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WELCOME ALL OF YOUFOR A

APPRICIATION PROGRAM

ON

ISO 9001: 2008

STANDARD REQUIREMENTS

SECTION -1

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This standard is applicable to sites where productsare manufactured to meet the customerrequirements.

All functions of the organization including remotelocations are to be covered.

Exclusions are permitted based on the operationsof the Organisation

SCOPE & APPLICATION OF THE STANDARD :

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Process oriented approach

Focus towards enhancing the customer satisfaction

BASIC FEATURES :

Additional specific requirements : Meeting the statutory & regulatory requirements

Periodic review of documents

Training effectiveness evaluation

Need for the employees to know the customer requirements Clarity on the Controls to be Exercised on the Out Sourced

Suppliers

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Emphasis on Management Commitment

Data analysis with a view to achieve continualimprovement in all the processes

Customer perception monitoring

MAJOR REQUIREMENTS :

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Quality Management System is a set of

interrelated or interacting processes that are

used to direct and control an organisation by

establishing and achieving quality policy and

objectives

Quality Management System

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Every individual wants to perform the best work

Problems arise in the operations due to lack of systemor in- effective implementation of system

System is to be developed based on the organisationalpolicy

Everyone in the organisation should contribute to theeffective implementation of the system

System should be defined through input, process andout put

The system should provide assurance to theorganisation & the customer

SYSTEM CONCEPT :

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1. Customer Focus The organisation should understand the specified and

implied requirements of the customer

Plan and implement methods to meet theserequirements

Organisation must exceed customer expectations

Measure the customer satisfaction and dissatisfaction

levels Take actions to enhance the customer satisfaction on

continual basis.

EIGHT QUALITY MANAGEMENT PRINCIPLES

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2. Leadership Create effective communication channels with in the

organisation for information sharing

Provide adequate resources both hardware and softwarefor effective functioning of the organisation

Provide conducive atmosphere to the employees forgetting the best out-of -them

Educate the employees on customer requirements/needs Motivate the employees to achieve the objectives set for

the organisation

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3. Involvement of Employees Accept that the employees are the strength of the

organisation

Make employees accountable for their performance

Identify the constraints of the employees performanceand help them to improve their performance

Understand their importance in achieving the corporate

goals Evaluate their performance against the goals and

objectives set for them

Encourage employees to take more responsibilities

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4. Process Approach Captures who, what, when, where and how for each

process

All the inter related activities are captured anddefined

Facilitates to identify the weakness in the activitiesrelated to each process

Ownership is defined for each process

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5. System Approach to Management Understanding and maintaining all interrelated

processes as a system helps the organisations effectiveness in achieving the objectives

Focus on key processes

Develop a structured system to achieve the

organisational goals

Helps to improve the system and processes throughconstant review & evaluation mechanism.

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6. Continual Improvement Performance monitoring for improving the organisational

capabilities

Providing training to employees on continualimprovements

Every employee participation in continual improvementactivity in the organisation

Quick reaction for the opportunities identified

Recognising and acknowledging improvements


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7. Factual Approach to Decision Making

Ensures that the data collected is sufficiently accurate &reliable

Making data available to persons who need

Analysis of data and information using structured

methods Decisions are taken based on the analysis of data

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8. Mutual beneficial Supplier Relationships

Organisation appreciates that it -self and the suppliers

have a mutually beneficial relationship Flexibility in dealing varying customer needs &

requirements

Optimisation of cost & resources

Sharing information with the supplier on the future plans

Open communication with the supplier

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An inter-relationship between different activities toconvert input into output.

Process:

PROCESS

WITH WHAT Equipment Support processes

WITH WHO Competent Personnel

HOW MUCH Performance Indicators

HOW Instructions Procedures

Methods

INPUT Customer requirements

OUTPUT Customer whose needs

are met

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Planning Policy establishment Defining the objectives/ targets Identify and providing resources Document the organisational structure Provide focus on customer requirements

P.D.C.A CYCLE OF SYSTEM OPERATION BY THE TOPMANAGEMENT

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Do Lead by example Show commitment Communicate the requirements of customer

through-out the organisation Deploy the policy with-in the organisation

Define and document measurable objectives Delegate authorities


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Check Effective system working for the organisation Achievement of policy and objectives Customer satisfaction Business results System changes for the future

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Act Based on the out-come of the review make changes

in the planning

Provide additional resources, if required

Provide training to the personnel whereverrequired.

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4.1 GENERAL REQUIREMENTS Quality Management System to be established,

documented, implemented and maintained with aview to continually improve the effectiveness

Out-sourced processes and the controls exercised onthem should be documented in the system

Control over out-sourced processes does not absolvethe organisations responsibility to ensure qualityproduct to the customer


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4.2 DOCUMENTATION REQUIREMENTS The Quality Management System documentation should

address all the requirements of the standard.

Scope and exclusions justification to be documented. Legibility of documents and records to be ensured.

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5.1 MANAGEMENT COMMITMENT :

Establishing the quality policy and objectives/ targets

Communicating the statutory regulatory requirementsrelated to the product to all the concerned.

Ensuring availability of resources

Conducting the reviews

5.1.1 Process Efficiency Monitor the product realisation and related processes

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5.2 CUSTOMER FOCUS Determine the customer requirements and meet them

with a view to enhance the customer satisfaction.

5.3 QUALITY POLICY Enunciate Quality Policy relevant to the organisational

goals and customer requirements.

5.4.1 QUALITY OBJECTIVES Document quality objectives in relation to the policy in

measurable terms and should be in-line with businessgoals

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5.5 RESPONSIBILITY AND AUTHORITY :

Responsibility and Authority of each function shouldbe documented and communicated

Authority for initiating the corrective action onprocess and product deviations should be specified .

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5.5.2 MANAGEMENT REPRESENTATIVE Establish and maintain the quality management

system.

Report the management on the performance of qualitymanagement system.

Promote awareness of customer requirements in theorganisation.


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5.5.3 INTERNAL COMMUNICATION Internal communication channels are to be defined

5.6 MANAGEMENT REVIEW Review should cover all the elements of the standard Opportunities for improvement to be identified

Review input and output requirements & defined

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6.0 RESOURCE MANAGEMENT Competency requirements for each function to be

documented and the personnel working in the functionsto be evaluated to identify the gaps

Training to be provided to bridge the gaps

Evaluate the effectiveness of the training provided

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6.2.2 COMTETENCY, AWARENESS AND TRAINING Competency of each function to be defined and persons in these

functions are to be evaluated.

Operating personnel should be aware of their contribution in

achieving quality objectives .

6.3 INFRASTRUCTURE The organisation should provide necessary

infrastructure for effective working

All the statutory and regulatory requirements to be metwith respect to the equipments and buildings usedduring manufacture.


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6.3.1 PLANT, FACILITIES AND EQUIPMENT PLANNING

The lay out should minimize material travel

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6.4 WORK ENVIRONMENT

The management should ensure that the workingenvironment conducive to safe operations.

Cleanliness of the premises to be maintained .

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7.1 PLANNING OF PRODUCT REALIZATION Processes required for product realization to be

identified

Acceptance of the product to be defined based on thecustomer requirements and specifications

Confidentiality of the customer related issues to bemaintained

Process changes made during the product realizationprocess to be controlled and validated .

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7.2 CUSTOMER-RELATED PROCESSES Customer requirements should be understood including

the statutory and regulatory requirements related to theproduct.

Order should be reviewed in relation to the organisations capability and capacities.

Any verbal requirements to be confirmed by theorganisation.

Customer communication channels to be defined.


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7.3 DESIGN & DEVELOPMENT

Design & development should include product andprocess design process.

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7.4 PURCHASING New suppliers are to be evaluated and selected

Supplier evaluation and Re- evaluation system andthe frequency to be defined and documented

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7.4 PURCHASING Re-evaluation of the suppliers to be conducted

Methods are identified for acceptance ofpurchased product

Supplier Performance to be monitored at definedintervals

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7.5 PRODUCTION AND SERVICE PROVISION Suitable equipment to be provided. Work Instructions should be provided wherever

required.

Process approval and monitoring records to bemaintained.

Preventive and Breakdown Maintenance activitiesto be evidenced.

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7.5 PRODUCTION AND SERVICE PROVISION Production Scheduling should be in line with the

Customer requirement. Wherever after sales is a requirement effectiveness of

the service provided to the end user to be evaluated . All process whose output can not be measured

immediately need to be validated at defined intervals

Identification system should be in place duringmanufacturing and storage as necessary.


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7.5 PRODUCTION AND SERVICE PROVISION A system to be in place for handling the customer

property Preservation methods to be developed and

implemented to ensure quality of the product duringstorage and transit.

Products which are in storage for long time need tobe re-validated before usage

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7.6 CONTROL OF MONITORING AND MEASURING EQUIPMENTS Calibration to be carried out against

national/international standards Calibration status to be evidenced

When the equipment is out of calibration validity ofprevious results to be verified. Calibration results need to be analysed

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8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

Methods for obtaining the customer satisfaction to bedefined and documented

Actions to be initiated on the areas where customerdissatisfaction is evidenced to enhance the customersatisfaction.

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8 MEASUREMENT, ANALYSIS AND IMPROVEMENT Internal Audits to be conducted at defined intervals to

verify the system compliance in the organisation

Evidence of compliance and non-compliance to becollected Audit evidence should be verifiable Corrective actions to be initiated on the non-

conformities observed with-out undue delay

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8 MEASUREMENT, ANALYSIS AND IMPROVEMENT All new manufacturing processes are to be validated

Product inspection to be carried out to ensure that allthe customer requirements are met.

A Procedure is required on control of non -conformingproduct

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8 MEASUREMENT, ANALYSIS AND IMPROVEMENT Customer to be informed in case non- conforming

product is shipped Data with respect to customer satisfaction, product

conformity, process trends and suppliers performanceneed to be analysed and improvements made whereverrequired.

Continual improvement philosophy should beevidenced through-out the organisation and coverproduct & process characteristics with a view toenhance the customer satisfaction

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8 MEASUREMENT, ANALYSIS AND IMPROVEMENT Corrective Actions need to be initiated on the process

and product non-conformances to eliminate/reduce theincidence .

Effectiveness of the Corrective Actions implemented tobe monitored.

Based on the analysis of data potential non-conformance to be identified and actions initiated toavoid non-conformances

Effectiveness of these actions to be monitored.

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THANK YOU

iso.9000 auditing 1

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