iso certification in philippines is a major benefit for organizations. ISO 13485 standard is generally called as the quality management system standard for the medical devices. ISO 13485 standard fulfil the requirements of international organisation for standardization publication as per the requirements of standard medical device maintenance. If the organisation goes for the implementation of ISO 13485 standard it will help them to have a manufacturing control and design capabilities of medical device in the medical sector. ISO 13485 standard helps the organisation to have a control over the working environment along with the established standard policy.
The analysis of each and every process with respect to every department in the organisation which are going for particular ISO implementation involves a lot of effort from our end. Identifying any shortcoming helps in fulfilling the standard requirement completely. We believe that training is the most important phrase in any stage of the process completion. Training from industry best expert ensure that it will inculcate the industry best practices. Our training program make sure all the elements that will brings all employees to a higher level so they all have required skills and knowledge in order to perform together for the better results.
• Increased alignment with regulatory requirements and, in particular, regulatory documentation
• More focus on post-market activities, including complaint handling and regulatory reporting
• Broadening of the standard’s application to encompass organizations that interact with the medical device manufacturer, including those involved in: Design and development or repair and maintenance of medical devices. Supply of raw materials, components or subassemblies. Performance of services such as contract manufacture, sterilization, logistics or calibration of measurement equipment. Import or distribution of medical devices
• Additional requirements in the design and development of medical devices, taking into consideration their usability, the use of standards, and a more robust planning for the verification, validation, transfer and records maintenance of the design and development activities
• Harmonization of validation requirements for different software applications, such as QMS software, process control software, software for monitoring and measurement. A greater emphasis on appropriate infrastructure, particularly for the production of sterile medical devices, and additional requirements for the validation of sterile barrier properties.
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision
iso certification in philippines of associated activities (e.g. technical support). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of this International Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
Factocert believes in end to end management system. We are proud to have a well-balanced relationship among her clients at every point of time. The integrity of the management system is analysed by the integrity of each individual in the organisation. The intellectuality that is created between the concert and the process leads in each department plays a major role during the implementation of ISO 13485 standard. We go through a well-known factor of in order to understand the requirements of customer and we put in a lot of effort in order to obtain the complete requirements. We always believe in the mantra says "your success is Our success". Implementation of ISO certification in the organisation will always help the organisation to reach or to obtain the desirable result. Factocert will always put forth the need of your company first. We believe in having a constant management relationship among the customers so that the client will never feel or absence when they need us.
The processes required by this International Standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes. If applicable
iso certification in philippines regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to this International Standard reflect any exclusion of design and development controls.
Post new
My articles
Deals Facebook
Google plus
Deals Twitter