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WELCOME ALL OF YOU FOR A APPRICIATION PROGRAM ON

ISO 9001: 2008

STANDARD REQUIREMENTS

SCOPE & APPLICATION OF THE STANDARD :

This standard is applicable to sites where products are manufactured to meet the customer requirements. All functions of the organization including remote locations are to be covered. Exclusions are permitted based on the operations of the Organisation

BASIC FEATURES :
Process oriented approach

Focus towards enhancing the customer satisfaction

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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MAJOR REQUIREMENTS :

Emphasis on Management Commitment Data analysis with a view to achieve continual improvement in all the processes Customer perception monitoring

Quality Management System

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

SYSTEM CONCEPT : Every individual wants to perform the best work

Problems arise in the operations due to lack of system or in- effective implementation of system System is to be developed based on the organisational policy Everyone in the organisation should contribute to the effective implementation of the system System should be defined through input, process and out put The system should provide organisation & the customer assurance to the
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EIGHT QUALITY MANAGEMENT PRINCIPLES

1. Customer Focus
The organisation should understand the specified and implied requirements of the customer Plan and implement requirements methods to meet these

Organisation must exceed customer expectations Measure the customer satisfaction and dissatisfaction levels Take actions to enhance the customer satisfaction on continual basis.
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EIGHT QUALITY MANAGEMENT PRINCIPLES

2. Leadership
Create effective communication channels with in the organisation for information sharing Provide adequate resources both hardware and software for effective functioning of the organisation

Provide conducive atmosphere to the employees for getting 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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EIGHT QUALITY MANAGEMENT PRINCIPLES

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 performance and 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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EIGHT QUALITY MANAGEMENT PRINCIPLES

4. Process Approach
Captures who, what, when, where and how for each process
All the inter related activities are captured and defined Facilitates to identify the weakness in the activities related to each process

Ownership is defined for each process

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EIGHT QUALITY MANAGEMENT PRINCIPLES

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 organisational goals system to achieve the

Helps to improve the system and processes through constant review & evaluation mechanism.
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EIGHT QUALITY MANAGEMENT PRINCIPLES

6. Continual Improvement
Performance monitoring for improving the organisational capabilities
Providing training improvements to employees on continual

Every employee participation in continual improvement activity in the organisation Quick reaction for the opportunities identified Recognising and acknowledging improvements
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EIGHT QUALITY MANAGEMENT PRINCIPLES

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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EIGHT QUALITY MANAGEMENT PRINCIPLES

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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Process:
An inter-relationship between different activities to convert input into output.
WITH WHAT Equipment Support processes INPUT Customer requirements HOW MUCH Performance Indicators OUTPUT PROCESS Customer whose needs are met WITH WHO Competent Personnel

HOW
Instructions Procedures Methods
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P.D.C.A CYCLE OF SYSTEM OPERATION BY THE TOP MANAGEMENT

Planning
Policy establishment Defining the objectives/ targets

Identify and providing resources

Document the organisational structure Provide focus on customer requirements

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P.D.C.A CYCLE OF SYSTEM OPERATION BY THE TOP MANAGEMENT

Do Lead by example Show commitment Communicate the requirements through-out the organisation of customer

Deploy the policy with-in the organisation Define and document measurable objectives

Delegate authorities

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P.D.C.A CYCLE OF SYSTEM OPERATION BY THE TOP MANAGEMENT

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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P.D.C.A CYCLE OF SYSTEM OPERATION BY THE TOP MANAGEMENT

Act
Based on the out-come of the review make changes in the planning Provide additional resources, if required Provide training required. to the personnel wherever

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STANDARD REQUIREMENTS
4.1 GENERAL REQUIREMENTS

Quality Management System to be established, documented, implemented and maintained with a view to continually improve the effectiveness
Out-sourced processes and the controls exercised on them should be documented in the system Control over out-sourced processes does not absolve the organisations responsibility to ensure quality product to the customer

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STANDARD REQUIREMENTS
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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STANDARD REQUIREMENTS

5.1 MANAGEMENT COMMITMENT : Establishing the quality policy and objectives/ targets Communicating the statutory regulatory requirements related 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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STANDARD REQUIREMENTS
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 business goals
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STANDARD REQUIREMENTS

5.5 RESPONSIBILITY AND AUTHORITY : Responsibility and Authority of each function should be documented and communicated

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

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STANDARD REQUIREMENTS
5.5.2 MANAGEMENT REPRESENTATIVE Establish system. and maintain the quality management

Report the management on the performance of quality management system. Promote awareness of customer requirements in the organisation.

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STANDARD REQUIREMENTS
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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STANDARD REQUIREMENTS
6.0 RESOURCE MANAGEMENT Competency requirements for each function to be documented and the personnel working in the functions to 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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STANDARD REQUIREMENTS
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 infrastructure for effective working necessary

All the statutory and regulatory requirements to be met with respect to the equipments and buildings used during manufacture.
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STANDARD REQUIREMENTS
6.3.1 PLANT, FACILITIES AND EQUIPMENT PLANNING

The lay out should minimize material travel

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STANDARD REQUIREMENTS

6.4 WORK ENVIRONMENT

The management should ensure that the working environment conducive to safe operations. Cleanliness of the premises to be maintained.

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STANDARD REQUIREMENTS
7.1 PLANNING OF PRODUCT REALIZATION

Processes required for product realization to be identified

Acceptance of the product to be defined based on the customer requirements and specifications Confidentiality of the customer related issues to be maintained

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

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STANDARD REQUIREMENTS
7.2 CUSTOMER-RELATED PROCESSES Customer requirements should be understood including the statutory and regulatory requirements related to the product.

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

Any verbal requirements to be confirmed by the organisation. Customer communication channels to be defined.
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STANDARD REQUIREMENTS

7.3 DESIGN & DEVELOPMENT Design & development should include product and process design process.

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STANDARD REQUIREMENTS
7.4 PURCHASING

New suppliers are to be evaluated and selected

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

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STANDARD REQUIREMENTS

7.4 PURCHASING

Re-evaluation of the suppliers to be conducted

Methods are identified purchased product for acceptance of

Supplier Performance to be monitored at defined intervals

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STANDARD REQUIREMENTS
7.5 PRODUCTION AND SERVICE PROVISION Suitable equipment to be provided.

Work Instructions should be provided wherever required.

Process approval and monitoring records to be maintained. Preventive and Breakdown to be evidenced. Maintenance activities

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STANDARD REQUIREMENTS
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 during manufacturing and storage as necessary.

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STANDARD REQUIREMENTS 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 during storage and transit. Products which are in storage for long time need to be re-validated before usage

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STANDARD REQUIREMENTS
7.6 CONTROL OF MONITORING AND MEASURING EQUIPMENTS

Calibration to be carried national/international standards Calibration status to be evidenced

out

against

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

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STANDARD REQUIREMENTS

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STANDARD REQUIREMENTS
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

Methods for obtaining the customer satisfaction to be defined and documented Actions to be initiated on the areas where customer dissatisfaction is evidenced to enhance the customer satisfaction.

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STANDARD REQUIREMENTS
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 be collected Audit evidence should be verifiable Corrective actions to be initiated on the conformities observed with-out undue delay non-

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STANDARD REQUIREMENTS
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT All new manufacturing processes are to be validated Product inspection to be carried out to ensure that all the customer requirements are met. A Procedure is required on control of non -conforming product

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STANDARD REQUIREMENTS
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 performance need to be analysed and improvements made wherever required. Continual improvement philosophy should be evidenced through-out the organisation and cover product & process characteristics with a view to enhance the customer satisfaction
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STANDARD REQUIREMENTS
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT Corrective Actions need to be initiated on the process and product non-conformances to eliminate/reduce the incidence. Effectiveness of the Corrective Actions implemented to be monitored. Based on the analysis of data potential nonconformance to be identified and actions initiated to avoid non-conformances Effectiveness of these actions to be monitored.
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THANK YOU

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