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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.
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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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
Quality Improvement
• 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
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)
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.
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.
This guideline standard provides guidance for continual improvement of your quality
management system to benefit all parties through sustained customer satisfaction.
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:
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.
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.
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.
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
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.
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.
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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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.
5.6 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.
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.
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.
7.3.7 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.
8.2.2 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.
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
8.5.2 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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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:
3. Management of the system in line with the eight principles of QMS mentioned
earlier.
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ISO-9001: Documentation and Records
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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
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.
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.
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