Preparing for Your ISO 9001 Audit: A Comprehensive Guide

Ensuring your organisation is well-prepared for an ISO 9001:2015 audit is crucial for maintaining certification and demonstrating a commitment to quality management.

To support you in this process, we have compiled a checklist to guide your preparations and ensure you meet all necessary requirements. We also have a Podcast on Demystify the Audit Process, providing you with a comprehensive understanding of what to expect when your organization undergoes an audit.

Key Areas to Address for an ISO 9001 Audit

Over the audit period, it is essential to review and maintain the following areas:

• Quality Documentation: Ensure the Quality Manual, procedural documents, and the Document Register are available and up to date.
• Quality Management System (QMS) Planning: Regularly review the planning of your QMS to ensure alignment with your business objectives.
• Quality Policy: Verify that the Quality Policy is signed, communicated to personnel, and prominently displayed.
• Authorisation of Key Documents: Confirm that the Quality Manual and the Scope of QMS document are signed as authorised.
• Training Records: Maintain up-to-date training records for each employee, ensuring they are reviewed, signed, and dated.
• Induction Training: Have evidence that new employees have received induction training, including an introduction to the QMS.
• Training Plans: Keep all training plans completed, reviewed, and current.
• Customer Complaints Management: Ensure a complaints file and register are available and up to date.
• Internal Issues Tracking: Maintain a register of non-conformances and reworks for review.
• Management Review: Document minutes from management reviews, ensuring all agenda items are addressed.
• Internal Quality Audit Programme: Record planned audits for the year and minute completed audits.
• Roles & Responsibilities: Ensure organisational responsibilities are up to date and authorities are clearly understood.
• Risk and Opportunities Review: Assess and document organisational risks and opportunities, including a review of the risk register if applicable.
• Quality Objectives: Evaluate whether quality objectives have been met and documented.
• Amendments & Updates: Maintain tables of amendments for any changes to the Quality Manual.
• Non-Compliance Actions: Ensure Internal Quality Audit Reports document non-compliances and actions taken, including their discussion in Management Review Meetings.
• Supplier Review: Conduct an annual review of the Preferred Suppliers List, ensuring it is signed and dated.
• Procurement Records: Keep records of all purchase orders placed.

How CCS Can Support You

At CCS, we understand that preparing for an ISO 9001 audit can be complex and time-consuming. To help ease the process, we offer Internal Audit Support and Pre-Audit Checks, ensuring your QMS meets the necessary standards before certification or surveillance audits.

Our expert team can also conduct internal audits, provide actionable feedback, and assist in addressing any non-conformities ahead of the official audit.

By also leveraging our optional ISO Managed Service Support services, you can be confident in your organisation’s readiness, ensuring a smoother audit process and continued compliance with ISO 9001:2015 as well as key ISO Standards that CCS provide support for.

For more information or to schedule a consultation, please contact us today.

This checklist is designed to assist you in preparing for your ISO 9001 audit. If you choose to use it, please retain it in your quality documents file for the auditor's reference during certification and surveillance audits.