Understand the ISO 9001 Audit and Its Requirements

A key element of every organization’s quality management plan is internal audits. For an organization to comply with ISO 9001, it must also fulfil the standards for internal audits.
By conducting audits, companies can evaluate how well their systems, procedures, and output meet their own stated goals. An objective assessment of an organization’s efficacy is provided by the findings of internal audits.

What is the Value of ISO 9001 Internal Audit?

A part of the ISO 9000 family of standards, ISO 9001 is the requirements. To establish and preserve a quality management system, an organization must adhere to the criteria outlined in this document. Internal audits must be carried out frequently.

As per the requirements of ISO 9001:2015, clause 9.2, the organization ought to carry out scheduled internal audits to ascertain whether the quality management system satisfies the organization’s needs, adheres to ISO 9001:2015 requirements, and is efficiently executed and upheld.

Internal audit findings give insight into how well the organization complies with regulations and offer direction for any required remedial action.

ISO 9001: A Systematic, & Documented Process

ISO 9001 defines an Internal Audit as the systematic, impartial, and documented procedure for gathering audit evidence and impartially assessing it to ascertain the degree to which audit requirements are met. Companies must carry out scheduled internal audits to ensure that their management systems are being followed and that ISO 9001:2015 requirements are being met.

Systematic: Systematic organizations should plan ISO 9001 audit for checklist regularly and allocate the necessary funds to complete them. The management’s support is crucial to this process.

Individual: A third-party auditor who is not personally accountable for the systems, procedures, or goods under audit must conduct the audit impartially. Bias and conflicts of interest must not exist in them.

Records: Through measurements, tests, observations, and other methods, the audit must record proof of compliance requirements. After the audit’s findings are shared with management, any necessary remedial action recommendations must be carried out as soon as possible.

ISO 9001 Internal Audit Requirements

Six essential steps comprise the basic requirements of an ISO 9001 internal audit, which are often set by the quality manager of an organization, who must have taken a certified ISO 9001 auditor training course from recognized training providers:

· Create, Set up, Carry out, and Maintain the Organization’s Audit Program: Included in the programme should be the frequency of audits, the techniques to be employed, and the individual or people in charge of conducting the audits. In addition, the quality manager will set up the guidelines and reporting protocols and guarantee that the findings and suggestions from earlier audits are carried out.

· Specify the requirements and audit parameters: Ensuring that the criteria from one audit are consistent is vital since it makes it easier to evaluate how well suggestions are being implemented over time.

· Choose Impartial auditors: To avoid a conflict of interest, internal auditors must objectively represent the organization and refrain from participating in any of the operations they are auditing.

· Report Findings to Management: If an audit’s findings are simply documented on paper, they are worthless. Internal audits provide an invaluable data set that evaluates an organization’s overall ISO 9001 compliance as well as areas that need to be corrected. For the appropriate action to be taken, these must be shared with the organization’s pertinent management structures. The internal audit’s findings may also be applied to the organization’s communications strategy.

· Put suggestions and remedial measures into practice as soon as you can:
Subsequent internal audits should evaluate how effective these procedures were.
Keep the records as proof of execution.

· To ensure that records are easily accessible at the appropriate access levels for remedial action, internal reporting, and external audits, documentation management systems are needed.