EU MDR Audit Template: Section I: Plan: (Announce and corroborate the audit details with the auditee, such as the audit team, scope, criteria, and objectives.)

• Conducted on

  Date

• Prepared by

• Location
  Address

• Audit Number (taken from Schedule)

Auditee Information:

• Auditee’s Name:

• Auditee Address

• Auditee State

• Auditee Country

• Auditee’s Responsible Host:

• (Extent and boundaries of the audit, including the locations, functions, activities, processes, and time period covered, as applicable)

  Yes

  No

  N/A

• Internal Audit For Cause Audit Supplier Audit

Audit criteria: *

• Audit Type

  Internal Audit

  For Cause Audit

  Supplier Audit

  Distribution Assessment (??)

• Location

• Number of Days performing audit

Type of Audit and Scope

• Extent and boundaries of the audit, including the functions, activities, processes covered, as applicable

Function, Process or Activity

• List all of the Functions, Processes or Activities to be audited [select PLUS (+) to add each]

Audit Criteria

• A set of policies, procedures, regulatory standards, agreements, contracts, or specifications used as a reference against which audit evidence is compared

• Audit Scope

  Select ISO 13485: 2003 ISO 13485: 2016 ISO 9001:2012 FDA 21 CFR Part 820, Quality System Regulations (US) FDA 21 CFR Part 210/211, cGMPs (US) European Medical Device Regulation (EU MDR 2017/745) Australian Regulations Procedure [TGA]:20xx Brazilian GMP RDC ANVISA:20xx Japan QMS MHLW Ordinance MO 169:20xx Health Canada Medical Devices Regulations [CMDR]:20xx Others: (List specific contracts, specifications, drawings, agreements, etc.)

  • ISO 13485: 2003
  • ISO 13485: 2016
  • ISO 9001:2012
  • FDA 21 CFR Part 820, Quality System Regulations (US)
  • FDA 21 CFR Part 210/211, cGMPs (US)
  • European Medical Device Regulation (EU MDR 2017/745)
  • Australian Regulations Procedure [TGA]:20xx
  • Brazilian GMP RDC ANVISA:20xx
  • Japan QMS MHLW Ordinance MO 169:20xx
  • Health Canada Medical Devices Regulations [CMDR]:20xx
  • Others: (List specific contracts, specifications, drawings, agreements, etc.)
List Specific Contracts, specifications, drawings, agreements [select plus (+) to add each document name]

• Document within Scope of Audit

Audit objective: *

• (a determination of the extent of conformity of the areas audited per the scope and the audit criteria)

• Assessing compliance to:

  Select National Regulations and International Standards as referenced in the criteria. Internal procedures, specifications, contracts, or agreements as referenced in the criteria Opportunities for improvement to internal systems that will demonstrate continual improvement in the effectiveness and efficiency of internal processes in relation to the quality system and the business in general.

  • National Regulations and International Standards as referenced in the criteria.
  • Internal procedures, specifications, contracts, or agreements as referenced in the criteria
  • Opportunities for improvement to internal systems that will demonstrate continual improvement in the effectiveness and efficiency of internal processes in relation to the quality system and the business in general.

Audit Methods: *

• (to obtain audit evidence via inquiry, interview, inspection, reviewing written documentation and records, observation, and confirmation)

• How will audit evidence be collected?

Audit Team

• Names

• Select auditor Role

  Lead Auditor

  Audit Team Member

Audit Team Qualification Review:

• Confirmed auditors have not provided consultancy for the auditee during the last five years

• Confirmed Auditor’s Training is Adequate

• Comments

• Section II: Agenda: (describes the order of activities, areas, elements, departments, or processes being audited after completing the desktop review)

Activity/Process/Element/Departments

• Opening Meeting

  Opening Meeting

  Lunch

  Closing meeting

• Time

  Date

• Auditor(s)

• Escorts

• Notes:

• Classification based on Level 1 to 3 and level 4 for OFI)

• Level 1 s a serious and/or systemic failure that, in the judgment and experience of the Lead Auditor, has directly compromised the assurance of controlled processes and products and/or directly compromises customer or patient safety and/or could likely result in significant regulatory action following a regulatory authority inspection. One or a combination of the following conditions would fit this definition include but are not limited to:
  • Distributed product that potentially poses a direct threat to patient safety
  • Quality System breakdown that is likely to result in significant adverse regulatory action if identified during an external inspection
  • An occurrence of fraud (i.e. data integrity breach or falsification of a product or a document)
  • An element of the quality system, international regulations, or international quality system standards not implemented
  • A repeat occurrence of a major nonconformance or FDA Form 483 observation cited in the previous or external audit of the site.
  Escalated to formal CAPA

• Level 2
  Major Level 2 is a quality system or process failure that, in the judgment and experience of the Lead Auditor, could potentially compromise the assurance of controlled processes and products. One or a combination of the following conditions would fit this definition include but are not limited to:
  • A Quality System breakdown that could shall a direct impact on patient safety or product performance that would not likely be identified as a result of subsequent controls or inspections. Implicated product has not been distributed out of control
  • A failure in a process or system that would likely be cited by a regulatory authority or customer as a significant non-compliance
  • Multiple level 3 nonconformities in different areas cited against the same requirement or (i.e. an apparent systemic problem)
  • Key records and/or evidence which cannot be properly traced leaving suspicion on their origin
  • A repeat occurrence of a Minor nonconformity or a significant number of minor nonconformance are raised in one system area that could shall a direct impact on product safety or performance or service performance
  Handled under the audit program CAPA

• Level 3 is an apparently isolated failure to comply with existing regulatory or requirements that is not likely to compromise the assurance of controlled processes and products. Types of situations that would fit this definition include but are not limited to:
  • A Quality System breakdown that could shall a direct impact on product performance that would likely be identified as a result of subsequent controls or inspections
  • A Quality System breakdown with no direct (indirect) impact on product safety or product performance or service performance
  Handled under the audit program CAPA.
  
  

• Opportunity for Improvement (OFI) is an identified area of weakness in the quality management system that can be improved upon or a suggestion to an existing system could be improved to minimize misinterpretation and void potential error. No
  Formal response recommended
  
  

• Capture each participants' name and title [Select plus (+) sign to add attendees. Indicate attendance for Opening meeting, Closing meeting, or Both

Name and Title

• Name

• Title

• Department

• Location

• Attended Opening Meeting

• Attended Closing Meeting

Findings (select plus (+) to add each finding

• Audit Finding Number:

• Rating

  Select Level 1 Level 2 Level 3 OFI (Opportunity for Improvement

  • Level 1
  • Level 2
  • Level 3
  • OFI (Opportunity for Improvement

• Reference/Requirement (Reference the quality system element, regulation, standard, procedure, contract, and/or agreement of which compliance could not be established)

• Statement

• Auditor name:

Conclusion

• Summary of the result of the audit with the main conclusions and the principal recommendations

• Outcome of the audit as it relates to the overall compliance, effectiveness of the quality system for the audited area, and after consideration of the audit objectives and evidence against the audit criteria; including nonconformities and opportunities for improvement

• Check here if an area requires re-auditing for audit schedule to be updated

Audit Report and Review

• Report Written by:

• Signature

  Sign

• Date

  Date

• Report Reviewed by:

• Signature

  Sign

• Date

  Date

• Comments: Document any disputes and / or concerns

Distribution

• Add name and Title (or Department) report is distributed to (Select Plus (+) to add names)

• Name

• Title

• Department

• Yes

  No

  N/A