Iso 9001 Audit Types And Their Processes

By Author: Miana
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A quality management system must meet the requirements of ISO 9001:2015, the only standard in the family that can be certified. Any organization, no matter how big or little, can use it, regardless of what they do. Numerous quality management concepts, such as a strong customer focus, senior management's incentive and involvement, the process method, and continuous improvement, form the foundation of this standard.

Types of ISO 9001 Audits and Their Procedures
ISO 9001 Audits fall into two primary categories: internal and external. Audits can be carried out in three different ways:
• On-Location Audit: Complete days have been spent conducting these audits. An audit's duration is determined by several variables, such as an organization's size, complexity, risk level, and type.
• Remote Audit: Web meetings, conference calls, or electronic process verification can all be used to carry out these audits. In general, on-site audits are more successful than remote audits, but they are less common.
• Self-audit: Not every time an internal audit happens. To get your customer to stop using their resources, ...
... you can ask them to complete a self-audit.

Audit Types:
• Internal Audits: Internal Audits are on-site, in-house assessments of your company's quality management system (QMS) carried out by your organization. Internal audits are essential to the success of your QMS and are mandated by ISO 9001. To guarantee objective findings, the internal auditor needs to be separate from the subject of the audit. Internal audits will be utilized to determine possibilities for improvement, evaluate effectiveness, and assess conformance. By conducting an internal audit, you can decide if there are any non-conformances by comparing your quality management system to the criteria. By doing this, you'll be able to make necessary corrections to your QMS, make sure your company satisfies the standards of the external auditor, and obtain certification.
• External Audit: The external audit includes customer, supplier, certification, and surveillance. A customer audit is when a current or prospective client examines your business to ensure you can fulfil their needs. We categorize your audit as a supplier audit if it involves an actual or prospective supplier.
• Audit for Certification: An audit that your chosen registrar will perform to confirm compliance with ISO 9001 standards before issuing your official ISO 9001 certificate is known as a certification audit. Usually, every three years, certification audits are carried out. Following certification, your registrar will conduct surveillance audits regularly to make sure you are still adhering to ISO standards and your QMS. By using readymade ISO 9001 audit checklist templates, organizations can prepare their employees for such QMS certification audit. Except for not granting or returning certificates, surveillance audits are quite similar to certification audits. Usually, your registrar conducts these once a year.
Certification audits are usually carried out in two phases, known as Stage 1 and Stage 2. Often, step 1 is carried out virtually to ensure that stage 2 is prepared. On-site audits will always be part of stage 2 audits. Here, the auditor will conduct staff interviews and go over your written data (records, procedures, etc.) to make sure you are complying with all ISO 9001 regulations.
The clause structure is one of the most obvious variations between the 9001:2008 and 9001:2015 standards. While ISO 9001:2015 has ten clauses (Clauses 4–10), ISO 9001:2008 only has eight (Clauses 4–8), which are mandatory.
• Surveillance Audit: The ISO 9001 surveillance audit is an annual process conducted by the certification body to ensure continuous compliance with ISO 9001 standards, focusing on key processes, management reviews, corrective actions, and changes made since the last audit.
• Supplier Audit: A Supplier Audit is a process conducted by a customer organization to assess the quality management system (QMS) of a supplier or subcontractor, ensuring their processes adhere to ISO 9001 standards.

link: ISO 9001 Audit