Our mission: to provide (your users) with products that guarantee a high level of (e.g.Customers: the devices are sold to (your customers: hospitals, individuals, health professionals, other MD manufacturers, etc.).Market: (by country and/or by zone: EU, US…).Organisation: See the document “Organisation chart of the company”.It creates, develops and markets innovative medical devices on the market of (your industry). (Name of your company) is a company created in XXXX. Identification of other organisations that may impact the conformity of your activities: critical subcontractors, distributors, certification body,….Description of the clinical and market context (difficult if you have varied products).History of your company, this can be useful if the “regulatory” history is complex, with for example buy-outs/mergers, transfers of certificates, or changes in the scope of the QMS.More detailed information can be added to the quality manual, beware: it will need to be kept up to date. Think of the recipient as a new employee, a new partner, or even an auditor. □ This quality manual template can be set up according to your activities and products, using Qualitio online templates. In this article, you will find a quality manual template conforming to the requirements of Regulation 2017/745 and EN ISO 13485:2016 + A11:2021. The European regulation for medical devices requires manufacturers to write and maintain a quality manual that documents the quality management system implemented, as specified in Regulation (EU) 2017/745, Chapter I.2.2 and Annex XI.A.6.2 :Īll the elements, requirements and provisions adopted by the manufacturer for its quality management system shall be documented in a systematic and orderly manner in the form of a quality manual and written policies and procedures such as quality programmes, quality plans and quality records. Role of the manual and scope of the QMS.
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