AUDIT GUIDE 08: Conducting On-Site Audit Activities – Execution and Communication
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On-site audit execution is the phase where auditors carry out the agreed audit plan at the auditee’s location. It runs from the opening meeting through document review, evidence collection by interview, observation and sampling, daily communication, and findings, to the closing meeting, following ISO 19011:2018 clause 6.4 so conclusions rest on verifiable evidence.
Executing an on-site audit effectively takes clear communication, defined roles and structured document review. Well-run opening meetings, daily reviews and closing activities keep the audit objective and produce results the organization can act on. For the groundwork that comes before this stage, read our guide on Preparing for On-Site Audits.
PopularCert is an independent consulting firm. Certification audits are performed by accredited certification bodies.
Table of Contents
Based on ISO 19011 Guidelines
This guide follows the audit execution principles in ISO 19011:2018, Guidelines for auditing management systems, the internationally recognized reference for planning and conducting first-, second- and third-party audits. Following this structure keeps your audit program in line with accepted practice, whether you are preparing for an internal audit or hosting an external certification body.
Opening Meeting
An opening meeting should be held with the auditee’s management or, where appropriate, those responsible for the functions or processes to be audited before the commencement of the audit.
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Internal audit: In small organization’s, the opening meeting may simply consist of communicating that an audit is being conducted and explaining its nature.
External audit: The meeting should be formal, chaired by the audit team leader, and attendance records kept. Visit our blog on Audit Methods and Evidence.
Opening Meeting Agenda
The following points should be covered:
Introduction of participants, including observers and guides, and outline of their roles
Confirmation of audit objectives, scope, and criteria
Confirmation of audit plan (timetable) and other arrangements
Presentation of methods to be used, including sampling
Introduction of methods to manage risks created by audit team presence
Confirmation of communication channels and language
Confirmation of cultural, religious, or social customs.
Availability of resources and facilities
Confidentiality and information security
Health, safety, emergency, and security procedures
Availability and role of guides
Reporting methods and grading of nonconformities
Conditions under which the audit may be terminated
Format and schedule of closing meeting
Feedback system from the auditee
On completion, a brief site tour may be conducted to acquaint the team with the premises.
Audit Objectives and Program Review
Clarify audit purpose: to evaluate systems, not reject the auditee
Review audit plan/schedule
Confirm working hours, lunch arrangements, and breaks
Before an ISO audit begins, the lead auditor should confirm the audit objectives, scope, criteria, schedule, and responsibilities with the organization’s representatives. The purpose is to establish how the management system will be evaluated against the applicable requirements using objective evidence not simply to search for faults or reject the auditee.
During this stage, the auditor typically:
- Confirms the audit objectives, scope, and applicable criteria.
- Reviews the audit plan, timetable, departments, sites, and processes to be assessed.
- Identifies the process owners and key personnel required during interviews.
- Reviews relevant previous audit findings and unresolved nonconformities, where applicable.
- Confirms how documents, records, interviews, observations, and sampling will be used as audit evidence.
- Establishes communication methods between the auditor and auditee during the assessment.
- Confirms practical arrangements such as working hours, breaks, site access, safety requirements, and confidentiality.
- Provides an opportunity for management to raise questions or clarify concerns before audit activities begin.
A well-defined audit program helps keep the assessment focused, minimizes unnecessary disruption to operations, and ensures that audit conclusions are based on consistent and verifiable evidence.
On-Site Audit Arrangements to Agree at the Opening Meeting
Topic | What to agree |
Methods and Procedures | Findings are discussed daily with the auditee. Agree who represents the auditee at the daily review meetings. |
Auditee’s Representative | The auditee assigns a representative to accompany the auditors. Representatives sign Audit Findings Reports as witnesses, not as agreement. |
Facilities | Confirm workspace, network access, printing and other facilities in advance, so there are no unsuitable last-minute arrangements. |
System Deficiency | Recurring findings may indicate a system deficiency. |
Extent of the Audit | An audit cannot cover every activity. Findings reflect the sample examined, and an absence of findings does not mean there are no issues. |
Final Meeting | Explain the format, date, time, venue and participants. |
Confidentiality | Findings are confidential. Reference NDAs where applicable. |
Aborting the Audit | An audit may be aborted if there are major documentation problems, senior management commitment is lacking, major system changes affect proper functioning, or co-operation is missing. |
Issue of Final Report | The report goes to the organization on whose behalf the audit is conducted. Third-party registration reports are also sent to the auditee. |
Legal Aspects | Legal waivers or releases are discussed if auditors could be held liable. |
Time Limit for Corrective Action | Agree the corrective action procedures and timeframes. |
Initial Look at the Premises | A site visit before the meeting improves planning and lets the schedule be adjusted. |
Performing Document Review During the Audit
Review documentation to determine conformity and gather evidence
Combined with other audit activities as long as effectiveness is not affected
If documentation is inadequate, audit may be suspended until resolved
Worked Example: Sampling and Evidence in Practice
An audit cannot examine every record, so auditors use sampling. ISO 19011:2018 does not prescribe sample sizes. The auditor chooses a sample that is representative and sensible for the risk, then reports conclusions only within what was actually examined.
Illustrative scenario (hypothetical figures): An internal audit of an ISO 9001:2015 manufacturer, covering control of nonconforming outputs (clause 8.7). The company raised 48 nonconformity reports (NCRs) in the last six months across two sites.
Step 1: Define the population and the question.
The population is all 48 NCRs from the last six months. The audit question is: Were nonconforming outputs identified, controlled and dispositioned by authorized people, with records kept?
Step 2: Choose the sampling approach and size.
The auditor selects 10 of the 48 NCRs. This is a judgement sample, not a standard requirement, and it is built as follows:
Selection basis | NCRs selected | Why |
Open longer than 30 days | 3 (all of them) | Highest risk of uncontrolled product |
Customer-reported | 2 | Escapes that reached the customer |
Site A, random | 3 | Coverage of the larger site |
Site B, random | 2 | Coverage of the second site |
Step 3: Collect and verify evidence.
For each NCR, the auditor combines three methods: document review (the NCR and disposition record), interview (the person who authorized disposition) and observation (the quarantine area).
NCR | Method | Evidence examined | Result |
NCR-014 | Record + interview | Disposition signed by QA manager, rework instruction completed | Conforms |
NCR-021 | Record + observation | Part tagged and found in the quarantine area | Conforms |
NCR-033 | Record + interview | “Use as is” approved by a supervisor with no authority; no customer concession on file | Gap |
NCR-039 | Record | Closed with no evidence of re-inspection | Gap |
Other 6 NCRs | Record + interview | Complete and consistent | Conform |
Step 4: Evaluate and report.
Two of the 10 sampled records show gaps. The auditor reports exactly that: “In a sample of 10 of 48 NCRs, 2 lacked evidence of authorized disposition or re-inspection.” The auditor does not claim that 20% of all 48 NCRs fail. Because the gaps point to a possible systemic issue with disposition authority, the audit team may extend the sample, and they agree this at the daily review.
Step 5: Agree the facts.
Present the two NCR numbers to the process owner at the daily review, so the facts are agreed before the closing meeting.
Communication During the Audit
- Hold periodic team discussions to assess progress.
- Report significant risks immediately to the auditee and the audit client.
- Report any out-of-scope issues so they can be communicated where appropriate.
Roles of Guides/Escorts and Observers
- Guides and observers assist the audit without interfering with it.
- Health, safety, security and confidentiality are managed between the audit client and the auditee.
- Guide responsibilities include arranging interviews and site visits, providing clarification and witnessing audit activities.
On-Site Audit Execution Checklist
Use this as a working checklist and adapt it to your audit plan and criteria.
Before the opening meeting
- Audit plan, scope, objectives and criteria confirmed with the auditee
- Auditee representative or guide assigned
- Workspace, network access and printing arranged
- Site safety, security and confidentiality requirements understood
Opening meeting
- Attendance recorded; team, observers and guides introduced
- Objectives, scope, criteria and timetable reconfirmed
- Audit methods and sampling approach explained
- Communication channels, language and daily review time agreed
- Grading of nonconformities and reporting method explained
- Conditions for terminating the audit stated
- Closing meeting format, date and attendees confirmed
During the audit
- Documented information reviewed against the criteria
- Evidence collected by interview, observation and record review
- Sample selected, with the basis for selection noted
- Every finding backed by a record reference, not recollection
- Significant risks reported immediately to auditee and audit client
- Out-of-scope issues noted for the audit client
- Daily team discussion and auditee review held
Before the closing meeting
- Findings graded and reviewed by the team
- Facts for each finding agreed with the process owner
- Audit conclusions drafted within the limits of the sample
- Corrective action process and timeframes explained
After the audit
- Report issued to the audit client, and to the auditee where required
- Corrective action follow-up scheduled
Conclusion
careful document review and clear roles for team members and guides. Following these steps keeps audits effective, objective and actionable.
PopularCert provides expert guidance on on-site audit execution and management system compliance. Partner with PopularCert to run audits that meet international standards efficiently and reliably, or return to the Complete ISO Audit Guide for the full series.
Sources and Further Reading
Conclusion
Successful on-site audit execution relies on structured opening meetings, active communication, careful document review, and clear roles for team members and guides. Following these steps ensures audits are effective, objective, and actionable.
We provide expert guidance for on-site audit execution and management system compliance. Partner with Popularcert to conduct audits that meet international standards efficiently and reliably.
FAQ
What is the purpose of an opening meeting?
To confirm the audit plan, introduce the team and establish communication with the auditee.
How should audit findings be communicated?
Through daily discussions and agreed reporting methods, which keep findings clear and let action start promptly.
How is evidence sampled during an on-site audit?
Auditors select a representative sample of records, activities and people based on risk and the audit plan, then verify it through document review, interviews and observation. Conclusions apply to what was sampled, and the sample may be extended if findings suggest a wider issue.
What are the responsibilities of guides and observers?
Guides assist and facilitate the audit without influencing outcomes. Observers must not interfere.
When can an audit be terminated?
An audit may be aborted if documentation is insufficient, senior management commitment is lacking, major system issues exist or co-operation is missing.
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