Dec 14, 20233 min read

Maximizing Company Quality through ISO 9001 Internal and External Audits

ISO 9001 is an international standard that specifies requirements for a quality management system (QMS). A QMS is a set of policies, procedures, and processes designed to ensure that an organization meets the needs and expectations of its customers.

One of the key elements of a QMS is auditing. Auditing is a systematic and independent process for evaluating whether a system meets specified criteria. In the context of a QMS, auditing is conducted to evaluate whether an organization's QMS meets the requirements of ISO 9001.

QMS audits can be divided into two types: internal and external. Internal audits are conducted by the organization itself, while external audits are conducted by an independent third party.

Internal ISO 9001 Audits

An internal audit is an audit conducted by the organization itself to evaluate the implementation of its QMS. Internal audits are typically conducted on a regular basis, usually once a year.

The purpose of an internal audit is to:

Ensure that the organization's QMS meets the requirements of ISO 9001
Identify and correct weaknesses in the QMS
Improve the effectiveness of the QMS

Internal audits are typically conducted by a team of auditors that includes employees from various departments within the organization. The audit team must have the appropriate knowledge and experience in QMS.

The process for conducting an internal audit typically begins with planning. At this stage, the auditor will determine the scope of the audit, the schedule for the audit, and the audit methods that will be used.

The next stage is the execution of the audit. At this stage, the auditor will collect evidence to assess whether the organization's QMS meets the requirements of ISO 9001. The evidence collected can be in the form of documents, records, and interviews with employees.

The final stage is reporting. At this stage, the auditor will report the results of the audit to the organization's management. The audit report should include the audit findings, recommendations for improvement, and actions that will be taken to address the findings.

External ISO 9001 Audits

An external audit is an audit conducted by an independent third party to evaluate the implementation of an organization's QMS. External audits are typically conducted by a certification body that is accredited by an international accreditation body.

The purpose of an external audit is to:

Ensure that the organization meets the requirements of ISO 9001
Issue ISO 9001 certification to organizations that meet the requirements

External audits are typically conducted in two stages: stage 1 and stage 2. Stage 1 audits are conducted to assess the organization's readiness for stage 2 audits. Stage 2 audits are conducted to assess whether the organization meets the requirements of ISO 9001.

The process for conducting an external audit typically begins with planning. At this stage, the auditor will determine the scope of the audit, the schedule for the audit, and the audit methods that will be used.

The next stage is the execution of the audit. At this stage, the auditor will collect evidence to assess whether the organization's QMS meets the requirements of ISO 9001. The evidence collected can be in the form of documents, records, and interviews with employees.

The final stage is reporting. At this stage, the auditor will report the results of the audit to the organization's management and the certification body. The audit report should include the audit findings, recommendations for improvement, and actions that will be taken to address the findings.

Benefits of ISO 9001 Audits

ISO 9001 audits have many benefits for organizations, including:

Improving the effectiveness of the QMS
Identifying and correcting weaknesses in the QMS
Improving customer satisfaction
Improving the organization's image
Increasing business opportunities

ISO 9001 Training

In order to conduct an ISO 9001 audit, the auditor must have the appropriate knowledge and experience. Therefore, auditors typically attend ISO 9001 training that is conducted by an accredited training body.

ISO 9001 training typically covers the following topics:

Basic concepts of QMS
Requirements of ISO 9001
Auditing methods
Auditing techniques
Auditing ethics

Conclusion

Internal and external ISO 9001 audits are two key elements of a QMS. These audits can help organizations to improve the effectiveness of their QMS, identify and correct weaknesses in their QMS, improve customer satisfaction, and improve the organization's image.

If you are interested in implementing ISO 9001:2015 in your business, you can contact an experienced business consultant. A business consultant can help you to study the ISO 9001:2015 standard, attend training, and implement ISO 9001:2015 in your business.

What are you waiting for? Contact a trusted business consultant today.

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