Chapter 10: Quality Management System

TOTAL QUALITY MANAGEMENT

BYDR. ASIF MAHMOOD

Institute of Business & ManagementUniversity of Engineering and Technology, Lahore

drasif@uet.edu.pk

MANAGEMENT SYSTEM

Management system means what the organization does to manage its processes, or activities in order that its products or services meet the organization's objectives

E.g. satisfying the customer's quality requirements, complying to regulations, meeting environmental objectives, etc.The ISO 9001 and ISO 14001 management system standards now make these successful practices available for all organizations.

QUALITY MANAGEMENT SYSTEM

It is the organizational structure, responsibilities, procedures and

resources for ensuring the quality of a product or service

STANDARD

“An agreement developed by several parties with the intent that all parties

comply”

Encapsulation of best practice- avoids repetition of past mistakes.

They are a framework for quality assurance processes - they involve checking compliance to standards.

They provide continuity - new staff can understand the organisation by understanding the standards that are used.

De jure Vs de facto Wars of Standards (DC/AC, Betamax/VHS, Blue

ray Disc/HD DVD)

SIGNIFICANCE OF STANDARDS

ISO Standards

WHAT IS ISO?

International Organization for Standardization

ISO—HISTORY

1906 - International Electro-technical Commission

1926 - International Federation of the National Standardizing Associations (ISA)

1946 London - delegates from 25 countries decided to create a new international organization "the object of which would be to facilitate the international coordination and unification of industrial standards

1947 - ISO began to officially function 1951 - The first ISO standard was published

"Standard reference temperature for industrial length measurement".

ISO ORGANIZATION

GeneralAssembly

TechnicalManagement Board

Technical AdvisoryGroups

Technical Committees

PolicyDevelopmentCommittees

Technical CommitteesTechnical CommitteesTechnical Committees

Council

ISO KEY FACTS ISO = International Organization for Standardization

� Based in Geneva, Switzerland� Made up of over 100 National Standards Bodies (“NSB’s”)� Almost 20,000 standards in the ISO portfolio� All standards are based on INTERNATIONAL CONSENSUS

ISO standards are usually developed by its Technical Committees (“TC’s”) and Sub-committees (“SC’s”)� ISO/TC176/SC2 (Quality Systems) is responsible for ISO 9001

ISO 9001:2015 is being developed by a specific SC2 Working Group (“WG24”)� WG24 is composed of international experts nominated by their

NSB or from formal liaison member to ISO (typically industry associations)

� WG23 is responsible for Communications and Product Support

ISO9000

A set of standards governing documentation of a quality program.

ISO14000

A set of international standards for assessing a company’s environmental performance.

ISO MOST POPULAR STANDARDS SERIES

ISO 9001 and ISO 14001 are among ISO's most well known standards ever

They are implemented by more than a million organizations in some 175 countries

ISO 9001 and ISO 14001 are generic standards Generic means that the same standards can be

applied: to any organization, large or small, whatever its

product or service, in any sector of activity, and whether it is a

business enterprise, a public administration, or a government department.

ISO MOST POPULAR STANDARDS SERIES

PROCESSES, NOT PRODUCTS

Both ISO 9001 and ISO 14001 concern the way an organization goes about its work.

They are not product standards. They are not service standards. They are process standards. They can be used by product

manufacturers and service providers.

PROCESSES, NOT PRODUCTS (CONT.)

Processes affect final products or services. ISO 9001 gives the requirements for what

the organization must do to manage processes affecting quality of its products and services.

ISO 14001 gives the requirements for what the organization must do to manage processes affecting the impact of its activities on the environment.

ISO9000

A set of standards governing documentation of a quality program.

QUALITY MANAGEMENT PRINCIPLES

The revised ISO 9000:2000 series of standards are based on 8 Quality Management principles.

The Principles are derived from collective experiences of the ISO/TC/176 members.

The eight quality management principles are defined in both the: - ISO 9000:2000:- (QMS Fundamentals and vocabulary) and ISO 9004:2000:- (QMS:-Guidelines for performance improvement) standards

ISO 9000 AND QUALITY MANAGEMENT (QM)

ISO standards based on the following QM principles:

1. Customer focus 2. Leadership 3. Involvement of people 4. Process approach 5. System approach to management 6. Continual improvement 7. Factual approach to decision making 8. Mutually beneficial supplier relationships

What QS/ISO 9000 Means To You

You MUST: Know Your Job Duties Know What Training Your Job Requires Be Able To Tell About How You Were Trained Know What Documentation Involves YOU! Know How To Find Out What The “Latest”

Version Is Know What The Documentation Says Know How The Documentation Applies To You! Know What The INTENT of the Documentation

Real Life

WHY IS ISO 9000 IMPORTANT? European Union directive

ISO 9000 certification required by suppliers of “Regulated Products” health, safety, and the environment

EC (European Committee) has strict corporate liability legislation protecting consumers

Globalization impact

ISO 9000 SERIES

There are 5 Standards in the basic ISO 9000 series: conformance models or guides.A conformance model is a Standard to

which the organisation must conform in order to be certified.

A guide is a set of recommendations concerning the establishment of an effective quality system in order to be certified in one of the conformance models.

ISO 9000

Guides·ISO 9000·ISO 9004

Conformance Models

·ISO 9001·ISO 9002·ISO 9003

ISO 9000 SERIES

GUIDES· ISO 9000

Guidelines for selection and use of the standards on quality management, quality system elements, and quality assurance.

· ISO 9004 Guidelines for sustained quality management

and quality system elements.

CONFORMANCE MODELS· ISO 9001

Quality assurance in design/development (customization), production, installation, and servicing was for companies and organizations whose activities included the creation of new products.

· ISO 9002 Quality assurance in production, installation, and

servicing without covering the creation of new products.

· ISO 9003 Quality assurance in final inspection and test

covering only the final inspection of finished product, with no concern for how the product was produced.

EVOLUTION OF QUALITY MANAGEMENT SYSTEM – ISO 9001:2008

1987 First Published – ISO 9001, 9002 & 9003

1994 First revision – ISO 9001, 9002 & 9003

2000 Second revision - ISO 9001 (9001, 9002 and 9003 were merged into 9001)

2008 Third revision – ISO 9001

ISO 9001:2008 It is the only standard in the series of the ISO

9000 that specifies the requirements of a quality management

system can be used for certification

ISO 9001:2008 did not introduce additional requirements, and nor did it change the intent of the ISO 9001:2000 standard.

ISO 9001:2008 was developed in order to: Introduce clarifications to the existing requirements

of ISO 9001:2000 and Introduce changes that are intended to improve

compatibility with ISO 14001:2004, Environmental Management Systems.

ISO 9001:2015 A change is coming…

Decrease the emphasis on Documentation

Increase the emphasis on Achieving Value for the Organization and its customers

Increase emphasis on Risk Management to achieve objectives

Reasons For The Changes

DOCUMENTING PROCEDURES

DOCUMENTING PROCEDURES

Say what you do

Do what you sayAnd where necessary

Show what you did

CERTIFICATION

CERTIFICATION AND REGISTRATION Certification is known in some countries as

registration. It means that an independent, external body

has audited an organization's management system and verified that it conforms to the requirements specified in the standard (ISO 9001 or ISO 14001).

Some customers require suppliers to be ISO 9000 certified although the need for flexibility here is increasingly recognised.

ISO does not carry out certification and does not issue or approve certificates.

ISO develops standards and guides to encourage good practice in accreditation and certification.

CERTIFICATION NOT A REQUIREMENT

Certification is not a requirement of ISO 9001 or ISO 14001.

The organization can implement and benefit from an ISO 9001 or ISO 14001 system without having it certified.

The organization can implement them for the internal benefits without spending money on a certification program.

WHAT IS CERTIFIED?

Your quality system must conform to the standard from ISO 9000 Standard series that your organisation selects.

It is the quality system that becomes certified (registered) during the certification process.

ISO 9000 REGISTRATION PROCESS

When an organization feels that its quality system is good enough, it may ask an accredited registrar or other third party audit team for pre-assessment.

The final audit begins with a review of the

company's quality manual, which the accredited registrar or third party audit team typically uses as its guide. The audit team checks if the documented quality system meets the requirement of ISO 9000.

When the registrar is satisfied with the favorable recommendation of the audit team, it grants registration and issues a registration document to the company.

QUALITY SYSTEM AUDIT

An investigation of the intent and the implementation of selected aspects of the quality system of an organization.

QUALITY AUDITING

Quality certificates are issued after conducting quality auditing in a systematic manner.

Auditing procedure is aimed at checking if the practices followed conforms with the quality manual or not.

Types of Quality AuditQuality auditing is done both by internal and

external bodies.Based on the type of auditor, it is classified as:

First party audit Second party audit Third party audit

First Party Audito Conducted by the organization on its own systemo Conducted by its own personnelo Identifies non-conformities in the systemo Suggests corrective actionso Effectiveness of quality management system is

ascertained.Second Party Audito Conducted by purchaser on the supplier of goodso Conducted to assess the suppliers’ ability to provide

quality goods or serviceso It is not a comprehensive audit, as the purchaser will be

only interested in areas of his purchase not on the company as a whole

o By this the purchaser comes to know about the weak areas of his supplier

o This will be helpful in framing surveillance audit procedure

Third party audit

o Conducted by person(s)/ agency who are neither suppliers nor purchasers and who are totally independent and have no vested interest in the outcome of the audit

o Usually conducted by the certifying agency or a statutory body

o Quality certificate can be issued only after third party audit is done

o It assures customers of the compliances of the quality requirements

ACCREDITATION

Accreditation is like certification of the certification body.

It means the formal approval by a specialized body - an accreditation body - that a certification body is competent to carry out ISO 9001:2008 or ISO 14001:2004 certification in specified business sectors.

Certificates issued by accredited certification bodies - and known as accredited certificates - may be perceived on the market as having increased credibility.

ISO does not accredit, approve or control the certification bodies.