Quality Mgmt Systems

 

Quality Management Systems (QMS)

Increasing global competitiveness requires that the company must focus on the value-added processes. We believe that properly designed and implemented Quality Management System (QMS) should, whenever possible, result in doing more with less, and running business working smarter not harder.

 

QUEXX assistance in quality system development and implementation process is based on many years of hands-on assistance provided to our Clients in the construction, service, research and development and manufacturing/fabrication environments.

Implementation of quality system usually creates unique opportunity to review and to improve also other aspects of present business practices. As we progress with the development of your quality system we will share improvement suggestions with your management. QUEXX consultants will guide your management team through the range of available options which our extensive experience and relentless pursuit of innovative solutions can provide.

CHOICE OF QUALITY MANAGEMENT SYSTEM DEVELOPMENT PROGRAMS:

Project-specific Quality Management Systems usually require some general alignment and compliance with the requirements of ISO 9001: 2015 International Standard. We believe that properly designed Quality Management System should be simple, practical, and fit working environment and budgetary constraints of the Project. While ensuring the required quality of provided services and complying with contractual requirements it should also utilize fully available resources, and protect interests of our client at all stages of the Project. Performance and compliance of project-specific Quality Management Systems with contractual, regulatory and statutory requirements is usually monitored and evaluated by the QA representatives or third-party auditors authorized by the Client.

ISO 9001: 2015 “Quality Management Systems – Requirements” International Standard defines a set of requirements which any organization needs to fulfill to achieve customer satisfaction through consistent quality of products and services. The authorized third-party auditors (the Registrars) audit the compliance of Quality Management System and grant formal certifications.

ISO 13485: 2016 represents Quality Management System requirements for the design and manufacture of medical devices. ISO 13485 Standard which is harmonized with ISO 9001 requires the demonstration of continuous improvement, proper controls of work environment, requirements for the inspection and traceability applicable to medical devices, documentation and validation of processes for sterilization, assessment of risks attributable to medical devices, implementation of stringent design transfer activities during product development, effective corrective and preventive actions (CAPA), etc.

ISO 16949: 2009 defines the quality system requirements for the design/development, production, installation, and servicing of automotive-related products. The ISO/TS 16949 was developed by the International Automotive Task Force (IATF) and the ISO/TC 176 committee. It aligns various ISO9001-like standards used by the automotive industry world-wide.   It replaced QS-9000 and, combined with the individual OEM customer-specific requirements, it defines the Quality Management System requirements for the automotive industry suppliers. Compliance with ISO 16949 must be certified by the IATF-authorized registrars.

Engaging services of professional consultant, initiation of formal Quality Management System development program and your gradual progress towards ISO 9001 certification may give you the required level of confidence necessary to close a profitable deal. Perhaps you need to address some nagging quality problems which require immediate implementation of selected elements of the Quality Management System. We will respond with a cost-effective Quality Management System development and implementation program which will address your particular needs and will fit your budget.

Quexx International Ltd. consultants are dedicated to providing you with exceptional quality services. Extensive experience and expertise of our consultants offers training and consulting services tailored to suit your needs and your unique work environment.

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