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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.
 

 


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. Read more...








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CIS CONTINUOUS IMPROVEMENT SOFTWARE is a complete management and document control software system that offers our clients a comprehensive cross platform solution to manage their complete organization.  We can set you up on CIS in less than 48 hours. You may quit at any time with no obligation or set-up costs. CIS use is simple with built in help files, more than 100 step-by-step training videos, 24/7 Help Line and presentations.  Read more...


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