introduction to iso 9000: 2008 every top management always maintains that their business...

INTRODUCTION TO ISO 9000: 2008

• Every top management always maintains that their business organization mission is to provide top quality products/service to meet the needs of their customer. The reality is that the organization has many other goals also to peruses, such as maximizing customers, profits, declaring more benefits to the dependents, enhancing employee’s job satisfaction and ultimately serving the community and society at large.


• “The ultimate goal of a company is to make profit. This can be fulfilled only if we have such cross-functional goals as quality, cost and delivery. Without achieving these goals, the company will be left behind by the competition. Out of these goals, which need to be fulfilled by the company, quality is the most important as inferior quality will lead to its profits eroded by higher costs and it will be enable to deliver the product in time for the customer.


• If these cross-functional goals are realized, profit will fallow. Therefore we should regard all other management functions as existing to serve the super ordinate goal of quality” . To survive in a competitive market, it is imperative for the organization not only to maintain the high levels of quality but keep on enhancing these levels continuously to keep pace with the ever increasing expectations of the customer. To achieve this the organization need to have a world class Quality Management Systems (QMS) One model of such a QMS, described in ISO 9000:2008series of standard, has been designed by top experts and specialists of the world in the field of quality after a great deal of deliberation and discussions in the ISO Technical Committee TC 176

The first steps

•1950’s and 1960’s

•Dominance of Military – based “Quality Programs” (MIL-Q-9858, AQAP, Def Std etc.)

•1970’s

•“QA” Standards

•BS 5750 first published (1979)

The birth of ISO 9000

• ISO 9000 series developed by ISO/TC 176 (early 80’s) and published (1987)

•ISO 9000 Concepts, selection and use

•ISO 9001/2/3 Certification

•ISO 9004 Guidelines

• Internationally developed, but not truly accepted worldwide.

Growth of QMS Standards

•1990’s•Widespread acceptance of ISO 9000

around the world (now over 9,00,000 cert. issued)

•Revision work done on ISO 9000 from 1997-2000; worldwide participation and strong consensus.

•Aim to simplify, consolidate and improve.

Key Elements of ISO 9001:2008

•Process approach and PDCA

•Comparison (may be a little unfair on ISO 9001:1994!)

• ISO 9001:1998 “Documented procedures evidenced by records”

• ISO 9001:2008“Defined and managed processes evidenced by results”.

Deming's Formula

•PLAN

•DO

•CHECK

•ACT

Deming's Formula

•Plan :• What do we want to achieve?•Vision, Mission, Objectives•How can we achieve it?•Business plan, Strategies,Resources•Dr. Deming – “It’s pointless to

establish an objective without defining a method to achieve it”

Deming's Formula

•Do :

•Get everyone involved, committed and motivated (“Leadership”!)

• Carry out “the plan”

•Deploy throughout the organization

•Break down the objectives to the appropriate functions and levels.

Deming's Formula

•Check :

• Is this want we expected?

• Are the results OK?

• Look for trends

Deming's Formula

• Act :Correct what went wrong (Correction) Plan to do it right next time (Corrective action)

• Learn to make things “error-proof” (Preventive action)

• Think – how can we do this……..• Faster?,• Cheaper?• Better?• Safer?

WHAT IS ISO 9000 CERTIFICATION ALL

ABOUT?

• CONFIDENCE• Providing CONFIDENCE to the customer that

requirements for the product will be met.• ISO 9001: 2008 Philosophy• ISO 9000 lays down what requirements your

quality management system must meet.• But it does not dictate how they should be met.• Allows great flexibility for implementation in

different business sectors and business cultures.

Do we need Certification?

• Some options :• Internal audits

• I want to use ISO 9001:2008 as a management tool, but my customers don’t require me to be ‘certified’.

• 2nd party audits• I provide my products to a very limited number of

customers, and they audit me to ISO 9001:2008as part of their supplier evaluation programme.

• 3rd Party Certification• I want to be able to demonstrate to a number of

customers that my QMS meets ISO 9001:2008 requirements.

•Avoid multiple audits by the organization’s clients or reduce the frequency or duration of client audits.

QUALITY

•Confirmation to specification

•Fitness for purpose

•Meeting the agreed requirements

Customers expect quality because –

•They want product or service that is reliable

•They want it to meet their requirements

•They want value for their money

QUALITY MATTERS TO YOU

•You want job satisfaction

•You want to be respected

•You want to enjoy work

•You want to do a good job

•You want to secure job

•You want to be proud to work for your organization.

CUSTOMER DISSATISFACTION

• Failure to meet delivery

• Failure to meet specification

• Not fit for the purpose

• Failure in service

• Results for which is –

• They complain

• They change the supplier

• They inspect

WE SHOULD ALWAYS REMEMBER

•Our customers are the only judge of whether we are a Quality Organization

•Never assume you know what your customer wants

Customer Assurance (Confidence)

•Quality will be achieved

•Quality will be maintained

•Problems will be minimized

•Confidence can be obtained by effective quality management.

QUALITY MEASUREMENT AND

IMPROVEMENTS

• Identify product characteristics

•Define levels of achievement

•Adopt statistics

•Measure achievement

• Innovate to improve

•Publicize improvement

6 aspects of ISO – 9000 (Cuboid)

• 1. Commitment• 2. People• 3. Processes• 4. Procedures• 5. Implement• 6. Maintain

BENEFITS OF ISO

• Customer confidence• International recognition• Acceptance in Global Markets• Identification of specified & implied needs of quality• Consistency in quality• Understanding customer’s requirement throughout the

organization• Reduction in product liability• Better Management of safety, Risk and Hazard• Reduction in waste and rework• Employee participation in company activity• Improvement in profits• Doing right work at the first time• Increase in the prestige or level of the organization

“A Customer is the mostimportant visitor on our premises.He is not dependent on us.We are dependent on him.He is not an interruption on our work.He is the purpose of it.He is not an outsider on our business.He is a part of it.We are not doing him a favourby serving him.He is doing us a favour by giving us anopportunity to do so.”

- Mahatma Gandhi

4.0 Quality Management System4.0 Quality Management System

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 and Improvement8.0 Measurement, Analysis and Improvement

1.01.0 SCOPESCOPE

This International Standard specifies This International Standard specifies requirements for a quality management requirements for a quality management system where an organizationsystem where an organization

A.A.needs to demonstrate its ability to needs to demonstrate its ability to consistency provide product that meets consistency provide product that meets customer and applicable regulatory customer and applicable regulatory requirements, andrequirements, and

B.B.Aims to enhance customer satisfaction Aims to enhance customer satisfaction through the effective application of the through the effective application of the system, including processes for continual system, including processes for continual improvement of the system and the improvement of the system and the assurance of conformity to customer and assurance of conformity to customer and applicable regulatory requirements.applicable regulatory requirements.

2.02.0 APPLICATIONAPPLICATION

• All requirements of this International Standard are All requirements of this International Standard are generic and are intended to be applicable to all generic and are intended to be applicable to all organizations, regardless of type, size and product organizations, regardless of type, size and product provided.provided.

• Where any requirements (s) of this International Where any requirements (s) of this International Standard cannot be applied due to the nature of an Standard cannot be applied due to the nature of an organization and its product, this can be considered organization and its product, this can be considered for exclusion.for exclusion.

• Where exclusion are made, claims of conformity to Where exclusion are made, claims of conformity to this International Standard are not applicable unless this International Standard are not applicable unless these exclusions are limited to requirements within these exclusions are limited to requirements within clause 7, and such exclusions do not affect the clause 7, and such exclusions do not affect the organization’s ability, or responsibility, to provide organization’s ability, or responsibility, to provide product that meets customer and applicable product that meets customer and applicable regulatory requirements.regulatory requirements.

4. Quality Management system4. Quality Management system4.1 General Requirement4.1 General Requirement

The organization shall establish, document, implement, The organization shall establish, document, implement, maintain and maintain and continually improve the QMS effectiveness in continually improve the QMS effectiveness in accordance withaccordance with the requirements of this International the requirements of this International Standard.Standard.

The organization shall:The organization shall:

1.1. Identify the process needed for the QMS Identify the process needed for the QMS and its application and its application thru out the organizationthru out the organization (see 1.2 Application); (see 1.2 Application);

2.2. Determine the Determine the sequence and interactionsequence and interaction of these processes; of these processes;

3.3. Determine criteria and methods needed to ensure Determine criteria and methods needed to ensure the the effectiveness of processes operations and control;effectiveness of processes operations and control;

4.4. Ensure the Ensure the resources and information necessary are availableresources and information necessary are available to support the process operation and monitoring;to support the process operation and monitoring;

5.5. Measure, monitor and analyze these processes; andMeasure, monitor and analyze these processes; and

6.6. Implement Implement necessary actions to achieve planned results and necessary actions to achieve planned results and continual improvement of these processescontinual improvement of these processes

7.7. Define outsourced process if any and its control (2008)Define outsourced process if any and its control (2008)

4.2.1 4.2.1 The quality management system The quality management system

documentation documentation shall include: shall include:

1.1. Documented Quality Policy and ObjectivesDocumented Quality Policy and Objectives

2.2. Quality Manual:Quality Manual:

3.3. Documented procedures required by the Standard.Documented procedures required by the Standard.

4.4. Documents required by the organization to ensure the Documents required by the organization to ensure the effective planning, operation and control of its processes.effective planning, operation and control of its processes.

5.5. RecordsRecords required by the Standard required by the Standard

The extent of documentation is dependent on the The extent of documentation is dependent on the organization size, type of activities, processes complexity, organization size, type of activities, processes complexity, their interactions as well as personnel competence. their interactions as well as personnel competence. Procedures required by the standard can be individual or Procedures required by the standard can be individual or combined. A single document can address one or more combined. A single document can address one or more procedures. Documentation can be any form, type of procedures. Documentation can be any form, type of medium. (2008) medium. (2008)

Discussion:Discussion:

• Define documentation including records to support Define documentation including records to support an effective and efficient operation of the an effective and efficient operation of the organization of processes.organization of processes.

• Extent of documentation to consider contractual Extent of documentation to consider contractual requirements, regulatory requirements and requirements, regulatory requirements and interested parties and organization competency, interested parties and organization competency,

• Evaluation of documentation from functionality, user Evaluation of documentation from functionality, user friendliness, resources needed, policy and friendliness, resources needed, policy and objectives, current and future requirements, objectives, current and future requirements, benchmarking and interface with interested parties.benchmarking and interface with interested parties.

4.2.2 Quality Manual4.2.2 Quality Manual

The Quality Manual shall include:The Quality Manual shall include:

• The Scope of the QMS, including any exclusion The Scope of the QMS, including any exclusion details & Justification.details & Justification.

• Documented procedures established for the QMS, Documented procedures established for the QMS, or make reference to them.or make reference to them.

• A description of the QMS processes interactionA description of the QMS processes interaction


– What should be covered in Quality Manual?What should be covered in Quality Manual?

4.2.3 Control of Documents4.2.3 Control of Documents

A documented procedure shall be established. The controls A documented procedure shall be established. The controls needed are:needed are:

1.1. Approval for adequacy prior to issueApproval for adequacy prior to issue

2.2. Review and update and re-approveReview and update and re-approve

3.3. Ensure identification of document changes and current Ensure identification of document changes and current revision statusrevision status

4.4. At points of uses, relevant versions of applicable At points of uses, relevant versions of applicable documents are availabledocuments are available

5.5. Ensure documents are readily identifiable and remain Ensure documents are readily identifiable and remain legiblelegible

6.6. To identify and control distribution of externally To identify and control distribution of externally originated documents relevant to QMS (2008) originated documents relevant to QMS (2008)

7.7. To prevent unintended use of obsolete documents and To prevent unintended use of obsolete documents and suitably identify them if they are retained for any suitably identify them if they are retained for any purpose.purpose.

4.2.4 Control of Records4.2.4 Control of Records

Quality records provide evidence of conformity and Quality records provide evidence of conformity and of the effective operation of the QMS. These shall of the effective operation of the QMS. These shall remain legible, readily identifiable and retrievable.remain legible, readily identifiable and retrievable.

A A documented proceduredocumented procedure shall be established to shall be established to define the controls for define the controls for identification, legibility, identification, legibility, storage, protection, retrieval, retention time and storage, protection, retrieval, retention time and disposition.disposition.

5.Management Responsibility5.Management Responsibility 5.1 Management Commitment5.1 Management Commitment

Top management shall provide evidence of its Top management shall provide evidence of its commitment to the development and implementation commitment to the development and implementation of the QMS and continually improve its effectiveness of the QMS and continually improve its effectiveness by:by:

1.1. Communication to the organization the importance of Communication to the organization the importance of meeting customer as well as statutory & regulatory meeting customer as well as statutory & regulatory requirements;requirements;

2.2. Establishing the quality policy:Establishing the quality policy:

3.3. Ensuring that the Quality Objectives are establishedEnsuring that the Quality Objectives are established

4.4. Conducting management reviews;Conducting management reviews;

5.5. Ensuring resources are availableEnsuring resources are available

Discussion:Discussion:Involvement of top management is essential for developing and Involvement of top management is essential for developing and maintaining an effective and efficient quality management maintaining an effective and efficient quality management system bysystem by

o Establishing vision, policies and strategic objectivesEstablishing vision, policies and strategic objectives

o Leading by exampleLeading by example

o Improvement projectsImprovement projects

o Identifying product realization processIdentifying product realization process

o Creating an environment that influences development and Creating an environment that influences development and involvement of people.involvement of people.

o To determine achievement of set objectivesTo determine achievement of set objectives

o Defining method for measurement of organizational Defining method for measurement of organizational performance.performance.

5.2 Customer focus5.2 Customer focus Top management shall ensure that customer Top management shall ensure that customer requirements are determined, and met with the aim of requirements are determined, and met with the aim of customer satisfaction enhancement.customer satisfaction enhancement.


Understanding and meet the needs and expectations of Understanding and meet the needs and expectations of interested parties by:interested parties by:

Identifying interested parties needs & expectationsIdentifying interested parties needs & expectations

Translate needs into requirementsTranslate needs into requirements

Communicate the requirement throughout the Communicate the requirement throughout the organizationorganization

Focus on process improvement to ensure value for the Focus on process improvement to ensure value for the identified interested parties.identified interested parties.

End user needs and expectations may includeEnd user needs and expectations may include Conformity Conformity

DependabilityDependability

AvailabilityAvailability

DeliveryDelivery

Post realization activitiesPost realization activities

Price and life cycle costPrice and life cycle cost

SafetySafety

LiabilityLiability

Environmental impactEnvironmental impact

5.3Quality policy5.3Quality policy

Top managementTop management shall ensure that the quality policy: shall ensure that the quality policy:

1.1. Is appropriate to the purpose of the organization;Is appropriate to the purpose of the organization;

2.2. Includes a commitment to meeting requirements Includes a commitment to meeting requirements and and continual improvement of the QMS continual improvement of the QMS effectivenesseffectiveness;;

3.3. Provides a Provides a framework for establishing and framework for establishing and reviewing quality objectivesreviewing quality objectives;;

4.4. Is communicated and understood in the Is communicated and understood in the organization;organization;

5.5. Is reviewed for Is reviewed for continuing suitabilitycontinuing suitability

5.4 5.4 Planning Planning

5.4.1 Quality Objectives5.4.1 Quality Objectives

• Top management ensures that quality objectives are Top management ensures that quality objectives are established at relevant functions and levelsestablished at relevant functions and levels within the within the organization, including those needed to meet organization, including those needed to meet requirements of product.requirements of product.

• Objectives Objectives shall be consistent with the quality policy shall be consistent with the quality policy shall beshall be measurablemeasurable..


Quality Policy provides a framework for the Quality Policy provides a framework for the setting of quality objective, leading to setting of quality objective, leading to improved performance.improved performance.

Communication of objectives to enable Communication of objectives to enable people to contribute.people to contribute.

5.4.2 Quality Management System 5.4.2 Quality Management System

PlanningPlanning • Top management shall ensure that:Top management shall ensure that:

• QMS planning is carried out in order QMS planning is carried out in order to meet to meet requirements in 4.1 and quality objectivesrequirements in 4.1 and quality objectives..

• Plans & implementation of changes to QMS shall Plans & implementation of changes to QMS shall not affect the integrity of the QMSnot affect the integrity of the QMS..


• Responsibility of management for quality Responsibility of management for quality planning of the organization.planning of the organization.

• Focusing on defining the processes needed Focusing on defining the processes needed to meet effectively and efficiently to meet effectively and efficiently organization quality objectives and organization quality objectives and requirements consistently.requirements consistently.

5.5. Responsibility, Authority & Communication5.5. Responsibility, Authority & Communication

5.5.1 Responsibility and authority5.5.1 Responsibility and authority

Top management ensures responsibilities Top management ensures responsibilities and authorities are defined & communicated.and authorities are defined & communicated.

• DiscussionDiscussion

Responsibility and authority of personnel Responsibility and authority of personnel throughout the organization defined to throughout the organization defined to enable them to achieve the quality enable them to achieve the quality objectives and to enable their involvement, objectives and to enable their involvement, motivation and commitmentmotivation and commitment..

5.5.2 Management representative5.5.2 Management representative

Top management shall appoint a member of the Top management shall appoint a member of the organisation’s management (2008) as MR.organisation’s management (2008) as MR.

Irrespective of other responsibilities, MR is responsible Irrespective of other responsibilities, MR is responsible and has authority to:and has authority to:

1.1. Ensure establishment, implementation & maintenance Ensure establishment, implementation & maintenance of of the processesthe processes needed for the QMS needed for the QMS

2.2. Reporting to top management on the QMS performance Reporting to top management on the QMS performance and and any improvement needany improvement need

3.3. Ensure Ensure awareness of customer requirements throughout awareness of customer requirements throughout the organization is promotedthe organization is promoted..

DiscussionDiscussion

Reporting to top management and communicate with Reporting to top management and communicate with customers and other interrelated parties on matters customers and other interrelated parties on matters pertaining to the quality management.pertaining to the quality management.

5.5.3 Internal communication5.5.3 Internal communication

• Top management shall ensure that appropriate Top management shall ensure that appropriate processes for communication within the organization processes for communication within the organization are established.are established.

• Top management shall ensure that communication Top management shall ensure that communication regarding the effectiveness of the QMS takes place.regarding the effectiveness of the QMS takes place.


Effective and efficient processes for communicating Effective and efficient processes for communicating the quality policy, requirements, objectives and the quality policy, requirements, objectives and accomplishments.accomplishments.

Encouragement for providing feedback and Encouragement for providing feedback and communication from people reflecting their communication from people reflecting their involvements including:involvements including:

Employee survey and suggestion scheme Employee survey and suggestion scheme

Team briefing and other meetingsTeam briefing and other meetings

5.65.6 Management reviewManagement review

5.6.1 General5.6.1 General

Top managementTop management shall review QMS at shall review QMS at planned planned intervalsintervals to ensure suitability, adequacy and to ensure suitability, adequacy and effectiveness.effectiveness.

Include assessing improvement opportunities and Include assessing improvement opportunities and the need for QMS, quality policy & quality objectives the need for QMS, quality policy & quality objectives changes.changes.

Maintain records of review.Maintain records of review.


Value addition to the organization from the Value addition to the organization from the management review.management review.

Control of performance of realization and support Control of performance of realization and support processes by systematic review based on quality processes by systematic review based on quality management principles.management principles.

Review of input and output that extends beyond the Review of input and output that extends beyond the effectiveness and efficiency of the quality effectiveness and efficiency of the quality management systems.management systems.

5.6.2 Review Input5.6.2 Review Input

Reviews inputs shall include the following information:Reviews inputs shall include the following information:

1.1. Audit results,Audit results,

2.2. Process performance and conformity of productProcess performance and conformity of product

3.3. Feedback from customerFeedback from customer

4.4. Status of corrective and preventive actionsStatus of corrective and preventive actions

5.5. ChangesChanges that could affect the QMS that could affect the QMS

6.6. Improvement opportunitiesImprovement opportunities


• Inputs to consider the requirement of customer and Inputs to consider the requirement of customer and other interested parties.other interested parties.

5.6.3 Review Output5.6.3 Review Output

Review output includes actions and decisions related Review output includes actions and decisions related to:to:

1.1. Improving the QMS effectiveness and its processesImproving the QMS effectiveness and its processes

2.2. Improving the product related to customer Improving the product related to customer requirementsrequirements

3.3. Resource needsResource needs


Use of output as inputs to improvement processes.Use of output as inputs to improvement processes.

Communication of selected output to the people in Communication of selected output to the people in the organization of how review process leads to new the organization of how review process leads to new objectives for the benefit of the organization.objectives for the benefit of the organization.

66 Resource ManagementResource Management 6.1 Provision of resources6.1 Provision of resources

Organization shall determine and provide the Organization shall determine and provide the necessary resources to:necessary resources to:

1.1. Implement, maintain and continually improving Implement, maintain and continually improving the QMS the QMS

2.2. Enhance customer satisfactionEnhance customer satisfaction


• Ensuring resources essential to the Ensuring resources essential to the implementation of strategy and the implementation of strategy and the achievement of the organizations objectives.achievement of the organizations objectives.

6.26.2 Human ResourcesHuman Resources

6.2.1 General 6.2.1 General

Personnel whose work affects conformity to product Personnel whose work affects conformity to product requirement (2008) shall be competent in terms of requirement (2008) shall be competent in terms of appropriate education, training, skills and experienceappropriate education, training, skills and experience..

Discussion: Discussion:

• Involvement of peopleInvolvement of people

6.2.2 Competence, 6.2.2 Competence, AwarenessAwareness & &

TrainingTraining • Organization shall determine competence for Organization shall determine competence for

personnel personnel performing work that affect conformity performing work that affect conformity to product requirements (2008)to product requirements (2008)

• Provide training or initiate other actions to meet Provide training or initiate other actions to meet these needsthese needs

• Evaluate effectiveness of these actionsEvaluate effectiveness of these actions

• Ensure personnel are Ensure personnel are aware of their importance & aware of their importance & relevance and their contribution to achieving relevance and their contribution to achieving quality objectivesquality objectives..

• Records of education, experience, training and Records of education, experience, training and skills shall be kept.skills shall be kept.


• Planning for education, training and Planning for education, training and development of peopledevelopment of people

• Ensuring necessary competence for Ensuring necessary competence for effective and efficient operation of the effective and efficient operation of the organizationorganization

6.3 Infrastructure6.3 Infrastructure

Organization to identify, provide and maintain Organization to identify, provide and maintain infrastructure to achieve product requirements infrastructure to achieve product requirements conformity, where applicable:conformity, where applicable:

• Workspace, buildings and associated utilities.Workspace, buildings and associated utilities.

• Equipment for processes (Equipment for processes (hardware and softwarehardware and software););

• Supporting servicesSupporting services (transportation, (transportation, communication or information systems ). (2008)communication or information systems ). (2008)


• Definition of “infrastructure”.Definition of “infrastructure”.

• Include provision, maintenance, evaluation and Include provision, maintenance, evaluation and environmental aspects of infrastructure.environmental aspects of infrastructure.

• Impact of nature phenomena on the infrastructureImpact of nature phenomena on the infrastructure

6.4 Work Environment6.4 Work Environment

Organization shall identify and manage the Organization shall identify and manage the work work environmentenvironment to achieve conformity of product to achieve conformity of product requirements.requirements.

• Work Environment relates to those conditions under Work Environment relates to those conditions under which work is performed including physical, which work is performed including physical, environmental and other factors (such as noise, environmental and other factors (such as noise, temperature, humidity, lighting or weather ) (2008)temperature, humidity, lighting or weather ) (2008)


Factors to consider when creating a suitable work Factors to consider when creating a suitable work environment.environment.

7.07.0 Product Product RealizationRealization 7.1 Planning of product realization7.1 Planning of product realization

Process shall be planned and developedProcess shall be planned and developed for product for product realizationrealization

Planning to be consistent with other QMS processes Planning to be consistent with other QMS processes requirements requirements

As appropriate, the following shall be determined:As appropriate, the following shall be determined:

1.1. Product requirements and quality objectivesProduct requirements and quality objectives

2.2. The need to establish product specific processes, The need to establish product specific processes, documentation and provision of resourcesdocumentation and provision of resources

3.3. Product-specific verification, validation, monitoring, Product-specific verification, validation, monitoring, inspection and test activities; and acceptance inspection and test activities; and acceptance criteriacriteria

4.4. Records to show evidence of realization processes Records to show evidence of realization processes and product conformityand product conformity

5.5. Planning output shall be in a form deemed suitable Planning output shall be in a form deemed suitable for the organization's operational methods.for the organization's operational methods.

7.27.2 Customer-related processesCustomer-related processes

7.2.1 Determination of requirements related to the product7.2.1 Determination of requirements related to the product

Organization shall determine:Organization shall determine:

1.1. Customer specified requirementsCustomer specified requirements, including delivery & , including delivery & post-delivery requirementspost-delivery requirements

2.2. Requirements that are Requirements that are not stated by customers, but are not stated by customers, but are necessarynecessary for the specified or intended use, where for the specified or intended use, where knownknown

3.3. Regulatory & statutory requirementsRegulatory & statutory requirements related to the related to the productproduct

4.4. Additional requirements determined by the organizationAdditional requirements determined by the organization


• Post delivery activities include , actions under Post delivery activities include , actions under warranty provisions, contractual obligations such as warranty provisions, contractual obligations such as maintenance services, and supplementary services maintenance services, and supplementary services such as recycling or final disposal (2008)such as recycling or final disposal (2008)

• Importance of meeting customers as well as Importance of meeting customers as well as interested parties needs.interested parties needs.

• Examples of relevant processes information.Examples of relevant processes information.

7.2.27.2.2 Review of requirements related to Review of requirements related to the productthe product

Review shall be conducted prior to commitment to ensure:Review shall be conducted prior to commitment to ensure:

1.1. Requirements of product are definedRequirements of product are defined

2.2. Order or contract requirements that differ from the Order or contract requirements that differ from the previously expressed are resolvedpreviously expressed are resolved

3.3. Has the ability to meet the defined requirements Has the ability to meet the defined requirements

o Shall maintain records of results of, and actions arising Shall maintain records of results of, and actions arising from, the from, the reviewsreviews

o If customer does not provide documented statement of If customer does not provide documented statement of requirement, organization shall confirm these requirement, organization shall confirm these requirements prior to acceptancerequirements prior to acceptance

o If product requirements are changed, If product requirements are changed, relevant documents relevant documents shall be amendedshall be amended and relevant personnel are made aware and relevant personnel are made aware of the changes.of the changes.

7.2.37.2.3 Customer communicationCustomer communication

Organization Organization shall determine and implement shall determine and implement effective communication arrangements related to:effective communication arrangements related to:

1.1. Product InformationProduct Information

2.2. Contract, Enquires or order handling (including Contract, Enquires or order handling (including amendments)amendments)

3.3. Customer feedback's and complaintsCustomer feedback's and complaints


– Methods of communicationMethods of communication

7.37.3 Design and developmentDesign and development7.3.1Design and development planning7.3.1Design and development planning

Organization shall Organization shall plan and controlplan and control design and design and development of product.development of product.

During planning, organization determines:During planning, organization determines:

1.1. Design and development stages Design and development stages

2.2. Review, verify & validate appropriate at each stageReview, verify & validate appropriate at each stage

3.3. Responsibilities and authorities for design and Responsibilities and authorities for design and developmentdevelopment

Shall Shall manage interfaces between various groups and manage interfaces between various groups and ensure communication & clear assignment of ensure communication & clear assignment of responsibilityresponsibility

As appropriateAs appropriate, planning output must be updated., planning output must be updated.


All factors to consider include:All factors to consider include:

• Life cycleLife cycle• Safety and healthSafety and health• TestabilityTestability• UsabilityUsability• User-friendlinessUser-friendliness• ErgonomicsErgonomics• EnvironmentEnvironment• Identified risksIdentified risks

Tools for risk assessment for design & developmentTools for risk assessment for design & development Design review, verification and validation can be Design review, verification and validation can be

recorded separately or in combination as suitable recorded separately or in combination as suitable (2008)(2008)

7.3.2 Design and development inputs7.3.2 Design and development inputs

• Inputs relating to product requirements shall include:Inputs relating to product requirements shall include:

1.1. Performance & functional requirementsPerformance & functional requirements

2.2. Applicable regulation and statutory requirementsApplicable regulation and statutory requirements

3.3. Inputs from previous designs, where applicableInputs from previous designs, where applicable

4.4. Other essential requirementsOther essential requirements

Shall maintain recordsShall maintain records

Inputs shall be reviewed for adequacy, completeness, Inputs shall be reviewed for adequacy, completeness, non-ambiguity & absence of conflicting requirementsnon-ambiguity & absence of conflicting requirements


• Examples of external & internal design inputs.Examples of external & internal design inputs.

• Importance of product-related inputs based on Importance of product-related inputs based on appreciation of the needs and expectation of users and appreciation of the needs and expectation of users and customers.customers.

7.3.3Design and development outputs7.3.3Design and development outputs

Outputs must be documented in a form that enables Outputs must be documented in a form that enables verification against design and development inputsverification against design and development inputs

Before release, outputs shall be approved.Before release, outputs shall be approved.

These outputs shall:These outputs shall:

1.1. Satisfy input requirementsSatisfy input requirements

2.2. Provide appropriate information for purchasing, Provide appropriate information for purchasing, production and service provision.production and service provision.

3.3. Reference product acceptance criteria.Reference product acceptance criteria.

4.4. Define the characteristics of the product for safe & Define the characteristics of the product for safe & proper useproper use..


• Examples of outputs include product, Examples of outputs include product, process, material and testing process, material and testing specifications and data demonstrating specifications and data demonstrating the comparison of process inputs the comparison of process inputs process outputs.process outputs.

• Output includes information needed for Output includes information needed for production and service provision production and service provision includes preservation of product. (2008) includes preservation of product. (2008)

7.3.4 Design and development review7.3.4 Design and development review

Organization shall Organization shall review design at suitable as per review design at suitable as per planned arrangements (clause 7.1)planned arrangements (clause 7.1)

1.1. Evaluate ability to meet requirementsEvaluate ability to meet requirements

2.2. Identify problems and propose necessary actionsIdentify problems and propose necessary actions

Representatives concerned with the design shall Representatives concerned with the design shall participate in the reviews.participate in the reviews.

Record of results of reviews and any necessary Record of results of reviews and any necessary actions shall be maintainedactions shall be maintained

Discussion: Design ReviewDiscussion: Design Review

a.a. Involves all functions (internal or external)Involves all functions (internal or external)b.b. Timing of design review is influenced by the cost of the Timing of design review is influenced by the cost of the

product and Complexityproduct and Complexityc.c. Satisfying all specified requirements for the productSatisfying all specified requirements for the productd.d. Safety considerationsSafety considerationse.e. Compatibility of process capability with product designCompatibility of process capability with product designf.f. Meeting functional and operational requirements Meeting functional and operational requirements g.g. Use of appropriate materials and facilitiesUse of appropriate materials and facilitiesh.h. Adequate compatibility of materials, components, Adequate compatibility of materials, components,

service elements.service elements.i.i. StandardizationStandardizationj.j. Provision of tolerance, and/or configurationProvision of tolerance, and/or configurationk.k. Validation of software used in designValidation of software used in designl.l. Requirement of Prototype testingRequirement of Prototype testing

7.3.5 Design and development 7.3.5 Design and development verificationverification

Organization shall verify outputs (Organization shall verify outputs (as per 7.3.1as per 7.3.1) ) to ensure ability to meet design or input to ensure ability to meet design or input requirementsrequirements

Shall Shall record results of verificationrecord results of verification & & necessary necessary actionsactions

7.3.6 Design and 7.3.6 Design and development validationdevelopment validation

• Design and development validation shall be Design and development validation shall be performed according to planned arrangements to performed according to planned arrangements to confirm that the resulting product conforms to the confirm that the resulting product conforms to the specified requirements or intended use/application, specified requirements or intended use/application, where known.where known.

• Wherever practicable, validation shall Wherever practicable, validation shall be completed be completed prior to the delivery or implementation of the prior to the delivery or implementation of the product.product.

• The results of the validation and necessary actions The results of the validation and necessary actions shall be recorded.shall be recorded.

7.3.7 Control of design and development 7.3.7 Control of design and development changeschanges

• Organization shall Organization shall identify and record design and identify and record design and development changesdevelopment changes..

• Review shall include Review shall include evaluation of the effect of the evaluation of the effect of the changes on constituent parts and products already changes on constituent parts and products already delivereddelivered..

• Changes shall be Changes shall be reviewed, verified and validated, as reviewed, verified and validated, as appropriate, and approvedappropriate, and approved before implementation. before implementation.

• The results of the The results of the review of changes and any necessary review of changes and any necessary actionsactions shall be recorded. shall be recorded.

Discussion: Design changesDiscussion: Design changes

• Procedure for review of changesProcedure for review of changes

• Communication to all concerned functionCommunication to all concerned function

• Design changes are approvedDesign changes are approved

• Undergoes same cycle of review / rectificationUndergoes same cycle of review / rectification

7.47.4 PurchasingPurchasing

7.4.1 Purchasing control7.4.1 Purchasing control

• The organization shall ensure product purchased The organization shall ensure product purchased conforms to specified purchase requirementsconforms to specified purchase requirements

• Type & extent of applicable control depends on the Type & extent of applicable control depends on the effect of the purchased product on the final product or effect of the purchased product on the final product or subsequent product realizationsubsequent product realization

• Suppliers shall be selected and evaluated on their Suppliers shall be selected and evaluated on their ability to meet organization's requirementsability to meet organization's requirements

• Criteria for selection, evaluation and re-evaluation Criteria for selection, evaluation and re-evaluation shall be defined.shall be defined.

• The results of evaluations and necessary actions shall The results of evaluations and necessary actions shall be recorded.be recorded.

7.4.27.4.2 Purchasing informationPurchasing information

Purchasing information shall contain description Purchasing information shall contain description about about product to be purchasedproduct to be purchased..

Where appropriate, information includes:Where appropriate, information includes:

1.1. Approval of product, procedures, processes & Approval of product, procedures, processes & equipment requirementsequipment requirements

2.2. Qualification of personnelQualification of personnel

3.3. QMS requirementsQMS requirements

Shall ensure adequacy of specified purchase Shall ensure adequacy of specified purchase requirements prior to communication with supplier.requirements prior to communication with supplier.


• Ensure that purchased products are Ensure that purchased products are adequate to satisfy the input requirements adequate to satisfy the input requirements of the organization processes.of the organization processes.

7.4.3 Verification of purchased product7.4.3 Verification of purchased product

• Shall establish & implement inspection or Shall establish & implement inspection or other necessary activities to ensure other necessary activities to ensure purchased product conformity.purchased product conformity.

• For customer's verification at the supplier's For customer's verification at the supplier's premises, the intended verification premises, the intended verification arrangements and product release method arrangements and product release method shall be stated in the purchasing shall be stated in the purchasing information.information.

7.57.5 Production and service Production and service operationsoperations• 7.5.1 Control of production & service provision7.5.1 Control of production & service provision

Organization shall plan & carry out production & Organization shall plan & carry out production & services provision under controlled conditions,services provision under controlled conditions,

As applicable:As applicable:

1.1. Available information that describes the product Available information that describes the product characteristicscharacteristics

2.2. Available work instructions, as necessaryAvailable work instructions, as necessary

3.3. Using of suitable equipmentUsing of suitable equipment

4.4. Available & use of measuring and monitoring devicesAvailable & use of measuring and monitoring devices

5.5. The The implementation of measuring & monitoring implementation of measuring & monitoring activitiesactivities

6.6. The The implementation of release, delivery and post-implementation of release, delivery and post-delivery activitiesdelivery activities

7.5.2 Validation of processes for production & 7.5.2 Validation of processes for production & service provisionservice provision

Validation of any processes for providing production Validation of any processes for providing production and service where the resulting output and service where the resulting output cannot be cannot be verified by subsequent measurement or monitoringverified by subsequent measurement or monitoring..

Includes any processes where deficiencies become Includes any processes where deficiencies become apparent only after the product is in use or the apparent only after the product is in use or the service has been delivered.service has been delivered.

Ability to achieve planned results shall be Ability to achieve planned results shall be demonstrated by the validationdemonstrated by the validation

Where Applicable:Where Applicable:• Define criteria for review & approval of processesDefine criteria for review & approval of processes• Personnel qualification & equipment approvalPersonnel qualification & equipment approval• Use of specific methods & proceduresUse of specific methods & procedures• Record keepingRecord keeping• Re-validationRe-validation

7.5.2 Identification and Traceability7.5.2 Identification and Traceability

• The organization shall identify the product by The organization shall identify the product by suitable means throughout the product realization, suitable means throughout the product realization, where appropriate.where appropriate.

• Identification of the product status with respect to Identification of the product status with respect to measurement and monitoring requirements.measurement and monitoring requirements.

• The organization shall The organization shall control and record the unique control and record the unique identificationidentification of the product, where traceability is a of the product, where traceability is a requirement.requirement.

Discussion:Discussion:– Where appropriate, define the means for Where appropriate, define the means for

identification e.g.: marking, tagging, location, identification e.g.: marking, tagging, location, color, batch nos.color, batch nos.

– Service identification may be achieved by Service identification may be achieved by documentation that accompanies the servicedocumentation that accompanies the service

– Traceability involves the ability to trace the Traceability involves the ability to trace the history, application or location of an item or history, application or location of an item or activityactivity

– - Traceability required when there is a need to - Traceability required when there is a need to track a Nonconformity back to the sourcetrack a Nonconformity back to the source

– In case of service functions, recording of In case of service functions, recording of identification evidenced through signature or identification evidenced through signature or serially numbered documents in invoicing and serially numbered documents in invoicing and banking operationbanking operation

– Cases wherein identification and traceability is Cases wherein identification and traceability is necessary. Example: relevant statutory & necessary. Example: relevant statutory & regulatory requirements & mitigation of risks.regulatory requirements & mitigation of risks.

7.5.47.5.4 Customer propertyCustomer property

The organization shall exercise care with customer The organization shall exercise care with customer property while it is under the organization's control or property while it is under the organization's control or being used by organization.being used by organization.

Identification, verification, protection and safeguardIdentification, verification, protection and safeguard of customer property shall be performed.of customer property shall be performed.

Loss, damages or suitability for use shall be Loss, damages or suitability for use shall be reported reported to customer & records shall be maintained.to customer & records shall be maintained.

Can include intellectual property and personal data Can include intellectual property and personal data (2008)(2008)

7.5.57.5.5 Preservation of productPreservation of product

• The organization shall define & implement The organization shall define & implement product handling, packaging, storage, product handling, packaging, storage, preservation and delivery processes.preservation and delivery processes.

• Prevent deterioration, damage & misuse to Prevent deterioration, damage & misuse to ensure product conformity ensure product conformity during internal during internal processing and deliveryprocessing and delivery to the intended to the intended destinationdestination

• Applicable also to constituent parts of a Applicable also to constituent parts of a productproduct

7.67.6 Control of Monitoring and Measuring Control of Monitoring and Measuring Equipment Equipment (2008)(2008)Determine measurement &monitoring to be undertaken Determine measurement &monitoring to be undertaken Determine devices required to provide evidence of product conformityDetermine devices required to provide evidence of product conformityEnsure MMD calibrations are carried out and in a manner consistent with Ensure MMD calibrations are carried out and in a manner consistent with

requirementsrequirements

Measuring equipment shall be:Measuring equipment shall be:

1.1. Calibrated or verified prior to use or at specified intervals against Calibrated or verified prior to use or at specified intervals against standards traceable to national or international standards, or record standards traceable to national or international standards, or record basis used if no such standard exist.basis used if no such standard exist.

2.2. Adjusted & re-adjusted Adjusted & re-adjusted 3.3. Calibration status be identifiedCalibration status be identified4.4. Safeguarded against adjustmentsSafeguarded against adjustments5.5. Protected against damage & deterioration during handling, Protected against damage & deterioration during handling,

maintenance & storage.maintenance & storage.

When devices are found to be out of calibration, previous results shall When devices are found to be out of calibration, previous results shall be assessed for validity & recorded. Appropriate action be taken on be assessed for validity & recorded. Appropriate action be taken on devices and any affected product.devices and any affected product.

Confirm ability of software used for measurement & monitoring Confirm ability of software used for measurement & monitoring prior to prior to initial use & reconfirmed if necessaryinitial use & reconfirmed if necessary. . Ability of the computer software to satisfy the intended application Ability of the computer software to satisfy the intended application would include its verification and configuration management to would include its verification and configuration management to maintain its suitability for use (2008)maintain its suitability for use (2008)

8.18.1 GeneralGeneral

Shall plan & implement the monitoring, measurement, Shall plan & implement the monitoring, measurement, analysis & improvement processes in order to:analysis & improvement processes in order to:

1.1. Demonstrate product conformityDemonstrate product conformity

2.2. Ensure QMS conformityEnsure QMS conformity

3.3. Continually improve QMS effectivenessContinually improve QMS effectiveness

Determine applicable methods, including statistical Determine applicable methods, including statistical techniques.techniques.

• Discussion:Discussion:

– How to measure process performance.How to measure process performance.– Issues to be considered to consider in Issues to be considered to consider in

measurement, analysis & improvement.measurement, analysis & improvement.

8.28.2 Measurement and monitoringMeasurement and monitoring

8.2.18.2.1 Customer SatisfactionCustomer Satisfaction

Determine methods to obtain & use information relating to Determine methods to obtain & use information relating to customer perception.customer perception.

Monitor this information as a means to measure QMS Monitor this information as a means to measure QMS performance.performance.

Monitoring customer perception can include obtaining inputs Monitoring customer perception can include obtaining inputs from sources such as customer satisfaction surveys, from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion customer data on delivered product quality, user opinion surveys, lost business analysis, complaints, warranty claims surveys, lost business analysis, complaints, warranty claims and dealer reports. (2008) and dealer reports. (2008)


-- Understand customer complaint relationship with customer Understand customer complaint relationship with customer satisfaction.satisfaction.

8.2.28.2.2 Internal audit Internal audit

Shall perform at planned interval Shall perform at planned interval Objectives are to determine whether:Objectives are to determine whether:

1.1. QMS conforms to planned arrangements & ISO QMS conforms to planned arrangements & ISO requirements requirements

2.2. QMS effectively implemented & maintained.QMS effectively implemented & maintained.

Plan audit taking into consideration importance & Plan audit taking into consideration importance & status of the processes & areas and the status of the processes & areas and the results of results of previous auditsprevious audits..Define audit criteria, scope, frequency and methodsDefine audit criteria, scope, frequency and methods..Auditors Auditors shall not audit their own workshall not audit their own work and shall and shall ensure objectivity & impartiality of the audit processensure objectivity & impartiality of the audit processDocumented procedure to define responsibilities & Documented procedure to define responsibilities & requirements for planning, conducting & reporting requirements for planning, conducting & reporting audits & maintaining recordsaudits & maintaining records..Responsible management shall take actions to Responsible management shall take actions to eliminate NC and eliminate NC and their causestheir causes without undue delay. without undue delay.Verification of the actions taken & reporting results of Verification of the actions taken & reporting results of such verification shall be performed.such verification shall be performed.

8.2.3Measurement and monitoring of 8.2.3Measurement and monitoring of processesprocesses

Apply suitable methods for monitoring, where Apply suitable methods for monitoring, where applicable, measurement of QMS processes to applicable, measurement of QMS processes to demonstrate ability to achieve planned resultsdemonstrate ability to achieve planned results

Corrective & preventive action shall be taken Corrective & preventive action shall be taken when planned results are not obtained.when planned results are not obtained.

Type and extent of monitoring or measurement Type and extent of monitoring or measurement appropriate to each of the process depends appropriate to each of the process depends upon their impact on the conformity to product upon their impact on the conformity to product requirements and on the effectiveness on QMS requirements and on the effectiveness on QMS (2008)(2008)

8.2.4Measurement and monitoring 8.2.4Measurement and monitoring of productof product

Measurement and monitoring of product to verify Measurement and monitoring of product to verify product requirements are satisfied, at appropriate product requirements are satisfied, at appropriate stages as per 7.1stages as per 7.1Evidence to conformity with acceptance criteria is to Evidence to conformity with acceptance criteria is to be maintained.be maintained.

Release of product with identification of personnel Release of product with identification of personnel authorizing the release shall be recorded.authorizing the release shall be recorded.

Shall not release product & delivery service until Shall not release product & delivery service until planned arrangements have been satisfactorily planned arrangements have been satisfactorily completed, completed, unless approved by relevant authority & unless approved by relevant authority & customer where applicable).customer where applicable).


How are measurement and monitoring How are measurement and monitoring of product requirement of product requirement implemented? implemented?

8.2.48.2.4 Measurement and Measurement and monitoring of productmonitoring of product

Measurement and monitoring of product to Measurement and monitoring of product to verify product requirements are satisfied, at verify product requirements are satisfied, at appropriate stages as per 7.1appropriate stages as per 7.1Evidence to conformity with acceptance criteria Evidence to conformity with acceptance criteria is to be maintained.is to be maintained.Release of product with identification of Release of product with identification of personnel authorizing the release shall be personnel authorizing the release shall be recorded.recorded.Shall not release product & delivery service until Shall not release product & delivery service until planned arrangements have been satisfactorily planned arrangements have been satisfactorily completed, completed, unless approved by relevant unless approved by relevant authority & customer (where applicable).authority & customer (where applicable).


-- How are measurement and monitoring of product How are measurement and monitoring of product requirement requirement implemented? implemented?

8.3 Control of nonconforming product8.3 Control of nonconforming product

Documented procedureDocumented procedure to define responsibilities & to define responsibilities & authorities to control nonconforming product.authorities to control nonconforming product.Shall ensure that NC products are identified and Shall ensure that NC products are identified and prevent against unintended use or delivery.prevent against unintended use or delivery.One or more of the following ways:One or more of the following ways:

1.1. Eliminating detected nonconformityEliminating detected nonconformity

2.2. Relevant authority authorize use, release or Relevant authority authorize use, release or acceptance under concession & where applicable, by acceptance under concession & where applicable, by customer.customer.

3.3. Preclude original application or intended use.Preclude original application or intended use.

Maintain records of nonconformity's nature & Maintain records of nonconformity's nature & subsequent actions taken, including any concessions subsequent actions taken, including any concessions obtainedobtained

Re-verify corrected product for conformanceRe-verify corrected product for conformance

Act appropriately, depending on the effects or Act appropriately, depending on the effects or potential effects, when potential effects, when nonconforming product is nonconforming product is detected after delivery or use.detected after delivery or use.

8.48.4 Analysis of dataAnalysis of dataShall determine, gather & analyze data to demonstrate Shall determine, gather & analyze data to demonstrate QMS effectiveness & suitability and to evaluate QMS effectiveness & suitability and to evaluate continual improvement of QMS effectiveness.continual improvement of QMS effectiveness.Data shall include results of measurement and Data shall include results of measurement and monitoring and other relevant information relating to:monitoring and other relevant information relating to:

1.1. Customer satisfactionCustomer satisfaction

2.2. Product conformanceProduct conformance

3.3. Characteristic & trends of processes & products and Characteristic & trends of processes & products and preventive action opportunitiespreventive action opportunities

4.4. SuppliersSuppliers

Discussion:Discussion:• -- Can statistical tools be used? Can statistical tools be used?

8.58.5 ImprovementImprovement8.5.1Continual improvement8.5.1Continual improvement

Organization shall use the quality policy, Organization shall use the quality policy, quality objectives, and result of audits, data quality objectives, and result of audits, data analysis, corrective & preventive actions and analysis, corrective & preventive actions and management reviews for the QMS continual management reviews for the QMS continual improvement.]improvement.]


Should be pro-active instead of waiting for a Should be pro-active instead of waiting for a problem to reveal opportunities for problem to reveal opportunities for improvementimprovementSmall-step improvement Vs breakthroughSmall-step improvement Vs breakthrough

8.5.28.5.2 Corrective actionCorrective action

Documented procedureDocumented procedure to define requirements for: to define requirements for:

1.1. Nonconformity's reviewsNonconformity's reviews

2.2. Causes of nonconformity's investigationCauses of nonconformity's investigation

3.3. Evaluation for action to prevent recurrence of Evaluation for action to prevent recurrence of nonconformity'snonconformity's

4.4. Determine & implement action neededDetermine & implement action needed

5.5. Recording results of action taken Recording results of action taken

6.6. Reviewing corrective actionReviewing corrective action

Corrective actions shall be appropriate to the effects of Corrective actions shall be appropriate to the effects of nonconformity's encountered, to prevent recurrencenonconformity's encountered, to prevent recurrence

8.5.38.5.3 Preventive actionPreventive action

Documented procedure for:Documented procedure for:

1.1. Determining potential nonconformity's and their Determining potential nonconformity's and their causes causes

2.2. Evaluate the need for action to prevent occurrenceEvaluate the need for action to prevent occurrence

3.3. Determine implementation required Determine implementation required

4.4. Recording results of action taken Recording results of action taken

5.5. Reviewing preventive actionReviewing preventive action

internal auditinginternal auditing

Auditing Techniques

Auditing is a process for obtaining audit evidence and evaluating objectively.Audit evidence is obtained by auditor.Auditor is a person with competence to conduct the audit by auditing the auditee.Auditee is the person / organization being audited.For obtaining audit evidence, auditors have to communicate with the auditee.Effective communication is essential to support auditor’s deliverable, which is the audit report based on facts.

Communication

Effective communications comprise:Speaking

•Speak at the level of the auditeeSpeak at the level of the auditee•Frame the messages in the language & Frame the messages in the language & vocabulary of the target vocabulary of the target •audience to get a clear answersaudience to get a clear answers•Structure your questioningStructure your questioning•Ensure the brain is in gear before operating Ensure the brain is in gear before operating mouthmouth

Likely problems of speakingLikely problems of speaking

• What is spoken, may not be heardWhat is spoken, may not be heard– Due to:Due to:– physical barriersphysical barriers– noisenoise– disinterestdisinterest– lack of concentrationlack of concentration– tirednesstiredness– undeclared deafnessundeclared deafness– BoredomBoredom

• What is heard, may not be understoodWhat is heard, may not be understood– Due to:Due to:– Lack of technical knowledge Lack of technical knowledge – Industry related vocabulary used Industry related vocabulary used – language / accentlanguage / accent– basic educationbasic education

ListeningListening

• Active listening is very important for an Active listening is very important for an auditor.auditor.

• Active listening is a way of listening and Active listening is a way of listening and responding to auditee to improve mutual responding to auditee to improve mutual understanding.understanding.

• Half listening Half listening • Half thinking about something elseHalf thinking about something else• Do not listen with a conflict in mind as you Do not listen with a conflict in mind as you

will be busy formulating a response to what will be busy formulating a response to what is being said and focus on how to win the is being said and focus on how to win the argument.argument.

• Active listening is a structured way of Active listening is a structured way of listening and responding that focuses the listening and responding that focuses the attention on the auditee.attention on the auditee.

An auditor should balance speaking and listening feature as:

Speaking Listening

20 % 80%

Questioning Technique

Open ended questions:Questions which has descriptive answers detailed information on the subject matter

•overall picture•huge amount of information•puts people at ease•to be used during

Interrogationin beginning of the audit interviewto get more information on a certain subject

Closed questions:Closed questions:Questions which has yes or no Questions which has yes or no

answers on the subject matteranswers on the subject matter– Zoom-inZoom-in– Clear answer (yes – no – don’t Clear answer (yes – no – don’t

know)know)– To be usedTo be used

•To check understandingTo check understanding

•To get a clear answerTo get a clear answer

•To stop communications hogs or To stop communications hogs or evasive answersevasive answers

Observing Auditor shall observe all details around during Auditor shall observe all details around during

the audit.the audit.– Requires attention to detail combined with Requires attention to detail combined with

analytical skillsanalytical skills– Body languageBody language– MannerismMannerism– DeductionDeduction

Do not report these conclusions based on Do not report these conclusions based on above observation unless substantiated by above observation unless substantiated by objective evidence.objective evidence.

ButBut

Use them to reach objective evidence of Use them to reach objective evidence of compliance and / or non-compliance.compliance and / or non-compliance.

ReportingReportingAudit report is the only deliverable of an auditor and Audit report is the only deliverable of an auditor and

audit report provide data to the top management for audit report provide data to the top management for review and identify opportunities for improvement.review and identify opportunities for improvement.

Make it as good combination of listening and writing.Make it as good combination of listening and writing.

Avoid giving an impression that you are more worried Avoid giving an impression that you are more worried about writing than understanding and appreciating about writing than understanding and appreciating the implementationthe implementation

Writing information based on facts is an important Writing information based on facts is an important parameter of auditing technology.parameter of auditing technology.– Note all supporting information based on factsNote all supporting information based on facts– Be concise but provide complete information. Do Be concise but provide complete information. Do

not sacrifice correctness, completeness or clarity not sacrifice correctness, completeness or clarity for the sake of brevity.for the sake of brevity.

– Be right – accurate information based on objective Be right – accurate information based on objective EvidenceEvidence

Functional responsibility:Functional responsibility: Audit investigation is planned based on each Audit investigation is planned based on each

function and all the applicable processes for function and all the applicable processes for

each function is auditedeach function is audited • AdvantagesAdvantages

– shows overall understanding of the quality shows overall understanding of the quality management system by department management system by department

– covers several processes in one locationcovers several processes in one location– verifies system implementationverifies system implementation

• DisadvantagesDisadvantages– requires experienced auditorsrequires experienced auditors– requires good notesrequires good notes

PLANINGPLANING

Audit PlanningAudit PlanningDescription of the activities and arrangement Description of the activities and arrangement

for an audit, for an audit,

PLANNING STAGESPLANNING STAGES

• ScopeScope– The scope define the objective of the The scope define the objective of the

audit audit – The depth of the auditThe depth of the audit

E.g.:E.g.:1.1. Audit of a company for design, manufacture and Audit of a company for design, manufacture and

installation of boilers.installation of boilers.

2.2. Audit of the activities of the QA/QC department Audit of the activities of the QA/QC department against the applicable procedures that are part of against the applicable procedures that are part of the ISO 9000 quality management systemsthe ISO 9000 quality management systems

RequirementsRequirements– Defines the audit criteriaDefines the audit criteria– Based on the scope of the auditBased on the scope of the audit

• External Requirements:External Requirements:– ISO- standardISO- standard– Other standardsOther standards– Laws and RegulationsLaws and Regulations– ContractContract– Customer – supplied documents / drawingsCustomer – supplied documents / drawings– Product / Business sector code of conduct Product / Business sector code of conduct

• Internal Requirements: Internal Requirements: – Quality Manual (policy & objectives)Quality Manual (policy & objectives)– ProceduresProcedures– Work instructions (where appropriate)Work instructions (where appropriate)– ProjectsProjects– ProcessesProcesses– ProductProduct

Collect Department / Functional Collect Department / Functional informationinformation

• Organizational unitsOrganizational units– Different sitesDifferent sites– LocationsLocations

Process complexity and importance of the Process complexity and importance of the processprocess

Previous audit results and statusPrevious audit results and status

Audit duration: Audit duration: No. of days for the audit.No. of days for the audit.

• Audit duration is based on:Audit duration is based on:– Size of the functionSize of the function– Complexity of the processesComplexity of the processes– Multiple locationsMultiple locations– IAF Guidance ISO/IEC 17021 IAF Guidance ISO/IEC 17021

Document reviewDocument review Review of QMS Documents for adequacy to the Review of QMS Documents for adequacy to the

requirements and is the preliminary and important requirements and is the preliminary and important stage in the Audit Process.stage in the Audit Process.

A Typical review of documents includeA Typical review of documents include – Quality ManualQuality Manual– Documented ProceduresDocumented Procedures– Policies and ObjectivesPolicies and Objectives– Process definitions and interfacesProcess definitions and interfaces– Resource provisionResource provision– Compliance to ISO 9001:2008 standard with emphasis on Compliance to ISO 9001:2008 standard with emphasis on

allowable exclusions in section 7.0.allowable exclusions in section 7.0.

Document review maybe an off site audit and does not refer to Document review maybe an off site audit and does not refer to the depth implementation.the depth implementation.

A Typical documentation structure may A Typical documentation structure may

include:include:

Quality Manual

Operating Procedures as per requirement of ISO 9001: 2008

Work Instructions/ Process Plans/Flowcharts

Forms / Check lists

QUALITY MANAGEMENT SYSTEM FORMATQUALITY MANAGEMENT SYSTEM FORMAT

Documents may be in aDocuments may be in a

– Hard copy / Soft copy Hard copy / Soft copy – multi layer / single layermulti layer / single layer– corporate and departmental manuals / just one corporate and departmental manuals / just one

manualmanual

The quality system is in the first place developed to The quality system is in the first place developed to suit the needs of the auditee.suit the needs of the auditee.

The auditors should be more practical to adapt to The auditors should be more practical to adapt to various type of documentation.various type of documentation.

QUALITY MANUALQUALITY MANUAL

Generally includes:Generally includes:

– Quality policyQuality policy– Quality objectivesQuality objectives– Information on the organizationInformation on the organization– Information on the structure of the quality systemInformation on the structure of the quality system– Scope of Quality Management System, including Scope of Quality Management System, including

details of and justification for any exclusionsdetails of and justification for any exclusions– A description of the interaction between the A description of the interaction between the

processes of the quality management systems.processes of the quality management systems.– Address all requirements of the ISO 9001:2008.Address all requirements of the ISO 9001:2008.

CAN INCLUDE PROCEDURES OR MAKE CAN INCLUDE PROCEDURES OR MAKE REFERENCE TO PROCEDURESREFERENCE TO PROCEDURES

PROCEDURESPROCEDURES

ISO REQUIRES DOCUMENTED PROCEDURES ISO REQUIRES DOCUMENTED PROCEDURES TO BE ESTABLISHED TO DEFINE CONTROLS TO BE ESTABLISHED TO DEFINE CONTROLS FOR THE FOLLOWING:FOR THE FOLLOWING:– control of documents (4.2.3)control of documents (4.2.3)– control of records (4.2.4)control of records (4.2.4)– internal audit (8.2.2)internal audit (8.2.2)– control of non conforming product (8.3)control of non conforming product (8.3)– corrective action (8.5.2)corrective action (8.5.2)– preventive action (8.5.3)preventive action (8.5.3)

Auditors shall investigate the strategy and methods Auditors shall investigate the strategy and methods adopted in planning arrangements to achieve the Quality adopted in planning arrangements to achieve the Quality Objectives of product/ project/contract and identify other Objectives of product/ project/contract and identify other documents within the QMS.documents within the QMS.

Title : Table of ContentsTitle : Table of Contents Section ASection A Page 1 of 1Page 1 of 1

Revision Nr.: 0Revision Nr.: 0 Date of Effective:Date of Effective:

Approved by the General Approved by the General ManagerManager

Signature :Signature :

SectioSection No.n No.

Section TitleSection Title RevisioRevision No.n No.

Date of Date of EffectivEffectivee

AA Table of ContentsTable of Contents 00 01.01.001.01.011

BB Revision Record SheetRevision Record Sheet 00 01.01.001.01.011

CC IntroductionIntroduction 00 01.01.001.01.011

DD Quality PolicyQuality Policy 00 01.01.001.01.011

EE Quality ObjectivesQuality Objectives 00 01.01.001.01.011

GG AbbreviationsAbbreviations 00 01.01.001.01.011

HH Control of DocumentsControl of Documents 00 20.02.020.02.011

II Control of RecordsControl of Records 00 20.02.020.02.011

JJ Internal Quality AuditsInternal Quality Audits 00 20.02.020.02.011

KK Control of Nonconforming ProductControl of Nonconforming Product 00 20.02.020.02.011

LL Corrective actionCorrective action 00 20.02.020.02.011

MM Preventive ActionPreventive Action 00 20.02.020.02.011

Audit ProgrammeAudit Programme Agenda specifying Time, Auditor, Function Agenda specifying Time, Auditor, Function that will be auditedthat will be audited

Based on:Based on:– Duration of the audit Duration of the audit – Team sizeTeam size– Technical skills of the auditorsTechnical skills of the auditors– Results of the document review (desk top results)Results of the document review (desk top results)– previous audit plansprevious audit plans– type of audit investigation (see chapter 8)type of audit investigation (see chapter 8)– the status and importance of the activity being the status and importance of the activity being

auditedaudited– Concurrence of the AuditeeConcurrence of the Auditee– More time for the larger & more complex More time for the larger & more complex

processesprocesses– Keep the audit programme realistic & flexible Keep the audit programme realistic & flexible

(time for the unexpected)(time for the unexpected)– Within company hoursWithin company hours

Team SelectionTeam Selection Audit team shall be competent to audit the Audit team shall be competent to audit the product sector under consideration.product sector under consideration.

BASED ONBASED ON

– Department Size / extent of activities and Department Size / extent of activities and locations of worklocations of work

– Product and services provided (technical Product and services provided (technical & audit skills needed)& audit skills needed)

– Independence (nobody can audit their Independence (nobody can audit their own department / activities / workown department / activities / work

It may be kept in mind that the total It may be kept in mind that the total duration of the audit may not exceed 5 days.duration of the audit may not exceed 5 days.

Audit NotificationAudit Notification

Formal Notification Formal Notification – Issued to the responsible managerIssued to the responsible manager– Notification should include:Notification should include:

• Scope and criteria of auditScope and criteria of audit• Name(s) of auditor(s)Name(s) of auditor(s)• Schedule / agendaSchedule / agenda• Date and time of opening meetingDate and time of opening meeting• Support requirements (Site, accommodation, Support requirements (Site, accommodation,

transportation etc.)transportation etc.)

– Any logistical informationAny logistical information– Matrix of requirementMatrix of requirement– Audit PlanAudit Plan

Typical example of Audit Plan MatrixTypical example of Audit Plan Matrix Example 1Example 1

DayDay Dept.Dept. Ref. ISORef. ISO

ElemenElementsts

Lead Lead AuditorAuditor

AuditorAuditor AuditAuditoror

09.00 09.00 AMAM

Opening Opening meetingmeeting

--

09.30 09.30 AMAM

Plant VisitPlant Visit --

10.00 10.00 AMAM

ManagementManagement

11.00 11.00 AMAM

MarketingMarketing

PurchasingPurchasing

Quality ControlQuality Control

0033.00 .00 PMPM

TrainingTraining

DesignDesign

MRMR

Workshop 5: MATRIX OF REQUIREMENT

AUDIT MATRIXAUDIT MATRIX

You have been assigned to plan and lead an internal audit You have been assigned to plan and lead an internal audit for the plant described below which has implemented a for the plant described below which has implemented a quality management system based on the ISO 9001-2008 quality management system based on the ISO 9001-2008 standard.standard.

You will be conducting a complete quality system audit to You will be conducting a complete quality system audit to ensure that an ISO 9001-2008 quality system has been ensure that an ISO 9001-2008 quality system has been developed, implemented and maintained.developed, implemented and maintained.

The plant has four major product lines, each involving The plant has four major product lines, each involving fabrication and assembly of various components. It has a fabrication and assembly of various components. It has a three-shift operation and 500 employees total.three-shift operation and 500 employees total.

Two other trained internal auditors will participate in the Two other trained internal auditors will participate in the audit with you.audit with you.

Plan the audit matrix.Plan the audit matrix.

Checklist preparationChecklist preparationPurposePurpose

o Provides consistency and uniformityProvides consistency and uniformityo Assures full coverage of the clauses to be auditedAssures full coverage of the clauses to be auditedo Reminds auditor of areas where nonconformities have been Reminds auditor of areas where nonconformities have been

found during the previous auditfound during the previous audito Supplements the auditor’s memorySupplements the auditor’s memoryo Provides a basis to reconstruct the audit when stuckProvides a basis to reconstruct the audit when stucko Improves the auditor’s efficiency (timing)Improves the auditor’s efficiency (timing)o Useful for training new auditorsUseful for training new auditorso Useful attachment to the audit reportUseful attachment to the audit report

Sources for the check listSources for the check list• Quality Management System documents like Quality Management System documents like

– Quality manualQuality manual– documented procedures and defined processesdocumented procedures and defined processes– work instructionswork instructions

o Applicable contractual standardsApplicable contractual standardso contractual requirementscontractual requirementso process/product regulationsprocess/product regulations

Type of Check ListType of Check List• list with key wordslist with key words• list with questionslist with questions

Check List is:Check List is:

• An integral part of audit reportAn integral part of audit report• Filled in by the auditorFilled in by the auditor• Check List should be FlexibleCheck List should be Flexible

• Caution: Caution:

• Do not let the checklist take over you.Do not let the checklist take over you.• Check list should not restrict your questions.Check list should not restrict your questions.

Sample Check List 1Sample Check List 1

• Key WordsKey Wordso evaluation of suppliersevaluation of supplierso record of validation of processesrecord of validation of processeso purchasing informationpurchasing informationo validation of designvalidation of designo review of purchase informationreview of purchase informationo report on damage / loss of customer propertyreport on damage / loss of customer propertyo procedure for internal auditprocedure for internal audit

SAMPLE Check List 2SAMPLE Check List 2

o Are the subcontractor evaluated?Are the subcontractor evaluated?o What are the criteria for subcontractor’s evaluation?What are the criteria for subcontractor’s evaluation?o What type of control exercised over subcontractors?What type of control exercised over subcontractors?o Are the records of evaluation of subcontractors maintained?Are the records of evaluation of subcontractors maintained?o Is there any verification arrangements at subcontractor works Is there any verification arrangements at subcontractor works

defined?defined?

AUDITAUDIT

Conducting the AuditConducting the Audit

Phase: Pre-Audit meetingPhase: Pre-Audit meetingParticipants: Lead Auditors and auditorsParticipants: Lead Auditors and auditorsPurpose: Purpose:

o Initial understanding of the quality management systems and Initial understanding of the quality management systems and processesprocesses

o Organization of audit teamOrganization of audit teamo Deciding on frequency of team reviewsDeciding on frequency of team reviewso Preparation of Check ListPreparation of Check List

Contents: Contents: o Audit scopeAudit scopeo Overview of document reviewOverview of document reviewo Logistical arrangementLogistical arrangemento Explain audit planExplain audit plano Define tasks of lead auditor & auditors (for more then one Define tasks of lead auditor & auditors (for more then one

member audit)member audit)o Review audit notification for scope and criteria for audit.Review audit notification for scope and criteria for audit.

Phase: Phase: Opening MeetingOpening MeetingParticipants: Participants: Lead auditor / auditors, Auditee, Lead auditor / auditors, Auditee,

GuidesGuidesPurpose: Purpose:

• Explain the objective of the audit to the auditee Explain the objective of the audit to the auditee managementmanagement

Contents:Contents:• IntroductionIntroduction• Audit scopeAudit scope• Explain auditing method including samplingExplain auditing method including sampling• Define everybody’s roleDefine everybody’s role• Audit scheduleAudit schedule• Define type of Nonconformities Define type of Nonconformities • Basis of evaluating effectiveness of quality systemBasis of evaluating effectiveness of quality system• Confirm logistical & safety issuesConfirm logistical & safety issues• Agree on final report distributionAgree on final report distribution• ClarificationClarification• Attendance recordAttendance record

Phase: Phase: Audit interviewAudit interviewPurpose: Purpose:

– Interview auditee in all functions as per the Interview auditee in all functions as per the scope /objective of the audit.scope /objective of the audit.

• Contents:Contents:– IntroductionIntroduction– Explain purpose of the auditExplain purpose of the audit– Ask auditee about his responsibility and the Ask auditee about his responsibility and the

process as relevant to the function process as relevant to the function – Check sample records to evaluate effective Check sample records to evaluate effective

understanding and implementationunderstanding and implementation– Make good notes of audited department, Make good notes of audited department,

auditee’s name, clauses audited, and auditee’s name, clauses audited, and nonconformities, if any, supported by objective nonconformities, if any, supported by objective evidenceevidence

– Thank auditeeThank auditee

Audit interview: what can go wrong?Audit interview: what can go wrong?

Role of auditor when problems Role of auditor when problems

encountered during the audit:encountered during the audit:

The unresponsive auditeeThe unresponsive auditee– Deliberate or unintentionalDeliberate or unintentional– Fear or lack of understandingFear or lack of understanding

What to do?What to do?– Put the auditee at easePut the auditee at ease– Explain the audit purpose once againExplain the audit purpose once again– Speak at the auditee’s level of understandingSpeak at the auditee’s level of understanding– Solicit feed-backSolicit feed-back

Evasive answersEvasive answers– Impress auditorImpress auditor– Lack of knowledgeLack of knowledge

What to do?What to do?– Remain calm, polite and tactfulRemain calm, polite and tactful– Restate the question (open-closed)Restate the question (open-closed)– Have escort clarify question to auditeeHave escort clarify question to auditee– Go to other employeeGo to other employee

ConfrontationConfrontation– Auditee does not agreeAuditee does not agree– What to do?What to do?– Remain calm, polite and tactfulRemain calm, polite and tactful– Stay in control of yourself and of the auditStay in control of yourself and of the audit– Be flexibleBe flexible– Review situation along with requirementsReview situation along with requirements– Do not use an argumentative approachDo not use an argumentative approach

Phase: Phase: Data CollectionData CollectionPurpose: Purpose:

– Collect data from audit interview and for the purpose of Collect data from audit interview and for the purpose of evaluating the effective implementation of QMS.evaluating the effective implementation of QMS.

Contents:Contents:• Objective evidenceObjective evidence• Copies of pertinent records (work checklists, Copies of pertinent records (work checklists,

report,)report,)• Accurate notesAccurate notes

– names & location of personnelnames & location of personnel– identification & location of records & documentsidentification & location of records & documents– No. of samples auditedNo. of samples audited– Observations substantiated by objective evidenceObservations substantiated by objective evidence– Number your pagesNumber your pages

Record the truth, the whole truth and nothing Record the truth, the whole truth and nothing but the truth!but the truth!

Phase:Phase: Meetings MeetingsPurpose: Purpose:

– For communication within the audit team and with client For communication within the audit team and with client managementmanagement Audit team meetingsAudit team meetings

• Contents:Contents:– Conducted by Lead AuditorConducted by Lead Auditor– Attended by lead-auditor and auditorsAttended by lead-auditor and auditors– Exchange information Exchange information – Discuss complex issues Discuss complex issues – Review and discuss evidence Review and discuss evidence – Reach consensus on findings Reach consensus on findings – Discuss on meeting audit schedulesDiscuss on meeting audit schedules– Meeting held at any time during lunch or other breaks. Meeting held at any time during lunch or other breaks. – Audit Briefings with client managementAudit Briefings with client management– Attended by audit team and auditee representatives Attended by audit team and auditee representatives – Discuss planned daily activities, significant findings, Discuss planned daily activities, significant findings,

areas of concern areas of concern and and schedule changesschedule changes– Held during each day morning or at the end of each dayHeld during each day morning or at the end of each day

Non - ConformanceNon - Conformance

Non-fulfilment of a requirementNon-fulfilment of a requirement

It is the departure or absence of one or more quality It is the departure or absence of one or more quality characteristics from specified requirements.characteristics from specified requirements.

Specified requirements may be with respect to the Specified requirements may be with respect to the product, process and system.product, process and system.

Non-Conformities may be classified as Major and Non-Conformities may be classified as Major and Minor categories. For non-conformances recorded Minor categories. For non-conformances recorded during internal audit, such classification may not be during internal audit, such classification may not be required.required.

Analyze the impact of non-conformance on the Analyze the impact of non-conformance on the product quality, customer satisfaction, safety of product quality, customer satisfaction, safety of interested parties and regulatory requirements while interested parties and regulatory requirements while deciding on the category of non-conformities.deciding on the category of non-conformities.

Following definitions may be used as for Following definitions may be used as for classification of major / minor non-classification of major / minor non-conformities.conformities.

Major nonconformities:Major nonconformities:• Clause of the ISO 9001 Standard is not addressed in Clause of the ISO 9001 Standard is not addressed in

the Quality Management System except as permitted the Quality Management System except as permitted by exclusions and justified.by exclusions and justified.

• Documented procedures and arrangements are not Documented procedures and arrangements are not ImplementedImplemented

• A series of minor non-conformities A series of minor non-conformities indicating an indicating an Overall weakness in particular area or activities, Overall weakness in particular area or activities, Which Which collectively have significant effect on? collectively have significant effect on? Product or service quality Product or service quality

• Not meeting the applicable regulatory requirements Not meeting the applicable regulatory requirements

• Ineffective corrective actions on previous Ineffective corrective actions on previous NonconformitiesNonconformities

Minor nonconformities:Minor nonconformities:

• there is a defined system and documented procedures there is a defined system and documented procedures and arrangement which generally satisfy agreed and arrangement which generally satisfy agreed requirements and the organization being audited is requirements and the organization being audited is able to demonstrate an acceptable level of able to demonstrate an acceptable level of implementation overall, but there are minor implementation overall, but there are minor discrepancies or lapses in discipline.discrepancies or lapses in discipline.

Non-conformity Non-conformity StatementsStatements

• State specific requirement not met (nature of State specific requirement not met (nature of requirement that is not being complied with Like specific requirement that is not being complied with Like specific clauses of ISO 9001-2008, clauses from the quality clauses of ISO 9001-2008, clauses from the quality system documents, clauses of regulations or contractual system documents, clauses of regulations or contractual requirements)requirements)

• State the process which is not meeting the requirements State the process which is not meeting the requirements and refer to the clause of the standard applicable for the and refer to the clause of the standard applicable for the process and not to the function.process and not to the function.

• Keep in mind that each function may have more than one Keep in mind that each function may have more than one process applicable.process applicable.

Ex. In purchasing function, there may be non-Ex. In purchasing function, there may be non-conformance in process like conformance in process like control of documents, control of documents, control of records, and training in addition to control of records, and training in addition to purchasing processpurchasing process

• Make a non-conformity statement that is not Make a non-conformity statement that is not meeting the requirements. Do not make statements meeting the requirements. Do not make statements like -----to be done,--to be trained etc.like -----to be done,--to be trained etc.

• Make a statement like Calibration not done, Make a statement like Calibration not done, documents in the department are not of the latest documents in the department are not of the latest revision and substantiate with objective evidence by revision and substantiate with objective evidence by referring to instrument no, revision no. of referring to instrument no, revision no. of documents not of the latest issuedocuments not of the latest issue

• Identify and locate the objective evidenceIdentify and locate the objective evidence

• Make clear and complete state of non-conformityMake clear and complete state of non-conformity

• Classify as major or minor, if applicable.Classify as major or minor, if applicable.

Importance of non-conformity statementsImportance of non-conformity statements..

• Starting point for corrective actionStarting point for corrective action

• Data for an auditor to conclude on the Data for an auditor to conclude on the effectiveness of the systemeffectiveness of the system

• Data for an auditee for analyses of the depth Data for an auditee for analyses of the depth of implementation and areas which does not of implementation and areas which does not meet the requirements of the QMS.meet the requirements of the QMS.

• Identifies the areas for improvementIdentifies the areas for improvement

Closing MeetingClosing Meeting• Participants:Participants:

– Lead AuditorLead Auditor– Auditee ManagementAuditee Management

• Purpose:Purpose:– To inform the auditee management on the outcome of To inform the auditee management on the outcome of

the audit.the audit.• Contents:Contents:

– lead auditor in complete controllead auditor in complete control– thank the auditee for cooperationthank the auditee for cooperation– review the scopereview the scope– present the strengths of the system implementationpresent the strengths of the system implementation– summary of audit findingssummary of audit findings– Summarise non-conformitySummarise non-conformity– explainexplain audit technique audit technique (sampling(sampling))– present conclusionspresent conclusions– present time frame for corrective actionspresent time frame for corrective actions– ask for any clarificationsask for any clarifications– follow company procedure for reporting (at the end of follow company procedure for reporting (at the end of

the meeting or within 3 the meeting or within 3 days)days)– attendance recordattendance record

Audit ReportAudit Report

• Audit report is the only deliverable of the auditor.

• Audit report shall be based on facts

• Audit report shall provide information on the strength of the system, Reliability of Internal audit.

• And the areas of improvement supported by objective evidence

• Submitted timely preferably at the closing meeting or within 3 days.

• Audit report must be brief

• Distribute the report as agreed with the auditee management.

Contents of audit reportContents of audit report

• Name of audited function / department

• Date & location of audit

• Scope of the audit

• Auditor’s name(s)

• Strengths and weakness

• Observations

• Summary of non conformities (narrative)

• Conclusion

Chapter 12Chapter 12Corrective Action and Follow-upCorrective Action and Follow-up

• Action to eliminate the cause of an existing nonconformity.

• It is the responsibility of the auditee NOT the auditor to initiate corrective action

• Corrective action shall be taken within an agreed time frame

• Develop a corrective action plan– Identify the root cause– Take action to eliminate the root cause– Establish an implementation period depending

upon the complexity of the non-conformity– Provide a response to the auditor– Verify implementation & effectiveness of the

corrective action– Close the nonconformity and revise relevant

procedures as required.

Use of Audit ReportsUse of Audit Reports

• Part of management review

• Evaluation of effectiveness of quality management system implementation

• Planning Audit programme

• Identify opportunities for improvement

• Evaluation of corrective action system

• Planning management reviews.

introduction to iso 9000: 2008 every top management always maintains that their business...

Documents

birth of iso

field of quality

inferior quality

quality productsservice

key elements of iso

high levels of quality

iso technical committee

super ordinate goal