ORA innovations boasts over 30 years of combined experience in Quality Management Systems, Compliance, Project Engineering, Product Development, Auditing, Training, New Product Introduction, Documentation and Manufacturing for diverse industries from Electronic Equipment, to Medical Devices and Pharmaceuticals.

With a wealth of experience in Implementing, Auditing and Managing Quality Management Systems ORA innovations has led a number of Medical Devices Companies to achieve their certification to ISO13485, CE Mark their products and others to ISO 9001.

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Quality Management Services

Range of Services

  • Develop, implement and maintain a Quality Management System, (QMS) tailored and suitable to your business needs.

  • Train your staff on the requirements of the applicable Standard and the use of the System documents and how to improve the business processes.

  • Advise on the selection of the Certification Body and arrange for the Certification Audit.

  • Assist your Organisation in building internal capacity to manage and maintain the QMS.

  • Assist in supplier evaluation, selection and monitoring.

  • Perform regular Internal Audit and train nominated staff on auditing skills and corrective actions.

  • Perform Pre-certification Audit on existing Systems.

  • Perform Supplier Audit, 2nd party Audit and OEM evaluation.

  • ISO 13485, Required for Medical Devices & Pharmaceutical Manufacturers and their major suppliers.

  • ISO 9001, Suitable for most Businesses, most Industries.

  • ISO 9001 + ISO 90003, Applies to Software Development Industry.

  • ISO 9001 + ISO 27001, Applies to Information Technology and Information Security Industry – ISMS.

  • ISO 14001, Suitable for most Businesses, most Industries.