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Evolution of Quality & Quality Management
System
Process Approach, PDCA Cycle
Quality Management Principles
ISO 9001 – 2000 – Terms & Definitions and QMS
Overview
ISO 9001 – 2000 QMS Requirements
Program contents:
3
WHY QUALITY ?
To satisfy customers
To stay in the market
To survive at all times
To satisfy customers, stake holders &
other interested parties
4
CONCEPT OF QMS
Reduction of variations and elimination of waste
Control of un-productive activities
Enhancing the effectiveness and efficiency of productive activities / processes
Customer satisfaction
Continual improvement
6
Customers
(ISO9001)
and other
Interested
Parties
(ISO 9004)
Note : 1) Interested parties include Customer, stake holder & Society
2) Based on PDCA Methodology
Product
Continual Improvement
Of the Quality Management System
INPUTRequirements
Customers
(ISO9001)
and other
Interested
Parties
(ISO 9004)
Satisfaction
Management
Responsibility
Resource
Management
Product
realization
Measurement,
Analysis &
Improvement
OUTPUT
MODEL OF THE PROCESS APPROACH
7
WHAT IS A PROCESS ?
Process is defined as a series of sequential actions
or tasks used to achieve an objective
A set of activities, inter linked together, to
achieve a single objective form a process.
Basic process elements include input, task &
output.
Task 1 Task 2 Task 3OutputInput
10
QUALITY MANAGEMENT PRINCIPLES
1. Customer Focused Organization
2. Leadership
3. Involvement of people
4. Process Approach
5. Systems Approach to Management
6. Continual Improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationships
11
ISO 9000:2000 REVISIONSQUALITY MANAGEMENT PRINCIPLES (Contd.)
Principle 1 Customer focus
Organizations depend on their customers and therefore should understand current
and future customer needs, should meet customer requirements and strive to
exceed customer expectations
Key benefits:
• Increased revenue and market share obtained through flexible and fast responses to market
opportunities
• Increased effectiveness in the use of the organization's resources to enhance customer satisfaction
• Improved customer loyalty leading to repeat business
Applying the principle of customer focus typically leads to: • Researching and understanding customer needs and expectations
• Ensuring that the objectives of the organization are linked to customer needs and expectations
• Communicating customer needs and expectations throughout the organization.
• Measuring customer satisfaction and acting on the results
• Systematically managing customer relationships
• Ensuring a balanced approach between satisfying customers and other interested parties (such as
owners, employees, suppliers, financiers, local communities and society as a whole)
12
ISO 9000:2000 REVISIONSQUALITY MANAGEMENT PRINCIPLES (Contd.)
Principle 2 Leadership
Leaders establish unity of purpose and direction of the organization. They should
create and maintain the internal environment in which people can become fully
involved in achieving the organization's objectives
Key benefits:• People will understand and be motivated towards the organization's goals and objectives.
• Activities are evaluated, aligned and implemented in a unified way.
• Miscommunication between levels of an organization will be minimized.
Applying the principle of leadership typically leads to: • Considering the needs of all interested parties including customers, owners, employees, suppliers,
financiers, local communities and society as a whole.
• 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.
• Establishing trust and eliminating fear.
• Providing people with the required resources, training and freedom to act with responsibility and
accountability.
• Inspiring, encouraging and recognizing people's contributions.
13
ISO 9000:2000 REVISIONSQUALITY MANAGEMENT PRINCIPLES (Contd.)
Principle 3 Involvement of people
People at all levels are the essence of an organization and their full involvement
enables their abilities to be used for the organization's benefit
Key benefits: • Motivated, committed and involved people within the organization.
• Innovation and creativity in furthering the organization's objectives.
• People being accountable for their own performance.
• People eager to participate in and contribute to continual improvement.
Applying the principle of involvement of people typically leads to: • People understanding the importance of their contribution and role in the organization
• People identifying constraints to their performance
• People accepting ownership of problems and their responsibility for solving them
• People evaluating their performance against their personal goals and objectives
• People actively seeking opportunities to enhance their competence, knowledge and experience
• People freely sharing knowledge and experience
• People openly discussing problems and issues
14
ISO 9000:2000 REVISIONSQUALITY MANAGEMENT PRINCIPLES (Contd.)
Principle 4 Process approach
A desired result is achieved more efficiently when activities and related resources are
managed as a process
Key benefits:Lower costs and shorter cycle times through effective use of resources
Improved, consistent and predictable resultsFocused and prioritized improvement opportunities
Applying the principle of process approach typically leads to:Systematically defining the activities necessary to obtain a desired result
Establishing clear responsibility and accountability for managing key activities
Analyzing and measuring of the capability of key activities
Identifying the interfaces of key activities within and between the functions of the organization
Focusing on the factors such as resources, methods, and materials that will improve key activities of
the organization
Evaluating risks, consequences and impacts of activities on customers, suppliers and other interested
parties
15
ISO 9000:2000 REVISIONSQUALITY MANAGEMENT PRINCIPLES (Contd.)
Principle 5 System approach to management
Identifying, understanding and managing interrelated processes as a system
contributes to the organization's effectiveness and efficiency in achieving its
objectives
Key benefits: • Integration and alignment of the processes that will best achieve the desired results.
• Ability to focus effort on the key processes
• Providing confidence to interested parties as to the consistency, effectiveness and efficiency of
the organization
Applying the principle of system approach to management typically leads to:• Structuring a system to achieve the organization's objectives in the most effective and efficient
way
• Understanding the interdependencies between the processes of the system
• Structured approaches that harmonize and integrate processes
• Providing a better understanding of the roles and responsibilities necessary for achieving common
objectives and thereby reducing cross-functional barriers
• Understanding organizational capabilities and establishing resource constraints prior to action.
• Targeting and defining how specific activities within a system should operate
• Continually improving the system through measurement and evaluation
16
ISO 9000:2000 REVISIONSQUALITY MANAGEMENT PRINCIPLES (Contd.)
Principle 6 Continual improvement
Continual improvement of the organization's overall performance should be a
permanent objective of the organization
Key benefits: • Performance advantage through improved organizational capabilities
• Alignment of improvement activities at all levels to an organization's strategic intent
• Flexibility to react quickly to opportunities
Applying the principle of continual improvement typically leads to:• Employing a consistent organization-wide approach to continual improvement of the
organization's performance
• Providing people with training in the methods and tools of continual improvement
• Making continual improvement of products, processes and systems an objective for every
individual in the organization
• Establishing goals to guide, and measures to track, continual improvement
• Recognizing and acknowledging improvements
17
Principle 7 Factual approach to decision making
Effective decisions are based on the analysis of data and information
Key benefits: • Informed decisions
• An increased ability to demonstrate the effectiveness of past decisions through reference to
factual records
• Increased ability to review, challenge and change opinions and decisions
Applying the principle of factual approach to decision making typically leads to: • Ensuring that data and information are sufficiently accurate and reliable
• Making data accessible to those who need it
• Analyzing data and information using valid methods
• Making decisions and taking action based on factual analysis, balanced with experience and
intuition
ISO 9000:2000 REVISIONSQUALITY MANAGEMENT PRINCIPLES (Contd.)
18
ISO 9000:2000 REVISIONSQUALITY MANAGEMENT PRINCIPLES (Contd.)
Principle 8 Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a mutually beneficial
relationship enhances the ability of both to create value
Key benefits:• Increased ability to create value for both parties
• Flexibility and speed of joint responses to changing market or customer needs and expectations
• Optimization of costs and resources
Applying the principles of mutually beneficial supplier relationships typically leads to: • Establishing relationships that balance short-term gains with long-term considerations
• Pooling of expertise and resources with partners
• Identifying and selecting key suppliers
• Clear and open communication
• Sharing information and future plans
• Establishing joint development and improvement activities
• Inspiring, encouraging and recognizing improvements and achievements by suppliers
20
ISO 9000:2000 REVISIONS SOME MAJOR CHANGES
Terminology:
Supplier changed to Organization
Subcontractor changed to Supplier
Scope: Permissible exclusions - limited to clause 7
Certain definitions are discussed in subsequent slides.
21
ISO 9000:2000 REVISIONS DEFINITIONS
Quality:
degree to which a set of inherent Characteristics fulfills
requirements
Quality Policy:
Overall intentions and direction of an Organization related to
quality as formally expressed by the top management
Quality Objective:
Something sought or aimed for, related to quality
22
ISO 9000:2000 REVISIONS DEFINITIONS
Quality Control:
Part of quality management focused on fulfilling quality
requirements
Quality Assurance:
Part of quality management focused on providing confidence that
quality requirements are fulfilled
Quality Improvement:
Part of quality management focused on increasing the ability to fulfill
quality requirement.
23
ISO 9000:2000 REVISIONS DEFINITIONS
Effectiveness :
Extent to which planned activities are realized and
planned results achieved.
Efficiency:
Relationship between result achieved and resources
used.
24
ISO 9000:2000 REVISIONS DEFINITIONS
Conformity:
Fulfillment of a requirement.
Non-conformity:
Non fulfillment of a requirement.
Defect:
Non fulfillment of a requirement related to an intended or
specified use.
25
ISO 9000:2000 REVISIONS DEFINITIONS
Correction:
Action taken to eliminate a detected non-conformity
Corrective action:
Action taken to eliminate the cause of a detected non-conformity or other
undesirable situation
(to prevent recurrence. See note 2 )
Preventive action:
Action taken to eliminate the cause of a potential non-conformity or other
potentially undesirable situation
(to prevent occurrence. See note 2)
26
ISO 9000:2000 REVISIONS DEFINITIONS
Quality Manual:
Document specifying the QMS of an Organization.
Document:
Guidelines ,Information and its supporting medium these can be
revised
Record:
Document stating the results achieved or providing evidence of
activities performed. These can not be revised
28
DOCUMENTED PROCEDURES
Following 6 documented procedures are required by the
Standard
Document Control ( 4. 2. 3 )
Quality Records ( 4. 2. 4 )
IQA Procedure ( 8. 2. 2 )
Nonconformity Control ( 8. 3 )
Corrective Action ( 8. 5. 2 )
Preventive Action ( 8. 5. 3 )
Other procedures / documents as required by the Organ. to
manage the processes & operation of QMS may be
documented
29
ISO 9001:2000 Requirements
Clause 4 : Quality Management System
Sub-clause 4.2: Documentation Requirements
4 .2 .3 : Control of documents
Documents required for QMS shall be controlled. A documentedprocedure shall be established to address : -
Approve documents for adequacy prior to use
Review and update and re-approve documents
Identify the current revision status of the documents
Ensure that relevant versions of applicable documents are availableat points of use
Ensure that documents remain legible, readily identifiable andretrievable
Ensure that documents of external origin are identified and theirdistribution controlled
Prevent unintended use of obsolete documents
Issue control of QMS documents and control of records (Records arespecial type of document) as per Cl. 4. 2. 4.
30
ISO 9001:2000 Requirements
Clause 4 : Quality Management System
Sub-clause 4.2: Documentation Requirements
4.2.4 : Control of Records
Quality records shall be maintained to provide evidence ofconformance to requirements and of effective operation of the QMS
A documented procedure shall be established for the identification,storage, retrieval, protection, retention time and disposition ofquality records
Records shall be legible, identifiable, retrievable, and stored,protected and disposed off after retention period
31
ISO 9001:2000 Requirements
Clause 5: Management Responsibility
Sub-Clause 5.2: Customer focus
Intent:
To Achieve and enhance customer satisfaction
Requirements:
Customer needs and expectations are determined
Converted into requirements and fulfilled/met
Aim to enhance customer satisfaction
Consider obligations related to product includinglegal and regulatory requirements
A procedure is required to determine the needs and expectations andmethods to exist defining the frequency & methods adopted forcollection of such information. To be an ongoing work.
IQA to verify the compliance to the procedure and actions taken basedon the feedback.
32
ISO 9001:2000 Requirements
Clause 5: Management Responsibility
Sub-Clause 5.3: Quality Policy
Intent:
Provide direction to Organization for achievement of quality
Requirements:
Top management to define and document the Quality policy and shall
ensure that the Policy :
is appropriate to the purpose of the Organization
includes a commitment to meeting the requirements and to continually
improve effectiveness of QMS
provides a framework for establishing and reviewing quality objectives
is communicated and understood at appropriate levels in the organization
is reviewed for continuing suitability.
33
ISO 9001:2000 Requirements
Clause 5: Management Responsibility
Sub-Clause 5.4: Planning
5.4.1: Quality objectives : requirements
Top management shall ensure that quality objectives are:
established at relevant functions and levels in the organisation
measurable and consistent with the quality policy and commitment to
continuous improvement
to include those needed to meet the requirements for product
34
ISO 9001:2000 Requirements
Sub-Clause 5.5: Administration
5.5.1 Responsibility and authority
Functions and their interrelations within the Organization, includingresponsibilities and authorities of personnel who manage , perform &verify shall be defined and communicated in order to facilitateeffective quality management
35
ISO 9001:2000 Requirements
Sub-Clause 5.5: Administration
5.5.2 Management Representative
Top management shall appoint member's of the management who,irrespective of other responsibilities, shall have responsibility and authoritythat includes:
ensuring that processes of QMS are established, implemented andmaintained.
reporting to top management on the performance of the QMS includingneeds for improvement;
promoting awareness of customer requirements throughout the organization
36
ISO 9001:2000 Requirements
Sub-Clause 5.5: Administration
5. 5.3: Internal Communication
The organization shall ensure appropriate communication processes areestablished within the Organization (between its various levels and functions)and that communication takes place regarding the effectiveness of QMS
.
37
ISO 9001:2000 Requirements
Clause 5: Management Responsibility
Sub-Clause 5.6: Management Review
Intent:
Ensure continuing suitability, adequacy and
Effectiveness of QMS
Requirements:
General ( 5.6.1)
Review Input ( 5.6.2 )
Review Output ( 5.6.3 )
38
ISO 9001:2000 Requirements
Clause 5: Management Responsibility
Sub-Clause 5.6: Management Review
5.6.1: General
Top management shall review the QMS at planned intervals,
to ensure its continuing suitability, adequacy and effectiveness
The review shall identify opportunities for improvement and evaluate
the need for changes to the QMS including quality policy and
quality objectives
39
ISO 9001:2000 Requirements
Clause 6: Resource Management
Intent:
Provision of resources - people, facilities and work environment essential tothe implementation of QMS and address customer satisfaction
Requirements:
Provision of resources (6.1)
Human resources (6.2)
Infrastructure (6.3)
Work environment (6.4)
40
ISO 9001:2000 Requirements
Clause 6: Resource Management
Clause 6.1 Provision of resources
Requirement:
The organization shall determine and provide, the resources needed
to implement and maintain the quality management system and improve QMS Effectiveness
to enhance customer satisfaction by meeting customer requirements
Requirements can be identified on need basis or for new assignments or as a
proposal or in MRM etc.
Records of such communication to be verified in IQA
41
ISO 9001:2000 Requirements
Clause 6.2 Human resources
Intent:
Assign competent persons for the work
6.2.1 General
Requirement:
The organization to ensure that personnel performing the work affectingquality shall be competent
Competency can be based on any or a combination of qualification ,experience and training
42
ISO 9001:2000 Requirements
Clause 6: Resource Management
Clause 6.2 Human resources
6.2.2 Competence, awareness and training:
The Organization needs to
identify competency needs
provide training to satisfy these needs
evaluate the effectiveness of training provided
ensure that its employees are aware of the relevance
and importance of their activities and how they contribute to theachievement of the quality objectives
maintain appropriate records of education, experience,
training, and qualifications (see 4.2.4)
43
ISO 9001:2000 Requirements
Clause 6: Resource Management
Clause 6.3: Infrastructure
Intent:
Achieve the conformity of product
Requirement:
identify, provide and maintain
workspace and associated facilities
equipment, hardware and software
supporting services such as transport services
facilities used for the realization of product is to be verified in IQA
44
ISO 9001:2000 Requirements
Clause 6: Resource Management
Clause 6.4: Work environment
Intent:
enhance performance of the Organization by
creating a work environment
Requirement:
Determine and Manage work environment to achieve conformity, whichrequires review of
-Human factors
- Physical factors
45
ISO 9001:2000 Requirements
Clause 7.4 : Purchasing
7.4.1 Purchasing process
Requirements:
Control purchasing processes to ensure that purchased products conform tospecified requirements
Type and extent of control depends on the effect on subsequent processes andtheir output
Evaluate and select suppliers based on their ability to meet requirements.
Define criteria for selection and periodic evaluation Record results ofevaluation and follow-up action (4.2.4)
46
ISO 9001:2000 Requirements
Clause 7: Product Realization
Clause 7.4 Purchasing
7.4.2 Purchasing information
Requirements:
Purchasing documents to contain information including, as appropriate, anyrequirement for qualification or approval of process, procedures, equipmentand personnel and any Quality Management System requirements
Ensure the adequacy of the requirements contained in the purchasingdocuments prior to release.
47
ISO 9001:2000 Requirements
Clause 7: Product Realization
Clause 7.4 Purchasing
7.4.3 Verification of purchased product
Requirements:
Identify and implement the necessary verification activities
Whenever verification at supplier’s premises is envisaged, the same shall bespecified along with the method of product release in purchasing documents.
48
ISO 9001:2000 Requirements
Clause 7: Product Realization
Clause 7.5 Production and service operations
7.5.3 identification and traceability
Requirements:
Identify, where appropriate, product by suitable means throughoutproduction and service operations.
Identify the status of product with respect to measurement and monitoringrequirements
Where traceability is requirement, control and record unique identification(4.2.4)
49
ISO 9001:2000 Requirements
Clause 7: Product Realization
Clause 7.6 Control of Measuring & Monitoring Devices
Requirements :
Identify measurements to be made and the measurement andmonitoring devices required.
Use and control, to ensure that measurement capability isconsistent with the requirements.
Measurement and monitoring devices shall:
be calibrated periodically or prior to use.
be safeguarded from damage and deterioration duringhandling, maintenance and storage.
have the results of their calibration recorded ( 4.2.4)
have the validity of previous results re-assessed, if they arefound to be out of calibration and the corrective action take
50
ISO 9001:2000 Requirements
Clause 8: Measurement, analysis and improvement
Intent:
To measure and monitor the product, process and system in a planned wayand to analyze the resultant data and use the same for continual improvementof product, process and system
Requirements:
General (8.1)
Measurement and monitoring (8.2)
Control of nonconforming product (8.3)
Analysis of data (8.4)
Improvement (8.5)
51
ISO 9001:2000 Requirements
Clause 8: Measurement, analysis and improvement
Clause 8.2 Monitoring and Measurement
8.2.1 Customer satisfaction
Requirements:
Monitor information on customer satisfaction and / or dissatisfaction
This is one of the measurements of performance of the quality managementsystem
Define the methodologies for obtaining and using this information
52
ISO 9001:2000 Requirements
Clause 8: Measurement, analysis and improvement
Clause 8.2 Monitoring and Measurement
8.2.2 Internal audit
Requirements:
Conduct periodic internal audits to determine whether the QMS:
conforms to the requirements of this International standard
has been effectively implemented and maintained
Plan the audits based on the status and importance of the activities of the
areas to be audited and the results of the previous audits
53
ISO 9001:2000 Requirements
Clause 8: Measurement, analysis and improvement
Clause 8.2 Monitoring and Measurement
8.2.2 Internal audit (contd)
Requirements :
Define audit scope, frequency and methodology
Shall be conducted by personnel independent of the area being audited.
Documented procedure shall include the responsibilities and requirements
for conduct of audits, independence, recording results and reporting
to management
Timely corrective action is taken on the deficiencies found by the Auditee.
Follow up actions include verification of the corrective action taken
and reporting of the results
54
ISO 9001:2000 Requirements
Clause 8: Measurement, analysis and improvement
Clause 8.5 Improvement
8.5.1 Continual improvement
Requirements:
Plan and manage the processes necessary for the continual improvement ofthe QMS
Facilitate continual improvement through use of quality policy, objectives,audit results, analysis of data, corrective and preventive action andmanagement review
55
ISO 9001:2000 Requirements
Clause 8: Measurement, analysis and improvement
Clause 8.5 Improvement
8.5.2 Corrective action
Requirements:
Take corrective action to eliminate causes of non conformities in order to
prevent recurrence. Corrective action shall be appropriate to the impact of the
problems encountered
Documented procedure for corrective action shall cover:
reviewing non conformities (including customer complaints)
determining causes of nonconformity
evaluating need for actions to ensure that non conformities do not recur
determining and implementing the corrective actions needed
recording results of action taken
reviewing of corrective actions taken for effectiveness
56
IMPROVEMENTS IN ISO 9001:2000
Continual improvement emphasis
Increased emphasis on the role of top management
Consideration of legal and regulatory requirements
To establish measurable objectives at relevant functions and levels
Monitoring Customer satisfaction as well as dissatisfaction
Resources, Human resources, Facilities & Work environment
Management and Control
Competency and training
Measurements extended to System, Processes and Product
Analysis of data for initiating improvements