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ISO 9001:2008

Awareness Program

Purpose of Program
Awareness of ISO 9001:2008. ¾ Self Improvement ¾ Improvements in routine working ¾ To improve the health of organization’s Quality Management System
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FAQ?
¾ What

is ISO? ¾ From where it comes? ¾ How it is helpful for us? ¾ How it works? ¾ What we have to do?

Contents Of Program
Background of ISO ¾ ISO Family ¾ Quality Management Principle ¾ Process Approach ¾ ISO 9001:2008 Overview ¾ Detail Of Different Clauses Of ISO 9001:2008
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.What is ISO 9001:2008? ¾ ¾ ¾ ISO = International Organization for Standardization ISO has representation from 162 countries and has issued many standards ISO 9001:2008 is a model for a quality management system.

Geneva Standards created in 1987 ƒ To eliminate country to country differences ƒ To eliminate terminology confusion ƒ To increase quality awareness .Who created the standard? ¾ ¾ International Organization for Standardization .

improvement ISO 9004-2009 Quality Management Systems – Guidelines for performance improvement .ISO 9000:2005 Consists of 3 Areas ¾ ¾ ¾ ISO 9000:2005 Quality Management Systems: fundamentals and vocabulary ISO 9001:2008 Quality Management Systems – Requirements (required for certification) Management responsibility Resource management Product/service realization Measurement. analysis.

or a government department. ¾ in any sector of activity. . large or small. Generic means that the same standards can be applied: ¾ to any organization. whatever its product or service. a public administration. and ¾ whether it is a business enterprise.Generic standards ISO 9001 is a generic standards.

) Generic also signifies that ¾ no matter what the organization's scope of activity ¾ if it wants to establish a quality management system. ISO 9001 gives the essential features .Generic standards (cont.

. It means that an independent. ISO does not carry out certification and does not issue or approve certificates.Certification and registration ¾ ¾ ¾ Certification is known in some countries as registration. external body has audited an organization's management system and verified that it conforms to the requirements specified in the standard (ISO 9001).

Accreditation ¾ ¾ ¾ ¾ Accreditation is like certification of the certification body. It means the formal approval by a specialized body an accreditation body . ISO does not carry out or approve accreditation. .and known as accredited certificates .may be perceived on the market as having increased credibility.that a certification body is competent to carry out ISO 9001:2008 certification in specified business sectors. Certificates issued by accredited certification bodies .

The organization can implement them for the internal benefits without spending money on a certification programme. The organization can implement and take benefit from an ISO 9001 system without having it certified. .Certification not a requirement ¾ ¾ ¾ Certification is not a requirement of ISO 9001.

.Certification is a business decision ¾ ¾ ¾ ¾ Certification is a decision to be taken for business reasons: if it is a contractual. regulatory. If it meets customer preferences if it will motivate staff by setting a clear goal. or market requirement.

Submit quality manual for approval 5. Registration! 9. Select the appropriate standard 1. Final assessment by registrar 8.Ten Steps to ISO Registration 10. Take corrective actions 7. Perform self-analysis audit 4. Select a third-party registrar and apply 3. Develop and implement the quality system 2. Set the registration objective . Pre-assessment by registrar 6.

.What is a Quality Management System? ¾A Quality Management System is a web of interconnected processes that are used to manage a business.

establish your overall objectives and set your interim targets. ¾ The Plan – Do – Check – Act (PDCA) cycle is the operating principle of ISO's management system standards Plan – establish objectives and make plans (analyze your organization's situation. ¾ ¾ ¾ ¾ . Check – measure your results (measure/monitor how far your actual achievements meet your planned objectives). Do – implement your plans (do what you planned to).Operating Cycle of ISO. Act – correct and improve your plans and how you put them into practice (correct and learn from your mistakes to improve your plans in order to achieve better results next time). and develop plans to achieve them).

ISO 9001:2008 CONTINUAL CONTINUALIMPROVEMENT IMPROVEMENTOF OFTHE THEQUALITY QUALITY MANAGEMENT MANAGEMENTSYSTEM SYSTEM Management responsibility Customers Clause 6 Clause 5 Customers Resource Resource management management Measurement. analysis and improvement Clause 8 Satisfaction Input Requirements Product realization Clause 7 Value adding activities Information flow Output Product Product .

PROCESS REQUIREMENTS With What? (Materials / Equipment) Objectives and Targets WHO? Special Skills? / Competence? Inputs Process Outputs How? (Methods / Procedure) Process Linkages Measure .

for leading and operating an organization.Management Principles ¾ A Quality Management Principle is a comprehensive and fundamental rule or belief. . aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all stakeholders.

8 Management Principles ¾ ¾ ¾ ¾ ¾ ¾ ¾ ¾ Principle 1 : Customer Focus Principle 2 : Leadership Principle 3 : Involvement Of People Principle 4 : Process Approach Principle 5 : System approach to management Principle 6 : Continual Improvement Principle 7 : Factual approach to decision making Principle 8 : Mutually beneficial supplier relationships .

Principle 1 : Customer Focus ¾ Organizations depend on their customers & therefore should understand current & future customer needs. should meet customer requirements & strive to exceed customer expectations .

They should create & maintain the internal environment in which people can become fully involved in achieving the organization's objectives. .Principle 2 : Leadership ¾ Leaders establish unity & direction of the organization.

Principle 3 : Involvement Of People ¾ People at all levels are the essence of an organization and their full involvement enables their abilities to be utilized for the organization's mutual benefit. .

can be called “Process Approach” . and their management to produce the desired outcome. together with the identification and interaction of these processes.Principle 4 : Process Approach ¾ The application of a system of processes within an organization.

. understanding & managing interrelated processes as a system contributes to the organization's effectiveness & efficiency in achieving its objectives.Principle 5 : System approach to management ¾ Identifying.

Continuous Improvement Continual Improvement .Principle 6 : Continual Improvement ¾Continual Improvement of the organization's overall performance should be the primary driver of the organization’s Quality Management System.

Principle 7 : Factual approach to decision making ¾ Effective decisions are based on the analysis of data & information .

Principle 8 : Mutually beneficial supplier relationships ¾ An organization & its suppliers are interdependent. and a mutually beneficial relationship enhances the ability of both to create value .

Management Responsibility.Resources Management 7.Scope 2.Analysis and Improvement .Quality Management System 5. 6.Clauses of ISO 9001-2008 ¾ ¾ ¾ ¾ ¾ ¾ ¾ ¾ 1.Normative References 3.Term & Definitions 4.Measurment.Product Realization 8.

Normative reference 3. Terms and definition e. Scope ‰ General ‰ Application 2.g.SCOPE OF STANDARD 1.. Supplier Organization Customer .

1 General requirements ¾ Document. maintain and continually improve ¾ Identify and determine sequence and interaction of processes ¾ Determine criteria and methods needed ¾ Ensure availability of resources ¾ Monitor.QUALITY MANAGEMENT SYSTEM REQUIREMENTS 4. implement. measure and analyze processes ¾ Implement actions to achieve planned results .

2 Documentation requirements ¾ Management system documentation ¾ Quality Manual ¾ Control of documents ¾ Control of records .QUALITY MANAGEMENT SYSTEM REQUIREMENTS 4.

QUALITY SYSTEM DOCUMENTATION STRUCTURE Quality Manual Procedures Work Instructions Machine instructions ‹ Computer inputs ‹ Detailed work instructions ‹ 1st Level Policy and Objectives 2nd Level 3rd Level What the company wishes to achieve How the company implements its policy Structured to reflect process flow of events Detailed instructions How to complete a job or task Technical Data International standards ‹ Computer operating manuals ‹ Detailed product specifications ‹ 4th Level .

4 Planning ¾ Document objectives.MANAGEMENT RESPONSIBILITY 5.3 Quality policy ¾ Must be documented ¾ Must be used for setting objectives 5.2 Customer focus 5.Must be Measurable ¾ Quality management system planning .1 Management commitment 5.

authority and communication ¾ Responsibility and authority ¾ Management representative ¾ Internal communication .5 Responsibility.MANAGEMENT RESPONSIBILITY 5.

MANAGEMENT RESPONSIBILITY 5.6 Management Review ¾ General ¾ Review input ¾ Review output .

1 Provision of resources 6.4 Work environment .RESOURCE MANAGEMENT 6. awareness and training 6.3 Infrastructure 6.2 Human resources ¾ General ¾ Competence.

PRODUCT REALIZATION 7.2 Customer-related processes ¾ Determination of requirements related to the product ¾ Review of requirements related to the product ¾ Customer communication .1 Planning of product realization 7.

control of changes 7. systematic reviews. inputs. source .PRODUCT REALIZATION 7. outputs. verification and validation.4 Purchasing ¾ Supplier evaluation and selection ¾ Relevant purchasing information ¾ Verification of purchased product .3 Design and development ¾ Planning.receiving.

monitoring and measuring devices.PRODUCT REALIZATION 7. work instructions (as necessary). delivery and post. monitoring and measurement. suitable equipment.delivery activities ¾ Validation of processes when no other method ¾ Identification and traceability of product and it’s status ¾ Care of customer property ¾ Preservation of product ¾Includes constituent parts .5 Production and service provision ¾ Controlled conditions including product characteristics. and release.

PRODUCT REALIZATION 7.6 Control of monitoring and measuring devices ¾Calibrated or verified where necessary ¾Adjusted and re-adjusted as necessary ¾Identified to enable calibration status ¾Safeguarded from invalid adjustment ¾Protected from damage and deterioration .

AND IMPROVEMENT 8.1 General 8.2 Monitoring and measurement ¾ Customer satisfaction ¾ Internal audit ¾ Monitoring and measurement of processes ¾ Monitoring and measurement of product . ANALYSIS.MEASUREMENT.

ANALYSIS.5 Improvement ¾ Continual improvement ¾ Corrective action ¾ Preventive action .3 Control of nonconforming product 8.4 Analysis of data 8. AND IMPROVEMENT 8.MEASUREMENT.

Any Questions or Query? .

Thanks Varinder Sandhu Abhived Bhardwaj Balram Sharma .