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ISO 9001:2008

Awareness Program

Purpose of Program
Awareness of ISO 9001:2008. Self Improvement Improvements in routine working To improve the health of organizations Quality Management System

FAQ?
What

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

Contents Of Program
Background of ISO ISO Family Quality Management Principle Process Approach ISO 9001:2008 Overview Detail Of Different Clauses Of ISO 9001:2008

What is ISO 9001:2008?


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.

Who created the standard?


International Organization for Standardization - Geneva Standards created in 1987 To eliminate country to country differences To eliminate terminology confusion To increase quality awareness

ISO 9000:2005 Consists of 3 Areas


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, improvement ISO 9004-2009 Quality Management Systems Guidelines for performance improvement

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

Generic standards (cont.)


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

Certification and registration


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

Accreditation

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

Certification not a requirement


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

Certification is a business decision


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

Ten Steps to ISO Registration


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

What is a Quality Management System?

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

Operating Cycle of ISO.

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, establish your overall objectives and set your interim targets, and develop plans to achieve them). Do implement your plans (do what you planned to). Check measure your results (measure/monitor how far your actual achievements meet your planned objectives). 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).

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

Management Principles

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

8 Management Principles

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


Organizations depend on their customers & therefore should understand current & future customer needs, should meet customer requirements & strive to exceed customer expectations

Principle 2 : Leadership

Leaders establish unity & direction of the organization. They should create & 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 utilized for the organization's mutual benefit.

Principle 4 : Process Approach

The application of a system of processes within an organization, together with the identification and interaction of these processes, and their management to produce the desired outcome, can be called Process Approach

Principle 5 : System approach to management

Identifying, understanding & managing interrelated processes as a system contributes to the organization's effectiveness & efficiency in achieving its objectives.

Principle 6 : Continual Improvement

Continual Improvement of the organization's overall


performance should be the primary driver of the organizations Quality Management System.

Continuous Improvement

Continual Improvement

Principle 7 : Factual approach to decision making

Effective decisions are based on the analysis of data & information

Principle 8 : Mutually beneficial supplier relationships

An organization & its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value

Clauses of ISO 9001-2008


1.Scope 2.Normative References 3.Term & Definitions 4.Quality Management System 5.Management Responsibility. 6.Resources Management 7.Product Realization 8.Measurment,Analysis and Improvement

SCOPE OF STANDARD
1. Scope General
Application

2. Normative reference 3. Terms and definition e.g., Supplier Organization Customer

QUALITY MANAGEMENT SYSTEM REQUIREMENTS


4.1 General requirements Document, implement, maintain and continually improve Identify and determine sequence and interaction of processes Determine criteria and methods needed Ensure availability of resources Monitor, measure and analyze processes Implement actions to achieve planned results

QUALITY MANAGEMENT SYSTEM REQUIREMENTS


4.2 Documentation requirements Management system documentation Quality Manual Control of documents Control of records

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

MANAGEMENT RESPONSIBILITY
5.1 Management commitment 5.2 Customer focus 5.3 Quality policy Must be documented Must be used for setting objectives 5.4 Planning Document objectives- Must be Measurable Quality management system planning

MANAGEMENT RESPONSIBILITY 5.5 Responsibility, authority and communication


Responsibility and authority Management representative Internal communication

MANAGEMENT RESPONSIBILITY 5.6 Management Review


General Review input Review output

RESOURCE MANAGEMENT
6.1 Provision of resources 6.2 Human resources General Competence, awareness and training 6.3 Infrastructure 6.4 Work environment

PRODUCT REALIZATION
7.1 Planning of product realization 7.2 Customer-related processes
Determination of requirements related to the product Review of requirements related to the product Customer communication

PRODUCT REALIZATION
7.3 Design and development
Planning, inputs, outputs, systematic reviews, verification and validation, control of changes

7.4 Purchasing
Supplier evaluation and selection Relevant purchasing information Verification of purchased product - receiving, source

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

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

MEASUREMENT, ANALYSIS, AND IMPROVEMENT


8.1 General 8.2 Monitoring and measurement Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of product

MEASUREMENT, ANALYSIS, AND IMPROVEMENT


8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement Continual improvement Corrective action Preventive action

Any Questions or Query?

Thanks
Varinder Sandhu Abhived Bhardwaj Balram Sharma