Quality Management System

1

International Organisation for Standardization (ISO)
defined the term quality system as follows:

"The quality system is the organisational structure,

responsibilities, procedures, processes and resources
for implementing quality management."

2

QMS involves:
(i) How-methods and process description;
(ii) Who- responsibilities and authorities;
(iii) When-records and evidence; and
(iv) Where-identification and traceability.

The QMS typically applies to and interacts with all activities,
pertinent to the quality of product/service. It involves all phases
from initial identification to final satisfaction of requirements and
customer expectations.

3
Need for ISO 9000 and Other Quality Systems

Every organisation is concerned with the quality of its product or service.
To assure the quality one has to ensure the quality. To ensure the
quality it is necessary to make quality assurance system. Sound quality
assurance system requires well defined quality system standards.



Quality and standardisation are the two essential pre-requisites for an
organisation to market its products and services in the competitive
business environment. Thus quality begins with standards. Also the ever
increasing pressure to provide better quality of products/services led to
the development of quality standards.

4
 Objectives of ISO 9000 Quality System
The five objectives of ISO 9000* quality system are given below.

1. To achieve, maintain and seek to continuously improve product/service

quality in relationship to requirements.
2. To improve the quality of operations to continually meet customers' and
stakeholders' stated and implied needs.
3. To provide confidence to internal management and other employees that
quality requirements are being fulfilled and that improvement is taking place.
4. To provide confidence to customers and other stakeholders that quality
requirements are being achieved in the desired product.
5. To provide confidence that quality system requirements are fulfilled.

5
 Benefits of ISO 9000 Certification

Organizations go for ISO 9000 certification because of the benefits listed below.


It forms a solid foundation for improvement, consistency, and profitability.

It provides good platform for continuous quality improvement.

It provides a status symbol for the organization and acts as powerful marketing tool.

It increases the potential market share.

It improves employees' morale and ensures their total involvement.

It establishes a firm base for management of growth, change and continuing
improvement.

It increases awareness of employees in company requirements and activities.

6

It ensures customer satisfaction.

It generates customer confidence through world-class
products/services.

It ensures confidence with all stakeholders in the organization including
suppliers, investors, shareholders, etc.

It fulfills the mandatory requirements of entry as a supplier to export
market and many domestic organizations.

It improves documentation, operating standards, and housekeeping.

It improves the perception of product quality.

It helps in reducing the wastage and reduction in the cost of production.

7
 ISO 9000 Family of Standards
1. ISO 9000:2015 Standard

Title

Quality Management Systems: Fundamentals and Vocabulary
(definitions)
Scope

Provides information about the concepts and vocabulary used in the
other two standards.

This standard serves as a reference to support the interpretation of
requirements.

8
 2. ISO 9001:2015 Standard
Title

Quality Management Systems: Requirements

Scope

Provides the requirements that organisation must meet in order to
achieve
certification.

ISO 9001 is the only standard within the ISO 9000 family that
may be used for registration or certification.

9
 3.ISO 9001:2018 Standard

Title

Quality Management - Quality of an Organization-Guidance to
Achieve Sustained Success .
(continuous improvement)
Scope

Provides guidelines for enhancing an organization's ability to
achieve sustained success.

Establishes a quality management that not only meets customer
requirements but also focuses on improving performance.

10
 Implementation of Quality System (Steps to
Registration)
Step 1: Top Management Commitment

The most important step in implementing a quality stem
is to get the full support of upper management.


The top management must be willing to commit the
resources necessary to achieve certification.

11
Step 2: Appoint the Management Representative

The next step is the appointment of a management
representative. The representative can be a member of
the top management group.

The management representative is responsible for
coordinating the implementation and maintenance of the
quality system. Also he is the contact person for all
parties involved in the process, both internal and
external.

12
Step 3: Awareness

The next step is to create awareness about the ISO 9000 QMS.

Since the implementation of the quality system requires involvement of
all members in the organisation, the members should understand the
process and implications of ISO program.
Step 4: Appoint an Implementation Team

Now the implementation team should be formed.

This team should be drawn from all levels and areas of the organisation.

The team should identify the QMS processes and their sequence and
interaction.

13
Step 5: Training

The implementation team, supervisors, and internal audit team
should be trained.

This activity can be accomplished through in-house training
programs, seminars, workshops, etc.
Step 6: Time Schedule

This activity develops a time schedule for the implementation and
registration of the system.

This time frame will vary, depending on the size and type of
organisation.

14
Step 7: Select Element Owners

The implementation team selects owners for each of the system elements.

Many of these owners will be members of the implementation team.

Each owner has the option of selecting a team to assist in the process.
Step 8: Review the Present System

A review of the present quality system should be performed.

Copies of all the quality manuals, procedures, work instructions, and form
spresently in use are obtained.

This activity is a gap analysis and can be performed by the element owners
and their teams or by an external consultant.

15
Step 9: Write the Documents

Written quality policy and procedure manuals should be
prepared.

This documentation of work instructions should be done by
the employee who performs the job.
Step 10: Install the New System

The policies, procedures, and work instructions should be
integrated into the day-to-day workings of the organisation.

16
Step 11: Internal Audit

An internal audit of the quality system should be conducted.

This step ensures that the system is working effectively and to
provide management with information for the comprehensive
management review.

This activity can be accomplished through in-house training
programs, seminars, workshops, etc.
Step 12: Management Review

The management review should be conducted in order to determine
the effectiveness of the system in achieving the stated quality goals.

17
Step 13: Preassessment

The preassessment is an optional step. If a good job has been done on the previous steps,
then preassessment is not necessary.
Step 14: Registration

The registration activity includes: choosing a registrar, submitting an application, and conducting
the registrar's system audit.

While choosing a registrar, one should consider so many factors such as cost, lead time,
customer's acceptance of the registrar, the registrar's accreditation, and familiarity with the
industry.

The application for registration should also include supplying the registrar with the policy and
procedure manuals for their review.

The time involved in the registrar's system audit will vary depending on the size and complexity
of the organisation and the number of auditors involved.

18
Step 15: Award of ISO 9000 Certificate

After accepting the application and setting a time frame for registration, the registrar will
review
the quality system documentation.

Based on the satisfactory report of the assessment team, licence i.e., ISO certificate will
be
granted to the organisation by ISO/BIS to use the certification mark in letter heads, quality
certificates, etc.

The certificate awarded is normally valid for 3 years.- During the period of validity,
surveillance audits are conducted to ensure that the document quality system is being
effectively maintained.

The surveillance audits will not be full audits but random checks of some elements to
ensure that the system continues to function.

19