Auditing for AS9100, ISO 9001 and ISO 13485: Your Comprehensive Guide

Identifying areas for improvement: Audits can help you to identify areas where your QMS is not working effectively. This can be due to a variety of factors, such as outdated procedures, poor communication, or lack of training. Once you have identified these areas, you can take steps to improve them.

Reducing costs: By improving your QMS, you can reduce costs associated with waste, rework, and customer complaints.

Improving efficiency: Audits can help you to identify and eliminate bottlenecks in your processes. This can lead to improved efficiency and productivity.

Delivering better products and services: By improving your QMS, you can deliver better products and services to your customers. This can lead to increased customer satisfaction and loyalty.

Internal audits: Internal audits are conducted by your own employees. These audits are typically used to identify areas for improvement and to ensure that your QMS is meeting your internal requirements.

Second-party audits: Second-party audits are conducted by your customers or suppliers. These audits are typically used to assess your organization’s ability to meet their specific requirements.

Third-party audits: Third-party audits are conducted by independent certification bodies. These audits are typically used to achieve certification to a recognized QMS standard, such as AS9100, ISO 9001, or ISO 13485.

Experience: The auditing provider should have experience auditing organizations in your industry and to the specific QMS standard(s) that you are certified to.

Qualifications: The auditors should be qualified and experienced professionals. They should be certified by a recognized professional body, such as the American Society for Quality (ASQ).

Independence: The auditing provider should be independent of your organization. This means that they should not have any financial or other interests in your organization.