Guide to Internal Quality Audits under ISO 9001

Guide To Internal Quality Audits Under ISO 9001 Having a quality management system (QMS) is essential for compliance with the ISO 9001 standard. It’s also important to audit this system to ensure it is having the desired effect. An internal quality audit evaluates the QMS to ensure its objectives are achieved and that the business…

Guide To Internal Quality Audits Under ISO 9001

Having a quality management system (QMS) is essential for compliance with the ISO 9001 standard. It’s also important to audit this system to ensure it is having the desired effect.

An internal quality audit evaluates the QMS to ensure its objectives are achieved and that the business complies with ISO 9001.

In this blog, we offer an overview of:

What is an internal quality audit?

An internal quality audit reviews and evaluates a company’s procedures and processes to ensure the system conforms to a quality standard such as ISO 9001. This is known as a quality system audit.

A quality audit can also focus on a service or product to assess whether it conforms to expected standards. This would be a product or service quality audit.

A successful internal quality audit highlights shortcomings and allows an organisation to change its QMS to ensure better compliance.

Essential benefits of internal quality audits

Setting up a quality management system but never double-checking its effectiveness is a recipe for disaster. Regular checks to ensure the system is compliant have many benefits.

Real-world testing

Comparing the theoretical quality management system to how it works when applied in the real world can highlight any impracticalities.

Highlighting areas of improvement

A full audit that considers feedback from staff and customers highlights weak areas in the quality management process.

Identifying non-conformance

An audit also exposes any problem areas in regard to ISO 9001 conformance that could lead to penalties.

Opportunities for upskilling

Internal audits often identify areas where employee skills are lacking or could be improved.

Preparation for an external audit

An internal audit is a good preparation for an external audit. Familiarise yourself with the expectations of an external audit and use the internal audit to ensure everything is ready.

Initiating corrective action

Audits are an opportunity to kickstart any necessary corrective and preventative actions (CAPA) that might have been overlooked.

Identifying wastefulness

Scrutinising your processes, especially in manufacturing, often highlights areas where waste of time or resources can be eliminated.

Audit report

The final audit report is a valuable resource that can be referenced as you continually improve your quality management system.

ISO 9001 requirements for internal auditing

ISO 9001 defines an internal audit as the “systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled”.

You can conduct an internal quality audit as often as necessary to improve your QMS processes. However, internal audits should be done regularly as part of a planned audit program.

Audits must be conducted by impartial auditors who are not directly responsible for the systems, processes, and products being audited to avoid conflicts of interest and bias.

All internal audits must be fully documented in a final audit report. This report, along with any recommendations for corrective action, should be provided to management.

How to conduct an ISO 9001 internal quality audit

Each organisation must implement an internal quality audit plan tailored to its services or products. Follow these basic steps when conducting an internal quality audit:

Planning

The internal audit plan should be an established process that happens regularly.

The plan should detail the audit’s scope and objectives. It should also include any forms or checklists needed for the audit, as well as who the auditors are and what they’re responsible for.

Execution

The auditing process should reference previous audits or corrective actions.

Auditors should communicate directly with the auditees so they know what to expect.

An audit should primarily look for compliance with the QMS but also identify areas for improvement and any inconsistencies.

Reporting

Once the auditors have all the information they need through interviews, documents, demonstrations, and process reviews, they must compile a report that is presented to management.

The report should be completed as soon as possible after the audit and should highlight any recommended improvements or corrective action.

Compliant process and QMS make the process very smooth and stress free.

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