Чеклист документации системы качества, соответствующей требованиям MDR
Вы можете использовать наш контрольный список документации по управлению качеством, чтобы оценить полноту вашей системы управления качеством и ее соответствие MDR.
Документация системы менеджмента качества составляет основу оценки соответствия медицинского изделия MDR и играет ключевую роль в процедуре получения CE-маркировки. Поэтому структурированная и полная документация СМК - один из факторов успеха при выведении медицинских изделий на рынок ЕС.
Документация СМК составляет основу процедуры оценки соответствия и сертификации. Благодаря этой документации производители могут продемонстрировать соблюдение нормативных требований и гарантировать, что процессы, используемые компанией, направлены на безопасность и эффективность их медицинских изделий на европейском рынке.
Ниже приводится чеклист документации системы качества, соответствующей требованиям MDR.
Примечание. Соответствие MDR и ISO 13485
ISO 13485 служит основным стандартом для систем управления качеством в области медицинских изделий. ISO 13485 - это гармонизированный стандарт. Это значит, что выполнение требований ISO 13485 предполагает выполнение какой-то части требований MDR. Однако важно знать, что ISO 13485 не охватывает все аспекты MDR. Существует ряд требований MDR, которые не отраженные в ISO 13485.
Примечание. Универсального решения не существует
Каждая компания структурирует свою систему управления качеством таким образом, чтобы она лучше всего соответствовала ее деятельности. Несмотря на наличие гибкости, достижение соответствия MDR требует соответствия общим принципам, изложенным в постановлении. Приведенный чеклист предлагает рекомендации по типичной структуре и организации документации СМК, обеспечивая отправную точку для обеспечения соответствия требованиям MDR конкретной организации.
Поскольку разные компании могут иметь свои уникальные процессы и процедуры, наш чеклист содержит раздел (внизу), в который вы можете вручную добавить конкретную документацию, связанную вашими уникальными процессами.
Чеклист документации СМК, соответствующей требованиям MDR
Заполните поле Компания/Подразделение/Отдел, отметьте флажками имеющиеся документы и поля N/A для требований, неприменимых в вашей ситуации. Распечатайте чеклист или создайте PDF-документ.
ИЛИ
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Загрузить шаблон чеклиста в формате ExcelЧеклист документации СМК, соответствующей требованиям MDR
| MDR requirements (Ann. IX, Ch. 1 (2.2)) | Mandatory documents / requirements, ISO 13485 | ISO 13485 ref., docs | Mandatory records, ISO 13485 | ISO 13485 ref., records | N/A | Available |
|---|---|---|---|---|---|---|
| QMS Mandatory Requirements | ||||||
| Manufacturer's quality objectives | Quality objectives | 4.2.1 | N/A | N/A | ||
| Quality manual | 4.2.1, 4.2.2 | N/A | N/A | |||
| Quality policy | 4.2.1 | N/A | N/A | |||
| Organisational structures with the assignment of staff responsibilities in relation to critical procedures, the responsibilities of the managerial staff and their organisational authority | The role(s) undertaken by the organization | 4.1.1 | N/A | N/A | ||
| Responsibilities and authorities | 5.5.1 | N/A | N/A | |||
| Procedure for competence, training and awareness | 6.2 | Records of education, training, skills and experience | 6.2 | |||
| Methods of monitoring whether the operation of the quality management system is efficient and in particular the ability of that system to achieve the desired design and device quality, including control of devices which fail to conform | Procedure for the validation of the application of computer software | 4.1.6, 7.5.6, 7.6 | Records of software validation activities | 4.1.6, 7.6 | ||
| Procedure for document and record control | 4.2.4, 4.2.5 | Records of product requirements changes | 4.1.6, 7.6 | |||
| Procedure for competence, training and awareness | 6.2 | Records of product requirements changes | 7.2.2 | |||
| Procedure for management review | 5.6.1 | Records of management review | 5.6.1 | |||
| Procedure for internal audit | 8.2.4 | Internal audit plan, Internal audit report | 8.2.4 | |||
| Requirements for the infrastructure | 6.3 | N/A | N/A | |||
| Requirements for the maintenance activities | 6.3 | Records of the maintenance activities | 6.3 | |||
| Requirements for the work environment | 6.4.1 | N/A | N/A | |||
| Procedure to monitor and control the work environment | 6.4.1 | N/A | N/A | |||
| Requirements for health, cleanliness and clothing of personnel | 6.4.1 | N/A | N/A | |||
| Procedures for validation of processes | 7.5.6 | Records of the results and conclusion of validation | 7.5.6 | |||
| Requirements for control of sterile medical device contamination | 6.4.2 | Records of the results and actions arising from review of requirements related to product | 7.2.2 | |||
| Procedure for rework | 8.3.4 | Records of rework | 8.3.4 | |||
| Requirements for control of sterile medical device contamination | 6.4.2 | Record of nonconformity. Records of the product acceptance by concession and the identity of the person authorizing the concession | 8.3.1, 8.3.2 | |||
| Procedure for control of nonconforming product | 8.3.1 | Record of nonconformity. Records of the product acceptance by concession and the identity of the person authorizing the concession | 8.3.4 | |||
| Procedure for analysis of data | 8.4 | Records of the results of data analyses | 8.4 | |||
| Procedure for preserving the conformity of product | 7.5.11 | N/A | N/A | |||
| Procedure for monitoring and measuring equipment | 7.6 | Records of the results of calibration and verification of monitoring and measuring equipment | 7.6 | |||
| Where the design, manufacture and/or final verification and testing of the devices, or parts of any of those processes, is carried out by another party, the methods of monitoring the efficient operation of the quality management system and in particular the type and extent of control applied to the other party | Written quality agreements with outsource partners | 4.1.5 | Records of the results of evaluation, selection, monitoring and reevaluation of supplier | 7.4.1 | ||
| Procedure for purchasing | 7.4.1 | Records of the purchased product verification | 7.4.3 | |||
| Strategy for regulatory compliance, including processes for identification of relevant legal requirements, qualification, classification, handling of equivalence, choice of and compliance with conformity assessment procedures | - | - | Records on identification of regulatory and customer requirements | - | ||
| Procedures for identification of applicable general safety and performance requirements and solutions to fulfil those requirements, taking applicable CS and, where opted for, harmonised standards or other adequate solutions into account | - | - | Records on identification of regulatory and customer requirements | - | ||
| Procedures for risk management as referred to in Section 3 of Annex I | Processes for risk management in product realization | 7.1 | Records of risk management activities. Outputs of product realization planning | 7.1 | ||
| Procedures for fulfilling the applicable specific requirements regarding design and construction, including appropriate pre-clinical evaluation, in particular the requirements of Chapter II of Annex I. | - | Records of design and pre-clinical tests and evaluation | - | |||
| Procedures for clinical evaluation, pursuant to Article 61 and Annex XIV, including post-market clinical follow-up | - | - | Clinical evaluation report, PMCF report | - | ||
| Procedures to keep up to date the clinical evaluation plan, taking into account the state of the art. | - | - | Clinical evaluation report, PMCF report | - | ||
| The documentation on the manufacturer’s post-market surveillance system and, where applicable, on the PMCF plan, and the procedures put in place to ensure compliance with the obligations resulting from the provisions on vigilance set out in Articles 87 to 92. | - | - | PMS report | - | ||
| Procedures in place to keep up to date the post-market surveillance system, and, where applicable, the PMCF plan, and the procedures ensuring compliance with the obligations resulting from the provisions on vigilance set out in Articles 87 to 92, as well as the undertaking by the manufacturer to apply those procedures. | - | - | PMS report, PMCF report | - | ||
| Solutions for fulfilling the applicable specific requirements regarding design and construction, including appropriate pre-clinical evaluation, in particular the requirements of Chapter II of Annex I | Procedure for design and development | 7.3.1 | Design and development planning documents Design and development inputs Design and development outputs Records of design and development review Records of the results and conclusions of the design and development verification Design and development validation plans Records of the results and conclusion of design and development validation Results and conclusions of the design and development transfer Records of the results and actions arising from review of requirements related to product Design and development file | 7.3.2, 7.3.3, 7.3.4, 7.3.5, 7.3.6, 7.3.7, 7.3.7, 7.3.8, 7.2.2, 7.3.10 | ||
| Procedure for purchasing | 7.4.1 | Records of the purchased product verification | 7.4.3 | |||
| In case if the design, manufacture and/or final verification and testing of the devices, or parts of any of those processes, is carried out by another party, the methods of monitoring the efficient operation of the quality management system and in particular the type and extent of control applied to the other party. | - | - | Supplier audit records | - | ||
| Device identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture | - | - | Design and development file | 7.3.10 | ||
| Management of design or quality management system changes | - | - | Records of product requirements changes, Records of design and development changes | 7.2.2, 7.3.9 | ||
| Verification and quality assurance techniques at the manufacturing stage and in particular the processes and procedures which are to be used, particularly as regards sterilisation and the relevant documents | Procedure and methods for the control of production | 4.5.1 | Record for each medical device or batch of medical devices Evidence of conformity of products with the acceptance criteria Identity of the person authorizing release of product Identity of personnel performing any inspection or testing of implantable medical devices |
7.5.1 8.2.6 8.2.6 8.2.6 |
||
| Requirements for medical device installation and acceptance criteria for verification of installation | 7.5.3 | Records of medical device installation and verification of installation | 7.5.3 | |||
| Procedure for servicing activities of medical devices | 7.5.4 | Records of servicing activities | 7.5.4 | |||
| Procedure for the validation of processes for sterilization | 7.5.7 | Records of the results and conclusion of sterile medical device validation. Records of the sterilization process parameters | 7.5.7, 7.5.5 | |||
| Arrangements for the control of contaminated or potentially contaminated product | 6.4.2 | Control records | N/A | |||
| Tests and trials which are to be carried out before, during and after manufacture, the frequency with which they are to take place, and the test equipment to be used; it shall be possible to trace back adequately the calibration of that test equipment. | Procedure for design and development | 7.3.1 | Design and development file | 7.3.10 | ||
| Verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29 (art. 10) | Procedure for product identification | 7.5.8 | Product identification records | - | ||
| Procedure for traceability | 7.5.9.1 | Records of traceability, Records of the name and address of the shipping package consignee | 7.5.9.2, 7.5.9.2 | |||
| Procedures for fulfilling the applicable specific requirements regarding the information to be supplied with the device, in particular the requirements of Chapter III of Annex I | - | - | N/A | 8.2.3 | ||
| Handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders (art. 10) | Procedure for customer feedback gathering | 8.2.1 | Customer feedback report | 8.2.1 | ||
| Procedure for complaint handling | 8.2.2 | Complaint handling records | 8.2.2 | |||
| Procedure for issuing advisory notices | 8.3.3 | Records of actions relating to the issuance of advisory notices | 8.3.3 | |||
| Arrangements for communicating with customers | 7.2.3 | Report to the customer about changes on his property | 7.5.10 | |||
| Processes for reporting of serious incidents and field safety corrective actions in the context of vigilance | - | - | Records of reporting to regulatory authorities | 8.2.3 | ||
| Management of corrective and preventive actions and verification of their effectiveness | Procedure for corrective actions | 8.5.2 | Records of corrective actions | 8.5.2 | ||
| Procedure for preventive actions | 8.5.3 | Records of preventive actions | 8.5.3 | |||
| Company-specific requirements | ||||||
| Procedures for company-specific processes | R&D and manufacturing company specific processes | |||||
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