Analysis of data procedure 13485

• [DOC File]ISO 13485 audit checklist

  https://info.5y1.org/analysis-of-data-procedure-13485_1_27a195.html

  ISO 13485:2003 Clause Text Sample Audit Question Evidence 4 Quality management system 4.1 General requirements 4.1q1 The organization shall establish, document, implement and maintain a …

---

• Internal Audit Checklist - Risk Analysis, Quality ...

  8.4 Analysis of data 8.4 Are appropriate data on the performance of the quality management system collected and analyzed, to include customer feedback, product conformity,

---

• [DOCX File]NSAI - NSAI | National Standards Authority of Ireland

  https://info.5y1.org/analysis-of-data-procedure-13485_1_eeef16.html

  8.4 If the analysis of data shows that the quality management system is not suitable, adequate or effective, does the organization use this analysis as input for improvement as required in 8.5 9 8.5.2

---

• [DOC File]Root Cause Failure Analysis SOP

  https://info.5y1.org/analysis-of-data-procedure-13485_1_cb9243.html

  – To methodically lead and execute a RCFA “root cause failure analysis” to uncover the actual cause of equipment failure using a defined process, facts data and logic. If the proper “root cause” is identified …

---

• [DOC File]ISO 13485 Quality Manual

  https://info.5y1.org/analysis-of-data-procedure-13485_1_ee57bb.html

  The quality system complies with ISO 13485:2016, Medical devices-Quality management systems-Requirements for regulatory purposes and the FDA’s CFR 21 Part 820: Quality System Regulation. …

---

• [DOCX File]Purpose - Medical Device Academy

  https://info.5y1.org/analysis-of-data-procedure-13485_1_327721.html

  The purpose of this procedure is to define [Company Name]’s requirements for conducting Management Reviews. Scope This procedure is the primary document meeting the applicable regulatory …

---

Nearby & related entries: