1. General Information
Audit Objective | Internal audit |
Auditors | List the names of internal auditors |
2. Internal Participants
Name | |
Team | |
Position/Role | |
Audit Date | |
Start Time | |
End Time | |
Scope | |
Audit Criteria |
3. Audit Activities
Refer to Section 4 of the IAU – Internal Audit Plan and transfer the audit schedule here.
4. Methodology
Throughout the audit, information related to the audit’s objectives, scope, and criteria was collected through appropriate sampling methods. This included information concerning interactions between functions, activities, and processes, which were verified. Only information that could be validated was considered as audit evidence, and findings were documented.
The auditor also reviewed relevant documents provided by the auditee to:
- Assess the system’s compliance with the audit criteria based on the available documentation.
- Collect necessary details to support audit activities.
Additionally, interviews with the auditees were conducted to gather information about the audited process.
5. Classification of Non-Conformities
Audit findings are categorized as follows:
- Major Non-Conformity (MNC): A significant deviation in the system or processes that could have serious implications, such as violating laws, compromising patient safety, or posing public health risks. It also reflects a major non-compliance with regulations.
- Minor Non-Conformity (mNC): A deviation in the system or processes that is unlikely to negatively affect patient safety or well-being.
- Opportunities for Improvement (OFI): Suggestions for enhancing processes to improve quality or minimize deviations.
6. Audit Protocol
Requirement | Audit Question | Audit Record & Evaluation / Finding |
---|---|---|
ISO 13485:2016, chapter 4.2.3 | For each type or family of medical devices, the organization must create and maintain one or more files containing or referencing documentation to demonstrate compliance with this International Standard and applicable regulations. These files must include, but are not limited to: |
- a) general description, intended use, and labeling, including any instructions for use;
- b) product specifications;
- c) specifications or procedures for manufacturing, packaging, storage, handling, and distribution;
- d) procedures for measurement and monitoring;
- e) installation requirements, as needed;
- f) service procedures, as applicable.
| State the audit record (e.g., Quality Manual) and findings. |
| Continue with the remaining requirements as outlined in the audit plan. | | |
7. Audit Conclusions
7.1 Major Non-Conformities
MNC No. | Requirement | Audit Proof | Finding |
---|---|---|---|
1 | Specify requirement here. | Record reviewed. | Describe the MNC. |
7.2 Minor Non-Conformities
mNC No. | Requirement | Audit Proof | Finding |
---|---|---|---|
1. | Specify requirement here. | Record reviewed. | Describe the mNC. |
7.3 Opportunities for Improvement
OFI No. | Requirement | Audit Proof | Finding |
---|---|---|---|
1 | Specify requirement here. | Record reviewed. | Describe the OFI. |
8. Follow-up on Actions from the Last Audit
Summarize the status of actions from the previous audit. Were there any gaps that needed addressing? Were there delays in resolving non-conformities?
9. List of Documents and Information Collected During the Audit
Provide a list of the documents reviewed during the audit.