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ISO 9001 Presentation

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Page 1: ISO 9001.ppt
Page 2: ISO 9001.ppt

Discussion TopicsDiscussion Topics

Introduction to Quality and StandardizationIntroduction to Quality and Standardization

Evolution of Quality Management System Evolution of Quality Management System (ISO 9000)(ISO 9000)

Quality Management System - Requirements Quality Management System - Requirements (ISO 9001:2008)(ISO 9001:2008)

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Introduction to Quality and Standardization

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What is Quality after all?What is Quality after all?

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Quality…!Quality…!

‘‘Fitness for use’ – Juran Fitness for use’ – Juran

‘‘Conformance to requirements’ – Crosby Conformance to requirements’ – Crosby

‘‘Customer satisfaction/delight’ – DemingCustomer satisfaction/delight’ – Deming

‘‘Degree to which a set of inherent characteristics Degree to which a set of inherent characteristics fulfils requirements’ - ISO 9000:2000 fulfils requirements’ - ISO 9000:2000

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Customer SatisfactionCustomer Satisfaction

“ “ Degree to which the customer’s requirements have been Degree to which the customer’s requirements have been fulfilled ”fulfilled ”

Performance < 1 - DissatisfactionPerformance < 1 - Dissatisfaction Satisfaction = = 1 - SatisfactionSatisfaction = = 1 - Satisfaction Expectation > 1 - Delight Expectation > 1 - Delight

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StandardizationStandardization

The process of developing and agreeing upon Standards.

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Aims of StandardizationAims of Standardization Fitness for purpose Interchangeability Variety reduction Compatibility Guarding against factors that affect the

health and safety of consumers Environmental protection Better utilization of resources Better communication and

understanding Better communication and

understanding Removal of trade barriers

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Standard?

Standards are documented agreements containing technical specifications or precise criteria to be used consistently as a guideline of characteristics, to ensure that materials, products, processes and services are fit for their intended purpose.

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TYPES OF STANDARDSVocabulary standards:Glossaries, signs and symbols; A few examples are Paper Vocabulary, List of Equivalent Terms Used in the Plastic Industry, Vocabulary for the Refractory Industry and Vocabulary of Information Processing.

Measurement standards:Material measure or physical property that defines or reproduces the unit of measurement of a base or derived quantity. Such as units of measures; The seven basic units of the SI system e.g. meter, Kg, Ampere etc.

Product standards:Cover specifications for dimensions, performance, health, safety, environmental protection and documentation; Standards for inspection, test methods and analysis.

Management Standards:Standards that focus on organization, such as for logistics, maintenance, inventory management, quality management, project management and production management such as ISO 9000, ISO 14000, ISO 17025, SA 8000, HACCP etc.

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Attributes of a standard

A standard generally has three attributes:

1. Level: such as at the company, national or international level.

1. Subject: such as engineering, food, textile or management.

1. Aspect: such as specification, testing and analysis, packaging and labeling (more than one aspect may be covered in a single standard: a standard may include specification of items such as the product, its sampling and inspection, related tests and analysis, packaging and labeling).

For example the term “Pakistan Standard Specification of Biscuits”, means that the standard is a national standard (level), in the food area (subject), and provides specifications (aspect) for the biscuits.

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CALIBRATION

Infrastructure for Standardization in Pakistan

Standards InstitutePSQCA

Legal framework in Pakistan

LABORATORIES

Microbe Chemical Textile

TESTING SERVICES

System certifiers..

System auditors

System consultants

Laboratory accreditationISO 17025

Accreditation BoardPNAC

Legal metrology

ISO

OIML

BIPM

ENTERPRISES

Factory metrology

lab

Trade transaction

ILACIAF

CA

LIB

RA

TIO

N

NPSL

HACCP ISO14000 ISO 9000

An institution for training and monitoring Auditors

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Renowned Standardization BodiesRenowned Standardization Bodies

ISO International Organization for Standardization

ASTM American Society for Testing and Materials

DIN Deutsches Institut für Normung

EN European Norms

IEC International Electrotechnical Commission

BSI British Standards Institute

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CertificationCertification

1.1. Means Means ComplianceCompliance with a standard or with a standard or specification (e.g. Systems or Product specification (e.g. Systems or Product Standards).Standards).

2.2. May be May be general in the scopegeneral in the scope of of recognitionrecognition

3.3. Considers total business .Considers total business .

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AccreditationAccreditation

1.1. It means It means recognition of competencerecognition of competence in a in a specific area and scope.specific area and scope.

2.2. Its scope is highly Its scope is highly specificspecific..

3.3. Evaluates people, skills and knowledge.Evaluates people, skills and knowledge.

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Evolution of Quality Management Evolution of Quality Management System – ISO 9001:2008System – ISO 9001:2008

19871987 First Published – ISO 9001, 9002 & 9003First Published – ISO 9001, 9002 & 9003

19941994 First revision – ISO 9001, 9002 & 9003First revision – ISO 9001, 9002 & 9003

20002000 Second revision - ISO 9001Second revision - ISO 9001

20082008 Third revision – ISO 9001Third revision – ISO 9001

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Quality Management SystemQuality Management System

Management System to direct & control an organization Management System to direct & control an organization with regard to quality.with regard to quality.

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Quality management PrinciplesQuality management Principles

1. Customer focus1. Customer focus2.2. LeadershipLeadership3.3. Involvement of peopleInvolvement of people4.4. Process ApproachProcess Approach5.5. System approach to managementSystem approach to management6.6. Continuous ImprovementContinuous Improvement7.7. Factual approach to decision makingFactual approach to decision making8.8. Mutually beneficial supplier Mutually beneficial supplier relationshipsrelationships

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Quality Management Principle No.1Quality Management Principle No.1

Customer FocusCustomer Focus

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

Application of this principle is reflected in Application of this principle is reflected in ISO 9001:2008 clauses 5.2, 7.2.3 and 8.2.1ISO 9001:2008 clauses 5.2, 7.2.3 and 8.2.1

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Customer Focus...Customer Focus...

Application of this principle involves :Application of this principle involves : Researching and understanding customer needs Researching and understanding customer needs

and expectations.and expectations. Ensuring that the objectives of the organization are Ensuring that the objectives of the organization are

linked to customer needs and expectations.linked to customer needs and expectations. Communicating customer needs and expectations Communicating customer needs and expectations

throughout the organization.throughout the organization. Measuring customer satisfaction and acting on the Measuring customer satisfaction and acting on the

resultsresults Systematically managing customer relationships. Systematically managing customer relationships.

Ensuring a balanced approach between satisfying Ensuring a balanced approach between satisfying customers and other interested parties (such as customers and other interested parties (such as owners, employees, suppliers, financiers, local owners, employees, suppliers, financiers, local communities and society as a whole)communities and society as a whole)

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Quality Management Principle No.2Quality Management Principle No.2LeadershipLeadership

Leaders establish unity of purpose and Leaders establish unity of purpose and direction of the organization. They direction of the organization. They should create and maintain the internal should create and maintain the internal environment in which people can environment in which people can become fully involved in achieving the become fully involved in achieving the organization’s objectives.organization’s objectives.

This principle is reflected in ISO This principle is reflected in ISO 9001:2008 clauses 5.3, 5.4, 5.5, 6.1, 6.29001:2008 clauses 5.3, 5.4, 5.5, 6.1, 6.2

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Leadership...Leadership...

Application of this principle involvesApplication of this principle involves:: Considering the needs of all interested parties including Considering the needs of all interested parties including

customers, owners, employees, suppliers, financiers, customers, owners, employees, suppliers, financiers, local communities and society as a whole.local communities and society as a whole.

Establishing a clear vision of the organization’s future. Establishing a clear vision of the organization’s future. Setting challenging goals and targets.Setting challenging goals and targets.

Creating and sustaining shared values, fairness and Creating and sustaining shared values, fairness and ethical role models at all levels of the organization.ethical role models at all levels of the organization.

Establishing trust and eliminating fear.Establishing trust and eliminating fear. Providing people with the required resources, training Providing people with the required resources, training

and freedom to act with responsibility and accountability.and freedom to act with responsibility and accountability. Inspiring, encouraging and recognizing people’s Inspiring, encouraging and recognizing people’s

contributions.contributions.

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People at all levels are essence of an organization People at all levels are essence of an organization and their full involvement enables their abilities to be and their full involvement enables their abilities to be used for the organization’s benefit. This principle is used for the organization’s benefit. This principle is reflected in ISO 9001:2008 clauses 5.3(d) and 6.2.reflected in ISO 9001:2008 clauses 5.3(d) and 6.2.

Quality Management Principle No.3 Involvement of people

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Involvement of people...Involvement of people...

Application of this principle involves:Application of this principle involves: People understanding the importance of their People understanding the importance of their

contribution and role in the organization.contribution and role in the organization. People identifying constraints to their performance.People identifying constraints to their performance. People accepting ownership of processes and People accepting ownership of processes and

problems and their responsibility for solving them.problems and their responsibility for solving them.

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Involvement of people...Involvement of people...

People evaluating their performance against their People evaluating their performance against their personal goals and objectives.personal goals and objectives.

People actively seeking opportunities to enhance their People actively seeking opportunities to enhance their competence, knowledge and experience.competence, knowledge and experience.

People freely sharing knowledge and experience.People freely sharing knowledge and experience. People openly discussing problems and issues.People openly discussing problems and issues.

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A desired result is achieved more efficiently when A desired result is achieved more efficiently when activities and related resources are managed as a activities and related resources are managed as a process.process.

This principle is reflected in almost all clauses of This principle is reflected in almost all clauses of ISO 9001ISO 9001

Quality Management Principle No.4Process Approach

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Application of this principle involves:Application of this principle involves:

Systematically defining the activities necessary to obtain a desired Systematically defining the activities necessary to obtain a desired result.result.

Establishing clear responsibility and accountability for managing Establishing clear responsibility and accountability for managing key activities.key activities.

Analyzing and measuring of the capability of key activities.Analyzing and measuring of the capability of key activities.

Process Approach...

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Identifying the interfaces of key activities within and Identifying the interfaces of key activities within and between the functions of the organization.between the functions of the organization.

Focusing on the factors - such as resources, methods, Focusing on the factors - such as resources, methods, and materials - that will improve key activities of the and materials - that will improve key activities of the organization.organization.

Evaluating risks, consequences and impacts of Evaluating risks, consequences and impacts of activities on customers, suppliers and other interested activities on customers, suppliers and other interested parties.parties.

Process Approach...

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Identifying, understanding and managing inter-Identifying, understanding and managing inter-related processes as a system contributes to the related processes as a system contributes to the organization’s effectiveness and efficiency in organization’s effectiveness and efficiency in achieving its objectives. This principle is reflected in achieving its objectives. This principle is reflected in ISO 9001:2008clauses 4.1& 4.2.ISO 9001:2008clauses 4.1& 4.2.

Quality Management Principle No.5System approach to management

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System approach to management...System approach to management...

Application of this principle involves:Application of this principle involves: Structuring a system to achieve the organization’s Structuring a system to achieve the organization’s

objectives in the most effective and efficient way.objectives in the most effective and efficient way. Understanding the inter-dependencies between the Understanding the inter-dependencies between the

processes of the system.processes of the system. Structured approaches that harmonize and integrate Structured approaches that harmonize and integrate

processes.processes.

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System approach to management...System approach to management...

Proving a better understanding of the roles and responsibilities necessary for Proving a better understanding of the roles and responsibilities necessary for achieving common objectives and thereby reducing cross-functional barriers. achieving common objectives and thereby reducing cross-functional barriers.

Understanding organizational capabilities and establishing resource constraints Understanding organizational capabilities and establishing resource constraints prior to action.prior to action.

Targeting and defining how specific activities within a system should operate.Targeting and defining how specific activities within a system should operate. Continually improving the system through measurement and evaluation.Continually improving the system through measurement and evaluation.

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Continual improvement of the organization’s overall Continual improvement of the organization’s overall performance should be a permanent objective of the performance should be a permanent objective of the organization.organization.

This principle is reflected in ISO 9001 clause 8.5.This principle is reflected in ISO 9001 clause 8.5.

Quality Management Principle No.6Continual Improvement

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Continual Improvement...Continual Improvement...

Application of this principle involvesApplication of this principle involves:: Employing a consistent organization-wide approach Employing a consistent organization-wide approach

to continual improvement of the organization’s to continual improvement of the organization’s performance.performance.

Providing people with training in the methods and Providing people with training in the methods and tools of continual improvement.tools of continual improvement.

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Making continual improvement of products, Making continual improvement of products, processes and systems an objective for every processes and systems an objective for every individual in the organization.individual in the organization.

Establishing goals to guide, and measures to track, Establishing goals to guide, and measures to track, continual improvement.continual improvement.

Recognizing and acknowledging improvements.Recognizing and acknowledging improvements.

Continual Improvement...Continual Improvement...

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Effective decisions are based on the analysis of Effective decisions are based on the analysis of data and information.data and information.

This principle is reflected in ISO 9001:2008 This principle is reflected in ISO 9001:2008 clauses 5.4.1, 5.6.2, 7.3 and 8.4clauses 5.4.1, 5.6.2, 7.3 and 8.4

Quality Management Principle No.7

Factual approach to decision making

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Factual approach to decision makingFactual approach to decision making

Application of this principle involves:Application of this principle involves: Ensuring that data and information are sufficiently Ensuring that data and information are sufficiently

accurate and reliable.accurate and reliable. Making data accessible to those who need it.Making data accessible to those who need it. Analyzing data and information using valid methods.Analyzing data and information using valid methods. Making decisions and taking action based on actual Making decisions and taking action based on actual

analysis, balanced with experience and intuitionanalysis, balanced with experience and intuition

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An organization and its suppliers are inter-An organization and its suppliers are inter-dependent and a mutually beneficial dependent and a mutually beneficial relationship enhances the ability of both to relationship enhances the ability of both to create value.create value.This principle is reflected in ISO 9001:2008 This principle is reflected in ISO 9001:2008 clause 7.4clause 7.4

Quality Management Principle No.8

Mutually beneficial supplier relationships

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Application of this principle involves:Application of this principle involves: Establishing relationships that balance short-term Establishing relationships that balance short-term

gains with long-term considerations.gains with long-term considerations. Pooling of expertise and resources with partners.Pooling of expertise and resources with partners. Identifying and selecting key suppliers.Identifying and selecting key suppliers. Clear and open communication.Clear and open communication.

Mutually beneficial supplier relationships

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Sharing information and future plans.Sharing information and future plans. Establishing joint development and improvement Establishing joint development and improvement

activities.activities. Inspiring, encouraging and recognizing improvements Inspiring, encouraging and recognizing improvements

and achievements by suppliers.and achievements by suppliers.

Mutually beneficial supplier relationshipsMutually beneficial supplier relationships

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ISO 9000 standardsISO 9000 standards

Three important standards in the family of ISO 9000 Three important standards in the family of ISO 9000 International Standard are:International Standard are:

ISO 9000:ISO 9000: Concepts, Principles, Fundamentals and Concepts, Principles, Fundamentals and VocabularyVocabulary

ISO 9001:ISO 9001: Sets the QMS Requirements to be metSets the QMS Requirements to be met

ISO 9004:ISO 9004: Provides guidance for Continual Provides guidance for Continual improvement of improvement of organization’s overall organization’s overall performanceperformance

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ISO 9001:2008ISO 9001:2008

Internationally accepted management standard that Internationally accepted management standard that has become a world benchmark for good has become a world benchmark for good management practicemanagement practice

Generic standard i.e. any industry sector viz. Generic standard i.e. any industry sector viz. manufacturing or service (education, hospitals, manufacturing or service (education, hospitals, hotels, banks, transport, accountancy, etc.) can use hotels, banks, transport, accountancy, etc.) can use it.it.

Any type (private, public, government enterprise, Any type (private, public, government enterprise, etc) and any size of enterprise can use it (big, small etc) and any size of enterprise can use it (big, small or tiny)or tiny)

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PDCA MethodologyPDCA Methodology

Plan

Do

check

Act

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Model of Process based Quality Management SystemModel of Process based Quality Management System

Continual Improvement of the quality management system

ProductProduct

realization

Managementresponsibility

Resourcemanagement

Measurement, analysis &

improvement

CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTION

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ISO 9001:2008 ISO 9001:2008 Quality Management System - RequirementsQuality Management System - Requirements

1.0 Scope1.0 Scope

2.0 Normative References2.0 Normative References

3.0 Terms and Definitions3.0 Terms and Definitions

4.0 Quality Management System Requirements4.0 Quality Management System Requirements

5.0 Management Responsibility5.0 Management Responsibility

6.0 Resource Management6.0 Resource Management

7.0 Product Realization7.0 Product Realization

8.0 Measurement, Analysis & Improvement 8.0 Measurement, Analysis & Improvement

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4.1 General Requirements4.1 General Requirements

a)a) Identification of the processes for the QMSIdentification of the processes for the QMS

b)b) Determine the sequence of these processesDetermine the sequence of these processes

c)c) Determine criteria for effective operation & Determine criteria for effective operation & control of these processescontrol of these processes

d)d) Ensure the availability of resourcesEnsure the availability of resources

e)e) Monitor, measure (where applicable) and Monitor, measure (where applicable) and analyze these processesanalyze these processes

f)f) Implement actions necessary for achieving Implement actions necessary for achieving planned results and continual improvementplanned results and continual improvement

Quality Management System - 1

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4.2.1 General

The QMS Documentation shall include:The QMS Documentation shall include:

a)a) Quality Policy & Quality ObjectivesQuality Policy & Quality Objectives

b)b) Quality ManualQuality Manual

c)c) Documented procedures and records required Documented procedures and records required by this Standardby this Standard

d)d) Documents needed for planning, operation and Documents needed for planning, operation and control of processescontrol of processes

e)e) Records required by this StandardRecords required by this Standard

4.2 Documentation Requirements - 14.2 4.2 Documentation Requirements - 1Documentation Requirements - 1

Quality Management System - 2

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4.2.2 Quality Manual

a)a) Scope of QMS / Justification of the ExclusionsScope of QMS / Justification of the Exclusions

b)b) Documented procedures or reference to themDocumented procedures or reference to them

c)c) Description of interaction between the processes Description of interaction between the processes of the QMSof the QMS

4.2 4.2 Documentation Requirements - 2Documentation Requirements - 2

Quality Management System - 3

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4.2.3 Control of documents

Establish Establish documented proceduredocumented procedure to define method to: to define method to:

a)a) Approve documentsApprove documents

b)b) Review, update and re-approve documentsReview, update and re-approve documents

c)c) Identify the revision status / changes Identify the revision status / changes

d)d) Ensure availability of relevant versions at point of Ensure availability of relevant versions at point of useuse

e)e) Ensure documents are legible and readily Ensure documents are legible and readily identifiableidentifiable

f)f) Identification and Control the external documentsIdentification and Control the external documents

g)g) Identification and Control of obsolete documentsIdentification and Control of obsolete documents

4.2 4.2 Documentation Requirements - 3Documentation Requirements - 3

Quality Management System - 4

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4.2.4 Control of records

a) Establish / Maintain records to demonstrate conformity to this International Standard

b) Keep records legible, readily identifiable and retrievable

c) Establish documented procedure for identification, storage, protection, retrieval, specify retention time and their disposition

4.2 4.2 Documentation Requirements - 4Documentation Requirements - 4

Quality Management System - 5

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DocumentsDocumentsQuality manualFlow chart of major processes and their interactionDocument control procedureRecord control procedure.Description of out sourced services and their control procedure.RecordsRecordsDocument updating recordsDisposal of quality records

Clause 4Clause 4

Documentation Requirements

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a) Communication to the organization the importance of meeting customer, statutory and regularity requirements

b) Establish Quality Policy & Quality Objectives

c) Conducting Management Reviews

d) Ensuring the availability of resources

5.1 Management Commitment 5.1 Management Commitment

Management Responsibility - 1

5.2 Customer Focus 5.2 Customer Focus

Determine and meet the customer requirements for enhancing customer satisfaction

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a) Is appropriate to the purpose of the organization

b) Includes a commitment to comply with and continually improve the QMS

c) Provides framework of establishing and reviewing Quality Objectives

d) Is communicated and understood within organization

e) Is reviewed for continuing suitability

5.3 Quality Policy 5.3 Quality Policy

Management Responsibility - 2

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5.4.1 Quality Objectives

a) Needed to meet the requirements of the

product are established at relevant functions

within the organization

b) Are measurable and consistent with the

Quality Policy

5.4 5.4 Planning - 1Planning - 1

Management Responsibility - 3

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SpecificMeasurableAchievableResults orientatedTime bound

SMART ObjectivesSMART Objectives

Management Responsibility - 4

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5.4.2 Quality Management System Planning

Top Management shall ensure that

a) Planning is done for meeting the requirements of this standard (4.1) and Quality Objectives

b) Integrity of the QMS is maintained when changes to QMS are planned and implemented

Management Responsibility - 5

5.4 5.4 Planning - 2Planning - 2

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5.5.1 Responsibility and Authority

Are defined and communicated

5.5.2 Management RepresentativeThe Management Shall appoint a Management Representative responsible to :

a) Ensure that processes for QMS are established, implemented and maintained

b) Reporting to top management on performance of QMS and any need for improvement

c) Ensure the promotion of awareness of customer

requirements throughout the organization

5.5 Responsibility, Authority and Communication5.5 Responsibility, Authority and Communication - 1 - 1

Management Responsibility - 6

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5.5.3 Internal Communication

Top management shall ensure that

appropriate communication processes are

established within the organization and that

communication takes place regarding the

effectiveness of quality management system.

Management Responsibility - 7

5.5 Responsibility, Authority and Communication5.5 Responsibility, Authority and Communication - 2 - 2

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5.6.1 GeneralThe management shall review the QMS at planned intervals to ensure it’s continued suitability, adequacy and effectivenessThe review shall include :

a) Assessing opportunities for improvement and need for changes to the QMS

b) Review of the Quality Policy and Quality ObjectivesRecords of the reviews must be kept

5.65.6 Management Review - 1Management Review - 1

Management Responsibility - 8

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5.6.2 Review InputsThe Inputs shall include information on:a) Results of audits b) Customer feedback c) Process performance and product conformity d) Status of preventive and corrective action e) Follow-up actions from previous

management review f) Changes which could affect the QMS g) Recommendations for improvement

Management Responsibility - 9

5.65.6 Management Review - 2Management Review - 2

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5.6.3 Review OutputsThe Outputs shall include any decisions and actions on:

a) Improvement of the effectiveness of quality management system and processes,

b) Improvement of product related to customer requirements

c) Resources needs

Management Responsibility - 10

5.65.6 Management Review - 3Management Review - 3

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DocumentsDocumentsQuality objectives at organizational and functional level.Organization structure and responsibilities of management representative and key functionaries whose job affects product quality.Description of internal communication channel. ( This could be specified in quality manual)Procedure for management review RecordsRecordsEvidence of quality planningRecord of management review

Clause 5Clause 5

Documentation Requirements

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The Organization shall determine and provide

resources needed to :

a) Implement and maintain the QMS and continually improve its effectiveness

b) Enhance customer satisfaction by meeting customer requirements.

Resource Management - 1

6.16.1 Provision of ResourcesProvision of Resources

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6.2.1 GeneralCompetent persons should perform work effecting quality 6.2.2 Competence, awareness and training

a) Determine the necessary competence for the personnel performing work effecting quality

b) Provide training and take action to satisfy these needs

c) Evaluate the effectiveness of the action taken

d) Ensure that its personnel are aware of relevance and importance of their activities and how they contribute to the achievement of the quality objectives

e) Maintain appropriate records of education, training, skills and experience

6.26.2 Human ResourcesHuman Resources

Resource Management - 2

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The organization shall determine, provide and maintain the infrastructure needed to achieve product conformity, it includes:

a) Building, workplace and associated utilities

b) Process equipment (both hardware and software)

c) Supporting services(such as transport or communication)

6.36.3 InfrastructureInfrastructure

Resource Management - 3

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The organization shall determine and manage the work environment needed to achieve conformity to product requirements

6.46.4 Work EnvironmentWork Environment

Resource Management - 4

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DocumentsDocumentsSpecific requirement of qualification and competence of personnelProcedure for identifying training needs and yearly training planList of special facilities or work environments affecting qualityProcedure for maintenance of buildings equipment and facilitiesRecordRecordRecord of training and experience of personnelMaintenance record

Clause 6Clause 6

Documentation Requirements

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Organization shall plan and develop the processes needed for product realization, while considering the Following factors as appropriate:

a) Quality objective and requirements for the product

b) Need to establish processes, documents, and provide resources specific to the product

c) Required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance

d) Records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4)

7.17.1 Planning of Product RealizationPlanning of Product Realization

Product Realization - 1

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7.2.1 Determination of requirements related to the product

The organization shall determine:

a) Requirements specified by customer including (delivery conditions & post Delivery activities)

b) Requirements not stated but necessary for the intended use, where known

c) Statutory & regulatory requirements related to product

d) Any additional requirement determined by the organization

7.27.2 Customer Related Processes - 1Customer Related Processes - 1

Product Realization - 2

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7.2.2 Review of Requirements Related to the Product

Review following before the acceptance of contract :

a) Product requirements are defined

b) Contract or order requirements differing from those

previously expressed are resolved

c) The organization has the ability to meet the defined

requirements.

Results of the reviews must be maintained

Any change in requirements is communicated to all

7.27.2 Customer Related Processes - 2Customer Related Processes - 2

Product Realization - 3

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7.2.2 Customer Communication

The organization shall define and implement Effective arrangements for communicating with customers in relation to :

a) Product information

b) Enquiries, contracts or order handling, including amendments, and

c) Customer feedback, including customer complaints

7.27.2 Customer Related Processes - 3Customer Related Processes - 3

Product Realization - 4

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7.3.1 Design and Development Planning

Organization shall determine thea) Design and development stages,b) Review, verification and validation that are

appropriate to each design and development stage, and

c) Responsibilities and authorities for design and development Planning output shall be updated, as appropriate, as the design and development progresses

7.37.3 Design and Development - 1Design and Development - 1

Product Realization - 5

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7.3.2 Design and Development InputsInputs related to product requirements including followingshall be determined,a) Functional and performance requirements,b) Applicable statutory and regulatory requirements,c) Where applicable, information derived from previous

similar design, and d) Other requirements essential for design and

development

The requirements must be complete, unambiguous and not in conflict in each other

The requirements must be reviewed for adequacy and records must be maintained

7.37.3 Design and Development - 2Design and Development - 2

Product Realization - 6

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7.3.3 Design and Development Outputs

The design and development outputs shall:a) Meet the input requirements for design and

developmentb) Provide appropriate information for

purchasing, production and for services provision

c) Contain or reference product acceptance criteria

d) Specify the characteristics of the product that are essential for its safe and proper use

7.37.3 Design and Development - 3Design and Development - 3

Product Realization - 7

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7.3.4 Design and Development Review

Reviews by representatives of the functionsconcerned shall be performed in accordance withplanned arrangements (see 7.3.1) to :

a) Evaluate the ability of the results of design and development to meet requirements, and

b) Identify any problems and propose necessary actions.

Records of reviews and any necessary actionsshall be maintained

7.37.3 Design and Development - 4Design and Development - 4

Product Realization - 8

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7.3.5 Design and development verification

Verification shall be performed in accordance with planned arrangements (7.3.1) to ensure that design and development outputs have met the design and development input requirements.

Records of the results and any actions shall be maintained.

7.37.3 Design and Development - 5Design and Development - 5

Product Realization - 9

Page 76: ISO 9001.ppt

7.3.6 Design and development validation

Validation shall be performed in accordance with planned arrangements (7.3.1) to ensure that Resulting product is capable of meeting requirements for intended use, where known.

Where practicable, validation shall be completed prior to the delivery or implementation of the product

Records of the results and any actions shall be maintained.

7.37.3 Design and Development - 6Design and Development - 6

Product Realization - 10

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7.3.7 Control of design and development changes

The changes will be reviewed, verified and validated as appropriate and approved before implementation.

The review for change shall include evaluation of the effects of the change on constituent parts and product already delivered.

Records of the changes and any actions shall be maintained.

7.37.3 Design and Development - 7Design and Development - 7

Product Realization - 11

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7.4.1 Purchasing Process

The organization shall ensure that purchased

product conforms to specified purchase

requirements

The type and extent of control applied shall

be dependent upon the effect on the final

product

7.47.4 Purchasing - 1Purchasing - 1

Product Realization - 12

Page 79: ISO 9001.ppt

7.4.2 Purchasing Information

Purchasing information shall describe the

purchased product, including where appropriate:

a) Requirement for approval of product,

procedures, process and equipment

b) Requirement for qualification of personnel

c) Quality management system requirements

7.47.4 Purchasing - 2Purchasing - 2

Product Realization - 13

Page 80: ISO 9001.ppt

7.4.3 Verification of the Purchased Product

Establish and implement the inspection

activities necessary for ensuring

conformance of purchased product to

purchase information.

Where verification at the supplier’s premises is required by organization / customer, it shall be indicated so in the purchase information.

7.47.4 Purchasing - 3Purchasing - 3

Product Realization - 14

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7.5.1Control of Production and Service ProvisionProduction and service provision shall be carried outunder controlled conditions, as applicable:

a) Availability of information that describes the characteristics of the product,

b) Availability of work instructions, as necessary,

c) Use of suitable equipment,

d) Availability and use of monitoring and measuring devices,

e) Implementation of monitoring and measurement, and

f) Implementation of release, delivery and post-delivery activities.

7.57.5 Production and Service Provision - 1Production and Service Provision - 1

Product Realization - 15

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7.5.2Validation of processes for production and service provision

Validation of process shall be done where the resulting output cannot be verified by subsequent monitoring or measurement, the following shall be addressed:

a) Defined criteria for review and approval of the processes

b) Approval of equipment and qualification of personnel

c) Use of specific methods and procedures

d) Requirements for records

e) Revalidation

7.57.5 Production and Service Provision - 2Production and Service Provision - 2

Product Realization - 16

Page 83: ISO 9001.ppt

7.5.3Identification and Traceability

Identification of product by suitable means

throughout product realization

Identification of the product status with

respect to the monitoring and measurement

requirements

Where traceability is required the

organization shall control and record the

unique identification of the product

7.57.5 Production and Service Provision - 3Production and Service Provision - 3

Product Realization - 17

Page 84: ISO 9001.ppt

7.5.4Customer Property

The organization shall

a) Identify, verify, protect and safeguard

customer property

b) In case of loss, damage or unsuitable for use

customer must be informed

c) Records must be maintained

7.57.5 Production and Service Provision - 4Production and Service Provision - 4

Product Realization - 18

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7.5.5Preservation of Product

The organization shall preserve the conformity of product during internal processing and delivery to the intended destination.

This preservation shall include identification, handling, packing, storage and protection. Preservation shall also apply to the constituent parts of product

7.57.5 Production and Service Provision - 5Production and Service Provision - 5

Product Realization - 19

Page 86: ISO 9001.ppt

The equipments Shall be:

a) Calibrated or verified at specific intervals, or prior to use, against measurement standards traceable to international or national measurement standards, where no such standards exist, the basis used for calibration or verification shall be recorded

b) Adjusted or re-adjusted as necessary

c) Identified to enable the calibration status to be determined

d) Safeguarded from adjustments that would invalidate the measurement result

e) Protected from damage and deterioration during handling, maintenance and storage

f) Records shall be maintained

7.67.6 Control of Monitoring and Measuring EquipmentsControl of Monitoring and Measuring Equipments

Product Realization - 20

Page 87: ISO 9001.ppt

DocumentsDocumentsQuality plan or other documents showing how quality is planned in products/projectsMethod of capturing customer requirementsReview of orders or contracts to assess capability to meet customer’s requirementsSpecifications for company’s productsProcedure for design and developmentSpecifications for purchased materials

Clause 7Clause 7

Documentation Requirements

Page 88: ISO 9001.ppt

DocumentsDocumentsProcedure for selection and approval of

suppliersProcedure for review of suppliers performanceProcedure for verification of purchased products

and dealing with non conforming supplies.Procedures or work instruction for critical

processes.Procedure for assessing process capability and

approval of processes.Qualification of operators and processes where

quality cannot be verified after work is finished.

Clause 7 contnd..Clause 7 contnd..

Documentation Requirements

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DocumentsDocumentsProcedure for maintenance of critical equipment.Procedure for identification and traceability of materials (where required).Inspection and testing plans/instructions.Procedure for showing inspection/test status of materials/equipment.Procedure for calibration measuring devices.Procedure for handling customer property.Procedure for preservation, packaging and storage of product.

Clause 7 contd…Clause 7 contd…

Documentation Requirements

Page 90: ISO 9001.ppt

RecordsRecordsContract review of major contractsDesign review recordResults of design verification/validationInspection results of purchased materials.Record of qualification of operators and processes where output cannot be assessed for non conformity.Inspection and testing recordsRecord of rework and rejectionCalibration record of measuring devices.Record of damaged or lost customer property (where applicable).

Clause 7Clause 7

Documentation Requirements

Page 91: ISO 9001.ppt

Organization must plan and implement the monitoring measurement, analysis and improvement processes needed to :

a) Demonstrate conformity of the product b) Ensure conformity of the QMS c) Continually improve the effectiveness of QMS

Determine applicable method including StatisticalTechniques and extent of their use

8.18.1 GeneralGeneral

Measurement, Analysis and Improvement - 1

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8.2.1 Customer Satisfaction

Establish a method for obtaining and using

the information about customer perception

as to whether the organization has met

customer requirements

8.28.2 Monitoring & Measurement - 1Monitoring & Measurement - 1

Measurement, Analysis and Improvement - 2

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8.2.2 Internal AuditDocumented procedures Shall be established and internal audits shall be conducted at regular intervals to determine whether the QMS :a) Conforms to standard and other requirements

determined by organizationb) Is effectively implemented and maintained

Audit shall be:1. Planned, Criteria / Scope / Frequency and method be

defined.2. Selection / conduct of audit shall ensure impartiality3. Follow-up activities shall be performed4. Records shall be maintained

8.28.2 Monitoring & Measurement - 2Monitoring & Measurement - 2

Measurement, Analysis and Improvement - 3

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8.2.3 Monitoring and measurement of processes

Apply methods for monitoring and where

applicable measurement of QMS processes.

Methods shall demonstrate the ability of the

processes to achieve the planned results.

In case planned results are not obtained

Corrective / Preventive actions must be taken

to ensure the conformity to the product.

8.28.2 Monitoring & Measurement - 3Monitoring & Measurement - 3

Measurement, Analysis and Improvement - 4

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8.2.4 Monitoring and measurement of product

Monitor the characteristics of the product at appropriate stages in accordance with planned arrangements (see 7.1)

Evidence of conformity and acceptance criteria must be defined.

No product or service delivery shall not proceed until the planed arrangement are satisfactorily completed and approved by authorized person.

Records shall also be maintained.

8.28.2 Monitoring & Measurement - 4Monitoring & Measurement - 4

Measurement, Analysis and Improvement - 5

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The nonconforming products must be identified and controlled to prevent unintended use or delivery.

Documented procedure stating responsibility and authority to deal with nonconforming products shall be defined.

8.3 Control of Nonconforming Product - 18.3 Control of Nonconforming Product - 1

Measurement, Analysis and Improvement - 6

Page 97: ISO 9001.ppt

The organization shall deal with nonconforming products by :

a) Taking action to eliminate the detected non conformity

b) Authorizing its use, release / acceptance under concession by relevant authority if allowed by customer.

c) Take action to prevent its original intended use

Records and actions taken shall be recorded.Incase of rework product shall be re-verifiedIncase the product has been delivered appropriate actions shall be taken

8.3 Control of Nonconforming Product - 28.3 Control of Nonconforming Product - 2

Measurement, Analysis and Improvement - 7

Page 98: ISO 9001.ppt

Determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the QMS can be made.Analysis of data shall provide information relating to:

a) Customer Satisfaction (see 8.2.1)

b) Conformity of product requirements (see 7.2.1)

c) Characteristics and trends of processes and and products including opportunities of Corrective action

d) Suppliers

8.48.4 Analysis of DataAnalysis of Data

Measurement, Analysis and Improvement - 8

Page 99: ISO 9001.ppt

8.5.1 Continual Improvement

The organization shall continually improve the effectiveness of QMS through the use of :

Quality Policy Quality Objectives, Audit Results Analysis of data, Corrective and Preventive Actions Management Review

8.58.5 Improvement - 1Improvement - 1

Measurement, Analysis and Improvement - 9

Page 100: ISO 9001.ppt

8.58.5 Improvement - 2Improvement - 2

8.5.2 Corrective Action

Corrective actions shall be taken to eliminate causes

of nonconformities to prevent their recurrence. Documented procedure shall be established to define requirements for:

a) Reviewing nonconformities (including customer complaints)

b) Determining the causes of nonconformitiesc) Evaluating the need for action to ensure that

nonconformities do not recur

Measurement, Analysis and Improvement - 10

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8.58.5 Improvement - 3Improvement - 3

d) Determining and implementing action needed e) Records of the action taken resultsf) Reviewing corrective action taken

Measurement, Analysis and Improvement - 11

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8.5.3 Preventive Action

Preventive actions shall be taken to eliminate causes

of potential nonconformities to prevent their occurrence. Documented procedure shall be established to define requirements for:

a) Determining potential nonconformities and their causes

b) Evaluating the need for action to prevent occurrence of nonconformities

c) Determining and implementing action needed

8.58.5 Improvement - 4Improvement - 4

Measurement, Analysis and Improvement - 12

Page 103: ISO 9001.ppt

d) Records of results action taken

e) Reviewing preventive action taken

8.58.5 Improvement - 5Improvement - 5

Measurement, Analysis and Improvement - 13

Page 104: ISO 9001.ppt

DocumentsDocumentsProcedure for measurement and monitoring of processes for effective control.Methods for use of statistical techniques for process control and data analysis for improvement.Procedure for inspection and release of final product.Procedure for dealing with non conforming product and use of material under concession.Procedure for monitoring customer satisfaction and dealing with customer complaints.

Clause 8Clause 8

Documentation Requirements

Page 105: ISO 9001.ppt

DocumentsDocumentsProcedure of internal audit of QMS, along with check list.Procedure for corrective and preventive action.Procedure for collection and analysis of data for effectiveness and improvement of QMS.RecordsRecordsProcess monitoring data and corrective action taken for process controlRecord of product non conformities and products accepted on concession.

Clause 8 contnd..Clause 8 contnd..

Documentation Requirements

Page 106: ISO 9001.ppt

RecordsRecordsData analysis and activities for continual improvement.Result of internal audits and follow up action.Data on customer feedback and action taken on customer complaints.

Clause 8 contnd..Clause 8 contnd..

Documentation Requirements

Page 107: ISO 9001.ppt

No bodyNo body

Can AchieveCan Achieve

QQUUALITYALITYWithoutWithout

UU

Page 108: ISO 9001.ppt

Thank you !!!