Clause 8.2.2 Internal audit

A second source of information is a periodic self-assessment (internal audit). This allows an organization to determine the strengths and weaknesses of the quality system in place. It should become apparent whether or not the quality system meets the requirements of this standard and if the system has been effectively maintained.

Each organization should develop competence in its members for internal auditing. The internal auditors should not audit there own work and should be objective and impartial in the audit process.
The planning of audits needs preparation. Critical areas in the organization or departments that have been reorganized should be audited more frequently and/or more in-depth than other areas. Similarly, if there are indications of weaknesses in certain areas, for example customer complaints or previous audit findings, then those areas deserve more attention during internal audits.

An auditor should look for evidence of compliance to the requirements. Are the activities done in the way they should be done? This is not an exercise in finding mistakes. Rather, it is gathering information about the system so that the organization knows its strengths and weaknesses and can therefore improve. Evidence of compliance can be collected, for example, by interviewing people, observing activities, looking at the records and procedures.

Organizations need to keep records of the results of internal audits. This can be done on a checklist or on a report. Either way, it should be clear which requirements have been audited and which areas were/or were not in compliance, with the requirements. These results then need to be reported to management so that timely corrective actions can be taken where necessary. The implementation of these corrective actions should then be verified to ensure that the deficiencies have been resolved.

Internal audit activities should be conducted at planned intervals with an objective to:

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  verify compliance to requirements of QMS


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  verify effectiveness of QMS implementation

Audit should be conducted by persons, independent of the area being audited. Audit should be impartial and auditor should not audit their own work.

When a nonconformity is observed, the person responsible for that area should correct the nonconformity, if needed and if possible, and should take appropriate corrective action without undue delay.

The best way to attack nonconformity is to analysis and note down all the possible causes of the nonconformity than priorities the reasons (causes) and then resolve one by one. You may decide not to take action on certain cause by justifying it. Reasons for such cases could be the reason beyond the control of the area or organization.

For example, reasons for delay in delivery could be delivery clearance not received from the customer, or non-payment by customer. Such reasons are beyond organizations control but it should be seen that the organizations made sufficient follow-up with the customer to move the things?

ISO 9001 requires that the responsibilities and requirements for conducting internal audits be documented in a procedure.
In 2008 edition a note at the end of clause now refers to ISO 19011 for guidance instead of ISO 10011 part 1, 2 and 3 (2000 edition).

ISO 19011 was released in 2002 and as such applicable for external audits. This standard can be used as guidance for internal audit also. Auditing guidelines given in this e-book is based on best industry practices, though they are broadly based on 19011: 2002.

External Document Reference: Documentation Kit

Procedure for Internal Quality Audit

Yearly Plan for Internal Quality Audit

Internal Audit Schedule

Internal Audit Report - Management Representative

Internal Audit Report - Maintenance

Internal Audit Report - Human Resources

Internal Audit Report - Marketing

Internal Audit Report - Purchase

Internal Audit Report - Production

Internal Audit Report - Stores

Internal Audit Report - Despatch

Internal Audit Report - Calibration

Internal Audit Report - Quality Assurance

Internal Audit Report - Corrective and Preventive Actions

Internal Audit Report - Design

Additional Key words: internal auditor examination, auditor qualification