ISO 14971:2007 Medical devices Application of risk management to medical devices ISO Guide Risk management - Vocabulary. Risk Management is a requirement-product Realization clause 7.1 o See guidance standards. Are audits reviewed at management review as a means to improve effectiveness? (5.6)ġ1.5: INTERNAL AUDIT CHECKLIST = + Requirements in addition to ISO 9001 are Highlighted in yellow in this document Throughout this document, you will find the following assistance: Links to supporting information are underlined blue text Links to buy Standards directly from the source are Underlined Bold Red text Here are some resources: Comparison between ISO 9001-and-ISO Buy copies of the ISO13485 standard to pinpoint the areas that need attention. Are corrective actions from internal audits closed in a timely manner? How many overdue actions are there? (8.5.2)ġ0. Is the audit programme on track (or have some audits been missed this year?) (8.2.4)ĩ. Are these records maintained? Are they up to date? (4.2.5) System Effectiveness & ImprovementĨ. Are records of internal audits maintained? (8.2.4)ħ. – Are actions then taken to address any non-conformances – addressing the cause and ensuring that the issue does not recur (8.5.2) Reporting & RecordsĦ. – How corrective actions are agreed, verified and followed up? – Nonconformity reporting – how is the achieved and what happens with the report? – Checklist preparation or similar as a means to record objective evidence? Review audit procedure (it must be documented) (8.2.4) does this cover: Are auditors competent? Check training certificates/records. Does the programme reflect the results of previous audits & importance of process? (8.2.4)Ĥ. Does the audit programme cover all processes & clauses of ISO 13485? (8.2.4 a and b)ģ. Is there an audit programme available, approved and communicated?(8.2.4)Ģ. Here is a checklist that will allow you to thoroughly audit your ISO 13485 internal audit system. This allows you to show that the system if fully implemented and effective.
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