Evaluate effectiveness of your organization’s Quality Management System (QMS) through digital audits
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 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. 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.
What is an ISO 9001 Audit?
An chung nhan 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 software to ensure that best practice processes are in place. An ISO 9001 audit is conducted in two methods:
- ISO 9001 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.
- ISO 9001 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.
Hình ảnh: Mẫu giấy chứng nhận ISO 9001:2015 tiếng Việt
Hình ảnh: Mẫu giấy chứng nhận ISO 9001:2015 tiếng Anh
ISO 9001: 2008 vs 2015
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.
Here is an example of an ISO 9001 PDF in the context of a QMS gap analysis. This upgrade in ISO 9001 forms ensures that potential risks can be identified and acted on accordingly, long before preventative measures become apparent.
ISO 9001 Checklist: Integrating PDCA
PLAN
- ISO 9001 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
- ISO 9001 Clause 5: Leadership
- Leadership and commitment
- Quality policy
- Organizational roles, responsibilities, and authorities
- ISO 9001 Clause 6: Planning
- Actions to address risks and opportunities
- Quality objectives
- Planning of changes
- ISO 9001 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
DO
- ISO 9001 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
CHECK
- ISO 9001 Clause 9: Performance Evaluation
- Monitoring, measurement, analysis, and evaluation
- Internal audit
- Management review
ACT
- ISO 9001 Clause 10: Improvement
- Continual improvement
- Nonconformity and corrective action
Click here to view ISO 9001: A Beginner’s Guide for free
What is an ISO 9001 Audit Checklist?
An 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. 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.
