Starting with management support and identifying the customer requirements for the QMS, you will need to start developing documentation including the Quality Policy, Quality Objectives, and Quality Manual. Together, these define the overall scope and implementation of the Quality Management System. Along with these, you will need to create the mandatory and additional processes and procedures necessary for your organization to properly create and deliver your product or service. For a good explanation on this, take a look at the article List of mandatory documents required by ISO
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A principal difference, however, is that ISO requires the organization to demonstrate continual improvement , whereas ISO requires only that the certified organization demonstrate the quality system is effectively implemented and maintained.
Additionally, the ISO requirements regarding customer satisfaction are absent from the medical device standard. Several registrars also act as Notified Body. For those medical devices requiring the pre-market involvement of a Notified Body, the result of a positive assessment from the Notified Body is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union. A very careful assessment of the company Quality Management System by the Notified Body, together with the review of the required Technical Documentation, is a major element which the Notified Body takes into account to issue the certificate of conformity to the company product s.
The Cofepris is the body assigned to its control, verification and to grant the records of compliance to the companies that implement this Standard of Good Manufacturing Practices. In , The Farmacopea de los Estados Unidos Mexicanos United Mexican States Pharmacopoeia , medical industrial sectors and Cofepris are working together for updating NOM Standard, putting special attention on managing risks during manufacture and regulating by manufacturing lines some of the most important medical devices manufacturing processes.
This standard will be published in August , and days after publication it will become mandatory for the industry. In Spain, medical devices are named in ISO as "Sanitary Products" as Castellano-language translation of ISO, but in Mexico they are known as "Medical Devices" and correspond to those used in medical practice and that meet the definition established by NOM as: Medical device, to the substance, mixture of substances, material, apparatus or instrument including the computer program necessary for its proper use or application , used alone or in combination in the diagnosis, monitoring or prevention of human or auxiliary diseases in the treatment of the same and of the disability, as well as the employees in the replacement, correction, restoration or modification of the anatomy or human physiological processes.
Medical devices include products of the following categories: medical equipment, prostheses, orthotics, functional aids, diagnostic agents, supplies for dental use, surgical, healing and hygiene products.
What is ISO 13485?
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 of associated activities e. ISO can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of ISO 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. If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system.