Basic advices and recommendations

Section 1: Introduction to Quality Management

1 INTRODUCTION TO QUALITY MANAGEMENT

This section will introduce you to the basic concepts and definitions in Quality Management. The
scope and contents of the Standards from the ISO 9000 series are summarized.

We encourage you to read carefully all the concepts and definitions. Try to identify how these
concepts or actions apply to the specifics of your work. Some examples are given for illustration.

What is relevant at this stage is to provide you with a general picture about Quality Management,
and to make you realize what you are still missing in your practice. The following section will
guide you to identify simple actions aimed to ensure the quality of your work, whilst Section 3
will provide guidance to implement a system fitting to the purposes of Electronics practice.

1.1 THE GOAL OF QUALITY MANAGEMENT

To lead and operate an organization successfully, it is necessary to direct and control it in a
systematic and transparent manner.

Success can result from implementing and maintaining a management system that is designed to
continually improve performance while addressing the needs of all interested parties (customer
and supplier).

MANAGING AN ORGANIZATION ENCOMPASSES QUALITY MANAGEMENT (QM) AMONGST OTHER

MANAGEMENT DISCIPLINES.

1.2 THE EARLIEST DEFINITION OF QUALITY

"How GOOD it is..." (Stone Age man, ≥ 10 500 years BP)

Since then, and despite the evolution of the language, there were always misunderstandings and
conflicts of interests. The need for an agreement in the definition of quality grew and grew...

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Section 1: Introduction to Quality Management

1.3 THE DEFINITION OF QUALITY AS CONSENSUALLY AGREED BY 2005 (ISO

9000)
"The degree to which a set of inherent characteristics fulfils requirements"

• Quality can be used with adjectives such as poor, good, excellent...

• 'Inherent ', as opposed to 'assigned ', means existing in something, especially as a

permanent characteristic...

• 'Requirement ': A need or expectation that is stated , generally implied or

obligatory
• Stated means usually explicitly in a document.
• Generally implied means that it is custom or common practice for the organization,
its customers and other interested parties.
• Requirement is the expression in the content of a document conveying criteria to be
fulfilled if compliance with the document is to be claimed and from which no deviation is
permitted.

1.4 ISO 9000:2005. LOOKING FOR A CONSENSUS

ISO 9000 standard series was developed to assist organizations, of all types and sizes, to
implement and operate effective quality management systems.

ISO 9000:2005 DEFINES GENERAL, FUNDAMENTAL ISSUES.

1.5 ISO 9000:2005 CONTENTS

• Fundamentals:
• Rationale
• Requirements for QMS
• Requirements for products
• QMS approach
• Process approach
• Quality policy and quality objectives
• Role of top management
• Documentation
• Evaluation of QMS
• Continual improvement
• Role of statistical techniques
• Terms and definitions

1.6 THE EIGHT QM KEY PRINCIPLES

• Customer focus
• Leadership
• People involvement
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationships

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1.6.1 QM KEY PRINCIPLES: CUSTOMER FOCUS

Organizations depend on their customers and therefore should understand current and
future customer needs, should meet customer requirements and strive to exceed customer
expectations.

THE CUSTOMER IS ALWAYS RIGHT!

1.6.2 QM KEY PRINCIPLES: LEADERSHIP

Leaders establish unity of purpose and direction of the organization.

• Leaders should create and maintain the internal environment in such a way that people
can become fully involved and committed in achieving the organization's objectives.

TO BECOME A REAL LEADER, NOT JUST THE BOSS!

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1.6.3 QM KEY PRINCIPLES: PEOPLE INVOLVEMENT

People at all levels are the essence of an organization and their full involvement enables
their abilities to be used for the organization's benefit.

IT’S EVERYBODY’S BUSINESS. UNITY MAKES STRENGTH.

1.6.4 QM KEY PRINCIPLES: PROCESS APPROACH

A desired result is achieved more efficiently when activities and related resources are
managed as a process.

PROCESS APPROACH IS BASED IN THE PDCA PRINCIPLE: PLAN DO CHECK ACT

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1.6.5 QM KEY PRINCIPLES: SYSTEM APPROACH TO MANAGEMENT

Identifying, understanding and managing interrelated processes as a system contributes to
the organization's effectiveness and efficiency in achieving its objectives.

1.6.6 QM KEY PRINCIPLES: CONTINUAL IMPROVEMENT

Continual improvement of the organization's overall performance should be a permanent
objective.

WE ARE GOOD... BUT WE CAN BE EVEN BETTER!

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1.6.7 QM KEY PRINCIPLES: FACTUAL APPROACH TO DECISION MAKING

Effective decisions are based on the analysis of data and information.

WE BELIEVE IN PEOPLE... BUT MUCH MORE IN THE FACTS.

1.6.8 QM KEY PRINCIPLES: MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS

An organization and its suppliers are interdependent and a mutually beneficial
relationship enhances the ability of both to create value.

ONE HAND WASHES THE OTHER... AND BOTH WASH THE BODY!

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1.7 KEY ELEMENTS IN QUALITY MANAGEMENT

1.8 QUALITY MANAGEMENT CONNOTATIONS

• Ethic value (performing at own best effort!).
• Documented procedures and records help to ensure traceability and dependability.
• Mutually beneficial outcome for supplier and customers.
• Customer satisfaction increases.
• Supplier organization efficiency, competence and capabilities enhance continuously.

1.9 OTHER RELEVANT QUALITY STANDARDS FROM THE ISO 9000 SERIES:
ISO 9001:2000. Quality Management Systems – Requirements.

ISO/IEC 17025:2005. General requirements for the competence of testing &

calibration laboratories.

1.9.1 INTRODUCTION TO THE ISO 9001:2000

ISO 9001:2000 Quality Management Systems – Requirements

This Standard specifies the requirements for a QMS where an organization needs to
demonstrate its ability to consistently provide product that meets customer and regulatory
requirements, and aims to enhance customer satisfaction through the effective application of

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the QMS, including processes for continual improvement and the assurance of conformity to
customer and applicable regulatory requirements.

CONFORMITY TO THIS STANDARD DOES NOT ITSELF DEMONSTRATE THE COMPETENCE OF THE
LABORATORY TO PRODUCE TECHNICALLY VALID DATA AND RESULTS IN TESTS OR
CALIBRATIONS.

1.9.2 INTRODUCTION TO THE ISO/IEC 17025:2005

ISO/IEC 17025:2005 General requirements for the competence of testing &

calibration laboratories

This Standard specifies the requirements for the competence to carry out tests and
calibrations (including sampling). It covers the use of standard, non-standard and laboratory
developed methods. The standard is meant to be used in developing the laboratory QMS, the
administrative and technical operations.

COMPLIANCE TO THIS STANDARD IMPLIES OPERATION IN ACCORDANCE WITH ISO 9001.

CONFORMITY TO THIS STANDARD DOES NOT IMPLY CONFORMITY OF THE LABORATORY QMS
TO ALL THE REQUIREMENTS OF ISO 9001.

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