Quality Management Pillars

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Transcript of Quality Management Pillars

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CONTENTSCONTENTS

I. Origination of Standard

II. Correct Understanding of Good System

III. Eight QMS Principles

IV.PDCA Cycle and Process Approach

1. Scope

2. Normative References

3. Terms and Definitions

4. Quality management system

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5. Management Responsibility

6. Resource management

7. Product Realization

8. Measurement, Analysis and Improvement

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Origination Of standardOrigination Of standard

ISO-9000-1987ISO-9000-1987

ISO-9000-1994ISO-9000-1994

ISO-9001-2000ISO-9001-2000

QUALITY ASSURANCE CHANGED TO QUALITY QUALITY ASSURANCE CHANGED TO QUALITY MANAGEMENTMANAGEMENT BASED ON 8 QM PRINCIPLESBASED ON 8 QM PRINCIPLES CONTINUAL IMPROVEMENT FOCUSSEDCONTINUAL IMPROVEMENT FOCUSSED SIMPLIFIED TERMINOLOGIESSIMPLIFIED TERMINOLOGIES REDUCED DOCUMENTATIONREDUCED DOCUMENTATION BASED ON PROCESS APPROACHBASED ON PROCESS APPROACH COMPATIBLE TO OTHER STANDARDSCOMPATIBLE TO OTHER STANDARDS

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Correct Understanding of a Good SystemCorrect Understanding of a Good System

ORGANISATION HAS CERTAIN OBJECTIVES TO BE ACHIEVED

THIS SHOULD BE ACHIEVED NOT BY INDIVIDUAL EXCELLENCE, BUT THROUGH AN EFFECTIVE INTEGRATED SYSTEM

ACHIEVING THE ORGANISATIONAL OBJECTIVES WILL BE THE SAME AS GETTING THE DESIRED BENEFITS FROM THE SYSTEM

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ANY SYSTEM SHOULD BE DEFINED THROUGH AN INPUT, PROCESS AND OUTPUT MODEL.

ISO Systems – DOES NOT SAY “HOW TO DO”, IT ONLY SAYS “WHAT TO DO”

ACTIVITIES TO BE VIEWED FROM THE “ASSURANCE” POINT OF VIEW.

“ASSURANCE” SHOULD BE FELT BY THE INTERNAL/ EXTERNAL CUSTOMER.

LOOK AT THE SYSTEM ADOPTED BY YOU AND VERIFY WHETHER ASSURANCE IS PROVIDED.

ANY SYSTEM SHOULD PROVIDE CONSISTENCY, LEVEL OF PERFORMANCE AND INTEGRATION.

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KEY QUALITY MANAGEMENT PRINCIPLESKEY QUALITY MANAGEMENT PRINCIPLES

1. Customer Focus

2. Leadership

3. Involvement of People

4. Process Approach

5. System Approach to Management

6. Continual Improvement

7. Factual Approach to Decision - Making.

8. Mutually Beneficial Supplier Relationship

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1.1. Customer FocusCustomer Focus

Applying the principle of Customer Focus typically leads to :

# Researching and understanding customer needs and Expectations.

# Communicating these needs and expectations throughout the organization.

# Measuring customer satisfaction and acting on results

# Managing customer relationships

# Ensuring a balanced approach between satisfying customers and other interested parties.

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5.1 Management Commitment5.1 Management Commitment

5.2 Customer Focus5.2 Customer Focus

5.5.2 Management Representative5.5.2 Management Representative

6.1 Provision of Resources6.1 Provision of Resources

8.2.1 Customer Satisfaction8.2.1 Customer Satisfaction

8.4 Analysis of Data8.4 Analysis of Data

8.5.2 Corrective Action8.5.2 Corrective Action

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2.2. LeadershipLeadership

Applying the principle of Leadership typically leads to

# Establishing a clear vision of the organization’s future.

# Setting challenging goals and targets.

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

# Educating, training, and coaching people

# Promoting open and honest communication

# Providing people with the required resources and freedom to act with responsibility and accountability.

# Implementing strategy to achieve these goals and targets.

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5.1 Management Commitment5.1 Management Commitment

5.3 Quality Policy5.3 Quality Policy

5.4.1 Quality Objectives5.4.1 Quality Objectives

5.6 Management Review5.6 Management Review

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'A Leader Should Know How to Manage Failure' (Former President of India APJ Abdul Kalam at Wharton India Economic forum , Philadelphia, March 22,2008)

Question: Could you give an example, from your own experience, of how leaders should manage failure? Kalam: Let me tell you about my experience. In 1973 I became the project director of India's satellite launch vehicle program, commonly called the SLV-3. Our goal was to put India's 'Rohini' satellite into orbit by 1980. I was given funds and human resources -- but was told clearly that by 1980 we had to launch the satellite into space. Thousands of people worked together in scientific and technical teams towards that goal. By 1979 -- I think the month was August -- we thought we were ready. As the project director, I went to the control center for the launch. At four minutes before the satellite launch, the computer began to go through the checklist of items that needed to be checked. One minute later, the computer program put the launch on hold; the display showed that some control components were not in order. My experts -- I had four or five of them with me -- told me not to worry; they had done their calculations and there was enough reserve fuel. So I bypassed the computer, switched to manual mode, and launched the rocket. In the first stage, everything worked fine. In the second stage, a problem developed. Instead of the satellite going into orbit, the whole rocket system plunged into the Bay of Bengal. It was a big failure. That day, the chairman of the Indian Space Research Organization, Prof. Satish Dhawan, had called a press conference. The launch was at 7:00 am, and the press conference -- where journalists from around the world were present -- was at 7:45 am at ISRO's satellite launch range in Sriharikota [in Andhra Pradesh in southern India]. Prof. Dhawan, the leader of the organization, conducted the press conference himself. He took responsibility for the failure -- he said that the team had worked very hard, but that it needed more technological support. He assured the media that in another year, the team would definitely succeed. Now, I was the project director, and it was my failure, but instead, he took responsibility for the failure as chairman of the organization. The next year, in July 1980, we tried again to launch the satellite -- and this time we succeeded. The whole nation was jubilant. Again, there was a press conference. Prof. Dhawan called me aside and told me, 'You conduct the press conference today.' I learned a very important lesson that day. When failure occurred, the leader of the organization owned that failure. When success came, he gave it to his team. The best management lesson I have learned did not come to me from reading a book; it came from that experience.

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3. 3. Involvement of PeopleInvolvement of People

Applying the principle of Involvement of People typically leads to:

# People accepting ownership of problems and their responsibility for solving them.

# People understanding the importance of their contribution and role in the organization.

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

# People freely sharing knowledge and experience.

# People openly discussing problems, issues and identifying constraints to their performance.

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5.3 Quality Policy5.3 Quality Policy

5.5.1 Responsibility and Authority5.5.1 Responsibility and Authority

5.5.3 Internal Communication5.5.3 Internal Communication

6.2 Human Resources.6.2 Human Resources.

6.4 Work Environment6.4 Work Environment

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4.4. Process Approach Process Approach

Applying the principle of Process Approach typically leads to:

# Define the processes needed to achieve desired results.

# Identify the interfaces of key activities within and between the functions of the organization.

# Identify and measure inputs and outputs.

# Evaluate the risks, consequences and impact on customers.

# Establish responsibility and accountability for managing processes.

# Focus on factors such as resources, methods, training, etc to achieve desired results

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4.1 QMS - General Requirements4.1 QMS - General Requirements5.4.2 QMS – Planning5.4.2 QMS – Planning5.5.2 Management Representative5.5.2 Management Representative7.1 Planning of Product Realization7.1 Planning of Product Realization7.2 Customer Related Processes7.2 Customer Related Processes7.3 Design and Development (NA)7.3 Design and Development (NA)7.57.5 Production and Service ProvisionProduction and Service Provision

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5. 5. System Approach to ManagementSystem Approach to Management

Applying the principle of System Approach typically leads to:

# Structure the system to achieve the organization’s objectives in the most effective and efficient way.

# Understanding the interdependencies between the processes in the system.

# Continually improve through measurement and evaluation

# Targeting and defining how specific activities within a system should operate.

# Define and Develop processes.

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4.2 Documentation Requirements4.2 Documentation Requirements

6.1 Provision of Resources6.1 Provision of Resources

6.3 Infrastructure6.3 Infrastructure

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6.6. Continual ImprovementContinual Improvement

Applying the principle of Continual Improvement Typically leads to:

# Employing a consistent organization-wide approach to continual improvement of the organization’s performance.

# Providing training on continual improvement tools

# Establishing measures and goals to guide and track improvements.

# Recognizing and acknowledging improvements.

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4.1 QMS - General Requirements4.1 QMS - General Requirements5.1 Management Commitment5.1 Management Commitment5.3 Quality Policy5.3 Quality Policy5.4.1 Quality Objectives5.4.1 Quality Objectives5.5.2 Management Representative5.5.2 Management Representative5.6 Management Review5.6 Management Review6.1 Provision of Resources6.1 Provision of ResourcesMeasurement, Analysis and Improvement Measurement, Analysis and Improvement

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7. 7. Factual Approach to Decision - Making.Factual Approach to Decision - Making.

Applying the principle of Factual Approach Typically leads to:

# Ensuring that data and information are accurate, reliable and accessible.

# Analyzing data and information using valid methods.

# Making decisions and taking action on result of analysis.

# Measuring and collecting data and information

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7.1 Planning of Product Realization 7.1 Planning of Product Realization 7.5.1 Control of production and service provision7.5.1 Control of production and service provision 7.6 Control of Monitoring and measuring 7.6 Control of Monitoring and measuring

devicesdevices 8.1 Measurement, Analysis and Improvement – 8.1 Measurement, Analysis and Improvement –

GeneralGeneral 8.2.2 Internal Audits8.2.2 Internal Audits 8.2.3 Monitoring and Measurement of Processes8.2.3 Monitoring and Measurement of Processes 8.2.4 Monitoring and Measurement of Products8.2.4 Monitoring and Measurement of Products 8.3 Control of nonconforming product8.3 Control of nonconforming product 8.4 Analysis of Data8.4 Analysis of Data

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8.8. Mutually Beneficial Supplier Relationships Mutually Beneficial Supplier Relationships

Applying the principle of Mutual Beneficial Supplier Relationships Typically leads to:

# Identifying and selecting key suppliers.

# Clear and open communication

# Sharing information and future plans

# Establish joint development and improvement activities.

# Establish relationship that balance short term gains with long term considerations

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7.4 Purchasing7.4 Purchasing

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What is a Process?

Set of interrelated or interacting activities

Input

Process

Output

Procedure(“Specified way to

carryout an activity or a process”-may be

documented or not)

Monitoring and Measuring opportunities (Before, During & After the Process)

Effectiveness of process(Ability to achieve

desired results)

Efficiency of process(Results achieved

v/s. Resources used)

PROCESS APPROACHPROCESS APPROACH

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PROCESS APPROACHPROCESS APPROACH

Systematic Identification and Management of processes employed within an organization and their interactions

FOUR PILLARS OF PROCESS APPROACHFOUR PILLARS OF PROCESS APPROACH

Management Responsibility

Resource Management

Product Realization

Measurement, Analysis, Improvement

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Plan•What to do?•How to do it?

Do•Do what wasplanned

Check• Did things happenaccording to plan?

Act•How to improvenext time?

Maintaining and continually improving the process capability can be achieved by applying the PDCA concept at all levels within the organization.

PDCA

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QUALITY MANAGEMENT SYSTEM CONTINUAL IMPROVEMENT OF THE

Managementresponsibility

Resourcemanagement

Value adding activitiesInformation

Key:

ISO9001:2000Model of a process-based quality management system.

Measurement,analysis andimprovement

Customer

Customer

Satisfaction

Productrealization

InputOutput

ProductRequirements

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Outputs: -1. Daily maintenance instructions 2. Preventive maintenance schedule 3. Preventive maintenance checklist 4. Machine breakdown register 5. Machine maintenance history sheet

Inputs1- Machine maintenance requirements 2- Communication of machine breakdown3- Communication of abnormalities of machine performance

Maintenance

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Purchase

Outputs (s) 1. Raw Material requirement 2. Prepare P.O approval for supplier 3. Delivery Schedule4. Closure of purchase Req.5. Supplier performance

Inputs1. Purchase requisition slip 2. Raw Material Requirement for production

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Stores

Outputs (s) 1. Material Return Slip 2. Discrepancy Report 3. Material Receipt Note4. Inventory Stock Status5. Stock Ledger

Inputs1. Supplier Schedule & Bill or Challan 2. Material issue request3. Accepted/Rejected Sticker

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Production

Outputs 1. Product wise Monthly production Plan 2. Daily production report 3. Production Slip

Inputs1. Customer schedules & amendments 2. Material Shortage Report

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Marketing

Outputs

1. Market Enquiry Review 2. Feasibility Review/ Quotation to customer3. purchase order4. Order acceptance to the customer.

Inputs1. Receipt of enquiries2. News Letters, Magazines3. Drawings/ samples/ specifications 4. Technical information / Drawing /specs standards

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Packing & Dispatch

Outputs (s)

1. Stock Ledger 2. Customer Satisfaction Rating Form3. CAPA report 4. Minutes of Meeting

Inputs1. Packing Standard2. Customer Schedule 3. Daily Dispatch Status

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1. SCOPE OF THE STANDARD1. SCOPE OF THE STANDARD

GENERAL

This international standard specifies requirements for a QMS where an organization

(a) Needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements.

(b) Aims to address customer satisfaction through the effective application of the system, including processes for continual improvement and the assurance of conformity to customer and applicable regulatory requirements

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PERMISSIBLE EXCLUSIONS PERMISSIBLE EXCLUSIONS

The organization is permitted to EXCLUDE those requirements of the standard, when “Nature of the organization’s product and applicable regulatory requirement do not require certain quality management systems”

Important: Reduced Scope only applies to Clause 7 “Product Realization” of ISO 9001: 2000. An organization is not permitted to reduce the Scope of Clause 4,5,6 & 8.

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2. NORMATIVE REFERENCES2. NORMATIVE REFERENCES

1. ISO9004:2000

2. ISO9000:2005

3. TERMS AND DEFINITION3. TERMS AND DEFINITION

The supply chain is described as:

Supplier Organization Customer

Product = Result of a process

Four generic product categories:Hardware, software, services, processed material

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4. QUALITY MANAGEMENT SYSTEM4. QUALITY MANAGEMENT SYSTEM

4.14.1 GENERAL REQUIREMENTS GENERAL REQUIREMENTS

The organization shall establish, document, Implement and maintain and continually improve a QMS in requirements of the standard.

The implementation shall be done by:

- identification of processes and their application throughout the organization

- determining sequence and interaction of these processes,

- determining criteria and methods for effective operational control

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- resources and information availability to support operation and monitoring of those processes

- measurement, monitoring and analysis of process

- implementing actions to achieve planned results and continual improvement of these processes

- ensure control over the outsourced process

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4.24.2 Documentation Requirements : Documentation Requirements :

4.2.14.2.1 QMS Documentation shall includeQMS Documentation shall include

(a) documented statements of a quality policy and quality objectives

(b) a quality manual,

(c) documented procedures required by this international standard

(d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and

(e) records required by this international standard

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# The terms “documented procedure” means that the procedure to be established, documented, implemented and

maintained

# The extent of the QMS documentation can differ from one organization to another due to

(a) the size of organization and type of activities,

(b) the complexity of processes and their interactions, and

(c) the competence of personnel

The documentation can be in any form or type of medium.

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4.2.24.2.2 QUALITY MANUAL QUALITY MANUAL

Establish and maintain a Quality manual that includes

(a) the scope of the QMS, including details of and justification for any exclusions

(b) the documented procedures established for the QMS, or reference to them, and

(c) a description of the interaction between the processes of the QMS

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4.2.34.2.3 CONTROL OF DOCUMENTS CONTROL OF DOCUMENTS

Documented procedure shall be established

(a) to approve documents for adequacy prior to issue,

(b) to review and update as necessary and re-approve documents,

(c) to ensure that changes and the current revision status of documents are identified

(d) to ensure that relevant versions of applicable documents are available at points of use,

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(e) to ensure that documents remain legible and readily identifiable,

(f) to ensure that documents of external origin are identified and their distribution controlled, and

(g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

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4.2.44.2.4 CONTROL OF RECORDSCONTROL OF RECORDS

# Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the Quality Management system.

# Documented procedure to be established for

Control Identification Storage Protection Retrieval Retention time Disposition of records

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5 MANAGEMENT RESPONSIBILITY5 MANAGEMENT RESPONSIBILITY

5.15.1 MANAGEMENT COMMITMENT MANAGEMENT COMMITMENT

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

(a) ensuring that concerned personnel are fully aware of importance of meeting customer requirements Statutory and regulatory requirements

(b) establishing quality policy & objectives

(c) conducting management review

(d) ensuring the availability of resources

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5.25.2 CUSTOMER FOCUS CUSTOMER FOCUS

Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction.

5.35.3 QUALITY POLICYQUALITY POLICY

Top Management shall ensure that the quality policy

a) is appropriate to the purpose of the organization

b) includes a commitment to comply with requirements and to continually improve the effectiveness of QMS

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c) provides a framework for establishing & reviewing quality objectives

d) is communicated and understood within the organization

e) is reviewed for continuing suitability

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5.45.4 PLANNING PLANNING

5.4.15.4.1 Quality Objectives Shall Be Quality Objectives Shall Be

a) needed to meet requirements for product

b) established at relevant functions and levels

c) measurable

d) consistent with the quality policy

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5.4.25.4.2 QMS Planning QMS Planning

Top management shall ensure that

(a) the planning of the QMS is carried out to meet the Quality Objectives

(b) the integrity of the QMS is maintained when changes to the QMS are planned and implemented.

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5.55.5 RESPONSIBILITY AUTHORITY AND COMMUNICATION RESPONSIBILITY AUTHORITY AND COMMUNICATION

5.5.15.5.1 Responsibility and Authority shall be defined and Responsibility and Authority shall be defined and communicated with in the organization communicated with in the organization

5.5.25.5.2 Top management shall appoint Management Top management shall appoint Management Representative. He shall have responsibility and Authority Representative. He shall have responsibility and Authority that that includes includes

- ensuring that process need for QMS are established, implemented and maintained

- reporting to top management on the performance of the QMS, and any need for improvement

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- promoting awareness of customer requirements throughout the organization

- liaison with external parties on matters relating to the QMS

5.3.35.3.3 Top management shall ensure that communication between Top management shall ensure that communication between various levels and functions regarding the processes of QMS various levels and functions regarding the processes of QMS effectivenesseffectiveness

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5.6 5.6 MANAGEMENT REVIEWMANAGEMENT REVIEW

5.6.1 5.6.1 Top Management shall Top Management shall

review the QMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness

evaluate the need for changes to the QMS, including quality policy and quality objectives

records from management reviews shall be maintained

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5.6.25.6.2 Review InputReview Input

The input to management review shall include information on

a) Results of audits

b) Customer feedback

c) Process performance and product conformity

d) Status of preventive and corrective actions

e) Follow-up actions from previous management reviews

f) Changes that could affect the QMS

g) Recommendation for improvement

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5.6.35.6.3 Review OutputReview Output

# The output from management review shall include any decisions & actions related to

a) Improvement of effectiveness of the QMS and its processes

b) Improvement of product related to customer requirements

c) Resource needs

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6.6. RESOURCE MANAGEMENTRESOURCE MANAGEMENT

6.16.1 PROVISION OF RESOURCESPROVISION OF RESOURCES

# IDENTIFY AND PROVIDE, THE RESOURCES NEEDED

(a) to implement and maintain QMS and continually improve its effectiveness

(b) to enhance customer satisfaction by meeting customer requirements.

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6.26.2 HUMAN RESOURCESHUMAN RESOURCES

6.2.1 6.2.1 Personnel performing work affecting product quality shall Personnel performing work affecting product quality shall be competent on the basis of appropriatebe competent on the basis of appropriate

- Education

- Training

- Skills

- Experience

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6.2.26.2.2 Competence, Awareness and Training Competence, Awareness and Training

(a) Determine the necessary competence for personnel performing work affecting product quality,

(b) Provide training or take other actions to satisfy these needs,

(c) Evaluate the effectiveness of the actions taken,

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

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

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6.36.3 INFRASTRUCTURE INFRASTRUCTURE

# Determine, provide and maintain the infrastructure which includes

(a) Buildings, workspace and associated utilities,

(b) Process equipment (both hardware and software)

(c) Supporting services (such as transport or communication)

6.4 WORK ENVIRONMENT6.4 WORK ENVIRONMENT

# Determine and manage the work environment needed to achieve conformity of product requirements

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7.7. PRODUCT REALIZATIONPRODUCT REALIZATION

7.17.1 PLANNING OF PRODUCT REALISATIONPLANNING OF PRODUCT REALISATION

# Plan and develop the processes needed for product realization

# Planning shall be consistent with the requirements of other process of QMS

# In planning product realization, the organization shall determine the following, as appropriate :

(a) Quality Objectives and requirements for the product;

(b) The need to establish processes, documents and provide resources specific to the product;

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

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

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7.27.2 CUSTOMER-RELATED PROCESSCUSTOMER-RELATED PROCESS

7.2.17.2.1 Determination of requirements related to the productDetermination of requirements related to the product

(a) Requirements specified by the customer, including the requirements for delivery and post-delivery activities,

(b) Requirement not stated by the customer but necessary for specified or intended use, where known,

(c) Statutory and regulatory requirements related to the product, and

(d) Any additional requirements determined by the organization

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

# The organization shall review the customer requirements related to the product

# This Review shall be done prior to the commitment to supply a product to the customer

# The Review shall ensure that

(a) Product requirement are defined

(b) Verbal requirements are confirmed before acceptance.

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Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

(c) The organization has the ability to meet the defined requirements

(d) Contract or order requirements differing from those previously expressed are resolved.

# Results of the review and actions arising from the review shall be recorded.

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7.2.37.2.3 Customer CommunicationCustomer Communication

# Determine and implement effective arrangements for communication with customers relation to

(a) product information

(b) enquiries, contracts or order handling including amendments

(c) customer feedback, including customer complaints

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7.37.3 DESIGN AND /OR DEVELOPMENTDESIGN AND /OR DEVELOPMENT

7.3.17.3.1 Design and Development Planning (NA)Design and Development Planning (NA)

# Design and development plan shall include :

(a) stages of design and development

(b) review, Verification and validations activities

(c) responsibility and authority for design and development activities

Interfaces between different groups

Planning output shall be updated, as the design and development Progresses.

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7.3.27.3.2 Design & development inputs (NA)Design & development inputs (NA)

# Design & development input shall include:

(a) functional and performance requirements

(b) applicable statutory and regulatory requirements

(c) information derived from previous similar design

(d) any other requirements essential for design and development

# Input shall be a reviewed for adequacy

# Requirements shall be complete, unambiguous, and not in conflict with each other

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7.3.37.3.3 Design and development outputs(NA)Design and development outputs(NA)

# Design and development outputs shall

- meet the input requirements

- provide information for purchasing, production and for service provision

- contain or reference product acceptance criteria

- specify the characteristics of the product that are essential for its safe and proper use

- documents shall be approved prior to release

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7.3.47.3.4 Design and development reviewDesign and development review

# Review at suitable stages shall be performed

(a) to evaluate the ability of result of design and development to meet requirement

(b) to identify any problems and propose necessary actions

# Shall be reviewed by cross functional team

# Records of the results of the review shall be maintained

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7.3.57.3.5 Design and development verificationDesign and development verification

# To be performed to ensure that the outputs have met the input requirements

# Records of the results of verification shall be maintained

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7.3.67.3.6 Design and development validationsDesign and development validations

# To be performed to ensure that the resulting product is capable of meeting the requirements for the intended use / specified application

# To be done prior to the delivery (or) implementation of the product

# Records of the results of validation shall be maintained

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7.3.77.3.7 Control of design and development changesControl of design and development changes

# Changes to be identified, and records maintained

# Changes to be reviewed, verified and validated and approved as appropriate

# The review of changes shall include the effect of the changes on constituent parts and product already delivered.

# The records of the result of the review of changes shall be

maintained .

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7.47.4 PURCHASING PURCHASING

7.4.17.4.1 Purchasing process Purchasing process

# Ensure that purchased product conforms to specified purchase requirements

# Type and extent of control to be applied to the supplier

# Evaluation and selection of suppliers

# Criteria for selection, evaluation and re-evaluation shall be established

# Maintain evaluation records

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7.4.27.4.2 Purchasing informationPurchasing information

# Requirements for approval of product, procedures, processes and equipment.

# Requirements for qualification of personnel

# Quality management system requirements

# Ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

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7.4.37.4.3 Verification of purchased productVerification of purchased product

# Establish and implement the system for inspection to ensure that

purchased product meets specified purchase requirements

# Organization verification at the supplier’s premises

# Customer verification at the supplier premises

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7.57.5 PRODUCT AND SERVICE PROVISIONPRODUCT AND SERVICE PROVISION

7.5.17.5.1 Control of production and service provision Control of production and service provision

# Plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable

(a) the availability of information that describes the characteristics of the product

(b) the availability of work instructions, as necessary

(c) the use of suitable equipment

(d) the availability and use of measuring and monitoring devices

(e) the implementation of monitoring and measurement

(f) the implementation of release, delivery and post – delivery activities.

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7.5.27.5.2 VALIDATION OF PROCESS FOR PRODUCTION AND VALIDATION OF PROCESS FOR PRODUCTION AND SERVICE PROVSIONSERVICE PROVSION

# Validate the process for production and service provision where the resulting output cannot be verified by subsequent

measurement or monitoring

# Validation shall demonstrate the ability of these processes to

achieve planned results.

# Establish arrangements for these processes including, as applicable

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(a) defined criteria for review and approval of the processes including as applicable

(b) qualification of personnel and approval of equipment

(c) use of specific methods and procedures

(d) requirements for records

(e) re-validation

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7.5.3 IDENTIFICATION AND TRACEABILITY7.5.3 IDENTIFICATION AND TRACEABILITY

# Identify the product throughout product realization

# Identify the product status with respect to monitoring and measurement requirements

# Control and record the unique identifications of the product, where traceability is a requirement

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7.5.47.5.4 CUSTOMER PROPERTYCUSTOMER PROPERTY

# System shall be established for

(a) identification

(b) verification

(c) protection

(d) safeguard

# Reporting to customer in case of loss, damage or otherwise unsuitable for use,

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7.5.57.5.5 PRESERVATION OF PRODUCT PRESERVATION OF PRODUCT

# Preserve the conformity of product during internal processing and delivery to the intended destination

# Preservation shall include identification, handling, packaging, storage and protection

# Preservation shall also apply to the constituent parts of a product

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7.67.6 CONTROL OF MONITORING AND MEASURING DEVICES CONTROL OF MONITORING AND MEASURING DEVICES

# Determine the monitoring and measurement to be undertaken,

# Measuring equipment shall

(a) be calibrated / verified at specified intervals or prior to use, against standards traceable to international / national standards, where no such standards exist, the basis used for calibration or verification shall be recorded.

(b) be adjusted or readjusted as necessary,

(c) be identified to enable the calibration status to be determined

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(d) be safeguarded from adjustments (e) be protected from damage and deterioration during

handling, maintenance and storage

# Assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements.

# Records of the results of calibration and verification shall be maintained

# The ability of computer software to satisfy the intended application shall be confirmed.

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8.8. MEASUREMENT, ANALYSIS AND IMPROVEMENT MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.18.1 PLANNINGPLANNING

# Plan and implement the measurement, monitoring, Analysis and improvement process

# Determine applicable methodologies including statistical techniques

8.28.2 MONITORING AND MEASURING MONITORING AND MEASURING

8.2.18.2.1 CUSTOMER SATISFACTIONCUSTOMER SATISFACTION - Monitor the customer satisfaction and/or dissatisfaction

- Methodologies shall be established

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8.2.2 INTERNAL AUDIT8.2.2 INTERNAL AUDIT

# Conduct periodic internal audits to determine whether the QMS conforms to the requirements of this International standardis effectively implemented and maintained

# Plan the audit program taking in to consideration

(a) the status and importance of the activities / processes

(b) areas to be audited as well as the results of previous audits

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# Define the audit scope, frequency and methodologies

# Auditors shall not audit their own work

# Responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records shall be defined in procedure.

# Ensure that actions are taken without undue delay to eliminate detected non conformities and their causes.

# Follow-up activities shall include the verification of the action taken.

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8.2.38.2.3 MONITORING AND MEASUREMENT OF PROCESSESMONITORING AND MEASUREMENT OF PROCESSES

# Apply suitable methods for monitoring and measurement of the QMS processes

# Demonstrate the ability of process to achieve planned results

# When planned results are not achieved, correction and corrective action shall be taken

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8.2.48.2.4 MONITORING AND MEASUREMENT OF PRODUCTMONITORING AND MEASUREMENT OF PRODUCT

# Monitor and measure the product characteristics at appropriate stages of the product realisation process is accordance with the planned arrangements.

# Evidence of conformity with the acceptance criteria shall be maintained.

# Record shall indicate the authority responsible for release of product

# Product release and service delivery shall not proceed until all the specified activities have been satisfactorily completed, unless otherwise approved by the customer

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8.38.3 CONTROL OF NONCONFORMING PRODUCTCONTROL OF NONCONFORMING PRODUCT

# System to consider

(a) identification

(b) control

(c) documentations

(d) correction

(e) re-verification after correction

# Report to customer / end-user about the proposed use or rectification of nonconforming product

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8.48.4 ANALYSIS OF DATA ANALYSIS OF DATA

# Determine, Collect and analyse data to demonstrate the suitability and effectiveness of the QMS and identify continual improvements that can be made

# Analyse the data to provide information relating to

(a) customer satisfaction

(b) conformity to product requirements

(c) characteristics and trends of processes and products including opportunities for preventive

action.

(d) suppliers

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8.58.5 IMPROVEMENT IMPROVEMENT

8.5.1 CONTINUAL IMPROVEMENT8.5.1 CONTINUAL IMPROVEMENT

# continually improve the effectiveness of the QMS through the use of the

- quality policy

- objectives

- audit results

- analysis of data

- corrective and preventive action

- management review

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8.5.28.5.2 CORRECTIVE ACTIONCORRECTIVE ACTION

# Action taken to eliminate the cause of nonconformities in order to prevent recurrence

# Documented procedure shall be established to define requirements for

(a) reviewing nonconformities (including customer complaints)

(b) determining the causes of nonconformities

(c) evaluating the need for action to ensure that nonconformities do not recur

(d) determining and implementing action needed

(e) records of the results of action taken

(f) reviewing corrective action taken

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8.5.38.5.3 PREVENTIVE ACTIONPREVENTIVE ACTION

# Action taken to eliminate the causes of potential nonconformities in order to prevent occurrence

# Documented procedure shall be established to define requirements for

(a) determining potential nonconformities and their

causes,

(b) evaluating the need for action to prevent occurrence of nonconformities,

(c) determining and implementing action needed,

(d) records of results of action taken, and

(e) reviewing preventive action taken.

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Thank You