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ISO 9100D Internal Audit

Internal Audits are extremely important for your QMS, and organization’s should look at them as their friends. Audits allow for organization’s to find ways to improve the effectiveness and efficiency of their system.

ISO management system standards are all required to meet the high level structure of the Annex SL. The Annex SL is a new format which is a high-level structure created by ISO. Annex Sl provides a universal structure, identical core text and common terms and definitions for all management systems (See Annex Details). Section 9.2 of the Annex  is internal audit, the requirements set by the Annex apply to quality management systems including:

  • ISO 9001:2015
  • ISO 14001:2015
  • AS9100:2016; AS9110:2016; AS9120:2016
  • IATF 16949:2016
  • ISO 27001:2013.

The AS9100:2016 standards for aerospace adopted Annex SL. The Annex is the same for ISO 9001:2015, but everything in bold italics was added.  The unique additions by the aerospace standards are preceded a “*” sign.

9.2 Internal Audit

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

Aligns with:

  1. the organization’s established requirements for its determined quality management system;

* The organization’s requirements should include customer and applicable statutory and regulatory quality management system requirements.

  1. the requirements of this International Standard;

is appropriately executed and maintained.

*When an organization conducts an internal audits, performance indicators can be assessed to determine if the quality management system is adequately executed and maintained.

9.2.2 The organization shall:

  1. plan, create, execute, and maintain an audit program including the frequency, methods, responsibilities, planning requirements, and reporting. This must take into account the importance of the processes concerned, changes affecting the organization, and the results of all prior audits;
  2. Characterize the audit criteria and scope for each audit;
  3. choose auditors and administer audits to ensure equitable results of the audit process;
  4. ensure that the results of the audits are reported to relevant management;
  5. take appropriate correction and corrective actions without undue delay 
  6. maintain documented information as evidence of the execution of the audit program and the audit results.

*NOTE: See ISO 19011 for guidance.

Helpful tips for your audit:

  • Make sure the authority of the audit team is well established. You want to work with a trained auditor who is independent of the areas they are to audit. This will help increase the cooperation from auditees.
  • Before the audit decide which areas of the company will be audited and the frequency of the audit.
  • Prepare a yearly audit schedule and distribute throughout company as appropriate
  • Establish an audit plan
  • Prepare a yearly audit schedule and distribute.
  • Develop an audit plan.
    • Determine what other audit resources are necessary such as checklists, other auditors?
  • Determine the purpose of the audit –
    • Is it a general overview of the area being audited?
    • Or is it to concentrate on a specific system within the area?
    • Do you wish to comply with government regulations? quality standards? internal procedures and system?
  • Meet with the auditors to discuss the plan, goal and scope of the audit to be conducted
  • Read the documents you will be auditing against. Understand these documents, and develop questions to ask the auditees.
  • Hold an opening meeting with the auditees.

During an Audit

  • Make sure to professional at all times, avoid being judgmental.
  • Follow all procedures including: safety, clean room, etc.
  • Explain the goal of the audit to the auditees.
  • Answer questions and/or discuss any compliance issues highlighted by auditees.
  • Make sure to be flexible, if you find a potential problem not within the scope of the audit, evaluate the potential risk of the problem
  • Encourage honesty with the auditees to get the best results

After the Audit

  • Hold a meeting to discuss the closing meeting content with the auditors.
  • Hold a closing meeting with all auditees involved with the audit.
    • Address what was done well
    • Next, address all nonconformances. Ensure that auditees understand the nonconformance and what part of the standard is not met.
  • Issue the audit report in a timely manner.
  • Advocate for auditees to decide on correction actions that will be most beneficial. Allowing them to have input will give them ownership in implementing changes.
  • Assist those responsibility for completing corrective actions by setting reasonable deadlines. The deadlines should vary depending on the severity of the nonconformance.
  • Be available and willing to help the auditees.
  • Ask for feedback on how you and your audit team were perceived – adjust your approach if necessary.
  • One last tip: Involve people!

Audits are a great way to help train others. We encourage companies to ask for a volunteer, who is not an auditor, to walk through the audit process with you. When this is done, it will help workers understand what an audit does and the importance of an audit.

Involving people creates a feeling that everyone is a vital contributor to the goal of the company:compliance.