Quality Management System

Chapter XXII Quality Mgt. System.

A. Introduction: Changes and improvements cannot

be consolidated in the absence of a proper system in the
organisation.

ISO 9000 : 2000 standards force the organisation to

evolve a system for managing quality in the organisation.
ISO 9001 :2000 calls for documentation of quality policy
and its wide circulation in the org.

All the employees must be educated in knowing the

meaning of quality policy statement of the CEO.
 ISO 9001 : 2000 standards, if implemented in true
spirit, will help organisations to be managed efficiently
and effectively. These standards help the org. to establish a
documented system, which will not give rise to different
interpretations by different employees.

The first step towards attaining Total Quality

Management (TQM ) is getting certified by an
independent certifying body for ISO 9001 : 2000
standards.
B. What is ISO ? ISO is the abbreviation for
International Organisation for Standardisation, with
headquarters in Geneva , Switzerland. Most countries are
members of this organisation.

ISO is engaged in formulating standard

specifications in a variety of disciplines like Quality
Management, Information Technology, Metrology etc.

ISO has published many standards. One of the most

acclaimed standards worldwide is the ISO 9000 family of
standards.
 The first edition of ISO 9000 series of standards
( ISO 9001 , ISO 9002 , ISO 9003 and ISO 9004) was
prepared in 1987 and revised in 1994. The third edition of
ISO 9001 : 2000 has cancelled and replaced the second
edition ( ISO 9001 : 1994 ), together with ISO 9002 : 1994
and ISO 9003 : 1994.

Those organisations, which were using

ISO 9002: 1994 and ISO 9003 : 1994, should use this
standard, by excluding certain requirements.

The quality management principles stated in

ISO 9004 were taken into account, during the development
of ISO 9001 : 2000.
 C. Benefits of ISO 9001 : 2000 Certification:

1) This certification has been made the minimum

requirement by many customers;

2) It is a status symbol for the organisation;

3) It improves the morale of the employees, because of

improvement in the system;

4) The customers get the benefits directly, because of

better products and services;

5) The suppliers get to know the exact requirements;

6) The organisation benefits, because every contract has to
be reviewed before acceptance. This reduces waste; and

7) Since the certification is targeted towards practicing

Total Quality Management (TQM ), the organisation
becomes healthy and prosperous in the long run.
D. Process Approach:
The standard promotes the adoption of a process
approach for developing, implementing and improving the
effectiveness of the quality management system, and for
enhancing customer satisfaction by meeting his
requirements.

The advantages of process approach are:

1) Understanding and meeting customer requirements.
2) The need to consider processes in terms of added value.
3) Obtaining results of process performance and
effectiveness.
4) Continuous improvement of processes based on
objective measurements.
E. ISO 9001 : 2000 Requirements:
ISO 9001:2000 aims at customer satisfaction through
quality assurance and is supported by another standard
ISO 9004 ; 2000 to give guidance in understanding it.
The various requirements of the standard are:

1) Clause 4 --- Quality Mgt. System--- The purpose of

this clause is to ensure that the org. adopts the process
approach to establish, document, implement and maintain
its QMS and continuously improve its effectiveness.
Clause 4.2.2 requires the org. to ensure establishing
and maintaining Quality Mgt.System Manual, which
should include scope of areas of activities of the org. ;
details of exclusions (design, customer property, product
traceability, and outsourced processes) ;
Cross reference to documented procedures and description
of the interaction between identified processes ;
Clause 4.2.3 requires control of all QMS documents and
clause 4.2.4 control of all records.

2) Clause 5--- Management Responsibility--- The top

mgt. must be visibly committed to a quality mgt. system by:

a) Communicating to the org. the importance of meeting the

customer as well as statutory and regulatory requirements;

b) Establishing and propagating a Quality Policy;

c) Ensuring that the quality objectives are established;

d) Conducting mgt. review meetings; and
e) Ensuring availability of resources.

Clause 5.5 requires that the responsibilities and

authorities are defined and communicated within the
organisation.

Clause 5.5.2 makes it mandatory to appoint a

Management Representative from among the members of
the mgt., who should coordinate the various requirements
of the QMS.

Clause 5.6 requires regular review of the QMS by

the top mgt.
3) Clause 6--- Resource Management--- To ensure that
the org. determines and provides all the needed resources
( human, infrastructure and work environment) needed to:

a) Implement and maintain the QMS and continuously

improve its effectiveness; and

b) Enhance customer satisfaction by meeting his

requirements.

The work environment refers to factors such as

layout, facilities, social environment, comfortable and safe
working conditions, cleanliness and hygiene, control of
pollution etc.
4) Clause 7---Product Realisation---To ensure that
planning covers all aspects of process development, quality
objectives, resource mobilisation, documentation etc.

The following are to be decided by the organisation:

a) Requirements for the product;

b) Provide resources specific for the product;

c) Required verification, validation, monitoring, inspection

and test activities specific to the product and the criteria for
product acceptance; and

(d) Records needed to provide evidence that the realisation

processes and resulting product meet requirements.
This includes:
Customer Communication ( cl.7. 2.3);

Design and Development ( cl.7. 3);

Purchasing (cl.7.4), including verification of purchased

product ( cl.7. 4.3);

Production and service provision ( cl. 7.5), including

customer property ( cl.7.5.4), and control of monitoring
and measuring devices (also called calibration---cl.7.6).
5) Clause 8- Measurement, Analysis and Improvement--
The org. should plan and implement the
monitoring, measurement, analysis and improvement
processes needed to:
a) Demonstrate conformity of the product;
b) Ensure conformity of the QMS; and
c) Continuously improve the effectiveness of the QMS.

This clause refers to: Customer perception or

satisfaction ( cl.8.2.1);
Internal Audit ( cl.8.2.2 );
Monitoring and measurement of processes and products
( cl.8.2.3 & 8.2.4);
Control of nonconforming product (cl.8.3); and
Improvement—Corrective and Preventive action—( cl.8.5)
F. Auditing the Quality Mgt. System:

1. Quality Audit: A quality audit is a systematic,

independent and documented process of examining any
activity of an org. based on objective evidence, to examine:

a) The extent to which quality activities and related results

comply with the planned arrangements;

b) The extent to which these arrangements have been

implemented effectively; and

c) Whether these arrangements are suitable to achieve the

quality objectives.
2.Adequacy Audit vs. Compliance Audit:
Adequacy Audit is the process of comparing the QMS
manual against the requirements of ISO 9001:2000, to
ensure that the manual has satisfactorily addressed all the
requirements of the standard and meets these requirements
in full.

Unless the QMS manual passes an adequacy audit,

no certifying agency will proceed further.

Compliance Audit is the process of checking whether

the org. has implemented what they have stated.
3. Types of Audit:
a) First party audit or Self-audit or Internal audit--- Carried
out by employees of the org. to examine its own QMS.

b) Second party audit or audit by customers---Carried out

by customer on the org. or by the org. on the suppliers .

c) Third party audit or External audit--- Carried out by an

external independent agency to assess compliance, usually
for the purpose of certification.
4. Internal Audit:
An audit should have a positive approach with the
objective of“Finding facts rather than faults”. However, in
the case of internal audit, where the primary goal is
“Correction and Improvement”, the more faults found, the
more the corrections and the greater the compliance.

These audits must be conducted regularly in

accordance with the audit plan and as per schedules
prepared each time for the audit.
4.1 Requirements for Internal Audit:

a) Plan--- The audit plan is a formal document, which

covers every area, process and department for the audit
activity. It is normally prepared for a full year and specifies
the following:

(i) The area, process or dept. to be audited;

(ii) The frequency of audit---as a good practice, every area,
process or dept. should be audited at least once every year;

(iii) The qualification of the auditors---the standard

requires they should be trained suitably;
(iv) The procedure to be followed; and
(v) The method of reporting the audit findings.
b) Timing--- The best time to audit is when people are
busy. However, the convenience of the auditee is essential
and their readiness and concurrence should be obtained
before proceeding with the audit.

c) Schedule--- The audit schedule is a document that gives

details of the area, process or dept. to be audited during the
scheduled audit. It also specifies the following:

(i) The dates of the audit;

(ii) The names of the auditors and the corresponding auditee
area, process or dept.; and
(iii) The provision for acceptance of the scheduled audit by
each auditor and auditee in token of accepting convenience
and readiness for the audit on the scheduled date.
d) Internal Auditors---Internal auditors are employees
from within the organisation, who have been trained to
conduct the audits. The most important precaution to be
taken is to ensure that people do not their own work ( to
avoid bias).

e) Checklist--- Checklists are a methodical way of

ensuring that all necessary areas are audited. The auditors
should adopt a flexible approach and use their own
judgement to deviate, if necessary.