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In ISO 9001 Certification, highly competent market industries
with ISO 9001 2000 certification hold a distinguished position. These industries
hold an advantage over others and have gained trust & credibility. The ISO
9001:2000 quality certification is based on the following eight fundamental
quality management principles:
- Customer focus
- Leadership
- Involvement of people
- Process approach
- System approach to management
- Continual improvement
- Factual approach to decision making
- Mutually beneficial supplier relationships
Overview of the ISO
9001:2000 standard
ISO 9001:2000 contains five requirements sections,
each dealing with one of the fundamental building blocks required by any
process. These are:
Quality Management System: This section
details the general and documentation requirements that are the foundation of
the management system. The general requirements ask you to look at the processes
of the management system, how they interact with each other, what resources you
need to run the processes; and how you will measure and monitor the processes.
The second part of the section then sets out the requirements for the
documentation needed to effectively operate the system and how the documentation
should be controlled.
Management Responsibility: The management of
the systems is the responsibility of the "top management" at a strategic level
in the organization. The "top management" must know customers' requirements at a
strategic level and make a commitment to meeting these as well as statutory and
regulatory requirements. "Top management" must also set policies; and to achieve
these policies set objectives through planning how the objectives will be met.
"Top management" should also ensure that there are clear internal communications
and that the management system is regularly reviewed.
Resource
Management: This covers the people and physical resources needed to carry
out the processes. People should be competent to carry out their tasks and the
physical resources and work environment need to be capable of ensuring that the
customers' requirements are met.
Product/Service realization:
These are the processes necessary to produce the product or to provide the
service. This is the act of converting the input of the process to the output.
For a manufacturing organization, this may be the process of converting iron ore
to steel via a blast furnace for example. For a service organization, this may
be the process of moving a product or person from one place to another, for
example, a taxi journey.
Measurement analysis and improvement:
These are the measurements to enable the systems to be monitored to provide
information on how the systems are performing with respect to the customer, the
management systems themselves through internal audits, the processes and the
product. Analyzing these, including any defect or shortfall in performance, will
provide valuable information for use in improving the systems and products where
this is required.
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Compliance with ISO 14000 certification series highlights
adherence with environmental management standards developed by the International
Organization for Standardization (ISO). ISO one of the world's principal
voluntary standards development bodies. The ISO 14000 certification standards
are designed to provide an internationally recognized framework for
environmental management, measurement, evaluation and auditing.
International Standards- ISO 14001:2004 intended to provide
organizations with the elements of an effective environmental management system
(EMS) that can be integrated with other management requirements and help
organizations to achieve environmental and economic goals
This
International Standard specifies requirements for an environmental management
system to enable an organization to develop and implement a policy and
objectives which take into account legal requirements and information about
significant environmental aspects. It is intended to apply to all types and
sizes of organization and to accommodate diverse geographical, cultural and
social conditions. The overall aim of this International Standard is to support
environmental protection and prevention of pollution in balance with
socio-economic needs.
To achieve ISO
14001 organisation requires followings :
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Establish an appropriate environmental policy.
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Identify the environmental aspects arising from the organizations past,
existing or planned activities, products and services, in order to determine
the environmental impacts of significance.
-
Identify applicable legal requirements and other requirements, to which
the organization subscribes.
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Identify priorities and set appropriate environmental objectives and
targets.
-
Establish a structure and a programme(s) to implement the policy and
achieve objectives and meet targets.
-
Facilitate planning, control, monitoring, preventive and corrective
actions, auditing and review activities to ensure both that the policy is
complied with and that the environmental management system remains appropriate
-
Be capable of adapting to changing circumstances.
Advantages of ISO 14001:2004
1. Process improvement.
2.
Environmental cost reduction.
3. Better relationships with
regulators
4.Better relationships with insurers, investors, and financial
markets
5.Product improvement
6. Marketing advantages
7. Better control
of liabilities
8.educed regulatory burden
9.Protection of company image
and name
10.emonstration of responsible management
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This International Standard ISO 22000 specifies requirements for
a food safety management system where an organization in the food chain needs to
demonstrate its ability to control food safety hazards in order to ensure that
food is safe at the time of human consumption.
It is applicable to all
organizations, regardless of size, which are involved in any aspect of the food
chain and want to implement systems that consistently provide safe products. The
means of meeting any requirements of this International Standard can be
accomplished through the use of internal and/or external resources.
This International Standard ISO 22000 specifies requirements to
enable an organization
- To plan, implement, operate, maintain and update a food safety management
system aimed at providing products that, according to their intended use, are
safe for the consumer
- To demonstrate compliance with applicable statutory and regulatory food
safety requirements
- To evaluate and assess customer requirements and demonstrate conformity
with those mutually agreed customer requirements that relate to food safety,
in order to enhance customer satisfaction
- To effectively communicate food safety issues to their suppliers,
customers and relevant interested parties in the food chain
- To ensure that the organization conforms to its stated food safety policy
- To demonstrate such conformity to relevant interested parties and
- To seek certification or registration of its food safety management system
by an external organization, or make a self-assessment or self-declaration of
conformity to this International Standard.
All requirements of
this International Standard (ISO 22000) are generic and are intended to be
applicable to all organizations in the food chain regardless of size and
complexity. This includes organizations directly or indirectly involved in one
or more steps of the food chain. Organizations that are directly involved
include, but are not limited to, feed producers, harvesters, farmers, producers
of ingredients, food manufacturers, retailers, food services, catering services,
organizations providing cleaning and sanitation services, transportation,
storage and distribution services. Other organizations that are indirectly
involved include, but are not limited to, suppliers of equipment, cleaning and
sanitizing agents, packaging material, and other food contact
materials.
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ISO 27001, titled "Information Security Management -
Specification With Guidance for Use", is the replacement for BS7799-2. It is
intended to provide the foundation for third party audit, and is 'harmonized'
with other management standards, such as ISO 9001 and ISO 14001.
The
basic objective of the standard is to help establish and maintain an effective
information management system, using a continual improvement approach. It
implements OECD (Organization for Economic Cooperation and Development)
principles, governing security of information and network systems.
The Contents of the Standard?
The broad content is of
course similar to the old BS7799. Included is:
1.Cross reference with ISO
17799 controls
2.Use of PDCA
3 Information Management System
4. Tems
and definitions
ISO 27001 Certification
As with BS7799-2, a
robust audit and certification scheme supports the standard. For those already
certified against BS7799, accredited certification bodies will establish
transitional arrangements. More detail and explanation is available on our
specific certification page
The ISO 27000 Series
The final
version of ISO 27001 was published in October 2005 to a great fanfare. It should
be noted, however, that this is in fact only the first of a series of standards
to support information security. Having stated this, it may well be the most
important, at least from a 'top down' perspective, as it defines the information
security management system.
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Many organizations are implementing an Occupational Health and Safety Management System (OHSMS) as part of their risk management strategy to address changing legislation and protect their workforce.
An OHSMS promotes a safe and healthy working environment by providing a framework that allows your organization to consistently identify and control its health and safety risks, reduce the potential for accidents, aid legislative compliance and improve overall performance.
BS OHSAS 18001 is the internationally recognized assessment specification for occupational health and safety management systems. It was developed by a selection of leading trade bodies, international standards and certification bodies to address a gap where no third-party certifiable international standard exists.
BS OHSAS 18001 has been designed to be compatible with ISO 9001 and ISO 14001, to help your organization meet their health and safety obligations in an efficient manner.
The following key areas are addressed by BS OHSAS 18001:
- Planning for hazard identification, risk assessment and risk control
- OHSAS management programme
- Structure and responsibility
- Training, awareness and competence
- Consultation and communication
- Operational control
- Emergency preparedness and response
- Performance measuring, monitoring and improvement
BS OHSAS 18001 can be adopted by any organization wishing to implement a formal procedure to reduce the risks associated with health and safety in the working environment for employees, customers and the general public.
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ISO / TS 16949:2002 certification is an international standard and "technical specification" containing requirements for establishing and maintaining a quality management system for the design and development, production and installation (when relevant) and service of automobile-related products. The 20 element structure of QS 9000 and ISO / TS 16949 : 1999 is now a thing of past. The 2002 version has adopted the content and structure of ISO 9001 certification : 2000, which promotes a "Process Approach" to develop, implement and improve a quality management system.
Benefits of ISO/TS 16949
1. Fosters improved product & process quality.
2. Incorporates the best lessons learnt from the global automotive realm.
3. Provides additional confidence for global sourcing.
4. Ensures a global quality system approach in the supply chain for supplier/subcontractor service consistency.
5. Reduces variation, waste & improves the overall efficiency in production levels.
6. Eliminates the need for multiple third party registrations.
7. Provides a common platform to address worldwide quality system requirements.
8. Formatted to allow easy conversion to ISO9001/2000.
9. Advantageous to the up gradation of existing quality systems.
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The CE Mark is a visible declaration by the manufacturer (or his representative, importer etc.) that the equipment which is marked complies with all the requirements of all the applicable directives. Having ensured that the equipment does meet all these requirements (including all the administrative requirements involved in being able to demonstrate compliance), the CE Mark may then be affixed and the product released.
CE Mark authorization of the PHAROS Vitesse stent supports our expansion into the large ischemic stroke market with a product that has important value-added features,” said John Kilcoyne, Chairman and CEO of Micrus Endovascular. “The PHAROS Vitesse is our second-generation stent designed with a series of technical advances for improved handling and navigability for more precise placement.
The PHAROS Vitesse is manufactured exclusively for Micrus Endovascular through a collaborative agreement with Switzerland-based Biotronik AG. It enables the intracranial delivery and deployment of a stent in one step, eliminating the need for pre-dilation of constricted vasculature. Among the PHAROS Vitesse features are a new distal tip that is longer and softer, a newly designed, thinner balloon and Micrus’ rapid exchange delivery system. Additionally, the PHAROS Vitesse incorporates a proprietary coating which the Company believes may reduce the need for retreatment due to restenosis
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