CHAPTER 8:

ISO 9000
SERIES
QUALITY SYSTEM
A quality system is the organisational structure,
responsibilities, procedures, processes, and resources
needed to implement quality management. It should only be
as comprehensive as needed to meet quality objectives.
THE NEEDS FOR A QUALITY
SYSTEM
A fully documented QMS (Quality Management Systems) will
ensure that two important requirements are met:
• The customers’ requirements – confidence in the ability of the
organisation to deliver the desired product and service
consistently meeting their needs and expectations.
• The organisation’s requirements – both internally and externally,
and at an optimum cost with efficient use of the available
resources – materials, human, technology and information.
These requirements can only be truly met if objective evidence is
provided, in the form of information and
data, to support the system activities, from the ultimate supplier to the
ultimate customer.
THE NEEDS FOR A QUALITY
SYSTEM
A quality system can :

• identify problem areas and rectify them quickly

• track customer feedback
• improve performance of staff
• develop or provide better quality products and services
• increase sales and profits
• define an appropriate supplier
• protect business
• standardize processes and procedures
• gain recognition from external bodies
• define roles and responsibilities of management and employees- reduce
overhead costs
WHAT IS CERTIFIED?
• Quality system must conform to the ISO 9000 Standard that
an organisation selects.
• It is the quality system that becomes certified (registered)
during the certification process.
TERMS

• Product: The material or service provided.

• Applies in the Standard to
· Incoming material/service
· In-process product/service
· Finished product/service
• Supplier: Your organisation
• Subcontractor: Your supplier
• Customer: The organisation that receives your roduct/service.
SELECTING A CONFORMANCE
MODEL

If your organisation … Then consider …

Has significant product/service design activities, 9001

Manufactures products or services according to approved 9002

design or customer specifications.
(This may be the case of companies without significant
new product/design activities.)

Has a product/service where the quality of this 9003

product/service is solely dependent on final inspection
and testing.
(This may be the case of distributors of certain products.)
QUALITY AUDITS

An audit is an evaluation of your quality system and

documentation.
Your organisation may undergo several types of audits:

• First-party audits
• Second-party audits
• Third-party audits
THIRD-PARTY AUDITS
The third-party audit is a quality system audit performed by
an auditor on the supplier in order to achieve certification for
one of the ISO 9000 Standards. The third-party auditor must
be independent of both the customer and the supplier.
Third-party audits cannot be performed by the customer or
the supplier.
WHAT IS LOOKED FOR?

Do your documents conform to the requirements of the

Standard?
Do your operations conform to the documents?
Do your records show past conformance to your
documents?
9 STAGES TO
CERTIFICATION
• Strategic planning
• Gap analysis
• Corrective action
• Documentation and records
• Implementation
• Pre-certification audit
• Registrar documentation review
• Site preparation
• Certification audit
1. STRATEGIC PLANNING

Management:
· Displays strong commitment to the certification effort
· Selects a registrar
· Selects a conformance model for which organisation may
seek certification
· Forms a project team
· Establishes a timeline
· Assesses training needs regarding ISO 9000 and
organisational background.
2. GAP ANALYSIS
Corrective action teams:
· Evaluate the existing quality system against the selected
conformance model
· Evaluate the documentation against the quality system and
the selected conformance model.
3. CORRECTIVE ACTION

Corrective action teams institute changes in quality system

as identified in stage 2.
4.DOCUMENTATION AND RECORDS

Corrective action teams:

· Implement a document structure and control system
· Institute a control of quality records process
· Revise documents as necessary
· Provide training about changes, additions, and other topics as
identified in stage 1.
5. IMPLEMENTATION

Management:
· Implements and monitors all changes in the quality system
· Ensures all gaps identified in stage 2 are closed
· Maintains records of all changes.
6. PRE-CERTIFICATION AUDIT

Pre-assessment auditor ensures that all operations and

documentation are according to the selected conformance
model.
7. REGISTRAR DOCUMENTATION
REVIEW
Registrar reviews quality manual (and any other requested
documents) as advance organiser to the organisation and
the supporting documentation.
8. SITE PREPARATION
Management prepares organisation for the registrar and
certification audit.
9. CERTIFICATION AUDIT

Registrar reviews quality system and documentation to

determine if quality system meets the selected conformance
model and can be certified as such.
QUALITY MANAGEMENT PRINCIPLES

The eight quality management principles are defined in ISO 9000:2005,

Quality management systems – Fundamentals and vocabulary, and in
ISO 9004:2009, Managing for the sustained success of an organization –
A quality management approach.

This document gives the standardized descriptions of the principles as

they appear in ISO 9000:2005 and ISO 9004:2009. In addition, it
provides examples of the benefits derived from their use and of actions
that managers typically take in applying the principles to improve their
organizations’ performance.
QUALITY MANAGEMENT PRINCIPLES
Principle 1 – Customer focus
Principle 2 – Leadership
Principle 3 – Involvement of people
Principle 4 – Process approach
Principle 5 – System approach to management
Principle 6 – Continual improvement
Principle 7 – Factual approach to decision making
Principle 8 – Mutually beneficial supplier relationships
QUALITY MANAGEMENT PRINCIPLES
Principle 1 – 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.

Key benefits :
• Increased revenue and market share obtained through flexible and
fast responses to market opportunities
• Increased effectiveness in the use of the organization’s resources to
enhance customer satisfaction
QUALITY MANAGEMENT PRINCIPLES
Principle 2 – Leadership
Leaders establish unity of purpose and direction of the organization.
They should create and maintain the internal environment in which
people can become fully involved in achieving the organization’s
objectives.

Key benefits :
• People will understand and be motivated towards the organization’s
goals and objectives
• Activities are evaluated, aligned and implemented in a unified way
QUALITY MANAGEMENT PRINCIPLES
Principle 3 – Involvement of people
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.

Key benefits :
• Motivated, committed and involved people within the organization
• Innovation and creativity in furthering the organization’s objectives
QUALITY MANAGEMENT PRINCIPLES
Principle 4 – Process approach
A desired result is achieved more efficiently when activities and related
resources are managed as a process.

Key benefits :
• Lower costs and shorter cycle times through effective use of
resources
• Improved, consistent and predictable results
QUALITY MANAGEMENT PRINCIPLES
Principle 5 – 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.

Key benefits :
• Integration and alignment of the processes that will best achieve the
desired results
• Ability to focus effort on the key processes
QUALITY MANAGEMENT PRINCIPLES
Principle 6 – Continual improvement
Continual improvement of the organization’s overall performance should
be a permanent objective of the organization.

Key benefits :
• Performance advantage through improved organizational capabilities
• Alignment of improvement activities at all levels to an organization’s
strategic intent
QUALITY MANAGEMENT PRINCIPLES
Principle 7 – Factual approach to decision making
Effective decisions are based on the analysis of data and information

Key benefits :
• Informed decisions
• An increased ability to demonstrate the effectiveness of past
decisions through reference to factual records
QUALITY MANAGEMENT PRINCIPLES
Principle 8 – Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a mutually
beneficial relationship enhances the ability of both to create value.

Key benefits :
• Increased ability to create value for both parties
• Flexibility and speed of joint responses to changing market or
customer needs and expectations
ISO SERIES STANDARD
ISO 9000 is a set of international standards on quality
management and quality assurance developed to help companies
effectively document the quality system elements to be
implemented to maintain an efficient quality system..

ISO 9000 can help a company satisfy its customers, meet

regulatory requirements, and achieve continual improvement.

• ISO 9000:2005
• ISO 9001:2008
• ISO 9004:2009
ISO 9000:2005
Quality management systems -- Fundamentals and vocabulary
ISO 9000:2005 describes fundamentals of quality management
systems, which form the subject of the ISO 9000 family, and defines
related terms.

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;
ISO 9000:2005
d) those concerned with a mutual understanding of the terminology used
in quality management (e.g. suppliers, customers, regulators);

e) those internal or external to the organization who assess the quality

management system or audit it for conformity with the requirements of
ISO 9001 (e.g. auditors, regulators, certification/registration bodies);

f) those internal or external to the organization who give advice or

training on the quality management system appropriate to that
organization;

g) developers of related standards.

ISO 9001:2008
Quality management systems -- Requirements

ISO 9001:2008 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, and
• aims to enhance customer satisfaction through the effective
application of the system, including processes for continual
improvement of the system and the assurance of conformity to
customer and applicable statutory and regulatory requirements.
ISO 9001:2008
Quality management systems -- Requirements

All requirements of ISO 9001:2008 are generic and are intended to be

applicable to all organizations, regardless of type, size and product
provided.

Where any requirement(s) of ISO 9001:2008 cannot be applied due to

the nature of an organization and its product, this can be considered for
exclusion.

Where exclusions are made, claims of conformity to ISO 9001:2008 are

not acceptable unless these exclusions are limited to requirements
within Clause 7, and such exclusions do not affect the organization's
ability, or responsibility, to provide product that meets customer and
applicable statutory and regulatory requirements.
ISO 9004:2009
Managing for the sustained success of an organization -- A quality
management approach

ISO 9004 is part of the ISO 9000 family of Standards including 

ISO 9000 and ISO 9001.

ISO 9004:2009 provides guidance to organizations to support the

achievement of sustained success by a quality management
approach. It is applicable to any organization, regardless of size, type
and activity.

ISO 9004:2009 is not intended for certification, regulatory or

contractual use.
ISO 9004:2009
What is sustained success?
The sustained success of an organization is the result of its ability to
achieve and maintain its objectives in the long-term. The achievement
of sustained success for any organization is a complex and
demanding challenge in an ever-changing environment.

How can sustained success be achieved?

• By meeting the needs and expectations of your customers
• By the effective management of your organization
• Through awareness of your organization's environment
• By learning and improving.
 ISO 9004:2009
How can the ISO 9004:2009 Standard help?
• Will provide your organization with guidance and support to achieve
sustained success by a quality management approach. It can be
used by any organization, regardless of size, type and activity.
• Promotes self-assessment as an important tool for the review of the
maturity level of your organization. It covers leadership, strategy,
management system, resources and processes, to identify areas of
strength and weakness and opportunities for improvements and
innovations.
• Provides a wider focus on quality management than ISO 9001. It
addresses the needs and expectations of all relevant interested
parties. ISO 9004 also provides guidance for the systematic and
continual improvement of your organization's overall performance.
ADVANTAGES PRACTICING ISO 9000

• Increased marketability
• Reduced operational expenses
• Better management control
• Improved internal communication
• Improved customer service
• Reduction of product-liability risks
• Attractiveness to investors
DISADVANTAGES
PRACTICING ISO 9000

• Owners and managers do not have an adequate understanding of

the ISO 9000 certification process or of the quality standards
themselves
• Funding for establishing the quality system is inadequate
• Heavy emphasis on documentation
• Length of the process