Published 9 Feb 2023
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.
ISO 9001 Audit Checklist
This ISO 9001 Checklist is used for a gap analysis which 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. This audit checklist consist of 7 main categories:
- Context of the Organization
- Leadership
- Planning
-
Support
-
Operation
-
Performance Evaluation
- Improvement
Use SafetyCulture (formerly iAuditor) to generate efficient on-site reports and assign corrective actions to appropriate team members.
In this article
What is an ISO 9001 Audit?
An ISO 9001 audit is done to ensure that the existing Quality Management System (QMS) complies with ISO 9001 standards. The audit helps organizations identify and address issues, and discover potential improvements they can make with their QMS software to ensure that best practice processes are in place. An ISO 9001 audit is conducted in two methods:
Internal Audit
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.
External Audit
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: 2008 vs 2015 comparison
ISO 9001:2015 intends to focus on the PDCA (Plan, Do, Check, Act) management method; therefore, the updated version of any ISO 9001 template is structured according to PDCA. The purpose of this change was to guard against complacency and give momentum to continuous improvements in quality management systems.
Refer to the table below in order to spot the main differences between the ISO 9001:2008 and ISO 9001:2015 structures:
ISO 9001:2008 Structure |
ISO 9001:2015 Structure |
|
0. Introduction |
0. Introduction |
|
1. Scope |
1. Scope |
|
2. Normative Reference |
2. Normative Reference |
|
3. Terms and Definitions |
3. Terms and Definitions |
|
4. Quality Management Systems |
4. Context of the Organization |
|
5. Management Responsibility |
5. Leadership |
|
6. Resource Management |
6. Planning |
|
7. Product Realization |
7. Support |
|
8. Measurement, Analysis, and Improvement |
8. Operation |
| – |
9. Performance Evaluation |
| – |
10. Improvement |
Furthermore, ISO 9001:2015 focuses on risk-based thinking rather than preventative measures. Therefore, the most recent ISO 9001 checklist reflects this by focusing on analyzing situations that are specific to your organization and deciding individual actions based on that risk analysis.
ISO 9001 Audit Checklist Example PDF
Here is an example of an ISO 9001 PDF in the context of a QMS gap analysis. This upgrade in ISO 9001 form ensures that potential risks can be identified and acted on accordingly, long before preventative measures become apparent.
What is an ISO Audit Checklist?
An internal ISO 9001 Audit Checklists can help assess the effectiveness of an organization’s Quality Management System (QMS) and the achievement of ISO 9001 certification requirements. ISO checklists integrated with an Internal Audit Software are great tools to help implement a QMS and prepare for a third party ISO 9001:2015 certification audit.
How to Prepare the Checklist
Audit checklists assist internal audits in catching any issues that may cause non-conformity with ISO 9001 standards. Preparing an audit checklist doesn’t need to be difficult; you can either create from scratch or use a template. Below is a ISO 9001 audit checklist template example.
Regardless of what you choose, the ISO 9001 audit checklist must include the following clauses:
Clause 4: Context of the Organization
- Understanding the organization and its context
- Understanding the needs and expectations of interested parties
- Determining the scope of the QMS
- The Quality Management System and its processes
Clause 5: Leadership
- Leadership and commitment
- Quality policy
- Organizational roles, responsibilities, and authorities
Clause 6: Planning
- Actions to address risks and opportunities
- Quality objectives
- Planning of changes
Clause 7: Support
- Resources (general, people, infrastructures, environment for the operation of processes, monitoring and measuring resources, and organization knowledge)
- Competence
- Awareness
- Communication
- Documented information
Clause 8: Operation
- Operational planning and control
- Determination of requirements for products and services (market needs and interactions with customers)
- Design and development of goods and services
- Control of externally provided goods and services
- Production of goods and provision of services
- Release of goods and services
- Control of nonconforming process outputs, products, and services
Clause 9: Performance Evaluation
- Monitoring, measurement, analysis, and evaluation
- Internal audit
- Management review
- ISO 9001 Clause 10: Improvement
- Continual improvement
- Nonconformity and corrective action
FAQs about ISO 9001
The latest revision of the ISO 9001 standard was published in September 2015. The current ISO 9001 standard is 9001:2015.
An ISO 9001 certification certifies that an organization’s Quality Management System (QMS) meets the standard. The organization is able to consistently provide products and services that meet customer satisfaction and regulatory requirements.
ISO 9001 and AS 9100 are almost identical due to AS 9011 being founded around the ISO 9001 standard. However, the similarities end when it comes to the additional requirements of AS 9100 for the aerospace industry.
Get Started with SafetyCulture
Get started with this ISO 9001:2015 Gap Analysis and Internal Audit Checklist built using SafetyCulture or check other ready-to-use ISO templates related to ISO 9001 compliance. Use SafetyCulture to assess your organization’s QMS and take note of gaps and areas of improvement, and assign actions to appropriate departments.
Featured ISO 9001 Audit Templates
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 includes the following 7 main categories:
- Context of the Organization
- Leadership
- Planning
- Support
- Operation
- Performance evaluation
- Improvement
Modify this template to suit your business requirements and the objectives of your QMS and certification requirements. Use SafetyCulture (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.
QMS Audit Checklist
A QMS audit checklist is used for evaluating an organization's quality management system (QMS) conformance with:
- policies;
- contract commitments; and
- regulatory requirements.
