Quality System

Quality Management System
Quality Management System

• A Quality Management System is a collection
of policies, procedures, plans, resources,
processes, practices, and the specification of
responsibilities and authority of an
organization designed to achieve product and
service quality levels, customer satisfaction
and company objectives.
ISO 9000
• 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. They are not specific to any one
industry and can be applied to organizations
of any size.
• ISO 9000 is a series, or family, of standards.
The ISO 9000 family contains these standards:
• ISO 9001:2015: Quality management systems -
Requirements
• ISO 9000:2015: Quality management systems -
Fundamentals and vocabulary (definitions)
• ISO 9004:2009: Quality management systems –
Managing for the sustained success of an
organization (continuous improvement)
• ISO 19011:2011: Guidelines for auditing
management systems
History of ISO 9000
• This quality standard was first introduced in 1987 by the
International Organization for Standards (ISO) in hopes of
establishing an international definition of the essential
characteristics and language of a quality system for all businesses,
irrespective of industry or geographic location. Initially, it was
used almost exclusively by large companies, but by the mid-
1990s, increasing numbers of small-and mid-sized companies had
embraced ISO 9000 as well. In fact, small and moderate-sized
companies account for much of the growth in ISO 9000
registration over the past several years.
• Underwent major revision in 2000; revised again in 2008
• Current versions of ISO 9000 and ISO 9001 were published in
September 2015
ISO 9000 Contd….
• It is important to stress that ISO 9000 is not a
rigid set of requirements, and that
organizations have flexibility in how they
implement their quality management system.
This freedom allows the ISO 9000 standard to
be used in a wide range of organizations, and
in businesses large and small.
ISO 9000 Contd….
• ISO 9000 is process-oriented approach. Once this
process-oriented approach is implemented, various
audits can be done as a check of the effectiveness of
your quality management system. There are three
main types of audits – 1st, 2nd, and 3rd party audits.
• Ist Party Audit: n internal audit is a 1st party audit. ISO
9000 encourages (and requires) this type of audit so
that an organization can get feedback quickly from
those who know the company best. However, this audit
process cannot be viewed as impartial
ISO 9000 Contd….
• 2nd Party Audit: allow for a consumer to
evaluate the performance on an organization.
• 3rd Party Audit: In this case, an independent
certification body comes into an organization
and evaluates it in terms of the ISO 9000
guidelines. If an organization meets the
requirements of the standard, it becomes
certified in ISO 9000 and carries a seal of
quality recognized throughout the world.
ELEMENTS OF ISO 9000 QUALITY
MANAGEMENT SYSTEMS
The standards of ISO 9000 detail 20 requirements for an
organization's quality management system in the following
areas:
• Management Responsibility
• Quality System
• Order Entry
• Design Control
• Document and Data Control
• Purchasing
• Control of Customer Supplied Products
• Product Identification and Tractability
ELEMENTS OF ISO 9000 QUALITY
MANAGEMENT SYSTEMS CONTD…
• Process Control
• Inspection and Testing Control of Inspection, Measuring,
and Test Equipment
• Inspection and Test Status
• Control of Nonconforming Products
• Corrective and Preventive Action
• Handling, Storage, Packaging, and Delivery
• Control of Quality Records
• Internal Quality Audits
• Training
• Servicing
• Statistical Techniques
ADVANTAGES OF ISO 9000
• Increased Marketability
• Reduced operational expenses
• Better management control
• Increased customer satisfaction
• Improved internal communication
• Improved customer service
• Reduction of product-liability risks
• Attractiveness to investors
DISADVANTAGES OF 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—Business executives and owners
familiar with the ISO 9000 registration process warn that
it is a process that takes many months to complete.
ISO 14000
• ISO 14000 is a series of international,
voluntary environmental management
standards, guides, and technical reports. The
standards specify requirements for
establishing an environmental policy,
determining environmental impacts of
products or services, planning environmental
objectives, implementing programs to meet
objectives, and conducting corrective action
and management review.
ISO 14000 Contd…
• The standards seek to provide cost-effective tools
that make use of best practices for organizing and
applying information about environmental
management.
• The ISO 14000 family was developed in response
to a recognized industry need for standardization.
With different organizational approaches to
environmental management, comparisons of
systems and collaboration had proved difficult.
ISO 14000 Contd…
It applies to any organization regardless of size or industry. ISO
14001:2015 is the most popular standard of the ISO 14000
family, which also includes standards such as the following:
– ISO 14004 - General guidelines on principles, systems and
support techniques
– ISO 14006 - Guidelines for incorporating ecodesign
– ISO 14015 - Environmental assessment of sites and
organizations (EASO)
– ISO 14020 - Environmental labels and declarations
– ISO 14031 - Environmental performance evaluation
– ISO 14040 - Life cycle assessment
– ISO 14050 - Vocabulary
– ISO 14063 - Environmental communication
– ISO 14064 - Greenhouse gases
ISO 14000 History
• The first environmental management system

standard, BS 7750, was published in 1992 by
the BSI group (British Standard Institution, UK)
• In 1996, the International Organization for
Standardization (ISO) created the ISO 14000
family of standards
• ISO 14001 underwent revision in 2004
• The current revision of ISO 14001 was
published in September 2015

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What are the main components of a Quality Management System?

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Quality Management System

Quality Management System

• The first environmental management system

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