Though, it is called the Quality
Management System, It contain world's best process quality improvement and
management practices distilled and put together in the form of a standard ISO
9001:2008. Our consulting services assist businesses and busines managers learn and implement
ISO 9001:2008 and help them on the path of continual improvement.
ISO 9001:2008 emphasizes customer satisfaction and continual improvement
for sustained growth of the business.
History
ISO 9000 is a series of quality management systems
standards created by the International Organization for
Standardization (ISO), a federation of 157 national standards
bodies.
The ISO 9000 quality management systems (QMS)
Standards are not specific to products or services, but apply to the
processes that create them.
The Standards are generic in nature so that they can
be used by both manufacturing and service industries. First released
in 1987 and revised in a limited manner in 1994, they underwent a
major revision in 2000 and amendment in november 2008.
The approval Standard, ISO 9001:2008, uses a simple
process-based structure, which fits easily the process management
structure of most businesses.
ISO 9000 Introduction
ISO 9000 has evolved into a Standard designed to
assist organizations in achieving 'quality'
whilst helping to
assure customers that quality will be achieved.
Whatever definition you choose to use for quality, and
there are many, it is essential that your customers are happy with
the product/service being supplied.
ISO 9000 is intended to assist that aim by helping to
ensure that the product/service is right - for both the organization
itself and its customers.
The poor implementation of the 1994 series resulted in
many people claiming that the Standards did not prevent
organizations producing sub-standard product.
The 2008 edition clearly requires organizations to
satisfy their customers and undertake continual improvement of their
quality management systems
therefore
compliance with ISO 9001:2008 should result
in significant benefits for
organizations and their customers.
The ISO 9000:2008 series consists of
·
ISO
9000:2005 - Fundamentals and vocabulary
·
ISO
9001:2008 - Requirements
·
ISO
9004:2000 - Guidelines for performance improvement
·
Customer focus
·
Leadership
·
The
involvement of people
·
Process approach
·
System approach to management
·
Continual improvement
·
A
factual approach to decision making
·
Mutually beneficial supplier relationships
These principles are NOT elements against which the
organization can be directly assessed
but their influence can be seen throughout the Standard.
They should be considered by any organization wishing
to comply with the spirit, as well as the text of ISO 9001.
ISO 9001:2008
Requirements
ISO 9002 and ISO 9003 became obsolete in December 2000.
ISO 9001:2008 contains all of the requirements which
an organization must address within their Quality Management System
(QMS) if they wish to be certified against the Standard.
The majority of these requirements would be identified
by many organizations as 'common sense' topics which they would want
to address in order to run their business well e.g. sales, design,
purchasing, training, calibration of test equipment, control of
records.
ISO 9001 is written by a committee (TC 176) and is
designed for use in any type of organization. This inevitably means
that there are compromises in the wording of the Standard and
some interpretation is often needed.
There are 8 sections in ISO 9001:
It is sections 4, 5, 6, 7 & 8
which contain the Requirements themselves and organizations wishing
to be certified against ISO 9001:2008 will need to demonstrate that
they have addressed all of these requirements.
The
organization shall:
·
Determine the needs and expectations of customers
·
Establish policies, objectives and a work environment necessary to
motivate people to satisfy these needs
·
Design, resource and manage a system of inter-related processes to
implement the policy and attain the objectives
·
Measure and analyse the effectiveness of each process in fulfilling
its objectives and
·
Pursue the continual improvement of the system from an objective
evaluation of its performance.
ISO 9001:2008 Approval
ISO 9001:2008 registration (certification) gives the
organization the benefit of an objectively evaluated and enforced
quality management system.
It is a tangible expression of a firm’s commitment to
quality that is internationally understood and accepted.
ISO 9001:2008 registration is carried out by
certification bodies (registrars), accredited organizations that
review the organization’s quality manual and working practices to
ensure that they meet the Standard.
Using ISO 9001:2008
It is important
that when an organization is certified to ISO 9001, it is clear
which aspects of the organization are covered by the certificate.
This is addressed through the Scope of Registration, and this
must clearly identify what is included so as not to mislead.
It is a
requirement that all elements of ISO 9001 must be addressed by the
organization. However, there are specific circumstances under
which certain requirements of the Standard can be excluded, yet
compliance with ISO 9001:2008 still be claimed:
·
any
excluded requirements do not affect the ability of the organization
to meet customer and regulatory requirements
·
any
excluded requirements do not affect the ability of the organization
to provide conforming products or services
·
any
excluded requirements must only come from section 7 (Product
realization) of ISO 9001. An example may be customer property.
Clearly if a company never deals with such property then the
requirement would not be applicable
The company's
quality manual must also clearly identify why specific requirements
of ISO 9001 have been excluded and the justification for that
exclusion.
What ISO 9001:2008 is not
ISO 9001 is NOT a product Standard
- it contains no product requirements.
It is a series of generic requirements for quality
management systems. Approval to ISO 9001 does not guarantee product
or service quality. Customer focused leadership, not Standards
produces satisfied customers.
Approval to ISO 9001 demonstrates that you meet the
minimum requirements of quality management.
ISO 9004:2000 Guidelines for performance improvement
ISO 9004 is not a guide on how to implement ISO 9001,
rather a guide on how to improve on the basic requirements that ISO
9001 specifies.
The requirements statements in ISO 9001 may be seen
sometimes as a little brief and it rarely, if ever, tells the user
'how' to achieve compliance with it.
ISO 9004 takes the basic requirement and expands on
it. It gives options for the organization to consider if they wish
to progress beyond basic compliance and into excellence.
Given that 'Continual Improvement' is a requirement of
ISO 9001:2008, it is strongly recommended that one consider using
ISO 9004 as a way forward in the journey of continual improvement.
Certification bodies cannot certify organizations
against ISO 9004 but auditors may use it for guidance. You should
consider using ISO 9004 to assist internal auditors when seeking
improvement of the more mature processes.
ISO 9004 reproduces the full requirement of ISO 9001.
It may also be that some of the guidance contained in ISO 9004 may
one day become part of the requirements of ISO 9001 when the
Standard is updated again in the future.
Benefits of ISO 9001:2008
·
Improved consistency of service and product performance
·
Higher customer satisfaction levels
·
Improved customer perception
·
Improved productivity and efficiency
·
Cost reductions
·
Improved communications, morale and job satisfaction
·
Competitive advantage and increased marketing and sales
opportunities
Dun and Bradstreet
findings :
85% of registered firms report external
benefits like :
·
Higher perceived quality
·
Greater customer demand
95% report internal benefits like:
·
Greater employee awareness
·
Increased operational efficiency
Case Studies show that ISO Registration
resulted in:
·
30% Reduction in customer claims
·
95% improvement in delivery time
·
Reduced defects from 3% to 0.5%
·
40% reduction in product cycle time
·
20% increase in on-time delivery
·
International acceptance and recognition
·
Facilitated trade in international markets
·
Promoting of safety, reliability and quality in food products.
2. References
3 .Terms and definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement