Quality Glossary Definition: Conformité Européene Mark (CE Mark) The Conformité Européene (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer’s declaration that products comply with the EU’s New Approach Directives. These directives not…
The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
Cosmetics Good Manufacturing Practices (GMP) is one of the pillars of the New European Regulation for Cosmetics. This regulation sets very high requirements to ensure consumers’ safety. Amongst these new legal requirements, all cosmetics products circulating onto the European Market will have to be produced according to the Cosmetics Good Manufacturing Practices described by the ISO 22716 standard. All participants in…
AQAI offers ISO/IEC 17025 accreditation to organizations performing various types of testing and calibration. The list below encompasses AQAI established ISO/IEC 17025 accreditation programs. There are two main sections in ISO/IEC 17025 – Management Requirements and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the…
MANAGEMENT SYSTEM PROGRAMMES Quality Management Systems ISO 9001, Environmental Management Systems ISO 14001, Occupational Health & Safety Management Systems OHSAS 18001, Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ISO 13485, HACCP Based Food Safety Management Systems ISO 22000, Information Security Management Systems ISO 27001 Information Technology Services Management System ISO 20000…
ISO 17020 INSPECTION AGENCIES AQAI inspection body accreditation covers many fields with related disciplines. Inspection bodies / and Inspection Agencies under the regulation of ISO/IEC 17020. This accreditation helps Inspection bodies to gain confidence of the customers on the technical competence and recognition of good management practice. AQAI assures transparent, independent, impartial service to its highly…
