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ISO 9001:2008 Quality management systems — Requirements
is a document of approximately 30 pages which is available from the
national standards organization in each country. It is supplemented by
two other standards, ISO 9000:2005
Quality management systems — Fundamentals and vocabulary and ISO 9004:2009
Managing for the sustained success of an organization — A quality management approach,
which do not contain specific requirements and are not used directly in
certification. Outline contents for ISO 9001 are as follows:
- Page iv: Foreword
- Pages v to vii: Section 0 Intro
- Pages 1 to 14: Requirements
- Section 1: Scope
- Section 2: Normative Reference
- Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)
- Pages 2 to 14 132 1
- Section 4: Quality Management System
- Section 5: Management Responsibility
- Section 6: Resource Management
- Section 7: Product Realization
- Section 8: Measurement, analysis and improvement
In effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS.
- Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards
- Page 23: Bibliography
The standard specifies six compulsory documents:
- Control of Documents (4.2.3)
- Control of Records (4.2.4)
- Internal Audits (8.2.2)
- Control of Nonconforming Product / Service (8.3)
- Corrective Action (8.5.2)
- Preventive Action (8.5.3)
In addition to these, ISO 9001:2008 requires a
quality policy and Quality Manual (which may or may not include the above documents).
Summary of ISO 9001:2008 in informal language
- The quality policy is a formal statement from management, closely
linked to the business and marketing plan and to customer needs.
- The quality policy is understood and followed at all levels and by
all employees. Each employee works towards measurable objectives.
- The business makes decisions about the quality system based on recorded data.
- The quality system is regularly audited and evaluated for conformance and effectiveness.
- Records show how and where raw materials and products were processed to allow products and problems to be traced to the source.
- The business determines customer requirements.
- The business has created systems for communicating with customers
about product information, inquiries, contracts, orders, feedback, and
complaints.
- When developing new products, the business plans the stages of
development, with appropriate testing at each stage. It tests and
documents whether the product meets design requirements, regulatory
requirements, and user needs.
- The business regularly reviews performance through internal audits
and meetings. The business determines whether the quality system is
working and what improvements can be made. It has a documented procedure
for internal audits.
- The business deals with past problems and potential problems. It
keeps records of these activities and the resulting decisions, and
monitors their effectiveness.
- The business has documented procedures for dealing with actual and
potential nonconformances (problems involving suppliers, customers, or
internal problems).
- The business (1) makes sure no one uses bad product, (2) determines
what to do with bad product, (3) deals with the root cause of problems,
and (4) keeps records to use as a tool to improve the system.
Certification
ISO
does not itself certify organizations. Many countries have formed
accreditation bodies to authorize certification bodies, which audit
organizations applying for ISO 9001 compliance certification. Although
commonly referred to as ISO 9000:2000 certification, the actual standard
to which an organization's quality management can be certified is ISO
9001:2008. Both the accreditation bodies and the certification bodies
charge fees for their services. The various accreditation bodies have
mutual agreements with each other to ensure that certificates issued by
one of the
Accredited Certification Bodies (CB) are accepted worldwide.
The applying organization is assessed based on an extensive sample of
its sites, functions, products, services, and processes. A list of
problems ("action requests" or "non-compliance") is first made known to
management. If there are no major problems on this list, or after it
receives a satisfactory improvement plan from the management showing how
any problems will be resolved, the certification body will issue an ISO
9001 certificate. The certificate is limited by a certain scope (e.g.
production of golf balls) and names the locations covered.
An ISO certificate is not a once-and-for-all award, but must be
renewed at regular intervals recommended by the certification body,
usually around three years. There are no grades of competence within ISO
9001: either a company is certified (meaning that it is committed to
the method and model of quality management described in the standard) or
it is not. In this respect, ISO certification contrasts with
measurement-based quality systems such as the
Capability Maturity Model.
Evolution of ISO 9000 standards
1987 version
ISO 9000:1987 had the same structure as the UK Standard BS 5750, with
three 'models' for quality management systems, the selection of which
was based on the scope of activities of the organization:
- ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.
- ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
- ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.
ISO 9000:1987 was also influenced by existing U.S. and other
Defense Standards
("MIL SPECS"), and so was well-suited to manufacturing. The emphasis
tended to be placed on conformance with procedures rather than the
overall process of management, which was likely the actual intent.
[citation needed]
1994 version
ISO 9000:1994 emphasized
quality assurance
via preventive actions, instead of just checking final product, and
continued to require evidence of compliance with documented procedures.
As with the first edition, the down-side was that companies tended to
implement its requirements by creating shelf-loads of procedure manuals,
and becoming burdened with an ISO bureaucracy. In some companies,
adapting and improving processes could actually be impeded by the
quality system.
[citation needed]
2000 version
ISO 9001:2000 combined the three standards—9001, 9002, and
9003—into one, called 9001. Design and development procedures were
required only if a company does in fact engage in the creation of new
products. The 2000 version sought to make a radical change in thinking
by actually placing the concept of
process management
front and center ("Process management" was the monitoring and
optimizing of a company's tasks and activities, instead of just
inspecting the final product). The 2000 version also demanded
involvement by upper executives in order to integrate quality into the
business system and avoid delegation of quality functions to junior
administrators. Another goal was to improve effectiveness via process
performance metrics: numerical measurement of the effectiveness of tasks
and activities. Expectations of continual
process improvement and tracking customer satisfaction were made explicit.
The ISO 9000 standard is continually being revised by standing
technical committees and advisory groups, who receive feedback from
those professionals who are implementing the standard.
[1]
ISO 9001:2008 only introduced clarifications to the existing
requirements of ISO 9001:2000 and some changes intended to improve
consistency with ISO 14001:2004. There were no new requirements. For
example, in ISO 9001:2008, a quality management system being upgraded
just needs to be checked to see if it is following the clarifications
introduced in the amended version.
(source wikipedia)
System ISO 9001 Quality Management Part 4 / 4
This video is sectioned into 4 parts
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