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Quality Philosophy of Deming

Deming was the first to note even in pre-World-War-II era the need for
improving the quality of products and services by reducing the uncertainty
and variability in the design and manufacturing processes. This moved the
erstwhile emphasis from product inspection to process improvement through
statistical checking and data analysis in the reconstruction efforts of
Japanese and some US industries after the World-war -II. In Deming`s view,
variation from specification of parts is the chief culprit for ‘poor quality’. Poor
quality not only means inconsistency in achieving quality specification, but
also entails lot of hidden cost. As a result, companies fail to provide value for
the money for their products. He observed that this leads to customer
complaints and dissatisfaction amongst them. He emphasized that post
manufacturing inspection of parts cannot be the solution to this problem;
Deming advocated prevention of defects by instituting statistical checking
during the manufacturing process. To achieve reduced variations and
increased conformance to specifications, he advocated a cycle of following
steps with statistical checking and data analysis.

1. Design the Product

6. Re-design for Improvement 2. Plan Mfg. Process & Controls

5. Analyze sources of Defects 3. Manufacture


& means for Improvement

4. Measure & Test Results by using statistical techniques

Figure 1: Deming’s concept of Product quality assurance through


identifying sources of variation and improvement.

These checks for ensuring quality later came to be known as: ‘Deming Cycle’
of Plan—Do—Check--&-Analyze (P – D – C - A). Deming stressed that steps
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to higher quality lead to: decreased cost, improved productivity, and


increased market share, which are the essence of any business process.
Deming is best known for developing a system of statistical quality control,
and for his advocacy that quality must be built into the product at all stages
of manufacturing. His overall approach focused on improvement of systems
and processes for efficient quality management. He believed, it is the system
and not the workers (- a widely held belief by many during that period),
which is responsible for the process variations and quality problems. As per
Deming, quality comes from the ability to produce with predictable degree of
uniformity and dependability at a lower cost, and the product must be
suitable for the market. Deming advocated that as quality improves,
productivity increases with decrease in overall cost. Such a situation creates
more jobs, greater market share for the products and ensures long-term
survival of the company. He prescribed fourteen universal points for quality
management, which are described below:
1. Create consistency of purpose with plan: This implies that companies
should have clear mission and statement of purpose. True purpose of a
business should be to serve its customers and all other stakeholders,
including employees.
2. Adopt the new philosophy of quality: This refers to viewing quality as
an outcome of improved systems and processes that enable to produce with
high degree of consistency and dependability at low cost. Deming referred
improvement as never-ending cycle – where improvements follow one
another with no letting up of efforts. He termed this approach as the new
the new philosophy of quality.
3. Stop the practice of mass inspection: Mass inspection does not stop
producing defectives, and does not add value to the products; it only adds
unnecessary cost and tends to dilute the responsibility of workmen for their
own output. Managers should understand the causes of variations and take
steps to reduce the same. Inspection, if any, should only be for the purposes
of information and data building.
4. Identify problems and work continuously for improving the
system: Problems will exist in a manufacturing system, and solving and
improving that situation should be the key to successful quality
management. Reducing the variability and thereby helping to establish a
stable and predictable production system can bring about the real change in
quality management practice.
5. Change the focus from quantity to quality: Ultimate value of
production lies in its quality and not in quantity. Often, focus on quantity
leads to production at any cost, and high cost of rework and scarp. This
violates all systems of good management.
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6. Stop asking for productivity improvement without identifying and
providing methods to achieve them without any risk of quality:
Productivity is a common buzzword, and every manager may ask for it from
the workers, but to get it right managers must plan the means and provide
the methods. Otherwise, it runs the risk of high cost and rework for
maintaining quality.
7. Adopt the method of training on the job: Employees need proper skill
and knowledge to do a job well. It is the responsibility of management to
provide necessary training and skill development programmes to employees
with regard to their classified jobs. Deming advocated that all employees
should be further trained in statistical tools and techniques for problem
solving.
8. End the practice of choosing suppliers based purely on price:
Deming advised that it is not the price but the quality of inputs that should
be the approach of good quality management. Cost due to inferior inputs can
lead to higher costs at later stages of processing due to scrap, rework and
failure to meet the delivery schedules of the customers. This should be
avoided for an efficient quality management system.
9. Eliminate work standards that prescribe numerical quotas:
Numerical quota as a part of standards of operations encourages short-term
gains, and allows violation of systems and procedures for work. This is
against good work culture and does not encourage people to look for
improvement opportunities. Hence, this should be strictly avoided during
setting up of work standards.
10. Drive out fear from the mind of people, encourage
communication: Fear in the mind is a strong barrier for understanding
about one’s job. Fear also stops people to communicate freely about their
jobs and ways of improvements. This hampers output and quality
production. All types of fear should be removed from the minds of workers,
such as fear of punishment or reprisal for not meeting one’s target, for these
inhibitions do not go well with a good production system.
11. Remove barriers to pride of workmanship: Pride of workmanship is
a strong motivator for quality jobs, and its recognition has many beneficial
effects in the workplace. If workers are denied their due recognition for their
skills and abilities, they tend to loose their self-confidence and motivation,
the root cause of most quality problems in industries.
12. Breakdown the barriers between departments: People do work
best when they are allowed to work as a team. Too many
departmentalization and compartmentalization of work does not allow
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development of team spirit amongst workers and spawns the tendency to


split the responsibility between ‘them’ and ‘I’. This is not conducive for good
work environment that is necessary for good quality management.
13. Institute vigorous education and retraining: Training is meant to
improve job skills, and education is necessary for self-development.
Management must provide the opportunities for self-development by
promoting educations and skill improvements by retraining of employees.
14. Create an appropriate management structure for implementation
and follow up of foregoing points for quality management in the
organization: This is the part of action for ensuring implementation of the
aforementioned points for good quality management. Top management must
create a suitable management structure with appropriate authority and
responsibility to implement and monitor the steps taken as per above
recommendations for good quality management practice. This is the task for
top management. Management structure so devised should, in turn, institute
suitable actions, processes and procedures for ensuring that governing
principles of good quality management are practiced throughout the
organization.
Apart from strong advocacy of moving away from inspection, and for
introduction of quality control based on statistical analysis and
improvements, Deming’s other important recommendations are: focus on
quality and not quantity, training for the job, system of working with focus
on improvements, and having a definite purpose of the business.
Unfortunately, many of the obstacles and observations that led Deming to
prescribe aforementioned ‘fourteen universal points’ for good quality
management are still prevalent in some industries in India and many other
developing countries. As a consequence, it is not uncommon to find that
quality of products and associated services is still continuing to suffer from
high degrees of inconsistency in those industries.

2 Quality Philosophy of Juran


Juran, who taught quality principles to Japanese in 1950s, was a principal
force in quality reorganization movement in Japanese industries in 1950s
and 1960s. Juran focused on three major aspects of quality management,
namely: Planning, Control and Improvement. As per Juran, quality planning
starts with identifying customers, be that internal in the organization or the
external one who is the ultimate user of the goods or service. Quality
planning also involves determining the needs of all customers (i.e. whoever
uses their products) and developing the product quality features for meeting
the customer needs. Juran identified customers as a critical factor in
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determining quality goals, and prescribed establishing control methods that meet the
needs of customers and suppliers alike at a minimum combined cost. Thus, customer
as a critical factor in the process of quality management got established as early as
1950s in Japan. Quality Control, as per Juran, should be invoked to:
(1) Determine what to control
(2) Establish measures and measurements
(3) Set standard of performance
(4) Evaluate performance versus goals or standards
(5) finally, take actions on the differences

Juran was first to introduce the managerial dimensions of quality management. He


introduced the need for planning, organizing and controlling as means to quality
management, and stressed the responsibility of management for achieving the quality
as per set goals. Based on his focus on these three aspects of quality management, he
outlined his approach to quality management, which is famously known as ‘Quality
Trilogy’ of Juran,
Briefly, they are:
Quality Planning: A process of pre-setting the quality goals, and working out the
preparations for meeting those goals.
Quality Control: The process for ensuring that quality goals are being achieved during
the operations, and
Quality Improvement: This is the process of solving the problems and for breaking
through to higher levels of quality for superior performances.

Quality Improvement

Quality Planning Quality Control


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Juran defined quality as ‘fitness for use’ by the customer in terms of design,
conformance, availability, safety and use.

3: Quality Philosophy of Crosby


Like Deming and Juran, Philip Crosby is another quality philosopher who
made significant contribution to the evolution of quality management during
this period by emphatically putting across his four absolutes of quality,
namely:

• Conformance to requirements
• System of prevention and not appraisal for quality
• 'Zero defect' as performance standard, and
• Price of non-conformance as measure of quality

Crosby’s concept of ‘zero-defect’ and price of non-conformance as measure


of quality had later on revolutionized quality management processes
throughout the world. The revolutionary concept of ‘Six-sigma’ process of
quality management, which was adopted by Motorola Inc. of USA in 1980s,
has its origin in these concepts of ‘zero-defect’ and need for managing the
cost of poor quality in industries.
Philip Crosby made important contribution to quality movements by
introducing the concept of ‘Zero-Defect’ and advocating to focus on the
measurement of ‘cost of non-conformance’. Crosby observed that poor
quality in average companies costs about 20% or more of all revenues, most
of which could be avoided by adopting good quality practices. Accordingly,
he prescribed four ‘absolutes for quality’, viz.:
1. Quality is conformance to requirements, not ‘goodness’. Crosby
treated quality as absolute necessity to meeting user requirements, and not
something fancy in the products.
2. The system of achieving quality is prevention, and not appraisal.
He emphasized the need for preventing the non-conformance to quality of
products, and brought the concept of ‘cost of quality’ as the expense for
non-conformance. Crosby pointed out that non-conformance in a production
system calls for high costs of appraisal actions – like inspection, testing, and
other quality control means – all of which can be avoided.
3. The performance standard is ‘Zero-Defect’, not a subjective ‘close
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enough’. Crosby strongly believed that a system must aim for ‘zero-defect’
i.e. do it first time right. This implies all-out efforts to prevent the
occurrence of defects rather than trying to inspect, rework and retrieve the
products. He wanted to change the mindset of people that error is inevitable,
and advised that whatever may be the situation, people must continually
bring down the errors by aiming at zero-defect target. By this he implied
that zero-defect is not a standard but a target, which should be pursued
relentlessly for quality improvement.
4. The measurement of quality is the price for non-conformance, and
not indexes. He prescribed that any measurement of quality should be in
terms of costs for non-conformance and not indexes of quality. Such
measurements and data only can provide the clear proof of need for
improvement, which is the aim of any quality management system. He
particularly wanted the people to note that assigning index to the degree of
non-conformance, such as 99% conformance to quality within a target of
plus-minus variations, do not reflect true picture of manufacturing quality.
As per Crosby, the measurement of cost of quality is the true reflection of
quality of manufacturing.

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ISO-9001 of 2000: The Quality Management
System (QMS)

Standards, guidelines and Purpose


ISO 9000:2000, Quality management systems - Fundamentals and vocabulary

Establishes a starting point for understanding the standards and defines the
fundamental terms and definitions used in the ISO 9000 family which you need to avoid
misunderstandings in their use.

ISO 9001:2000, Quality management systems - Requirements

This is the requirement standard you use to assess your ability to meet customer and
applicable regulatory requirements and thereby address customer satisfaction.

It is now the only standard in the ISO 9000 family against which third-party certification
can be carried.

ISO 9004:2000, Quality management systems - Guidelines for performance


improvements

This guideline standard provides guidance for continual improvement of your quality
management system to benefit all parties through sustained customer satisfaction.

3. Applicability and Systems of ISO-9000 QMS.


ISO-9000 is a quality assurance and customer satisfaction model, which is made up of
documented quality system requirements aiming to assure quality in the products and
services for customer satisfaction. The model applies to all organizations that produce,
install and service products and services of any kind.
Industries and business houses engaged in the production and delivery of various kinds
of products and services can be grouped under the following four generic categories:
Hardware: This covers all product producing units, like machine, equipments, tools and
associated component manufacturing etc, which can be considered as hardware inputs
to the facilities. Examples: Machines, Cranes, Cars, Bearings, TV sets, Music and
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entertainment equipments, Refrigerator, Labour etc.


Software: This covers the means and processes that are used by the hardware for
production / generation / usage of goods and services. As for example, tools are a type
of software for a machine to produce a part. Examples of software category are:
Projects and Project Planning unit, R&D, Software Development, Toolings, Process
control means, Administrative functions etc.
Processed Materials: This covers all units that deal with processed materials i.e.
produce or sale any product or service that is used for finishing and final consumptions.
Examples are Food and Beverage industries, Packaging, Assembly units, Raw-material
Processing units, Retails shops, Dealers etc.
Services: This covers all units who are engaged to deliver services of any kind to
consumers. Examples are Financial Services units, Education and Health Care units,
Marketing, Logistic Services, Customer Services unit, Banks, Govt. Offices etc.

ISO-9001of 2000: The Quality


Management System (QMS)
The ISO-9000 family of standards primarily prescribes:

1. Establishment and adherence of ‘Quality Management System’ (QMS) as per the


system requirements of ISO-9001.
2. Process approach to all activities relating to quality and customer satisfaction
3. Documentation of systems, procedures, instructions, records and specifications.
4. Standardization of practices, and continual improvement
5. Measurement and control to facilitate analysis of data pertaining to product
quality conformance, customer satisfaction, supplier performance, quality
improvement etc.
6. Control of records relating to the quality management system.
7. Management review for assessment of performance and conformance to QMS,
8. Continual improvement of systems and processes.

ISO-9001: 2000 is the principal standard that guides the company to establish the
quality management system (QMS) covering the aforesaid areas and requirements.
QMS is simply defined as: The process of management of the systems of an
organization, with regard to its quality related activities, for meeting and exceeding
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customer satisfaction, and also taking care of other interested parties such as
employees, suppliers, shareholders, legislative and regulatory bodies, etc. For
effectively organizing and establishing the process of quality management under this
system in a company, ISO-9000 QMS prescribes eight quality management
principles as guide for forming and managing the system. They are:

1. Customer Focus 5. Fact Based Decision Management


2. Leadership Management 6. System Approach to Quality
3. People’s Involvement 7. Continual Improvement, and
4. Process Approach 8. Supplier Relationship Management.

ISO-9000 Quality Management Principles


1.Customer: Organization has to rely on customers for success in business.
Focus Therefore, Organization must understand customer needs, meet the
customer requirements, and try to exceed the customer expectations.

2. Leadership: Organizations rely on leaders for performance. Therefore, leaders


must establish a unity of purpose and set the direction of the business.
Leaders must also create a work environment that motivates people to
achieve the organization’s goals and objectives.

3. People’s People are at the core of any business activity. Therefore, people
Involvement: at all levels must be encouraged to get involved in quality
management, and they must be helped to develop and use their skills.

4. Process It is now established that in the organizational activities process


Approach: approach is the most efficient and effective way of doing business.
Therefore, organizations must develop appropriate processes and
resort to process approach to manage all activities and resources.

5. Fact Based Organizations perform better when their decisions are based on facts.
Decision: Therefore, organizations must have system of analysis of information
and data for fact based decision-making.

6. System For consistent results, system approach is essential. Therefore,


Approach: organizations should identify inter-related processes and manage them
under a system approach.

7. Continual Continual improvement is the key to customer satisfaction and delight.


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Improvement: Therefore, organizations must make commitment to continual


improvement in all processes and activities.
8. Supplier All organizations depend on the supply capability of their suppliers.
Relationship: Therefore, organizations must develop and maintain a mutually
beneficial relationship with their suppliers.

System Requirements of ISO-9001: 2000

The ‘system requirements’ are covered under ISO-9001, the main operating
standard of ISO-9000 family. These are designed to establish the QMS,
document the system requirements and elements, implement, maintain, and
continually improve.
Quality system elements of ISO-9001: 2000 standard are spread under five
main clauses in 23 sub-clauses of quality system requirements.

Clauses and Sub-clauses of ISO-9001 QMS


Clause 4. Quality Management 4.1 General Requirements
System (QMS) 4.2 Documentation Requirements:
Mandatory Requirements of QMS,
Quality Manual, Control of Dcuments,
and Control of Records.

Clause 5. Management 5.1 Management Commitment


Responsibility 5.2 Customer Focus
5.3 Quality Policy
5.4 Planning: Quality Objectives, and
Quality Management System.
5.5 Responsibility, Authority and
Communication:
Responsibility & Authority,
Management Representative, and
Internal Communication
5.6 Management Review: General
Requirements, Review Inputs, and
Review Outputs

Clause 6. Resource 6.1 Provision of Resources


Management 6.2 Human Resources: General,
Competence, Awareness, Training
6.3 Infrastructure
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6.4 Work Environment.


Clause 7. Product 7.1 Planning of Product Realization
Realization 7.2 Customer Related Processes:
Determination of Requirements,
[This refers to the interconnected Review of Requirements, and
processes that are used to bring Communication to Customers.
Products into being] 7.3 Design and Development:
Design and development of
Planning, Inputs, and Outputs.
Design and Development Review,
Design and Development Verification,
Design and Development Validation,
Control of Design and Development
Changes.
7.4 Purchasing: Purchasing Process,
Purchasing Information, Verification
Of Purchased Products.
7.5 Production and Service Provisions:
Validation of Processes for Production
& Service Provision, Control of
Production & Service Provisions,
Identification & Traceability,
Customer Property.
7.6 Control of Monitoring & Measuring
Devices.

Clause 8. Measurement, Analysis 8.1 General


And Improvement 8.2 Monitoring and Measurement:
Customer Satisfaction, Internal Audit,
Monitoring & Measurement Processes,
Monitoring & Measurement of Products
8.3 Control of Non-conforming Products.
8.4 Analysis of Data.
8.5 Improvement: Continual Improvement,
Corrective Actions, Preventive Actions.

These clauses and elements are considered essential for designing and establishing a
properly documented QMS capable of fulfilling the needs and expectations of customers
through continual improvements.
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Requirements of ISO-9001: Spirit and Purpose

Requirements of some important clauses of IS0-9001 of 2000 need to be understood


with respect to their spirit and purpose for appreciating the scope, objectives, and
design of this standard. This is necessary for efficient implementation of the QMS. Spirit
and purpose of the important clauses are briefly described below. For the sake of
clarity, original clause numbers have been retained for reference.

Clause 4: Quality Management System (QMS)

4.1 General: Purpose of the QMS is to ensure that the organization adopts the process
approach in line with the spirit of the standard in order to establish, document,
implement and maintain the quality management system and continually improving the
system. QMS once made and approved should not be changed during the operational
period of the ISO certificate.

Spirit of implementation of this clause demands identification of processes that are


required for management of QMS, and to determine interrelation and interaction of the
identified processes and then to establish process interrelationship diagram as per the
sequence of activities that should necessarily be followed for continual customer
satisfaction.

4.2 Documentation: This refers to the act of documenting the Manual, Procedures and
Records relating to QMS. This includes quality policy, quality objectives, procedures for
management review, procedures for control of documents, quality records, control
records, work instructions, internal audit procedure, control of non-conforming products,
corrective actions, and preventive actions. This list is not the full exhaustive list of
documentation; only the important ones have been mentioned. Documentation is an
important aspect of ISO standards, and its intended purpose is to ensure that the
organization carefully documents all critical activities and procedures, and also
maintains the mandatory requirements of the standard. They should be easy to
understand and must be verifiable for adequacy of practice and compliance to the QMS.

Clause 5: Management Responsibility

5.1 Management Commitment: This clause has been inserted to emphasize that top
management must demonstrate their commitment to the establishment, implementation
and maintenance of the QMS, and promote continual improvement of the system in the
organization. Management commitment is the principal driver of QMS. Hence,
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management commitment has to be demonstrated by acts and decisions of the top


management team.
5.2 Customer Focus: This clause aims to ensure that the entire organization and
organizational activities set their focus on determining customer needs and meeting
those requirements. Customer focus has been adopted in the new version of ISO-9000,
because of its essentiality in the new business environment. Though Japanese, US and
many European industries had recognized customers as central to any business long
ago, Indian industries did not pay much attention to them due to prevalence of 'seller's
market' condition. This changed very drastically with the opening up of Indian economy
in 1990s, which has turned the clock to 'buyer's market'. With the growing competition
and opening up of global market, business has since become totally dependent on
customers and their satisfaction with the marketed products. This change of situation
has made it essential for the industries to focus on their customers and customer
satisfaction in conducting the business. This clause of ISO is to guide the industries to
set their focus right.

5.3 Quality Policy: This refers to a documented policy statement on quality. Objective
is to ensure that the organization has focused approach to quality, and that is
documented as a quality policy of the organization.

Quality policy should not only state the quality intent, but also should refer to the means
by which the quality will be realized in the organization. Quality policy should commit to
customer satisfaction by continual improvement in line with the ISO-9001 of 2000.
Quality policy should be communicated to all employees, and it should be motivating
and inspiring to the people. An example of quality policy is: "The company will
continuously strive to deliver world-class goods and services to its customers by
developing and marketing innovative, value-added products of contemporary design
and international standards. Committed and skilled work-force, dedicated R&D,
teamwork, customer-first work culture, and innovation will be the driving force for
meeting the company's quality policy objectives".

5.4.1 Quality Objectives: The quality objectives should relate to actions and quality
targets required for achieving the quality goals and improvements for the products,
processes and systems of the organization. Quality objectives can be for the
organization, departments, units or major processes, but those have to be consistent
with the quality policy and quality goals of the organization. This is to ensure that the
organization or a department identifies and establishes those quality targets, which are
required for achieving the organizational goals. This in effect is a planning process to
ensure that organizational quality goals are achieved. Like quality policy, quality
objectives must be expressed in clear, brief and unambiguous terms. For example,
quality objectives of a service department could be stated as: 1) To maintain trained and
skilled staff, 2) To reduce the customer complaint resolution time, 3) To improve
communication between customers and staff etc. Spirit of these objectives is to serve
the customers better for earning their confidence and satisfaction.
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5.5.1 Responsibility and Authority: People are at the centre of all processes.
Therefore, in order to ensure that these processes are conducted in efficient and
effective manner, it is necessary to clearly assign or define the responsibility and
authority of all contributing people. This is an important enabler for making quality
happen in the organization. Responsibility and authority should be communicated to all
and be made clear and explicit to all concerned.

5.5.2 Management Representative: This clause is intended for to ensure that


management appoints a competent managerial person from the organization who will
be the responsible to ensure that the QMS is appropriately established, implemented
and maintained. Management Representative (MR) is a key co-ordinating position. MR
should be given appropriate responsibility and authority by the top management for
functioning. MR is responsible for all communication to the people (employees) for
customer requirements and make them aware for the necessity to fulfill the
requirements. MR is also responsible and accountable to top management for
communication of performance of QMS and improvement needs. MR is the key person
with whom the auditors and certifiers interact for QMS implementation and compliance.

5.6 Management Review: This is to ensure that the top management periodically
reviews QMS. The purpose is (a) to ensure that quality objectives are being achieved
and resources being provided, (b) correction, prevention and continual improvement
processes are in place, and (c) to keep the QMS appropriate with the change of time for
improvement. Review of audit reports is an important part of this review system. This
means that at a specified periodical interval, management should take up the reviews of
QMS, and make improvement. Records of such reviews must be maintained.

Clause 6: Resource Management

6.2 Human Resource: All QMS activities and processes are carried out by people of
the company. This clause is meant to ensure that each such job is clearly defined and
requirements are determined. Based on this determination, jobs are allocated to
competent persons. For fulfilling this condition, management has the responsibility to
assess the competence of the people by taking into consideration the education,
training, experience and skills. This clause implies the need of well thought out human
resource management policy, supported by facilities of training and skill improvement
programmes.

6.2.2 Competence, Awareness and Training: This clause is intended for ensuring that
only suitably trained and skilled personnel are engaged for jobs pertaining to quality
outputs. This clause provides that organization should determine competence and skill
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required for jobs that are likely to affect the quality, then provide training to people, and
maintain records for their training, education and experience.
6.4 Work Environment: Purpose is to make sure that the workers are provided with
conducive work environment for encouragement to work, motivation and performance.
Conducive work environment means openness of work place, cleanliness and hygiene
of the place, pollution free, good social environment, and above all safety. Providing
employees with right condition of work environment is important to get them committed
and motivated for quality work first time right, which is essential for customer
satisfaction.

Clause 7: Product Realization

7.1 Planning of Product realization: Purpose is to make sure that every actions that
lead to production and realization of product quality for satisfying the customers are
planned for execution i.e. nothing should be left to chances. Planning for product
realization should cover the quality to be produced as per quality objectives, process of
manufacturing, integration of processes and development of processes where
necessary, resources required, and documentation. The process steps for product
realization may embrace number of small sub-processes, which should also be
determined and planned. Care should be taken in planning that the requirements of one
process do not conflict with other processes of QMS. Finally, all processes pertaining to
the realization of product and the output result must be recorded and documented.

7.2 Customer Related Processes:

7.2.1 Determination of Requirements related to products: This is perhaps one of the


critical requirements of QMS. Without an understanding and estimation of what exactly
customers want, no organization will be able to satisfy the customers. This clause
makes the organization work for understanding of all specified and implied needs of
customers, analyze the process for production and delivery on time, and to examine the
statutory or any special needs. Purpose of this determination is not for record, but to act
upon. This activity must get proper attention of the management and should be a
regular system of working in the organization.

7.3.7 Control of Design and development Changes: Documentation and control are
the key mechanism by which the QMS systems and procedures are ensured. This
brings discipline in thoughts, systems and focus in the work. This clause demands that
any changes made in the design and development of a product must be recorded for
reference, after that has been validated and verified in actual practice. Wherever
necessary, customer’s agreement should be obtained.

8. Measurement, Analysis and Improvement


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8.2.1 Customer satisfaction: The standard does not allow only promises to be made
for customer satisfaction, but demands that company regularly measures and estimate
the extent of success of meeting the customer satisfaction target. This measurement is
an elaborate process, which calls for appropriate facilities for data collection and
analysis. This is essential for setting improvement target for customer satisfaction level.

8.2.2 Internal Audit: ISO-9000 system conformance calls for periodical internal audits,
and rectification of any deficiency. Purpose of this clause is to determine if the quality
management system conforms to plan, conforms to the stipulations of the standard, and
conforms to requirements set by the organization.

This is a specialized job, to be conducted by trained people. Records of internal audits


must be maintained and any non-conformance must be corrected at the earliest.

8.3 Control of Nonconforming Product: This clause makes it mandatory for the
organization to identify and control the non-conformed products going out of the system
and reaching to customers. Means of this control is not inspection, but prevention;
though some degree of detection and elimination work can not be avoided. The method
for preventing and controlling the nonconformance must be documented and
meticulously adhered to in the system, and should come up for audit and review.

8.5 Improvement

8.5.1 Continual Improvement : This is one of eight principles of QMS. Purpose is to


ensure that the organization is mindful to the need of improvement and enhancement of
the QMS and its outcomes. Main sources of management information about where to
practice and achieve continual improvement come from: analysis of measurements and
data, audit records, list of corrective actions taken, preventive action results, and points
from management reviews. This is a critical driver of the QMS for consistently achieving
customer satisfaction.

ISO-9000 system has adopted the term 'continual improvement' in variance to


'continuous improvement' being used in TQM, because the ISO system believes that
result of any improvement efforts come in steps and not in unbroken continuous
manner. For more about the difference between these two terms, refer to 'Glossary of
Terms and terminology' at the end of the Book.

8.5.2 Corrective Action: This clause is to make sure that in case of any non-
conformance occurring in the system, that must be detected and the source should be
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eliminated by taking immediate corrective action.


There must be an established corrective action-taking documented procedure in
compliance with the QMS, and the records of actions taken must be maintained.

8.5.3 Preventive Action: This is to ensure the age old saying that prevention is better
than cure. Any quality system must be sensitive to reduce the cost of poor quality in
order to satisfy the customer with value for their money. This is best done by designing
the system on the basis of preventive measures. To prevent the potential non-
conformance occurring in the process or system, root-cause analysis and documented
preventive measures should be implemented in the organization. Preventive actions
and measures should be recorder and maintained.

It should be noted from the foregoing points that important drivers of ISO-9001 quality
management system are:

1. Quality policy and Quality Objectives,

2. Quality Manual and Quality Procedures, and

3. Management of the system in line with the eight principles of QMS mentioned
earlier.

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ISO-9001: Documentation and Records

Documentation procedure of ISO-9000: 2000 version has a number of levels, starting


with the parent document, ISO-9001: 2000, at level 0. Categories of basic documents
under different levels are shown in Table below. Documents are mentioned as per
hierarchical order (Levels) in order to ensure that the documents of lower levels are in
congruity with the higher ones; lower level documents being applicable to the actual
work positions and points as per the policy, objectives and procedures outlined in
documents of higher order.

Table: Documents under Quality System Requirements of ISO-9001: 2000

Level – 0: Parent Document ISO-9001: 2000 QMS

Level-1: Documents Vision Statement


Quality policy
Quality Objectives
QMS Manual [Quality Manual]
Quality Plans

Level-2: Documented Procedures Document Control


for: Control of Quality Records
Internal Quality Audit
Control of Non-conformity
Corrective Actions
Preventive Actions

Level –3: (Work) Instructions Planning, Operations, Inspection


Maintenance, Calibrations,
Drawings, Specifications etc

Level-4: Records Work records, Formats, Forms,


Tags, Levels etc.

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Table: Mandatory Records with reference to Level-4 Documents
Records Reference Clause nos. of ISO-9001
1. List of Out-sourced Processes 4.1
2. Procedure for control of Document 4.2.3
3. Management Review Records 5.6.1
4. Employee records on education, training 6.2.2
experience and skills
5. Product realization plan records 7.1
6. Customer requirement review & actions 7.2.2
7. Design & development in-put records 7.3.2
8. Design & development review records 7.3.4
9. Design & development verification records 7.3.5
10. Design & development validation record 7.3.6
11. Design and development changes records 7.3.7
12. Supplier evaluation and action taken records 7.4.1
13. Process validation records 7.5.2
14. Control and use of customer property records 7.5.4
15. Calibration and verification of monitoring & 7.6
measuring devices records
16. Customer satisfaction and dissatisfaction records 8.2.1
17. Internal Audit records 8.2.2
18. Product conformance records 8.2.4
19. Non-conformity nature and action taken records 8.3
20. Corrective actions and results 8.5.2
21. Preventive actions and results 8.5.3

Implementation of ISO-9001: 2000 Quality System

ISO-9001 of 2000 is the only implementable standard under ISO-9000 family for general
industries and businesses. Broadly, primary steps in the implementation of ISO-9001
are:

• Establish the QMS by defining ‘Quality Policy’ and ‘Quality Objectives’ and
putting them into the ‘Quality Manual’ as per ISO requirements.
• Document the established QMS, including quality manual, quality procedures,
work instructions, specifications, record / data formats etc.
• Implement the documented procedures and instructions at work places in line
with the documented quality manual and the guiding principles of QMS.
• Maintain the established quality system by regular auditing and reviewing of
conformance, and actions for corrective measures wherever necessary.
• Continually improve the level of performance by correction, prevention and
improvement actions in all areas of quality.
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Quality auditing is a part of ISO-9000 implementation system. Purpose is to determine:
• Compliance with the requirements of ISO –9001 QMS
• Compliance with the implemented system requirements of ISO-9001.
• Continued adequacy of the system for quality objectives and customer
satisfaction.

Thus, audit process can be for: adequacy of the system, and compliance to the system.
Purpose of adequacy audit is to confirm that the ‘Quality Manual’ adopted by an
organization is fully addressing the quality requirements of ISO-9001 of 2000 in the
areas of operations under certification, and that the adopted system is continuing to be
adequate with the change in business scenario, if any. Quality manual (QMS Manual)
must pass the adequacy audit before the final audit by external agency for ISO-
certification, and continue to be valid in future. Compliance audit is carried out to check
if the organization has implemented what has been stated in the QMS-manual, and
employees are following the documented procedures in their respective jobs.

Since audit is a process of continual check for conformance to QMS-manual and


documented procedures, it is generally carried out in following manners for effective
checks:

Internal Audit: It is carried out by suitably trained people of the organization itself to
examine if all the requirements of QMS are being met. Purpose of internal audit is to
identify the areas where correction and improvement actions are required for making
the system fully compliant and effective. It is carried out at regular intervals, and all non-
conforming areas are corrected for compliance to QMS.

External Audit: It is carried out by an external independent agency or source to assess


the compliance to QMS of ISO-9001: 2000. This can be by a second party who is
interested to procure some critical components from the organization or by the external
certifying body for the purpose of certification.

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