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ISO , Medical devices –. Quality management systems –. Requirements for regulatory purposes, is an internationally agreed standard that sets out. ISO (E). PDF disclaimer. This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or . The revised ISO was published on 1 March IAF. Resolution details a covered by ISO and the life-cycle stages covered.
Hamilton Miranda. Controlled conditions shall include. These processes shall be managed by the organization in accordance with requirements of this International Standard. Where the customer provides no documented statement of requirement. Page 19 of Implementing a project like ISO Design and development changes include all changes during the product program life see 7.
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NOTE 1 If a medical device can only be validated following assembly and installation at point of use. Records of the results of the verification and any necessary actions shall be maintained see 4. Participants in such reviews shall include representatives of functions concerned with the design and development stages being reviewed as well as other specialist personnel see 5.
Page 20 of Validation shall be completed prior to the delivery or implementation of the product. These reviews are normally coordinated with the design phases and should include manufacturing process design and development. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and delivered product. Design and development changes include all changes during the product program life see 7.
Records of the results of the review of changes and any necessary actions shall be maintained see 4.
Page 21 of The changes shall be reviewed. To the extent required for traceability given in 7. When there are mergers. Records of verification shall be maintained see 4.
Purchased products above includes all products and services that affect customer requirements such as sub-assembly. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
The organization shall ensure the adequacy of specified purchase requirements prior to communication to the supplier. Specific Requirements 7. The organization shall establish and maintain a record see 4.
NOTE A batch can be a single medical device. Controlled conditions shall include.
If product is cleaned in accordance with a or b above. The batch record shall be verified and approved. Page 24 of This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.
Records of installation and verification performed by the organization or its authorized agent shall be maintained see 4.
Validation shall demonstrate the ability of these processes to achieve planned results. If the agreed customer requirements allow installation to be performed other than by the organization or its authorized agent. Sterilization records shall be traceable to each production batch of medical devices see 7.
The organization shall establish arrangements for these processes including. NOTE Servicing can include. Records of servicing activities carried out by the organization shall be maintained see 4. The organization shall establish documented procedures to ensure that medical devices returned to the organization are identified and distinguished from conforming product [see 6.
Records of validation shall be maintained see 4. Inspection and test status is not indicated by the location of product in the production flow unless inherently obvious such as material in an automated production transfer process.
Such software applications shall be validated prior to initial use. Where traceability is a requirement. In some Industry sectors. Records of validation of each sterilization process shall be maintained see 4. Sterilization processes shall be validated prior to initial use. Such procedures shall define the extent of product traceability and the records required see 4. Alternatives are permitted.
NOTE Configuration management is a means by which identification and traceability can be maintained. The identification of product status shall be maintained throughout production. Records of the name and address of the shipping package consignee shall be maintained see 4. Page 26 of The organization shall require that its agents or distributors maintain records of the distribution of medical devices to allow traceability and that such records are available for inspection.
Page 27 of The organization shall identify. The organization shall establish documented procedures or documented work instructions for the control of product with a limited shelf-life or requiring special storage conditions. Such special storage conditions shall be controlled and recorded see 4. Customer-owned returnable packaging is included in this clause. This preservation shall include identification.
Customer Property can include intellectual property. If any customer property is lost. A number of other identifier traceable to the device calibration record meets the intent of requirement c above. In addition. Records of the results of calibration and verification shall be maintained see 4.
Where necessary to ensure valid results. The organization shall take appropriate action on the equipment and any product affected. Page 29 of This shall be undertaken prior to initial use and reconfirmed as necessary.
The organization shall establish documented procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. The organization shall establish a documented procedure for a feedback system [see 7. The organization shall monitor information related to customer perception as the whether the organization has fulfilled customer requirements.
If national or regional regulations require the organization to gain experience from the post-production phase. Consideration should be given to both internal and external customers. The methods for obtaining and using this information shall be determined. Page 30 of NOTE National or regional regulations might require documented procedures for implementation and control of the application of statistical techniques.
The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Auditors shall not audit their own work.
The audit criteria. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Page 31 of Follow-up activities shall include the verification of the actions taken and the reporting of verification results see 8. The responsibilities and requirements for planning and conducting audits. An audit program shall be planned. Product release and service delivery shall not proceed until all the planned arrangements see 7.
When planned results are not achieved. When selecting product parameters to monitor compliance to specified internal and external requirements. Page 32 of Records shall indicate the person s authorizing release of product see 4.
This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements see 7. Evidence of conformity with the acceptance criteria used shall be maintained.
If product needs to be reworked one or more times. The organization shall ensure that nonconforming product is accepted by concession only if regulatory requirements are met. The organization shall deal with nonconforming product by one or more of the following ways: The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.
Page 33 of Records of the identity of the person s authorizing the concession shall be maintained see 4. When nonconforming product is detected after delivery or use has started. Prior to authorization and approval of the work instruction. When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. Records of the results of the analysis of data shall be maintained see 4.
Page 34 of The analysis of data provide information relating to: This shall include data generated as a result of monitoring and measuring and from other relevant sources. Records of all customer complaint investigations shall be maintained see 4. These procedures shall be capable of being implemented at any time. If national or regional regulations require notification of adverse events that meet specified reporting criteria. A documented procedure shall be established to define the requirements for: If investigation determines that the activities outside the organization contributed to the customer complaint.
Corrective Action shall be appropriate to the effects of the nonconformities encountered.
The organization shall establish documented procedures for the issue and implementation of advisory notices. A documented procedure shall be established to define requirements for: Preventive action shall be appropriate to the effects of the potential problems. Page 37 of Who supports the process? List Objectives as appl How is Process Measured? Is Process Effective? Personnel Interviewed: Process Name: What are the inputs of the process?
How is the process controlled and understood 4. Are individuals competent and trained in the process 6. How is output records 4. Are the objectives of the process accomplished. Flag for inappropriate content. Buscar dentro del documento. Instructions Need not be include with reports Location: Lead Auditor: Audit Team: Audit Dates: Customer-specific requirements take precedent over the ISO The format of this checklist encourages the auditor to document objective evidence based on the: