ISO 9001 Stage-1 Audit - Document Review

An ISO 9001 stage-1 audit, also known as a document review, is the initial audit that a company undergoes as part of the ISO 9001 certification process. The purpose of this audit is to assess the company's readiness for a full ISO 9001 certification audit.

During a stage 1 audit, the auditor will review the company's documentation, procedures, and processes to ensure that they meet the requirements of the ISO 9001 standard. The auditor will also interview key personnel to gain an understanding of how the company operates and how it intends to meet the standard.

The stage 1 audit typically results in a report that outlines any areas where the company needs to make improvements in order to meet the requirements of the standard. The report may also include recommendations for how the company can address these areas.

Once the company has addressed any areas of improvement identified in the stage 1 audit, it will be ready to undergo a stage 2 audit, which is a full certification audit. If the company passes the stage 2 audit, it will be awarded ISO 9001 certification.

The Documents Required for ISO 9001 Stage-1 Audit

The documents that should be ready for an ISO 9001 stage 1 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.

It is important to note that the auditor may request additional documents or information during the stage 1 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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