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Section 2
Quality
Management System
Key
Vocabulary
ISO
9000:2000 Series - Purpose and Structure
Quality
Management Process Model
Quality
Management System
The purpose of a Quality Management System (QMS) to a recognized standard
is to provide organizations with a controlled, consistent approach for effective
operation of its business. This
provides organizations with many benefits such as structured process management,
controlled operations and controlled management of change.
ISO 9000:2005 defines Quality Management System as:
Management
system to direct and control an organization with regard to
quality.
Management
System being defined as:
System to establish a quality policy and quality objectives and to
achieve those objectives.
ISO
9001:2008 Section 4.2.1 describes the Quality Management System’s
documentation as including:
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The quality
management system documentation shall include
(a) documented statements of a quality policy
and quality objectives,
(b) a quality manual,
(c) documented procedures
and records required by this
International Standard,
and
(d) documents,
including records, determined by the organization
to be necessary to ensure the
effective planning, operation and control of its processes.
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Quality Management Systems must be established for each and every
function where controls are crucial to ensure integrity of output, product or of
service quality.
The QMS must be approved and supported by Top Management and their
subordinates. The established QMS
can then be used as the basis against which the company conducts its business
with respect to quality attainment.
Standards such as ISO 9001:2008 lay down a requirement that the company
which supplies a product to a customer shall produce some form of documented
system.
Typically,
it is a Policy Manual, sometimes referred to as the Quality Manual, that
establishes the framework to satisfy these requirements.
The Policy Manual is a document of some form or another setting out the
general quality policies of an organization.
The Quality Management System is made up of several types of processes at
several levels of an organization; these include such processes as
macro-processes (system), micro-processes (process), sub-micro-processes (task),
each in itself could affect its own set of additional levels and controls.
These processes interact with each other as mutually interdependent
entities; and, process based Quality Management Systems provide the greatest
opportunity for efficiency and effectiveness!
Further, processes fall into two families: management and realization.
Management processes are those that support structure and system;
realization processes are those that support product or service.
Key Vocabulary
The following key vocabulary is referenced in ISO
9000:2005 and ISO 19011:2002:
Degree to which
a set of inherent characteristics fulfils requirements
Group of people
and facilities with an arrangement of responsibilities, authorities and
relationships.
Examples of an organization are: company, corporation,
firm, enterprise, institution, charity, sole trader, association or parts or
combination thereof.
Organization or
person that provides a product.
Examples of a supplier are: producer, distributor,
retailer or vendor of a product, or provider of a service or information.
A customer can be internal or external to the
supplier’s organization.
Result of a
process.
There are four agreed generic product categories:
Hardware (e.g., engine mechanical part)
Software (e.g., computer program, dictionary)
Services (e.g., transport)
Processed materials (e.g., lubricant)
Hardware is generally tangible and its amount is a
countable characteristic.
Processed materials are generally tangible and their
amount is a continual characteristic.
Software consists of information and is generally
intangible and can be in the form of approaches, transactions or procedures.
Service is the
result of at least one activity necessarily performed at the interface between
the supplier and customer and is generally intangible.
Service may involve an activity performed on a
customer-supplied tangible or intangible product.
Service may involve the delivery of a tangible product.
Service may involve the delivery of an intangible
product or the creation of ambience for the customer.
Set of interrelated or interacting activities which transforms
inputs to outputs
Person or group
of people who directs and controls an organization at the highest level.
Person or group
having an interest in the performance or success of an organization.
Examples: Customers, owners, employees, suppliers,
bankers, unions, partners or society.
NOTE: A group may comprise of an organization, a part
thereof, or more than one organization.
Systematic,
independent and documented process for obtaining audit evidence and evaluating
it objectively to determine the extent to which audit criteria are fulfilled.
Management
system to direct and control an organization with regard to quality.
Management System:
System to establish a quality policy and quality objectives and to
achieve those objectives.
Person with the
competence to conduct an audit.
Nonfulfillment
of a requirement.
Demonstrated
ability to apply knowledge and skills
ISO
9000:2000 Series - Purpose and Structure
The ISO 9000:2000 Series is structured around three documents:
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ISO
9005:2000 ... Quality management systems - Fundamentals and vocabulary
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ISO
9001:2008 ... Quality management systems - Requirements
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ISO
9004:2000 ... Quality management systems - Guidelines for performance
improvement
The series has been revised from the 1994 version to strive towards a
more universal set of documents assisting organizations toward World Class
Excellence. It begins with ISO
9000:2000 Series. This document serves to
lay out the fundamentals of quality management systems, quality management
principles and terminology.
The central document of this series is the Standard ... ISO
9001:2008.
It is this document that organizations certify against.
The ISO 9001:2008 Standard addresses the Quality Management System
requirements for an organization to demonstrate its capability to meet customer
requirements.
The ISO 9004:2000 Guideline is intended to lead beyond ISO 9001 towards
the development of a comprehensive quality management system and its improvement
of performance.
The series has been developed to support each other from within, and not
to depend on further outside documents and schemes. ISO 9001 and ISO 9004 work in harmony as the Consistent Pair. The Consistent
Pair works as a basis for a harmony of activities that leads the
organization down the path of continual improvement, stronger and better
customer relations, customer satisfaction ... and, overall mutually beneficial
supplier relationships.
This relationship of the Consistent Pair can be best described below:
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ISO 9001 ...
PROVIDING CONFIDENCE IN PRODUCT CONFORMANCE TO ESTABLISHED REQUIREMENTS
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ISO 9004 ...
PROVIDING BENEFITS FOR ALL INTERESTED PARTIES THROUGH SUSTAINED
CUSTOMER SATISFACTION
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Lastly,
the final support documents are for the auditing of the Standard:
Quality
Management Process Model
The Quality Management Process Model is a presentation of the Quality
Management System requirements specified in the ISO 9001:2000 Standard.
This model reflects the integration of the four major clause titles:
Management Responsibility, Resource Management, Product Realization, and
Measurement, Analysis and Improvement.
Quality
Management Process Model
The model approaches the Quality Management System with both vertical and
horizontal process integration. The
vertical addresses the Quality Management System requirements; the horizontal
begins and ends with the customer.
Customer interaction is a key component to the input and output of this
process model. Customers identify
needs and requirements at the beginning, and provide feedback to the
organization at the end. With the
customer becoming more integral in the activities of the organization, continual
improvement and customer satisfaction become part of the closure process.
Further, both vertical and horizontal processes share measurement,
analysis and improvement requirements which will serve in the feedback loop for
retrieving information from the customer as well as better understanding the
levels of success of internal activities relative to the organization.
Lastly, the process model introduces the Plan-Do-Check-Act cycle
philosophy and disciplines within the vertical (internal) loop where measurement
requirements lead back to Management Responsibility.
Essentially, this cycle completes an integral component of this model and
sets the mandate that an organization establish baseline measurable targets for
its processes, seek to understand its processes, then improve its processes.
In development of business management systems companies may effectively
demonstrate and document key business processes from customer input to company
deliverables, with interfaces between inputs, outputs, inter-related processes
through process planning. This can
involve extensive complicated, complex process plans or simple flow plans based
on the type of organization. The
plans can be an integral part of the Quality Management Systems for management
control of the business.
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