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Important Stages to Follow During ISO 9001 QMS Internal Audit Process

ISO 9001 is an international standard that has definite requirements for a quality management system. Organizations use the standard to validate the ability to consistently offer products and services that meet customer and regulatory requirements. It is the most prevalent standard in the ISO 9000 series and the only standard in the series to which organizations can certify. ISO 9001 was primarily published in 1987 by the International Organization for Standardization and the existing version of ISO 9001 was released in September 2015. As stated above, ISO 9001:2015 is an internationally recognized standard for generating, applying and preserving a Quality Management System for an organization.

It is important to be used ISO 9001 standard by organizations of any size of the industry, and it can be used by any organization. As an international standard, it is recognized as the basis for any company to create a system to guarantee customer satisfaction and enhancement and, as such, many corporations need this certification from their suppliers. ISO 9001 certification offers customers assurance that recognized a Quality Management System based on the seven quality management principles of ISO 9001. An ISO 9001 awareness training will help to learn more about the quality management principles behind the ISO 9001 standard. ISO 9001 is such a significant standard that it is used as the basis when industry groups want to create their industry standards; this contains AS9100 for the aerospace industry, ISO 13485 standard for the medical devices industry, and IATF 16949 for the automotive industry, etc. Below mentioned 13 phases, help to understand the process of an internal audit in the organization.

  1. Initiate the Audit: To start the audit process, the ISO 9001 internal auditor must begin the audit by communicating with the process owner to be audited and confirming the audit will be practicable. It is important to make sure someone is available to present evidence when you want to audit.
  2. Review the Documents: After that, it is important to review the ISO 9001 documents for further process. This will help to understand how big of an audit it will be. This knowledge is vital for the next step.
  3. Make an Audit Plan: The document assessment process helps to develop an audit plan like what will be audited and the auditing is done by whom.
  4. Allocate Work to Auditors as per Plan: This step may be voluntary, because larger audits may allocate work amongst several auditors, with each taking more than one process to audit. Which helps to reduce the time and energy of an internal auditor. 
  5. Make Working Papers: The assigned auditor prepares the audit working papers that will categorize what the auditor wants to verify, what questions must ask, and what they need as evidence.
  6. Decide the Audit Sequence: The following step is to regulate the sequence of audits from the opening meeting through presenting audit findings. If done right, the sequence of process audits can benefit to make the audit process easier.
  7. Conduct Opening Meeting: The audit starts with an opening meeting. The agenda behind the opening meeting is to make sure that everybody knows the opportunity and scope of this audit.
  8. Review Documents and Communicate: After the meeting, any documents directly presented by the auditee should be reviewed to gather applicable information that might not have been available before. For that, communication should be continued during the audit.
  9. Carry out the Audit: In this stage, the auditor asks the questions and collects the records, and remarks that the processes meet the QMS requirements.
  10. Generate Audit Findings: After the auditor finishes the verification, they must create the audit findings and prepare an audit conclusion to be obtainable. Also, some companies use a process of having internal audits classify opportunities for improvement, which the process owner can review and accept if they wish.
  11. Present Findings and Conclusions: In this step, normally a closing meeting is for the process owners to realize and ask questions as well as present clarification if something was misunderstood in the audit.
  12. Formally Distribute Audit Report: The final findings are officially written and circulated in an audit report. This gives everybody a reference on actions required, as well as offers a record as an outcome of the audit.
  13. Follow Up on Actions: Undoubtedly the most important part of an audit is for the auditor to follow up on any actions, as a way of confirming remedial action is taken and finalizing the audit.

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Learn management system awareness and internal/lead auditor training with certification. We have trained worldwide more than 27,000 trainees.

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