Quality and Regulatory Affairs

Rayner has established and maintains a quality management system based upon and satisfying the management system standard ISO 13485.

The Quality Policy for the Rayner QMS is contained in the following statements.

We will provide products and services that fully and consistently meet the agreed requirements of our customers.

We will satisfy the requirements of all appropriate national and international regulations.

This includes compliance with the following legislation:

  • European Medical Devices Directive (MDD) 93/42/EEC
  • Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR), 820 Quality System Regulation (QSR)
  • Canadian Medical Devices Regulations, SOR/98-282
  • Australian Therapeutic Goods Act 1989
  • Relevant Environmental Directives and Regulations

The commitment to quality by every employee is essential to the maintenance of this policy. The requirements of the quality management system apply to all staff and there must be no unauthorized deviations from them.

Top Management will review the quality system compliance at regular intervals to ensure it maintains its effectiveness. Resources will be allocated and improvements implemented where necessary.

We will continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

Management ensure that the Quality Policy is understood, implemented and maintained at all levels in the organisation. The policy is reviewed annually to confirm that it accurately reflects the current quality related goals and objectives of Rayner.