Preparing for Your ISO 9001 Audit: A Comprehensive Guide
Making sure that your organization is well-prepared for an International Organization for Standardization (ISO) 9001:2015 audit is essential to maintain certification and showcase a dedication to quality management practices. To assist you in this endeavor, we have created a thorough checklist designed to steer your preparations and guarantee compliance with all mandatory criteria.
Key Areas to Address for an ISO 9001 Audit
During the audit period, it is essential to review and maintain the following areas:
Quality Documentation: Make sure 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 make sure alignment with your business objectives.
Quality Policy: Verify that the Quality Policy is signed, communicated to personnel, and prominently displayed.
Authorization of Key Documents: Confirm that the Quality Manual and the Scope of QMS document are signed as authorized.
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: Make sure a complaint 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 organizational responsibilities are up to date and authorities are clearly understood.
Risk and Opportunities Review: Assess and document organizational 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 Supplier List, ensuring it is signed and dated.
Procurement Records: Keep records of all purchase orders placed.
How Bizpact Can Support You
At Bizpact, 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, guaranteeing 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 using our optional ISO Managed Service Support services, you can be confident in your organization’s readiness, which guarantees a smoother audit process and continued compliance with ISO 9001:2015 as well as key ISO Standards that Bizpact provide support for.