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Quality Assurance

Quality assurance extends throughout all functions in Vitalograph for greater company efficiency and improvement of product and customer service. Clinical Data, Management, Training, Distribution and Service Standards.

ISO 9001:2008 - Certificate: Q 05640

This international standard specifies requirements for a quality management system to ensure an organisation is able to consistently provide products and services that meet customer and applicable regulatory requirements. Thus a company is able to enhance customer satisfaction through the effective application of the system including processes for continual improvement of the system and the assurance of conformity to customer and regulatory requirements.

ISO 9001:2008 Certificate Expires: Dec 2014

ISO 13485:2003 - Certificate: MD 78055

ISO 13485 specifies requirements to achieve regulatory compliance in the medical devices industries. The requirements given in this standard are applicable to the design, development, production, installation and servicing of medical devices of all kinds, including software. It describes concepts and methods that can be considered by organisations which are establishing and maintaining quality management systems.

ISO 13485:2003 Certificate Expires: Nov 2014

ICH - GCP

International Conference on Harmonisation (ICH) GCP guidelines provide an international ethical and scientific quality standard for designing, conducting, recording and reporting Clinical Trials to ensure these are carried out in conformance to Good Clinical Practice.

Design and Manufacture

The main Vitalograph manufacturing facility is located in Ennis, Ireland. Quality assurance extends throughout all functions at Vitalograph for greater company efficiency and improvement of product and customer service.

Manufacturing Standards

ISO 13485:2003 - Certificate: MD 82182

ISO 13485 specifies requirements for quality management systems in order to achieve regulatory compliance in the medical devices industries. The requirements given in this standard are applicable to the design, development, production, installation and servicing of medical devices of all kinds. It describes concepts and methods that can be considered by organisations which are establishing and maintaining quality management systems.

Medical devices have special requirements over and above consumer products for safety and efficiency; these are covered in this standard to ensure full product reliability and traceability, starting with the design process through to their use on patients. Vitalograph have been certified to conform to this standard and its predecessors {BS5750, ISO 9001, EN 29001, and EN46001} for over 20 years.

ISO 13485:2003 Certificate Expires: April 2015

FDA Quality System Regulation (QSR), CFR 820 & 803

The Food and Drug Administration has provided guidance and standards to manufacturers supplying medical product and devices to the USA since the 1970s; Vitalograph is registered and regularly audited on the application of these.

FDA Pre-market Approval

The introduction of new medical devices onto the US market require submission to the FDA of full documentation on the safety and efficacy of any new products - this is incorporated into the design stage of all Vitalograph products to ensure full compliance with the legal requirements.

CE Mark

The European Community recognised the need for harmonised standards on Medical device safety, and published the Medical Device Directives in 1995, laying down essential requirements for product safety, with guidelines for ensuring safety even when no particular standards existed. These are obligatory for all products placed on the market after June 1998. Vitalograph products have been CE marked since January 1996.

Full Quality Assurance Certificate CE 00772 Expires: Jul 2015
Production Quality Assurance Certificate CE 85553 Expires: Jul 2014

The Canadian Medical Devices Conformity Assessment System (CMDCAS)

In Canada, regulations require that certain medical devices be designed and manufactured under a registered quality management system (QMS), which came into force on January 1, 2003. The Canadian Medical Devices Conformity Assessment System (CMDCAS) was developed by Health Canada's Therapeutic Products Directorate (TPD), in collaboration with the Standards Council of Canada (SCC).

The role of the Standards Council in CMDCAS is to qualify the organisations that register the QMS of medical device manufacturers. Under this sector-specific program, only SCC accredited registration bodies are eligible to register manufacturers. Vitalograph have been successfully audited and accredited to the CMDCAS regulatory requirements by the British Standards Institute (BSI)

ISO 13485:2003 Certificate Expires: Apr 2015

Safety and Performance Standards

IEC 60601-1:2005 series

This International standard is in a number of parts, covering electrical safety, RFI/EMC, and other safety aspects of electrical products. Vitalograph Products have been certified to conform to the appropriate parts since their inception in the late 1970s, providing a clear assurance of safety in line with the essential requirements.

ISO EN 10079

Section three of this standard covers human powered suction equipment, and was produced to ensure effective performance of these devices in emergency use; Vitalograph were pleased to participate in this standard, and the Emergency Aspirator fully conforms to these requirements.

ISO 10651–4

ISO 10651-4:2002 specifies requirements for operator-powered resuscitators intended for use with all age groups and which are portable and intended to provide lung ventilation to individuals whose breathing is inadequate. Operator-powered resuscitators for infants and children are designated according to body mass range and approximate age equivalent. ISO 10651-4:2002 is not applicable to electrically- and gas-powered resuscitators.

The predecessor to ISO 10651-4, ISO 8382 also covered operator powered resuscitators, providing guidance on their performance and safety; Vitalograph was pleased to participate in this standard, and the Resuscitators supplied by Vitalograph conformed to this standard until it was replaced by ISO 10651-4 in 2002. Vitalograph Resuscitator fully comply with this new standard.

ISO 23747:2007

This performance and safety standard addresses the discrepancy in readings obtained from peak flow meters and spirometers, together with issues caused by the peak flow meters with the Wright's scale, which is non-linear. The standard requires testing for accuracy, reproducibility and frequency response. A meter with poor frequency response will result in errors leading to potential issues diagnosing and monitoring lung conditions. The standard also requires the meters to be checked for accuracy on a routine basis, as recommended by the manufacturer.

ISO 23747:2007 Standard

Clinical Practice Guidelines

The American Thoracic Society (ATS)

The American Thoracic Society first produced guidelines for spirometry in 1979, which were last updated in 2005 when they jointly published with the ERS. There are related guidelines that are a part of the same series. Vitalograph equipment enables clinicians to meet or exceed these guidelines.

The European Respiratory Society (ERS)

The European Respiratory Society was commissioned to produce spirometry guidelines and 'normal values' by the European Coal and Steel Community in the 1960s, which have been subsequently developed to meet the requirements of today, with the latest version published in 2005 which they jointly published with the ATS. There are related guidelines that are a part of the same series. Vitalograph equipment enables clinicians to meet or exceed these guidelines. The 1993 ERS 'normal value' regressions are widely used in Europe.