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ISO9001:
2008
ISO 9001: 2008
"Quality
Management Systems – Requirements", defines a set of requirements which any
organization needs to fulfill to achieve customer satisfaction through
consistent quality of products and services. It contains the requirement for
continual improvement guided by ISO 9004 Standard.
The ISO 9001: 2008 standard requires, as a minimum, documented Quality Policy,
Quality Manual and six following 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)
Some of the
requirements in ISO 9001:2008 also include:
-
Documented
procedures for all key processes
-
Monitoring the
effectiveness of these processes
-
Maintaining of
adequate records of the above and all activities that affect quality
-
Checking output for
defects, with corrective/preventive action where necessary
-
Periodic review of
individual processes and the quality system itself
-
Continual
improvement (processes, quality management system and quality of
products/services)
CONSULTING
PROFILE
For over 20 years we specialize in design and implementation of Quality
Management Systems compliant with ISO 9001: 2008 Requirements. Quexx assisted
over 30 companies in achieving their ISO 9001 registration. Our services
included:
-
analysis of company
needs and expectations
-
Quality Management
System assessment – gap analysis
-
Quality Management
System development and implementation plan
-
research, design, implementation and integration of
Quality Management Systems
compliant with
ISO 9001:2008
and other related standards, customer-specific (i.e.
Automotive, Medical Devices) and regulatory (i.e. FDA, Health Canada)
requirements
-
preparation of
Quality Manual, procedures/protocols, instructions and forms
-
preparation of the
specifications, validation and verification of processes and products,
workmanship standards
-
selection and
customization of suitable software, where applicable
-
step-by-step
guidance and on-going advice throughout the program
-
hands-on
participation in Quality Management System implementation
-
Internal Audits and
Management Review activities
-
preparation to
Quality Management System for assessment by the Registrar
-
assistance during
Quality Management System assessment by the Registrar
BENEFITS:
Quexx
International Ltd. consultants have extensive experience and expertise and are
dedicated to providing you with services of exceptional quality. We realize that
your trust in our competency and your investment in our consulting services
should, whenever possible, result in doing more with less, and running your
business smarter not harder. The benefits from Quexx services include:
-
no hassles (and
extra costs) associated with external training
-
marketing edge and
unrestricted access to export, government and other contracts which require
ISO 9001 and/or other regulatory compliance
-
stress-free (well,
almost) compliance with ISO 9001 and other regulatory requirements
-
trained and
motivated personnel
-
better
documentation, repetitive processes, improved performance
-
continuous
improvement with effective cost-down initiatives in place
TRAINING:
We offer tailor-made
training suitable for all employees. Our training is conveniently performed
in-house or at the suitable location near your premises. This approach
guarantees minimum disruption to your operations, and the training is delivered
at a fraction of cost when compared to the cost of the same training performed
externally. Our services are delivered at a level tailored to suit your needs
and the needs of your unique work environment.
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EXCEPTIONAL TERMS
Flexible
structure of compensation allows organizations to direct 20 -
40%
of their planned budgetary expenses towards other urgent business
needs while, at the same time, benefiting from comprehensive services,
assistance and organizational support provided by Quexx.
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FOCUS ON STARTUP COSTS
Quexx business strategy, semi-virtual corporate structure and
flexible
compensation plan are designed to minimize startup costs. Our
extensive professional network offers comprehensive range of services
delivered by competent industry experts who combine proven solutions of the
world-class organizations with the “out-of-the-box” innovativeness and
creativity.
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more…
INTELLECTUAL
PROPERTY (IP) is the key asset of rapidly growing number of
organizations, in particular those focused on research, development and
commercialization of the leading-edge technologies. Intimate knowledge of
the market players and the critical access to the key decision-makers are
the cornerstone of our marketing strategy.
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CIS CONTINUOUS
IMPROVEMENT SOFTWARE is a complete management and document control software
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