Internal audit is an effective tool that is used for self-assessment of the organization and to determine the extent to which the QMS requirements are fulfilled. The results of the audit (the audit findings) shall demonstrate the effectiveness of the QMS and identify nonconformities and opportunities for improvement. Let us review the ISO 9001 requirements.
9.2.1
- The organization shall conduct internal audits at planned intervals.
- The internal audit shall provide information on whether the QMS conforms to the organization’s own requirements for the QMS.
- The internal audit shall provide information on whether the QMS conforms to the requirements of the ISO 9001 Standard.
- The internal audit shall provide information on whether the QMS is effectively implemented and maintained.
9.2.2
- The organization shall define, implement, and maintain an internal audit program.
- The program shall refer to
- The frequency and intervals of the audit
- The methods for conducting the audit
- Roles and responsibilities that take part in an internal audit
- Planning requirements
- Reporting the results
- The organization shall define the scope of the audit.
- The results shall include reference to
- The importance of the audited processes, activities, or operations
- Changes that may affect or might have affected the organization
- The results of previous audits
- The organization shall define the criteria for the audit.
- The organization shall select auditors and conduct the audit to ensure objectivity and the impartiality of the audit process.
- The organization shall ensure that the results of the audit are communicated and distributed to the appropriate relevant managerial levels.
- The organization shall ensure that nonconformities are addressed and corrective actions are applied without unnecessary delays.
- The organization shall retain documented information referring to the findings and results of the audit as evidence of the implementation of the audit program and the audit results.
- Remark—the ISO 19011 Standard may serve as guidelines for establishing and implementing QMS auditing.
Audit Program
The organization must maintain a documented program for conducting audits (internal and external). An audit program is a series of steps or specifications required by the organization in order to be able to conduct the audit. The goal of the program is to identify the required organizational elements that will be audited and determine when they will be audited. The program has several objectives:
- The audit program will ensure that the audits are conducted as planned.
- Through publication of the program, employees and personnel will understand that the internal audit is a continuous measure of the QMS and not a capricious decision made by the top management.
- The audit program shall introduce the auditor with the scope and objectives of the audit (fields, subjects, departments, locations, sites, products, areas, roles, processes, or the specific status of processes).
- The program shall specify the authorities and responsible parties that will participate in the audit (the auditor or audit team, employees, specific roles, management representatives, technical experts, etc.).
- The program shall detail the resources required for the audit (meeting rooms, personnel, records, products, production lines, etc.).
- The program shall give a description of the agenda or topics and issues that will be audited and discussed.
- The program shall indicate scheduled time frames for the different audit stages.
It is recommended that you publish and communicate the audit program. The program can appear as a list or a procedure. Some organizations also include detailed tests, investigations, or examinations that are conducted during the audit. I will refer to it as the “plan” of the audit. The program must be documented and will be submitted to the controls suggested in clause 7.5—Documented information.
Defining Planned Intervals for Internal Audits
The audits will be planned and conducted at planned intervals. The intervals shall be documented on the audit program. The goals of planning ahead are
- To allow the different units of the organization time to prepare for the audit
- To maintain a periodical plan for internal audits (usually an annual plan)
- To ensure the continuity of the audit
In practice, you may define appointments for the audit on the organizational calendar.
The ISO 9001 Standard does not require specific dates but it is more practical. If you would like to perform
Conformance of QMS to the Organization’s Requirements
The organization has determined its own requirement of the QMS while designing and developing it. The internal audit is one instrument for self-review of whether those requirements are achieved. Which type of requirements?
- Quality plans for the product: Any requirement for product realization must be evaluated on whether it was performed as planned. The best way is to sample and evaluate a product against its relevant predefined criteria. Sample a product or an output of a process, review its quality plan, detect its specifications, and check whether the product was realized according to the plan. Document the results.
- The identification and implementation of international, national, or local regulations will be evaluated. The audit shall examine the identification of appropriate regulations, their introduction to the quality processes (such as management review, or integration in the training program), implementation throughout the realization
processes, and maintenance of the appropriate records. - Processes and procedures: The audit must evaluate whether the realization processesare performed as required. It could be correlated with the quality plans. The evaluation would refer to required results or predefined criteria. Generally speaking, an audit must sample the processes and outputs and evaluate two things:
- Whether the process is managed as planned: according to its definition (process chart, diagram, SOP, etc.)
- Whether the process achieves its objectives: if the parameters of the process are valid and the outputs are as expected
This webpage contains only a fragment of the chapter 9.2 Internal audit from the book: ISO 9001: 2015 – A Complete Guide to Quality Management Systems published by:
Why choose the book ISO 9001:2015?
Share This
