ISO 9001 Audit Checklists
Evaluate effectiveness of your organization's Quality Management System (QMS) through digital auditsJump to featured templates
Published September 3rd, 2020
What is an ISO Audit?
An ISO Audit is an official assessment sanctioned by the International Organization for Standardization (ISO) to determine if a company fulfills a set criteria, usually for developing a product, or rendering a service. An ISO certification gives merit to companies, and protects consumers by ensuring that international safety, reliability, and quality standards are met.
In this article we will answer the following questions:
- What is an ISO 9001 Audit?
- What is the difference between ISO 9001:2015 and ISO 9001:2018?
- What is an ISO 9001 Audit Checklist?
An ISO 9001 audit is done to ensure that the existing Quality Management System (QMS) complies with ISO 900 standards. The audit helps organizations identify and address issues, and discover potential improvements they can make with their QMS to ensure that best practice processes are in place. An ISO 9001 audit is conducted in two methods:
This type of audit is by an assigned member of the organization to compare existing QMS with ISO 9001 standards. Performing internal ISO 9001 audits help organizations prepare for the external audit by identifying signs of non-conformance, and see opportunities for improvement to ensure that QMS processes meet requirements for certification.
this type of audit is performed prior to obtaining ISO certification. It is conducted with the help of an external auditor. The auditor will verify and ensure that the organization’s documentation meets the requirements of the ISO 9001 standard. At the end of the audit, the auditor will recommend whether you’ll be granted a certification or require corrective actions before you can be accredited.
ISO 9001:2015 was intended to focus on the PDCA (Plan, Do, Check, Act) management method. Therefore these checklists are structured in that format. The purpose of this was to mitigate against complacency but giving momentum to continuous improvements in quality management systems.
Furthermore, ISO 9001:2015 focuses on risk-based thinking rather than preventative measures. Therefore the checklists reflect this by focusing on analyzing situations that are specific to your organization and deciding individual actions based on that risk analysis. This ensures that potential risks can be identified and acted on accordingly, long before preventative measures become apparent.
ISO 9001 Internal Audit Checklists can help assess the effectiveness of an organization’s Quality Management System (QMS) and the achievement of ISO 9001 certification requirements. Internal audit checklists are great tools to help implement a QMS and prepare for a third party ISO 9001:2015 certification audit. Learn more about ISO 9001 and QMS in our beginner’s guide.
Get started with this ISO 9001:2015 Gap Analysis and Internal Audit Checklist built using iAuditor – the world’s number #1 inspection software platform. Use iAuditor to assess your organization’s QMS and take note of gaps and areas of improvement, and assign actions to appropriate departments.
Digital ISO 9001 Audit Checklists
Gap Analysis ISO 9001 Checklist
This Gap Analysis ISO 9001 Checklist can help you prepare for ISO 9001:2015 certification. Conduct a gap analysis in order to find out to what extent your company is already meeting ISO 9001 requirements and where the emphasis of your implementation efforts should be. Use this to evaluate if the context of the organization, planning, operation, quality control, and product improvement complies with the ISO standard. Use iAuditor to generate efficient on-site reports and assign corrective actions to appropriate team members.
ISO 9001 Internal Audit Checklist
This ISO 9001 Internal Audit checklist can be used as an internal audit to assess your organization’s QMS and your readiness for third-party ISO 9001:2015 certification. The audit checklist consist of 7 main categories that will evaluate the conformance of your company in terms of 1) Context of the Organization, 2) Leadership, 3) Planning, 4) Support, 5) Operation, 6) Performance evaluation, and 7) Improvement. Modify this template to suit your business requirements and the objectives of your QMS and certification requirements. Use iAuditor to record and keep track of your internal audit scores. Perform regular inspections to ensure you continue meeting your ISO 9001:2015 certification requirements.
ISO 9001:2015 Corrective Action Report Template
This ISO 9001:2015 Corrective Action Report Template is a detailed set of steps which aim to eliminate process discrepancies, identify root cause/s or problems, and ultimately prevent their recurrence. They are implemented to identify, resolve, and prevent issues of quality non-conformity. Use this template to collaborate with cross-functional teams and have a well-documented, risk-based corrective action process that is compliant with ISO 9001:2015.