- The device manufacturer must publish an audit schedule that reflects audits at planned intervals (yes, it is acceptable to perform all of the audits at once; however, the practice is not extremely effective).
- The internal audits should be driven by importance and results of previous audits (if previous audits uncover weaknesses in the QMS, the frequency of audits in the problem area should probably be increased).
- Make sure the auditor requirements are built into the procedure, i.e., certified quality auditor or specific training requirements (recommend reviewing ISO 19011).
- The audit procedure should contain a requirement for an opening meeting (as needed).
- The audit procedure should contain a requirement for a closing meeting (as needed).
- The audit procedure should contain a requirement for documenting the results of internal audits, including record retention.
- As part of the documentation process it is imperative that the area(s) audited, personnel interviewed, processes reviewed, and procedures reviewed be documented.
- The audit procedure should address the process of pursing corrective action to correct audit deficiencies.
- The audit procedure should contain a clause for performing additional audits, when the results of an audit are unsatisfactory.
- Finally, the results of audits need to find their way into management review, including actions taken to address QMS performance issues.
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2012, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (EN ISO 13485:2012).
- Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control and quality control for medical devices and in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf