Quality Management system Total Quality Management

Quality Management System

1. Benefits of ISO (International Organization for Standardization)
Registration

There are various reasons for implementing a quality system that conforms to an ISO standard.

• The primary reason is that customers or marketing are suggesting or demanding

compliance to a quality system.

• Other reasons are needed improvement in processes or systems and a desire for global
deployment of products and services

• A study of manufacturing firms was undertaken to determine if there was any

improvement in performance after registration. Significant improvement was noted in:

– Internal quality as measured by the percent of scrap, rework, and

nonconformities at final inspection.

– Production reliability as measured by the number of breakdowns per month,

percent of time dedicated to emergencies, and percent of downtime per shift.

– External quality as measured by product accepted by customers without

inspection, claims of nonconforming product, and returned product.

– Time performance as measured by time to market, on-time delivery, and

throughput time.

2. ISO 9000 Series of Standards

The ISO 9000 Series of Standards is generic in scope. By design, the series can be tailored to fit
any organization’s needs, whether it is large or small, a manufacturer or a service organization.

The three standards of the series are:

– ISO 9000:2005—Quality Management Systems (QMS)—fundamentals and

vocabulary: discusses the fundamental concepts related to the QMS and provides
the terminology used in the other two standards.

Notes Compiled By: Engr. Abdul Rahim Khan (Assistant Professor CET, UOS)
Quality Management system Total Quality Management

– ISO 9001:2008—Quality Management Systems (QMS)—requirements: specifies

requirements for a quality management system where an organization. needs to
demonstrate its ability to consistently provide product that meets customer and
applicable statutory and regulatory requirements

– ISO 9004:2000—Quality Management Systems (QMS)—guidelines for

performance improvement: provides guidelines that an organization can use to
establish a QMS focused on improving performance.

It is applicable to the following:

a) Organizations seeking advantage through the implementation of a quality management
system;

b) Organizations seeking confidence from their suppliers that their product requirements will be
satisfied;
c) Users of the products;

d) Those internal or external to the organization who give advice or training on the quality
management system appropriate to that organization;
e) Developers of related standards.

3. Sector-Specific Standards

The ISO 9000 system is designed as a simple system that could be used by any industry. Other
systems have been developed that are specific to a particular industry. One of the problems with
sector-specific standards is the need for suppliers with customers in different industries to set up
quality systems to meet each sector’s requirements.

• AS9100: This aerospace industry quality system was officially released by the Society of
Automotive Engineers in May 1997. In March 2001, the International Aerospace Quality
Group (IAQG) aligned AS9100 with ISO 9001:2000. Industry-specific interpretations
and methodologies are identified in italics and bold type. These additions are accepted
aerospace approaches to quality practices and general requirements.

• ISO/TS 16949: It harmonizes the supplier quality requirements of the U.S. big three as
provided in QS 9000 Third Edition6 with the French, German and Italian automakers.
The goal is the development of fundamental quality systems that provide for continuous

Notes Compiled By: Engr. Abdul Rahim Khan (Assistant Professor CET, UOS)
Quality Management system Total Quality Management

improvement, emphasizing defect prevention, and the reduction of variation and waste in
the supply chain.

• TL 9000: It is a specific set of requirements based on ISO 9001 that defines the design,
development, production, delivery, installation and maintenance of telecommunications
products and services.

4. ISO 9001 Requirements

• The standard has eight clauses:

1. Scope,
2. Normative References,
3. Definitions,
4. Quality Management Systems,
5. Management Responsibility,
6. Resource Management,
7. Product and/or Service Realization, and Measurement,
8. Analysis, and Improvement

• The first three clauses are for information while the last five are requirements that an
organization must meet.

ISO 9001 Requirements

• Scope: The requirements of the standard are intended to be applicable to all types and
sizes of organizations. Requirements in Clause 7, Product Realization, that are not
appropriate to the organization, can be excluded.

• Quality Management System (QMS): The organization shall establish, document,

implement, and maintain a QMS and continually improve its effectiveness.

• Management Responsibility: There are several aspects of management responsibility

– Management commitment

– Customer Focus

Notes Compiled By: Engr. Abdul Rahim Khan (Assistant Professor CET, UOS)
Quality Management system Total Quality Management

– Quality Policy

– Planning

– Responsibility, authority and commitment

• Resource management: The organization shall determine and provide the resources
needed (a) to implement and maintain the QMS and continually improve its
effectiveness, and (b) to enhance customer satisfaction by meeting customer
requirements. Resources include human resource, infrastructure and work environment

• Product Realization:

– Planning: The organization shall plan and develop the processes needed for
product realization.

– Customer related processes: Organization shall determine requirements

specified by customer

– Design and development: It shall plan and control design and development of
product

– Purchasing: The organization shall ensure that purchased product conforms to

specified purchase requirements

– Production and service provision: It shall plan and carry out production and
service provision under controlled conditions.

– Control of Monitoring and measuring equipment: It shall determine the

monitoring and measurement to be undertaken and the monitoring and measuring
equipment needed to provide evidence of conformity of product to determined
requirements

• Measurement, Analysis, and Improvement: The organization shall plan and implement
the monitoring, measurement, analysis, and improvement processes needed for its
business. Some important aspects are:

– Monitoring and measurement

Notes Compiled By: Engr. Abdul Rahim Khan (Assistant Professor CET, UOS)
Quality Management system Total Quality Management

– Control of non-conforming product

– Analysis of data

– Improvement

• Implementation: There are a number of steps that are necessary to implement a quality
management system:

– Top Management Commitment

– Appoint the Management Representative

– Awareness

– Appoint an Implementation Team

– Training

– Time Schedule

– Select Element Owners

– Review the Present System

– Write the Documents

– Install the New System

– Internal Audit

– Management Review

– Pre-assessment

– Registration

5. Registration

Quality system registration is the assessment and audit of a quality system by a third party,
known as a registrar. There are two parts:

Notes Compiled By: Engr. Abdul Rahim Khan (Assistant Professor CET, UOS)
Quality Management system Total Quality Management

• Selecting a registrar: In the United States, Registrar Accreditation Board (RAB)

maintains a list of approved registrars. In India, Quality Council of India (QCI),
carries out assessment of certification bodies. This is done under the National
Accreditation Board for Certification Bodies (NABCB) scheme. In Pakistan
ISOQAR is a uniquely independent third party certification body operating from a
global network of offices in many countries providing registration and training
services across a diverse range of industrial and commercial sectors.

• ISOQAR provides service to a variety of industrial and commercial sectors

including food, pharmaceutical, chemical, textile, automotive, tourism,
construction, industrial, medical and so on…

• Registration process: It has six basic steps: application for registration,

document review, pre-assessment, assessment, registration, and follow-up
surveillance.

Registrars require a completed application to begin the registration process

For Construction Industry

Certification to ISO 9001

This certificate is provided for companies who carry out design activities as the major business
operation. These companies carry out the design, development, production, installation and the
final servicing.

Certification to ISO 9002

These are provided for the companies that does not carry out design activities. This includes
production and installation.

There are twenty different areas a company have to focus and pass in order to get certified as a
ISO 9001 certified company.

Notes Compiled By: Engr. Abdul Rahim Khan (Assistant Professor CET, UOS)
Quality Management system Total Quality Management

Need for Certification to ISO for Construction Industry

To get a construction industry ISO certified, the following 20 requirements determined by the
standard must satisfied:

1. Management Responsibility

2. Quality System

3. Review of Contracts

4. Control of Design

5. Control of Documents

6. Purchasing

7. Purchaser Supplied Product

8. Identification of Product and the traceability

9. Process Control

10. Inspection and the testing

11. Inspection, measurement and equipment testing

12. Status of Inspection and the test

13. Control of products that are non-conforming

14. Corrective action

15. Handling, storing, packaging and the delivery

16. Quality records

17. Internal quality system auditing

18. Training

19. Servicing

20. Statistical Techniques

Notes Compiled By: Engr. Abdul Rahim Khan (Assistant Professor CET, UOS)
Quality Management system Total Quality Management

Notes Compiled By: Engr. Abdul Rahim Khan (Assistant Professor CET, UOS)
Quality Management system Total Quality Management

Notes Compiled By: Engr. Abdul Rahim Khan (Assistant Professor CET, UOS)