Registration to the ISO 9001 standard requires which of the following types of audit?

Registration to the ISO 9001 standard requires a formal assessment by an independent, accredited organization, commonly known as a registrar or certification body. This type of audit is defined as a third-party audit. The "third party" is an external organization that is impartial and independent of the organization being audited (the first party) and its customers (the second party). The purpose of this audit is to provide an objective evaluation of the quality management system's conformity to the ISO 9001 requirements, leading to official certification or registration upon successful completion.

A. Process: This describes an audit's scope or focus (evaluating a specific process), not the relationship between the auditor and auditee required for certification.

B. Product: This describes an audit's scope focused on a specific product's conformance to specifications, which is different from a system-wide registration audit.

C. Second-party: This is an external audit performed by a customer on its supplier. It is not for independent, internationally recognized registration.

1. ISO 19011:2018

Guidelines for auditing management systems

Clause 3

"Terms and definitions." This standard

which provides guidance on auditing

defines a third-party audit as one "conducted by an independent auditing organization

" such as those that provide certification/registration of conformity to the requirements of ISO 9001.

2. Breyfogle III

F. W. (2015). The ASQ Certified Quality Engineer Handbook (4th ed.). ASQ Quality Press. In Chapter 8

"The Quality Audit

" Section II.C

"Types of Quality Audits

" it is explicitly stated: "Third-party audits are performed by an independent organization for the purpose of certification or registration."

3. International Organization for Standardization (ISO). (n.d.). Certification. Retrieved from the official ISO website. The site explains that "certification is not a requirement of ISO 9001

but is a way of providing independent verification... This is carried out by third-party certification bodies." This confirms that the process leading to registration is a third-party activity.

4. Purdue University

Manufacturing Extension Partnership (MEP). (n.d.). ISO 9001 Certification Process. Courseware and guidance materials from Purdue MEP

a reputable institution-affiliated body

describe the certification process

stating

"The third-party audit is the final step before you can be certified... The auditor is from an accredited certification body."