Purpose of audit: | Internal audit |
Auditors: | Enter names of your internal auditors |
Name | |
Team | |
Position/Role | |
Audit date | |
Start | |
End | |
Scope | |
Audit Criteria |
See IAU - Internal Audit Plan section 4 and copy the audit schedule here.
During the audit, the auditor gathered, using appropriate sampling, information relating to the audit objectives, scope and criteria, including information relating to the interfaces between functions, activities and processes, and verified it. Only verifiable information constituted audit evidence. Audit evidence leading to audit findings was recorded.
Relevant documentation from the auditee was reviewed in order to:
In addition, information related to the audited process was gathered through interviews of the auditees by the auditors.
The classification of audit findings is established as follows:
Requirement | Audit Question | Audit Record & Evaluation / Finding |
---|---|---|
ISO 13485:2016, chapter 4.2.3 | For each medical device type or medical device family, the organization shall establish and maintain one or more files either containing or referencing documents generated to demonstrate conformity to therequirement of this International Standard and compliance with applicable regulatory requirements.The content of the file(s) shall include, but is not limited to: | State here the audit record (e.g. the Quality Manual) and the audit finding. |
Continue with the requirements that are listed in the audit plan and programme. |
MNC No. | Requirement | Audit Proof | Finding |
---|---|---|---|
1 | State the requirement here. | List the audited record. | Describe the MNC. |
mNC No. | Requirement | Audit Proof | Finding |
---|---|---|---|
1. | State the requirement here. | List the audited record. | Describe the MNC. |
OFI No. | Requirement | Audit Proof | Finding |
---|---|---|---|
1 | State the requirement here. | List the audited record. | Describe the MNC. |
Describe the follow-up of actions from the last Audit. Where there any gaps needed to be closed? Are there delays in the closing of non-conformities?
List the documents that have been audited here.
Template Copyright openregulatory.com. See template license.
Please don’t remove this notice even if you’ve modified contents of this template.