ISO 9001 CERTIFICATION

ISO 9001 Certification audit

An ISO 9001 certification audit is a formal audit conducted by an independent third-party certification body to determine if a company's Quality Management System (QMS) complies with the requirements of the ISO 9001 standard. The ISO 9001 standard specifies the requirements for a company's QMS, which includes processes for quality planning, control, and continuous improvement.

The certification audit is conducted in two stages. In the first stage, also known as the "document review," the auditor reviews the company's QMS documentation to determine if it meets the requirements of the ISO 9001 standard. The auditor may also interview key personnel to gain an understanding of how the QMS is implemented and how it is intended to meet the standard.

If the company passes the first stage, it proceeds to the second stage, also known as the "certification audit." In this stage, the auditor will evaluate the company's QMS in operation to determine if it is effectively implemented and meets the requirements of the standard. The auditor will review records, observe processes, and interview personnel to gather evidence of the company's compliance with the standard.

If the company meets the requirements of the standard, it will be recommended for ISO 9001 certification. The certification is valid for three years, after which the company must undergo a re-certification audit to maintain its certification.

The documents required for ISO 9001 Certification Audit

The documents required for an ISO 9001 certification audit will vary depending on the company and the auditor, but typically the following documents should be available:

  • Quality manual - This is the top-level document that outlines the company's quality management system (QMS).
  • Procedures - These are documents that outline the steps involved in various processes within the company.
  • Work instructions - These are detailed instructions that describe how specific tasks should be performed.
  • Forms and records - These are documents that are used to record information related to the QMS, such as non-conformities, corrective actions, and customer complaints.
  • Organizational charts - These are documents that show the company's structure and the roles and responsibilities of each employee.
  • Training records - These are documents that show the training that each employee has received related to the QMS.
  • Risk management documentation - This includes risk assessments and risk treatment plans.
  • Process flow charts - These are diagrams that show the sequence of steps involved in various processes within the company.
  • Internal audit reports - These are reports generated from internal audits that have been conducted on the QMS.
  • Management review meeting minutes - These are minutes from management review meetings that assess the QMS and identify areas for improvement.

It is important to note that the auditor may request additional documents or information during the certification audit, depending on the specific requirements of the ISO 9001 standard and the auditor's own assessment of the company's QMS.

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