ISO 9001 Clause 9.2 Internal Audit

In ISO 9001 9.2 Internal Audit focuses on Quality Management System (QMS) and 9.2 is one of the most important tools an organization uses to check whether its QMS is effectively implemented and maintained. This clause ensures that an organization regularly evaluates its QMS through its internal audits.

In this blog post we will be discussing the following:

9.2.1 General Requirements

9.2.2 Internal Audit Program

Key Takeaways from 9.2

International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements

9.2 Internal audit

9.2.1 The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system:

a) conforms to:

1) the organization’s own requirements for its quality management system;

2) the requirements of this International Standard;

b) is effectively implemented and maintained.

9.2.2 The organization shall:

a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits;

b) define the audit criteria and scope for each audit;

c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;

d) ensure that the results of the audits are reported to relevant management;

e) take appropriate correction and corrective actions without undue delay;

f) retain documented information as evidence of the implementation of the audit programme and the audit results.

NOTE See ISO 19011 for guidance.

9.2.1 General Requirements

The organizations must:

·       Conduct internal audits at planned intervals

·       Ensure that audits determine whether the QMS conforms to:

o   The organization’s own requirements for its QMS (procedures, policies)

o   ISO 9001:2015 standard

·       Is effectively implemented and maintained

This helps identify nonconformities, risks and opportunities for improvement before external audits or customer issues arise.

9.2.2 Internal Audit Program

Organizations must:

·       Plan, establish, implement, and maintain an internal audit program, considering:

o   The importance of processes

o   Changes affecting the organization

o   The results of previous audits

Key audit program requirements:

·       Define audit criteria and scope for each audit

o   Criteria: what you’re auditing against (ISO clauses, company procedures)

o   Scope: what areas, processes, or departments will be audited

·       Select auditors and conduct audits objectively and impartially

o   Auditors should be independent of the area being audited to avoid bias.

·       Report audit results to relevant management

·       Take appropriate corrective actions without undue delay if nonconformities are found

·       Retain documented information as evidence of the implementation of the audit program and audit results

The purpose of this is to systematically and regularly verify the health of the QMS and drive continuous improvement.

Key Takeaways from 9.2

·       Internal audits check if the QMS conforms to ISO 9001 and the organization’s internal requirements.

·       A planned, risk-based audit program ensures all critical areas are audited appropriately.

·       Results must lead to corrective actions and continual improvement to maintain certification and customer trust.

In conclusion, implementing Clause 9.2 Internal Audit ensures that organizations systematically assess their QMS through planned internal audits. The insights gained from these internal audits help drive continuous improvement and strengthen overall operational control. In the next blog post we will be diving deeper into 9.3 Management Review. 

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