helps the organization to achieve the global recognition. ISO 13485 standard is generally called as the quality management system of medical field. Procedure for sterile medical devices. For sterile medical devices, the organization must document requirements for control of contamination with microorganisms or particulate matter and maintain the required cleanliness during assembly or packaging processes. Procedure for risk management.
What are the requirements of Iso 13485!
ISO 13485 has a lot of requirements regarding documentation, so it is imperative that you optimize the volume of your QMS documentation by trying to develop documentation that meets all requirements, while remaining simple and light. Although there are requirements for more than 20 procedures, many of them can be merged together, and this approach can provide you with a smaller number of documents. This is especially important for the small and midsize companies that want to implement the standard. The general advice is to identify common requirements or requirements that relate to the same element of your QMS, and try to merge documented procedures. The following recommendations take into consideration the best practice in developing QMS documentation: Document the role undertaken by the organization. The organization needs to document its roles in the market under the applicable regulatory requirements. Those roles can be manufacturer, authorized representative, importer, or distributor. The roles of the company are rarely documented as a separate document; Written quality agreements with outsource partners. When the organization chooses to outsource any process that affects product conformity with requirements, it shall monitor and ensure control over such processes, because it retains responsibility for conformity of the product to customer and regulatory requirements. Quality policy. A policy represents a declarative statement by an organization. A Quality Policy should state the commitment of the organization to quality and continual improvement, and provide a framework for setting quality objectives.
Procedure for document control. This document defines how ISO Certification in Kuwait you approve, update, and re-approve your documents. Requirements for maintenance activities. In cases when the maintenance activities can affect the product quality, the organization needs to document those requirements. This document defines what maintenance activities need to be performed and the interval of the activities. Requirements for work environment and procedure for monitoring and controlling the work environment. When conditions for the work environment can have an adverse effect on product quality, the organization needs to document the requirements for the work environment and the procedures to monitor and control the work environment.
Part of the planning of product realization is assessment of ISO consultants in Kuwait risks that can result in noncompliance with the requirements for product or processes of the Quality Management System. The organization needs to document one or more processes for risk management for product realization. Arrangements for communicating with customers. The organization must document arrangements for communicating with customers in relation to product information, inquiries, contracts, or order handling, including amendments, customer feedback and complaints, and advisory notices. These requirements are often merged with the Sales Procedure. Procedure for design and development. Requirements regarding the design and development process are among the most demanding in the standard. Every step of the design and development process needs to be documented in the form of a record, from design and development inputs, controls, and outputs, to changes in design and development. Considering all the requirements regarding the design and development process, it is best to document the Procedure for Design and Development and define all mandatory records that should accompany the procedure.
Benefits of ISO 13485 standard:
High performing organizations expect ISO 13485 auditing to be thorough, competent, relevant and challenging of the manufacturers quality management systems;
Effective auditing drives significant benefits to the manufacturer. The beneficial outputs of an effective audit include most of the economic improvements.
Meaningful feedback on the effectiveness of the quality management system.
Confidence in compliance with regulations.
Identification of areas requiring attention.
Confirmation that best practise is achieved.
Detection of areas of non-compliance and possible risk.
Reporting and certification that is valuable and recognized.
Factocert believe in optimal documentation. Our method in what’s the internal audit process which is a very dynamic and professional tool. Overall efficiency of an organisation also involved the improvements in each individual organisation. Our enrich training of internal audit improves the quality of internal auditors or process head of the organisation. To make sure the implemented tool is running smoothly, the review meeting that is conducted among the management will have the effectiveness of the process reports which will be analysed and Factocert that ensures that all the process is reviewed at a highest possible level