![]() ![]() Work instructions cover the same elements as a procedure but providing greater detail about the activities that should be achieved. The term quality procedure refers to the approach used to achieve the goals set by the quality policy. So, QMS will contain a variety of documents, that can be the group into the following (with its respective hierarchy):Ī quality manual is a document that states the company's intentions for operating the processes within the QMS.Ī quality policy is a document developed by management to express the directive of the top management with respect to quality. Take in mind that some of the documents won’t be mandatory if the company doesn’t perform relevant process. Clause 8.5.3: Procedure and records for preventive action.Clause 8.5.2: Procedure and records for corrective action.Clause 8.4: Procedure and records for data analysis.Clause 8.3.1: Procedure and record of control of nonconforming product.Clause 8.2.6: Identity of the person authorizing release of product.Clause 8.2.4: Records of audits and their results.Clause 8.2.4: Procedure for internal audit.Clause 8.2.3: Records of reporting to regulatory authorities.Clause 8.2.2: Procedure and records for complaint handling.Clause 8.2.1: Procedure for customer feedback.Clause 7.6: Procedure and records for validation of the application of computer software used for monitoring and measuringĨ.Clause 7.6: Procedure for monitoring and measuring.Clause 7.5.11: Procedure for preserving the conformity of product.Clause 7.5.10: Report on changes on customer property.Clause 7.5.9.2: Records of traceability and name and address of the shipping package consignee.Clause 7.5.9.1: Procedure for traceability.Clause 7.5.8: Procedure for product identification.Clause 7.5.7: Procedure and records for validation of process for sterilization and sterile barriers systems.Clause 7.5.6: Procedure and records of production and service provision process validation.Clause 7.5.5: Records of sterilization process.Clause 7.5.4: Procedure and records for servicing of the medical device.Clause 7.5.3: Records for medical device installation and verification of installation.Clause 7.5.3: Requirements for medical device installation and acceptance criteria for verification of installation.Clause 7.5.2: Requirements for the cleanliness of the product.Clause 7.5.1: Record for each medical device or batch that provides traceability.Clause 7.4.3: Record of verification of purchased product.Clause 7.4.1: Criteria and records for evaluation and selection of suppliers.Clause 7.3.10: Design and development file.Clause 7.3.9: Procedure and records for control of design and development changes.Clause 7.3.8: Procedure for transfer of design and development outputs to manufacturing.Clause 7.3.7: Design validation plans, results, and conclusions.Clause 7.3.6: Design verification plans, results, and conclusions.Clause 7.3.5: Records of design and development review.Clause 7.3.4: Design and development outputs.Clause 7.3.2: Design and development planning.Clause 7.3.1: Procedure for design and development.Clause 7.2.3: Arrangements for communication with customers.Clause 7.2.2: Records of the results of the customer requirements review and actions arising from it.Clause 7.1: Outputs of product realization planning.Clause 7.1: Process for risk management in product realization.Clause 6.4.2: Arrangements for control of contaminated or potentially contaminated product.Clause 6.4.1: Requirements for a work environment.Clause 6.3: Requirements for infrastructure and maintenance activities.Clause 5.6.1: Procedure and records for management review.Clause 5.5.1: Responsibilities and authorities.Clause 4.2.5: Procedure for record control.Clause 4.2.4: Procedure for document control.Clause 4.1.6: Procedure and records for the validation of the application of computer software.Clause 4.1.1: Roles undertaken by the organization under applicable regulatory requirements.This is the list of documents and records needed for compliance with ISO 13485:2016: ![]() The purpose of QMS documentation is to provide a clear framework for the company’s operations and a better understanding of the QMS, and finally to show the evidence of accomplishing the company’s goals and objectives. Besides, correctly organized documentation will make operations much easier. Preparation of the QMS documentation is based on the organizational needs, and it is crucial for an efficient QMS. ![]()
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