ISO 9001 Lead Auditor Training

Module 6 Conducting On-site Activities

6.1.4 Collecting and verifying information During the audit, information relevant to the objectives, scope and criteria, including information relating to the interfaces between functions, activities and processes, should be collected by appropriate sampling and should be verified. Only information that is verifiable may be audit evidence. Audit evidence should be recorded. The audit evidence should be based on samples of the available information. Therefore, there is an element of uncertainty in auditing, and those acting upon the audit conclusion should be aware of this uncertainty.

See Figure 6.1.4

Process for collecting information to reaching audit conclusions:
6.1.4.1  Audit Evidence
The purpose of an audit is to collect audit evidence to permit audit findings and by evaluating the evidence against audit criteria and then reviewing all individual findings to reach an overall audit conclusion about the degree of conformity and effectiveness of the quality management system. Auditors must not allow their opinions or prejudices to influence decisions.

ISO 9001 Auditor Training - Audit evidence supports the existence or conformity of an element of the quality management system. The evidence must be capable of being verified and may be: 
• Information, records, or statements of fact
• Qualitative (non-numerical) or quantitative (numerical)
• Based on observation, measurement, or test

Audit information can exist in a variety of forms:
1. It may be quantitative, such as numerical performance data on products, processes and the QMS.
2. It may be qualitative, such as from interview, observations and documents.
3. The auditor must decide if the information is relevant to the product or quality system.
4. Statements can be used as objective evidence when made by those responsible for the activity being audited - known as “admissible statements”.
5. If possible, auditors should gather documented support for the admissible statements.
6. Nonconformities, when found, must be quantified for communication to the auditee.

6.1.4.2   Techniques to obtain objective evidence include:

Interview People:
Ø that manage, perform, and verify activities
Ø with responsibility and authority for work 
Observe Operations:
Ø for identification, status, condition, flow, and operation of:
Ø facilities, materials, product, equipment, processes, and tasks
Review Documents:
Ø pertaining to processes and activities
Ø for details of why, who, what, when, and where
Examine Records:
Ø for objective evidence of implementation of:
Ø processes, activities, controls, inspections, and tests
Evaluate Results:
Ø to summarize and analyze the audit observations  
Ø to determine the effectiveness of the quality system

6.1.4.3   Audit Sampling
• Objective evidence is obtained by sampling processes, people, documents, and records
• It is based on a small representation of the audited activities
• Not finding nonconformities does not equate to total assurance of control
• Determine sample size and selection based on:
  - complexity
  - volume
  - risk
  - past problems
  - audit time span
• Collect the sample on a random basis (ask permission of the auditee)
• Don’t let the auditee select the samples and possibly bias the representation
• Don’t dig deeper, or select another sample, if first sample doesn’t find nonconformities
• If no nonconformities are found, move on to the next area of the audit
• Review and agree on conformity with the auditee, guide, and department head
• Deviate from the audit checklist, if appropriate
• Follow unexpected audit trails only if warranted (consult Management Representative or team leader)
• Consider minimal sample size guidelines of:  4/10; 10/100; 20/1000 

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