Internal Audit Coordination
An internal audit helps the organization understand whether its quality management system meets requirements and works in practice. It is a structured comparison of evidence with criteria.
This lesson follows an audit from planning to follow-up. Watch for the need for objectivity, the difference between a supported finding and a personal preference, and the evidence needed before an action is considered complete. The purpose is to understand the process, not to find someone to blame.
Evaluate conformity and operation
An internal audit evaluates conformity with planned arrangements, applicable requirements, and the organization's own quality management system requirements. It also examines whether the system is effectively implemented and maintained.
Having a procedure is not enough. Evidence should show how the process actually operates.
An audit is also distinct from management review. Audit results can help management evaluate the wider system, but the audit itself is a focused evaluation against defined criteria rather than a substitute for management's overall review.
Plan what will be examined
Define and record the audit scope, criteria, interval, and methods. Scope explains what is included. Criteria provide the requirements against which evidence will be assessed.
For a purchasing audit, the scope might include supplier selection and ongoing monitoring. Criteria could include applicable standard requirements and the approved purchasing procedure.
Clear planning gives the audit a useful focus. It helps the auditor and the people supporting the audit understand what evidence is relevant and what conclusions the work can reasonably support.
Use the condition of the process
When planning the audit program, consider the status and importance of the processes and the results of previous audits.
A significant change, repeated issue, or safety concern may justify focused attention instead of simply repeating last year's schedule. The plan should remain connected to what is happening in the organization.
This does not mean every process needs an identical audit each time. It means that the decisions about audit attention are informed by the process and the available evidence.
Preserve objectivity
Select competent auditors and arrange the audit to be objective and impartial. Auditors must not audit their own work.
In a small company, giving the same person another job title does not create independence. A suitable person from another function or a qualified external auditor may help.
The Quality Manager can coordinate the audit program and records while another qualified person evaluates work the Quality Manager personally performs. The arrangement needs to address the actual work and relationships, not just the names on a schedule.
Build a supported finding
A useful finding connects an applicable requirement, the evidence examined, and the observed gap. Retain the processes and areas audited, the evidence, and the conclusions.
For example, a procedure requires periodic supplier reevaluation, but the sampled supplier records lack the required review. The finding identifies that requirement and what was found in the evidence.
This gives the responsible people a clear issue to evaluate and address. A vague statement that purchasing needs improvement does not provide the same basis for action.
Stay within the evidence
State what the evidence supports. One sample does not establish that every record in the company is wrong. At the same time, an identified gap deserves attention within the scope supported by the evidence.
A recommendation or preference should not be presented as a nonconformity unless it is tied to an applicable requirement. An auditor's preferred form or layout is not itself a requirement.
This discipline makes findings fair and useful. It keeps the discussion focused on the process and evidence rather than on personal style.
Assign and carry out the response
Management responsible for the audited area ensures that necessary corrections and corrective actions occur without undue delay.
Correcting a sampled record may address that instance. A wider cause or recurring gap may need corrective action. The response should consider what the finding reveals about the process, not only how to make the sampled paperwork complete.
Using an external auditor does not transfer ownership of the response. The organization remains responsible for its actions and for following them through.
Verify the follow-up
Follow-up verifies the action taken and records the result. A status marked closed does not replace verification evidence.
Consider an external auditor checking document-control work performed by the Quality Manager. The internal team owns the response to findings. Follow-up then examines evidence that the relevant action was taken, instead of relying only on a completion statement.
Audit results and unresolved issues feed management review. That connection helps the organization use the audit to evaluate and improve the quality management system.
What to carry into your work
A useful audit has a clear plan, competent and objective evaluation, findings grounded in evidence, and follow-up that verifies action. The Quality Manager helps connect those activities while preserving the independence needed to evaluate the work fairly.
This lesson draws on the AAMI and ISO practical guide to ISO 13485, section eight point two point four. It provides introductory education. Applicable requirements and your company's approved procedures govern actual work.
SOURCE CREDIT AAMI/ISO 13485:2016 — Medical Devices: A Practical Guide (ISO 2017), §8.2.4; purchased through ANSI. This video presents original educational explanations informed by the guide. It is not an official AAMI, ISO, ANSI or FDA course. Applicable requirements and company procedures govern actual work.