ISO 13485 Certification in Kuwait is the globally recognized standard specifies requirement for quality management system, which is considered to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. ISO 13485 standard is based on process approach of the quality management system. ISO 13485 standard does not contain requirements specific to other management systems standard such as environmental management system and occupational health and safety management system.
Normally, ISO 13485 is coordinated with ISO 9001. However, the major key differences are while ISO 9001 requires organizations to demonstrate continual improvement and has requirements to ensure customer satisfaction. ISO 13485 requires the organization to demonstrate only that its quality system is maintained and effective and it does not rely on customer satisfaction as a metric. Furthermore, ISO 13485 has other modifications including the areas of risk management, design, control, corrective and preventative action management.
The quality manual (QM) is really the key to any organization’s quality system. The ISO 13485 standard requires a documented Quality Manual, which includes the scope of the Quality Management System (QMS), including details and justification for any exclusions documented procedures for the QMS or references to them and a description of the interaction between the processes of the QMS. The QMS is often the one document that is freely shared with external parties, as it is used to provide evidence of the organization’s quality system at least at a high level. Some organizations, even have it available on their website. Some organizations may approve suppliers, based on the information in the Quality Manual. So being able to supply it to them can bring a real value to both organizations.