ISO 13485 Certification In Jordan specifies standards and requirements for a quality management system that can be used by any organization that has anything to do with the design, manufacture, provision or support of a medical device in any of the stages of its life cycle. By certifying an organization as conforming to the ISO 13485 standard and accredited third party body of auditors attests to the organization conforming to the quality management requirements of the standard, including being compliant with applicable regulatory requirements, which must be identified within the quality management system or QMS.
Clause 4 is an introductory section describing some general requirements, starting with the need to have an effective quality management system or QMS as that meets regulatory requirements for the type of medical device and the requirements of the ISO 13485 standard itself. You have to identify the processes that make up the QMS and show how they are interconnected and controlled using a risk based approach. You have to document your QMS or references to it in a quality manual. Each medical device type or family must be documented in a medical device file. You have to keep records where appropriate and all relevant documentation and records must be controlled according to a documented procedure.
Clause 5 is for top management to show its commitment to establishing and maintaining an effective quality management system. This means establishing a quality policy and setting quality objectives for the whole organization, top management have to define and document responsibilities and authorities for effectively operating the organization in conformity with its QMS, including to appoint a management representative who among other things, shall report on the effectiveness of the QMS and management reviews conducted at Planned intervals.
ISO 13485 Certification In Jordan is as of late reconsidered in the year 2016 and which incorporates numerous advancements that will help the association in the medical devices manufacturing industries to have an extreme change in Jordan. ISO 13485 Certification in Jordan is considered as one of the best and wonderful ISO standards on the planet.