QUALITY

MANAGEMENT
P080-4

Quality Management
P080-4
TOTAL QUALITY MANAGEMENT (TQM)
Introduction :
The term 'Quality' may be defined as the totality of features and
characteristics of a product or service that bear on its ability to satisfy
stated or implied needs. The term 'Quality Control' QC' may be defined as
the operational techniques and activities that are used to fulfil requirements
for quality. In 'QC' the aim is to inspect to prevent defects from occuring and
not to find defects after they have occurred. The QC programme would be
geared to root out the problems that can cause defective products during
production.
Quality evolution phases have been shown in figure 1 below. Operator
inspection and foreman verification phases focussed on part defect detection
through post production inspection. It is concerned with conforming to
standards/specifications and sorting out rejects.

The organisations' outlook on the business front is going through a

metamorphosis from the earlier reactive approach to pro-active interaction
with the customers, suppliers, including employees and all other
stakeholders. Thus, to stay in business and be excellent, situation calls for
continuously changing process/methods/procedures that produce goods and
services delighting its customers. TQM is a process that creates such an
organisation. Total quality control (TQC) could not succeed in this, because
even though it is supposed to be a company wide movement, but, actually
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is largely limited to the manufacturing department.

The Statical Quality Control, SQC, concept has been extensively refined
during the last 50 years. SQC can be broken into two areas : Acceptance
Sampling and Statistical Process Control (SPC).
Acceptance Sampling is the basis of traditional inspection based
quality control approaches and is essentially retrospective. It deals with
problems of quality after they have been built in. It is still used where there is
no guarantee of incoming quality from previous stages or from suppliers. The
techniques uses either 100 percent inspection or sampling inspection where
only an 'acceptable number' of defects get through.

On the other hand, SPC, attempts to monitor and improve things while they
are still happening. Statistical methods are employed to detect trends that
will ultimately lead to the production of defective parts. The aim is to identify
the causes for such trends and then taken the necessary corrective actions
before any defective parts are produced. The essence of SPC is that 'if the
process is under control, any variations are due only to random causes. The
basic way of checking this out is via Control Charts. Lack of control of a
process is indicated by the following conditions :
1. A point falling outside the control lines (UCL and LCL).
2. A run of more than 8 points on the same side of the centre
line.
3. A trend with at least 7 points.
4. 13 out of 15 points falling on the same side of the centre
line.
When any of these conditions exists, then corrective actions need to be
taken.
Quality Assurance (QA) Phase.
Quality assurance, QA, recognizes that inspection is not the answer and that
"the entire manufacturing process must be committed to meeting the quality
needs of the design". It incorporates all those planned and systematic
actions necessary to provide adequate confidence that a product or a service
will satisfy the requirements for quality. For effectiveness, QA usually requires
a continuing evaluation of factors that affect the adequacy of design or
specifications for intended application as well as verifications and audits of
production, installation and inspection operations. QA focusses on procedure
compliance and product conformity to specifications through production and
operations management, often using SPC as a tracking tool.
The concept of "QA" originated in early 1960s. However, by 1969, it had
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degenerated into an increasingly dogmatic, bureaucratic and specialized

function. It mainly became an increasingly bureaucratic set of rules and
procedures which suppliers needed to go through to obtain certification.
Due to all this, a good idea in principle, the concept of QA became a book of
rules rather than a live principle.

Definition of TQM.
TQM is an integrated organisational approach in delighting customers (both
external and internal) by meeting their expectations on a continuous basis
through everyone involved with the organisation working on continuous
improvement in all product/processes alongwith proper problem
methodology. In other words, TQM means activities involving everyone in a
company-management and workers in a totally integrated effort towards
improving performance at every level. This improved performance is directed
towards satisfying cross-functional goals as Quality, Cost, Manpower
development, Quality of worklife etc. These activities ultimately lead to
increased customer and employee satisfaction.
In short, the definition says "Continuously meeting agreed customer
requirements at the lowest cost by realising the potential of all employees".
TQM Culture.
Total quality is a new approach to improve the effectiveness and flexibility of
an organisation as a whole. It basically aims to involve every person in every
department of an organisation working together to eliminate errors and
prevent waste. It is an organisational culture to ensure things are done right
first time.
According to "Ten Compelling reasons for TQM" by Dr. Steve Smith, the
results are almost invariable :
1. Committed customers.
2. Improved productivity.
3. Reduced costs.
4. Improved certainly in operations.
5. Improved company image.
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6. Dedicated management.
7. Increased employee participation.
The only way to achieve these results is through commencement by
management,starting with the top management. TQM must be
management lead, company wide in implementation, dedicated to
continuous improvement, and the responsibility of every employee.

TQM principles.
The guideline principles of TQM are given below :
1. Agree customer requirements.
2. Understand customers/suppliers.
3. Do the right things.
4. Do things right first time.
5. Measure for success.
6. Continuous improvement is the goal.
7. Management must lead.
8. Training is essential.
9. Communicate as never before.
TQM is a process of change in terms of values, beliefs, style and activity.
The concepts are essentially simple to understand and yet are difficult to
implement.
Where Applicable.
TQM is applicable to all functions as broadly interpreted: Quality means.
Quality of work, Quality of service, Quality of information, Quality of
process, Quality of division, Quality of people, Quality of system, Quality of
company, Quality of objectives etc. Quality has an element of cost
consideration in it. Idea is to minimise the cost with quality as the
objective.
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The various companies have evolved many versions of teamwork

approach, such as given below :
(a) Quality Improvement Team (QIT).
A quality improvement team is a group of people with the appropriate
knowledge, skill and experience who are brought together by management
specifically to tackle and solve a particular problem, usually on a project
basis. They are cross functional and often multidisciplinary. The QIT
determines policy, establishes direction, provides support, and by example
demonstrates commitment to quality improvement. The composition of QIT
varies from company to company. It may consist of General Manager, the
first line reporting managers and a specialist for facilitating the operations
of the quality improvement groups and the corrective action team.

(b) Quality Circles.

Quality circles may be defined as a small group of workers (5 to 10) who do
the same or similar works, voluntarily meeting together regularly in their
normal working time, usually under the leadership of their own supervisors
to identify, analyse and solve work related problems, presenting solutions to
management and where possible, implementing the solutions themselves.
The Quality Circle is also a means of establishing a better lines of
communications between management and workers. The quality circle
concept first originated in Japan in the early 1960s, by combining the
principles of quality control and small group participation
The basic cycle of a Quality Circle goes from selection of a problem through
analysis, solution generation, presentation to management and finally
implementations by management.

Quality circle usually consists of :

1. Members
2. Leaders
3. Facilitator or Co-ordinator
4. Management

Relationship of TQM to other Quality Initiatives.

Some Definitions.
The definitions of 'Quality', 'Quality Control', and 'Quality Assurance' have
already been given. The other definitions are given below :
1. Quality Policy. The overall quality intentions and directions of an
organisation as
Regards quality as formally expressed by top management.
2. Quality Management. That aspect of the overall management
function that
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determines and implements the quality policy.

3. Quality System. The organisational structure, responsibility,
procedures,
processes and resources for implementing quality management.
4. Quality Plan. A document setting out in specific quality practices,
resources and
sequence of activities relevant to a particular product, service,
contract or
project.
4. Quality Audit. A systematic and independent examination to
determine whether
quality activities and related results comply with planned
arrangements and whether these arrangements are implemented
effectively and are suitable to achieve objectives.

STANDARDS FOR QUALITY MANAGEMENT

The standards on quality system are ISO 9000/IS : 14000.
The introductory clause of ISO 9001:2000 contains a statement that the aim
is to enhance customer satisfaction through the effective application of the
quality management system and the assurance of conformity to customer
and applicable regulatory requirements.
These standards provide a sound base for TQM. They require the
manufacturers "to establish and maintain a documented quality system as a
means of ensuring product conformance to specified requirements. The
documented quality system embraces all functional areas right from design
to after-sales service. Practised in right spirit, it will bring about total
standardisation, Compliance with ISO 9000/IS : 14000 quality system
standard provides the foundation for TQM, the four principal elements of
which are :
1. The involvement of functions other than manufacturing also in quality
activities.
2. The participation of employees at all levels.
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3. Continuous quality improvement.

4. Careful attention to customers definition of quality.
Objectives of ISO 9000 :
1.
2.
3.
4.

Reducing multiplicity of quality standards.

Facilitation of International trade.
Facilitate implementation of quality management system.
Providing one standard applicable to all countries.

Concepts behind ISO 9000 :

1. PDCA cycle.
2. Self-control.
3. Do it right first time.
4. Customer oriented strategy.
5. Co-operation-Collective wisdom.
6. Transparency and evidence.
7. Continuous improvements.
8. Quality - Everyone's responsibility.
9. Use of Statistical techniques.
10. Customer-Supplier Chains.

Relevant Standards
1. ISO 9000. Quality management and quality assurance standards.
Guidelines for
selection and use.
2.
ISO 9001. Quality System - Model for quality assurance in
design/development,
production, installation and servicing.
3.
ISO 9002. Quality Systems - Model for quality assurance in
production and
installation.
4. ISO 9003. Quality System - Model for quality assurance in fmal
inspection and
testing.
Components of TQM
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1. Quality policy and its communications.

2. Teamwork and participation.
3. Problem solving tools and techniques.
4. Standardisation.
5. Design and implementation of Quality System.
6. Quality Costs/Measurement.
7. Process Control.
8. Customer/Supplier integration.
9. Education and Training.
10. Quality and Training

TQM Model
The definition of a quality system as given by the American National Standards Institute (ANSI)/American Society for Quality Control (ASQc) Standard
A3 (1987) is as follows:
Quality System: The collective plans, activities, and events that are
provided to ensure that a product, process, or service will satisfy given
needs.
The systems approach to quality integrates the various functions and
responsibilities of the different units, and it provides a mechanism to ensure
that the goal of the organization is being met through the coordination of the
goals of the individual units.

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Figure 3 Alternative model of a process based management system

This shows the six stages of process management linked between the needs
and expectations of interested parties and their satisfaction. It is clear in this
model that process management is not simply about converting inputs into
outputs. Effective management results from:
setting goals that serve the interested parties;
developing processes to achieve these goals;
operating and maintaining the processes as designed;
measuring achievement of the process goals;
improving efficiency by finding better ways of doing things and;
improving effectiveness by validating the goals and changing them if
they
are no longer relevant to the needs and expectations of the
interested parties.
The linkage between these six stages and the clauses of ISO 9001 is shown
in table below.
PROCESS STAGE
Determine the goal

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BASE CLAUSE
5.3

Establish

organizations

BASE CLAUSE
5.1 Management responsibility

purpose
5.1 Establish Quality policy
5.4.1
Establish
objectives

Develop processes
to achieve the goal

5.3 Quality policy

Quality

4.1a Identify processes

4.1b Determine sequence and

interaction of processes

4.1c
Develop
methods

criteria

4.1d Provide information

4.1d Provide resources

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and

5.1 Management responsibility

5.2 Customer focus
7.1 Planning of product
realization
7.2.1 Determination of
requirement related to the
product
7.3.2 Design and development
inputs
5.4.2 QMS planning
7.1 Planning of product
realization
7.3.1 Design and development
planning
7.1 Planning of product
realization
7.3.1 Design and development
planning
7.4.1 Purchasing process
7.5.1 Control of production and
service provision
8.1 General
5.5.1 Responsibility and
authority
5.5.2 Management
representative
7.1 Planning of product
realization
7.4.1 Purchasing process
7.5.1 Control of production and
service provision
7.5.3 Identification and
traceability
7.5.4 Customer property
7.5.5 Preservation of product
8.1 General
8.3 Control of nonconforming
product
4.2.1 General documentation
requirements
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of records
5.1 Management commitment
5.5.3 Internal communication
7.1 Planning of product
realization
7.2.3 Customer communication
7.3.3 Design and development
outputs
7.4.2 Purchasing information
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment

7.1
Planning
realization

of

product

Operate and
maintain processes

4.1 Implement
QMS

and

maintain

4.2.2 Quality manual

4.2.3 Control of documents
5.1 Management commitment
5.4.2 Quality management
system planning
5.5.2 Management
representative
6.3 Infrastructure
7.2.3 Customer communication
7.5.1 Control of product and
service provision

Establish that goal

is being achieved

8.2.4 Monitor
product

and

measure

7.2.2 Review of requirements

related to the product
7.3.4 Design and development
review
7.3.5 Design and development
verification
7.3.6 Design and development
validation
7.4.3 Verification of purchased
product
7.5.1 Control of production and
service provision
7.6 Control of monitoring and
measuring devices
8.1 General
8.2.1 Customer satisfaction
8.2.2 Internal audit

Establish that goal

is being achieved
(continued)

8.4 Analyse product

4.1f Implement actions to

achieve planned results

Establish goal is
achieved in the best
way

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4.1e Monitor and measure

processes

8.1 General
8.5.2 Corrective action
8.5.3 Preventive action
8.3 Control of nonconforming
product
5.6 Management review
7.3.7 Control of design and
development changes
8.1 General
8.2.3 Monitoring and
measurement of processes
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action
5.6 Management review
7.5.2 Validation of processes for
production and service provision
7.6 Control of monitoring and
measuring devices
8.1 General
8.2.2 Internal audit
8.2.3
Monitoring
and
measurement of processes

4.1e Analyse processes

4.1f Continually improve
processes
Establish if its the
right goal

8.4 Analyse suitability,

adequacy and effectiveness
5.6.1
Review
system
effectiveness
4.1f Continually improve
processes

8.1 General
8.4 Analysis of data
8.1 General
8.5.1 Continual improvement
5.6.2 Review input
7.6 Control of monitoring and
measuring devices
5.6 Management review
8.5.1 Continual improvement

Establishing a quality management system

The standard requires the organization to establish a quality management
system in accordance with the requirements of ISO 900.
To establish means to set up on a permanent basis, install, or create and
therefore in establishing a management system, it has to be designed,
constructed, resourced, installed and integrated into the organization
signifying that a management system on paper is not a management
system.
As indicated above, establishing a system means designing and constructing
it, which can be referred to as system development. System design is dealt
with under identifying processes. Constructing the system covers
documentation, resourcing, installation, commissioning, qualification and
integration. Documentation is dealt with under Documenting a quality
management system.
Step on establishing quality standard:
The cycle commences with the Organizations purpose from which are
developed objectives. In planning to meet these objectives the
a) processes are identified and
b) their sequence and interaction determined.
c) Once the relationship between processes is known, the criteria and
methods for effective operation and control can be developed and
documented.
d) The processes are described in terms that enable their effective
communication and a suitable way of doing this would be compile the
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e)
f)
g)
h)

process descriptions into a quality manual that not only references

the associated procedures and records but also shows how the
processes interact.
Before implementation the processes need to be resourced and the
information necessary to operate and control them deployed and
brought under document control.
Once operational the processes need to be monitored to ensure they
are functioning as planned.
Measurements taken to verify that the processes are delivering the
required output and actions taken to achieve the planned results.
The data obtained from monitoring and measurement that is captured
on controlled records needs to be analysed and opportunities for
continual improvement identified and the agreed actions
implemented.

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System management process model

16

Identifying processes (a)

The standard requires the organization to identify the processes needed for
the quality management system and their application throughout the
organization.
Processes produce results of added value. Processes are not procedures (see
Chapter 2 on Basic Concepts).
The results needed are those that serve the organizations objectives.
Processes needed for the management system might be all the processes
needed to achieve the organizations objectives and will therefore form a
chain of processes from corporate goals to their accomplishment.
There are several ways of identifying processes but the two that we will
discuss here are the top down approach and the bottom up approach.
Top down approach
From the organizations mission statement determine the factors upon which
accomplishment of the mission depend these are the critical success
factors (CSF).
The CSFs indicate the capabilities needed and consequently identify the
processes required to delivery these capabilities. Another CSF would be the
ability of the organization to identify customer needs and expectations in its
chosen markets and consequently a need for an effective marketing process
is identified.
Bottom up approach
Take any group of tasks within a function and establish the processes to
which they contribute, keeping the focus on the external party. This approach
can commence at the functional level and grow outwards until all groups are
represented in the chain.
Documenting a quality management system (c)
The standard requires the organization to document a quality management
system in accordance with the requirements of ISO 9001.
A document (according to ISO 9000 clause 2.7.1) is information and its
supporting medium. A page of printed information, a CD ROM or a computer
file is a document, implying that recorded information is a document and
verbal information is not a document.
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Valid reasons for why documents are necessary :

To communicate requirements, intentions, instructions, methods and

results
effectively
To convert solved problems into recorded knowledge so as to avoid
having
to solve them repeatedly
To provide freedom for management and staff to maximize their
contribution
to the business
To free the business from reliance on particular individuals for its
effectiveness
To provide legitimacy and authority for the actions and decisions
needed
To make responsibility clear and to create the conditions for self-control
To provide co-ordination for inter-departmental action
To provide consistency and predictability in carrying out repetitive
tasks
To provide training and reference material for new and existing staff
To provide evidence to those concerned of your intentions and your
actions
To provide a basis for studying existing work practices and identifying
opportunities for improvement
To demonstrate after an incident the precautions which were taken or
which
should have been taken to prevent it or minimize its occurrence

ISO 9001 requires management system documentation to include 5 types of

document :
(a) Quality policy and objectives
(b) Quality manual
(c) Documented procedures
(d) Documents needed to ensure the effective planning, operation and
control
of processes
(e) Records
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Establishing quality policy :

The standard requires that top management establish the quality policy.
ISO 9000 defines a quality policy as the overall intentions and direction of an
organization related to quality as formally expressed by top management. It
also suggests that the policy be consistent with the overall policy of the
organization and provide a framework for setting quality objectives.
Furthermore ISO 9000 advises that the eight quality management principles
be used as a basis for forming the quality policy. The quality
policy can therefore be considered as the values, beliefs and rules that guide
actions, decisions and behaviors.
They are not objectives because they are not achieved they are
demonstrated by the manner in which actions and decisions are taken and
the way your organization behaves towards others.
The purpose of corporate policies is to influence the short and long-term
actions and decisions and to influence the direction in which the mission will
be fulfilled. If there were policies related to the organizations customers,
they could be fulfilled at the expense of employees, shareholders and
society. If there were policies related to profit, without other policies being
defined, profit is positioned as a boundary condition to all actions and
decisions.

Corporate terminology :
Purpose - Why we exist, why we do what we do
Mission - Where we are going the journey
Goals - Our intended destination
Vision - What we want to become
Values - What beliefs will guide our behavior
Strategy - How we are going to get there
Policy - Rules that guide our actions and decisions the signposts en route
Principles - Fundamental truth
Objectives - What we want to achieve the results
Targets - What we aim at to achieve objectives
Establishing quality objectives :
ISO 9000 defines quality objectives as results sought or aimed for related to
quality. It also suggests that these objectives be based on the quality policy
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and be specified at different levels in the organization, being quantified at

the operational level.
Preparing the quality manual (d)
The standard requires a quality manual to be established and maintained
that includes the scope of the quality management system, the documented
procedures or reference
to them and a description of the sequence and interaction of processes
included in the quality management system.
ISO 9000 defines a quality manual as a document specifying the quality
management system of an organization.
Why we need quality manual. It has several uses as :
- a means to communicate the vision, values, mission, policies and
objectives
of the organization
-a means of showing how the system has been designed
-a means of showing linkages between processes
-a means of showing who does what
-an aid to training new people
-a tool in the analysis of potential improvements
-a means of demonstrating compliance with external standards and
regulations
Its content may therefore include the following:
1 Introduction
(a) Purpose (of the manual)
(b) Scope (of the manual)
(c) Applicability (of the manual)
(d) Definitions (of terms used in the manual)
2 Business overview
(a) Nature of the business/organization its scope of activity, its
products
and services
(b) The organizations interested parties (customers, employees,
regulators,
shareholders, suppliers, owners etc.)
(c) The context diagram showing the organization relative to its
external
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environment
(d) Vision, values
(e) Mission
3 Organization
(a) Function descriptions
(b) Organization chart
(c) Locations with scope of activity
4 Business processes
(a) The system model showing the key business processes and how
they are
interconnected
(b) System performance indicators and method of measurement
(c) Business planning process description
(d) Resource management process description
(e) Marketing process description
(f) Product/service generation processes description
(g) Sales process description
(h) Order full-fill element process description
5 Function matrix (Relationship of functions to processes)
6 Location matrix (Relationship of locations to processes)
7 Requirement deployment matrices
(a) ISO 9001 compliance matrix
(b) ISO 14001 compliance matrix
(c) Regulation compliance matrices (FDA, Environment, Health, Safety,
CAA etc.)
8 Approvals (List of current product, process and system approvals)

Documented procedures:
The standard requires the management system documentation to include
documented procedures required by ISO 9001.
ISO 9000 defines a procedure as a specified way to carry out an activity or a
process.
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Procedures tell us how to proceed they are a sequence of steps to execute

a routine activity and result in an activity or a task being performed
regardless of the result.
The specific procedures required are:
(a) A documented procedure for document control
(b) A documented procedure for the control of records
(c) A documented procedure for conducting audits
(d) A documented procedure for nonconformity control
(e) A documented procedure for corrective action
(f) A documented procedure for preventive action
Clearly procedures are required so that people can execute tasks with
consistency, economy, repeatability and uniformity but there is no logical
reason why procedures are
required for only the above six subjects

Records
Records are essential in ensuring the effective operation and control of
processes because they capture factual performance from which decisions
on process performance can be made.
Records are defined in ISO 9000 as documents stating the results achieved
or providing evidence of activities performed. Records are therefore
produced during an event or immediately afterwards. Records do not arise
from contemplation.
They contain facts, the raw data as obtained from observation or
measurement and produced manually or automatically. The information may
have been received verbally, visually or as a printout from a machine

Implementing a quality management system (4.1)

Implementation therefore applies to the use and operation of the
management system following its construction and integration and is
therefore concerned with the routine operation of an already established
documented and resourced system. Effective implementation means
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adhering to the policies and practices, following what is stated, not changing
your procedures after changing your practice.
Managing the process then involves managing all the inherent characteristics
of the process in such a manner that the requirements of customers and
interested parties
are fulfilled by the process outcomes. This means:
a)
b)
c)
d)
e)
f)
g)

Managing
Managing
Managing
Managing
Managing
Managing
Managing

the
the
the
the
the
the
the

process inputs
work
physical resources
financial resources
human resources
constraints
outputs

Measuring, monitoring and analysing processes (f & g) :

Measuring processes is rather different to measuring the output of processes
this is commonly referred to as inspection or product verification.
Measuring is concerned with determination of the quantities of an entity such
as time, speed, and capability indices whereas monitoring is concerned with
continual observation aside from periodic
measurement.
In order to measure the process you need (Juran, J. M., 1995) :
1 Process objectives (what the process is designed to achieve) e.g. a sales
process may be designed to convert customer enquiries into sales orders
and
accurately convey customer requirements into the product/service
generation
process
2 Indicators of performance (the units of measure) e.g. for a sales
process
measures may be:
_ The ratio of confirmed orders to enquiries
_ The ratio of customer complaints relative or order accuracy to total
orders
completed
_ The ratio of orders lost due to price relative to total order won. Similar
indicators could be applied for quality and delivery
There may be other indicators related to the behavior of sales staff in
23

dealing with customers and internal functions such as whether the sales
promise matched the true capability of the organization etc.
3 Defined performance standard (the level above or below which
performance
is deemed to be sub standard or inferior)
4 Sensors to detect variance before, during or after operations. There
may be
human or physical sensors each of which has an element of measurement
uncertainty
5 Calibrated sensors so that you can be assured the results are accurate
and
precise. There are two types of measurements to be made:
_ Measurements that tell us whether the process is operating as intended
_ Measurements that tell us whether the process is effective

Procedure Design
24

7.1 Some Procedures Are Mandatory Documents

Par. 4.2.1(c) of the Standard leaves no doubt that there are certain
documented procedures that are clearly required
as part of the QMS. However, only six are stipulated:
1. Control of documents (Par. 4.2.3);
2. Control of records (Par. 4.2.4);
3. Internal audit (Par. 8.2.2);
4. Control of nonconforming product (Par. 8.3);
5. Corrective action (Par. 8.5.2);
6. Preventive action (Par. 8.5.3).
Summary of Global Mandatory Requirements As a memory jogger and
very handy check-off list, the following global
documentation has been shown to be mandatory (although there are
requirements that are partially discretionary):
A QMS;
A quality manual (tier I);
Documented quality policy (tier I);
Documented quality objectives (tier I);
Identification of processes (tier I);
Sequence and interaction of the processes (tier I);
Management reviews (tier I);
Process plans (tier II);
Monitoring, measuring, analysis, and improvement plans (tier II);
Six documented procedures (tier II);
Work instructions as applicable (tier III);
Other documents needed to ensure the effective planning, operation, and
control of its processes (all
tiers);
Records as required (exist at all tier levels)to indicate objective evidence of
effective operation;
This document was created by an unregistered ChmMagic, please go to
http://www.bisenter.com to register it. Thanks.
Documents that describe product characteristics (tier III);
Method of linkage between tiers;
Declaration of the ISO management representative;
Description of the organization to be certified;
Specific description of responsibility and authority of at least the top
management;
Inter and intra organizational interfaces;
Demonstration of the effective implementation of the system;
The use of sensible levels of documentation;
The effective management of customer complaints;
Declaration of factored items (if applicable);
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Master list of current Standards and codes.

Reference :
1) Hoyle, David, Quality Systems Handbook ISO 9000, 4th Edition,
Butterworth Heinemann
2) Amitava Mitra, Fundamentals of Quality Control and Improvement,
Macmillan Publishing Company, New York.

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