System of a company is certified against ISO 9001:2008 (As on today) which specifies the requirement for documented procedures, work instructions and quality manual.

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ISO Quality Systems-DOCUMENTATION

WHY- Documentation

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Documentation brings the predictability, visibility & transparency and therefore Verifiability. Documentation leads to systematic working & provides relief from ad-hoc Management. Gives assurance to senior management that a tool/ framework exists for good management control. Ensures retention of past experience & knowledge. Means of communication & eliminate ambiguity. Documentation is the evidence of managements commitment to quality.
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ISO Quality Systems-Documentation

Preparation of Documents Quality Manual Quality Procedure Manual, Work Instructions / Operating formats Implementation of Quality System Establishment of Quality Management System Conduction Of Internal Quality Audits Finalization Of Certifying Agency for External Audit External Audit Documentation review audit Pre-assessment audit Final audit Recommendations Corrective Action Plan ISO-9001 Certification

Oct,2012

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ISO Quality Systems

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DOCUMENTED QUALITY SYSTEM

LEVEL 1

MANUALS

LEVEL 2

PROCEDURES JOBS/ WORK INSTRUC TIONS RECORDS

LEVEL 3

LEVEL 4 DEPT1 Fn1 DEPT2 Fn2 DEPT3 Fn3 QA QUALITY DEPT4 DEPT5 Fn5 DEPT6 Fn6

Fn4

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ISO Quality Systems

DOCUMENTATION : Quality Manual

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PURPOSE Package to give assurance to a prospective client and appraisal agencies. Provides guidelines to the managers/ all employees for operating and maintaining a system. Evidence of commitment of top management to quality for certifying agency & customers(Internal & External Auditors) CONTENTS The scope of QMS including details of any exclusion. The documented procedures established for QMS or reference to them A description of the interaction between the process of QMS It must address all the clauses. It shows management structure, responsibilities with regard to quality assurance and an outline of how the company operates to ensure compliance with the requirements of a standard. 29

ISO Quality Systems

DOCUMENTATION : Quality Procedure Manual

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Guidelines/Instructions for the employees for work so that the policies and objectives expressed in the quality manual are translated into activities.
Procedures are simply formalized statements of established working practices, followed within the company. In other words, the procedure lays down what is to be done.

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ISO Quality Systems

DOCUMENTATION : Mandatory Procedures

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1. 2. 3. 4. 5. 6.

Procedure for Control of Documents Procedure for Control of Records Procedure for Control of Non-Conformities Procedure for Internal Audit Procedure for Corrective Action Procedure for Preventive Action

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ISO Quality Systems

DOCUMENTATION : Work Instructions/Formats

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Instruction for carrying out any specific activity Staff responsibility for each and every activity and they must contain: Scope / process / product / activity affected Responsibility Action required Issue and control Approving authoritys signature

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ISO Quality Systems

DOCUMENTATION : Records

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Provide objective evidence of the QMS Procedure manual should include a procedure / work instruction on what records are maintained Practically all clauses spell out the records which are to be maintained Typically records that should be kept are: Management review agenda & minutes (5.6.1) Audit reports & results of corrective action Supplier assessments reports & approval lists. Inspection reports
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ISO Quality Systems

DOCUMENTATION : Records

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Test data Qualification reports Calibration data Records of education, skill & experience of employees Results of Product Review and actions arising out of the review Design Development Review Records of Design verification Design validation records Records of Traceability Control of Monitoring and Measuring Devices
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ISO Quality Systems

ACCREDITATION & CERTIFICATION :

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QUALITY COUNCIL OF INDIA ACCREDITATION BODY OF INDIA 31 MEMBERS CHAIRPERSON NOMINATED BY PRIME MINISTER

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ISO Quality Systems

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AUDITS
ADEQUACY COMPLIANCE

INTERNAL AUDIT FIRST PARTY AUDIT

EXTERNAL AUDIT SECOND PARTY AUDIT THIRD PARTY AUDIT
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ISO Quality Systems

PHASES OF THE THIRD PARTY AUDIT

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ADEQUACY AUDIT:
Also known as System Audit, Documentation Audit or Management Audit ,determines the extent to which the document system represented by the Quality Manual and associated Procedures adequately meet the requirements of applicable standards.

COMPLIANCE AUDIT:
Audit which seeks to establish the extent to which documented system is implemented and observed by the work force i.e. Are people complying with the system ?

SURVEILLANCE AUDIT:
After initial certification of the company, the certification bodies carry out the surveillance audit of the quality systems normally twice a year to ensure that the auditee organization is continuing to maintain the quality system in accordance with the term of certification.
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QMS-ONGC Academy

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1. Document the way your activities are done (required to be done). 2. Do your activities the as documented. 3. Measure the output of activities.. 4. Take the customers feedback on product 5. Compare the out put with targets set and customers feedback. 6. Identify remedial measure and take necessary action.. Document it 7. Keep repeating 5 &6 as and when needed.. 8. Audit as planned & Implement the audit recommendations as per MRM decision.
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QMS-ONGC Academy

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INTERFACE BETWEEN VARIOUS PROCESSES OF TRAINING & DEVELOPMENT

Asset Managers/ Basin Managers/ Head RO / Head Institutes/ Chief of Services Trg. Needs & Designing Annual Training Calendar (By MPC) Heads/ In-charges F/G & Coordinators

Faculty / Trg. Agencies

Prog. Design & Development of Course Material

Customer Representative

Faculty/ Trg. Agencies

Programme Coordination (by Coordinators)

Finance & Accounts

Administrative Services (HR) Feedback Mechanism (By Coordinators and Group In-charges)

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ISO Quality Systems

Documentation Requirements

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Documented statement of a Quality Policy and Quality Objectives. Quality Manual Documented Procedures and Records and Documents including records

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QMS-ONGC Academy

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QUALITY POLICY: ONGC Academy is committed to improve knowledge and skills of its customers through continual improvement in effectiveness, quality and reliability of its process of QMS and products through involvement of its employees

QUALITY OBJECTIVES: To achieve improve feedback rating of at least 86% of the trainings from 6.5 to 7.5(Scale1-9) by March 2014. To put in-place an online system of knowledge enhancementPerformance support by March 2012. Training through e-Learning modules by 2015. To improve classroom and auditorium and foyer facilities by 41 March 2015.

QMS-ONGC Academy
Management Review Meeting (MRM)

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Conducted for periodic reviews of Quality System to determine its effectiveness and area of improvement. Conducted by Steering committee consisting of: Chairman : HOI- ONGC Academy Co-Chairman : Next senior officer Members : Group heads, MR & Dy. MRs and MPC. May also include In-charges of-Finance, MM, HR-ER Periodicity : At least once in six months. Members of steering committee to be informed at least 7 days in advance.
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QMS-ONGC Academy
Management Review Meeting (MRM)

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Agenda : Review of previous MRM. MR report on effectiveness and suitability of Q. System Review of corrective actions and its effectiveness. Review of Internal Q Audit, closure of NC/Observations. Assessment of results of statistical techniques applied & corrective actions for quality improvement. Review of training system-TNI to ATC. Review of customer complaints& Feedback Review of Quality Planning suggestions. These are essential points of MRM Agenda. 43

QMS-ONGC Academy
Management Review Meeting (MRM

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Review of Quality Procedures to ascertain its adequacy- Once in two years. Suitability of Quality Policy and Objectives. Resources required and its effective utilization Review of stock Maintenance , inventory control purchase process & status etc.

Upkeep of building, Hostel, Library etc.

Review of performance of suppliers, Training agencies/Faculties.

Any other suggestion effecting the quality

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QMS-ONGC Academy

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Deliberations of MRM are recorded with identification of action to be taken, authority responsible for execution and a time frame. MR to circulate the MRM minutes within 5 days of MRM. Follow up within 15 days of MRM.

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Quality is an endless journey...

Quality is an endless journey...

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Total quality is a marathon and not a sprint Total quality is a marathon and not a sprint

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THANKS FOR YOUR ATTENTION

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