Getting Certified to ISO 9001 - the Stage 1 Audit

Posted by Craig Thornton

Part 31: Getting Certified to ISO 9001 - the Stage 1 Audit

You have created your quality management system (QMS) and you have your Certification Body all signed up and ready to go, now is the time to book in your Stage 1 audit.

Stage 1 is where the Certification Body (CB) confirms that you are ready for the full audit. The CB checks that you have in place all the required processes, related procedures and that your resources are ready. 

Most CBs recommended that this stage 1 audit is conducted on your site.  However, if the CB already has experience of you and your industry, then this audit could be done by off site.

stage 1.png

During the audit the auditor will review your scope of the management system. 

They will obtain information on your organisation’s processes and operations, the equipment being used, the levels of control that you have established as well as any applicable statutory or regulatory requirements. 

Your internal audits and management reviews will be evaluated to ensure they are being planned and performed. 

The CB will determine the overall level of implementation of the quality management system will decide if you are ready to move forward with the Stage 2 Certification Audit.

They will the review the allocation of resources and details for the next phase of the audit. 

The CB will give you a stage 1 report to outline the state of your readiness for Stage 2. They will identify any areas of concerns that could be classified as potential non-conformance during the Stage 2 Audit.

The Stage 1 audit is much shorter in duration than stage 2.  The audit will usually be carried out in one or two days.  If you have more than one location, the audit would usually be carried out at your head office location.

Typically there are a few weeks between a Stage 1 and a Stage 2 audit.  This is to allow you to address any observations prior to the full audit (called a Stage 2 audit).

In addition the CB needs to determine the size of the audit team to conduct the audit.  They also need to determine if they need technical experts are required to help with complex technicalities during the audit.

So the objective of a Stage 1 Audit is to determine your readiness for their Stage 2 audit of your QMS.

Here at Mango, the stage 1 audit was conducted remotely.  Because we use our product Mango to manage our QMS the auditor didn’t need to visit us at our site. We gave the auditor a username login (and a password) to Mango.The benefit of this approach was:

  • The auditor could do this in their own time.
  • The audit didn’t hold up any of our personnel in a visit.
  • Communication was all online.
  • Questions were emailed though and easily answered.
  • Auditor was not under pressure to rush through the audit
  • Saved thousands $$$ on flights and accommodation, because the auditor was from Australia

We only had a couple of areas to tidy up.  We even threw in a curve ball in the internal audit procedure.  We added a couple of funny statements just to check that the auditor was doing their job.  Fortunately he picked those up.  At the end of the Stage 1 our CB determined that we were ready for Stage 2.

 

Takeaways

  1. To save time and money, ask the auditor to do the Stage 1 audit remotely.
  2. Make sure everything is ready:
    • Internal audits are done
    • Management Review done
    • QMS documentation is ready
    • Capture evidence that the systems are in place
  3. Learn from the findings from the CB audit report.

 

Integrated_Management_System_manuel.jpg

 

View previous blogs in this series "How to Implement a QMS and Achieve ISO 9001 Certification":

How to Implement a QMS and Achieve ISO 9001 Certification - Part 1: Introduction

How to Implement a QMS and Achieve ISO 9001 Certification - Part 2: Customer Focus

How to Implement a QMS and Achieve ISO 9001 Certification - Part 3: Leadership

How to Implement a QMS and Achieve ISO 9001 Certification - Part 4: Engagement of People

How to Implement a QMS and Achieve ISO 9001 Certification - Part 5: Process Approach

How to Implement a QMS and Achieve ISO 9001 Certification - Part 6: Improvement

How to Implement a QMS and Achieve ISO 9001 Certification - Part 7: Evidence Based Decision Making 

How to Implement a QMS and Achieve ISO 9001 Certification - Part 8: Relationship Management

How to Implement a QMS and Achieve ISO 9001 Certification - Part 9: Clauses 0.1, 0.2, 0.3, 1, 2 and 3 of ISO 9001:2015

How to Implement a QMS and Achieve ISO 9001 Certification - Part 10: Clauses 4.1, 4.2, 4.3 and 4.4 – Context, Interested Parties, Scope, QMS

How to Implement a QMS and Achieve ISO 9001 Certification - Part 11: Clauses 5.1 Leadership and Commitment

How to Implement a QMS and Achieve ISO 9001 Certification - Part 12: Clause 5.2 Policy

How to Implement a QMS and Achieve ISO 9001 Certification - Part 13: Clause 5.3 Roles, Responsibilities and Authorities

How to Implement a QMS and Achieve ISO 9001 Certification - Part 14: Clause 6.1 Actions to Address Risks and opportunities

How to Implement a QMS and Achieve ISO 9001 Certification - Part 15: Clause 6.2 Objectives

How to Implement a QMS and Achieve ISO 9001 Certification - Part 16: Clause 7.1 Resources

How to Implement a QMS and Achieve ISO 9001 Certification - Part 17: Clause 7.2 and 7.3 - Competence and Awareness 

How to Implement a QMS and Achieve ISO 9001 Certification - Part 18: Clauses 7.5 - Documented Information

How to Implement a QMS and Achieve ISO 9001 Certification - Part 19: Clauses 8.1 - Operational Planning and Control

How to Implement a QMS and Achieve ISO 9001 Certification - Part 20: Clauses 8.2 - Requirements for Products and Services

How to Implement a QMS and Achieve ISO 9001 Certification - Part 21: Clauses 8.3 - Design and Development

How to Implement a QMS and Achieve ISO 9001 Certification - Part 22: Clauses 8.4 - Control of Externally Provided Processes, Products and Services

How to Implement a QMS and Achieve ISO 9001 Certification - Part 23: Clauses 8.5 - Production and Service Provision

How to Implement a QMS and Achieve ISO 9001 Certification - Part 24: Clause 8.6 - Release of Products and Services

How to Implement a QMS and Achieve ISO 9001 Certification - Part 25: Clause  8.7 - Control of Non-Conforming Outputs

How to Implement a QMS and Achieve ISO 9001 Certification - Part 26: Clause  9.1 - Monitoring, Measurements, Analysis and Evaluation

How to Implement a QMS and Achieve ISO 9001 Certification - Part 27: Clause  9.2 - Internal Auditing

How to Implement a QMS and Achieve ISO 9001 Certification - Part 28: Clause  9.3 - Management Review

How to Implement a QMS and Achieve ISO 9001 Certification - Part 29: Clause  10 - Improvement

How to Implement a QMS and Achieve ISO 9001 Certification - Part 30: Getting Certified to ISO 9001:2015 - Selecting a Certification Body 

Tags: Quality Management, ISO 9001, ISO 9001 certification, ISO 9001 accreditation