Introduction to ISO 9001
ISO 9001 is an international standard published by the International Organisation for Standardisation (ISO) and outlined the specification for a Quality Management Systems (QMS). The standard sets the benchmarks for what a QMS should meet, to support organisations improve the quality of their operations, systems, products and services. This standard is based on several fundamental quality management principles, for instance continuous improvement, customer focus, and commitment to quality.
ISO 9001 Internal Audit Checklist
Validating that an organisation is conforming to ISO 9001 and their internal policies and procedures can be a time-consuming task. Validating conformance is done by trained and competent internal auditors and sometimes organisations choose to use a third party to get instant access to competencies and save cost. One of the key elements when conducting these audits, is developing an ISO 9001 internal audit checklist. An audit checklist is generated as part of the preparation for an audit and covers elements from the seven auditable clauses within the ISO 9001 standard. The 7 key areas to consider when developing an ISO 9001 internal audit checklist are listed below.
- Context of the organisation
- Leadership
- Planning
- Support
- Operation
- Performance Evaluation
- Improvement
An ISO 9001 internal audit checklist which considers these categories, is used as guidance during the audit. The audit checklist should include relevant questions to ask or items to investigate, under each of the 7 categories.
Organisation context
When it comes to the context of the organisation, we need to understand the needs and expectations of interested parties that can have an impact on the organisation. Under this clause, we additionally need to ensure the scope of the QMS is available in documented format and that a management system has been implemented with all its processes.
Leadership
Within the ISO 9001 internal audit checklist, the section related to leadership should validate the leadership’s commitment to the QMS. The auditor should look for proof that Senior Management exhibits leadership and commitment in regard to the quality management system. This could be through validating their involvement in developing the Quality Policy and objectives for the organisation being audited. It could be beneficial to review how these are aligned with the context of the organisation and strategic direction. Other elements to cover include how the leadership assign adequate resources and ensure they are trained and competent.
Planning
The planning part of the ISO 9001 internal audit checklist should cover risk management. How does the organisation manage risks and opportunities that have been identified. It needs to be validated that the organisation has an adequate mechanism in place to action and address risks and how the success of the actions is evaluated.
Support
As far as support is concerned, we need to establish in what manner organisation’s resources for the setup, execution, operation and improvement of the QMS. How the necessary people are assigned to regularly fulfill customer, legal and regulatory requirements for the QMS, together with the essential processes of the business. In addition to covering resources (personnel, infrastructure and equipment), control of documented information needs to be addressed.
Operation
Operation is the biggest clause within the ISO 9001 standards and is the most time consuming and technical part of an audit. There are a lot of elements to cover and should consider all activities from an initial enquiry is received from a customer, to the product or service is delivered and invoiced. This section also needs to cover management of the supply chain and any design and development work within the organisation.
Performance Evaluation
The next category for the ISO 9001 internal audit checklist is performance evaluation. The organisation must be well-equipped to offer documented information showing that they measure performance of products and services provided against the needs and expectations. Other elements that need to be covered are the internal audit program and evidence that management reviews cover the items that need to be considered according to the ISO 9001 standard.
Improvement
Last but not least, the final component for the ISO 9001 internal audit checklist is Improvement. There should be evidence of improvement projects or initiatives within the organisation. These could be improvements such as implementing a new software application, changing a procedure or similar. There should also be evidence of nonconformities being addressed in due course when identified. This should include steps such as root cause analysis and verification of the corrective actions have been effective.
If you need to develop an ISO 9001 internal audit checklist as part of your internal audit program, then our Internal Audit Checklist ISO 9001 might be of interest to you.
Alternatively, if you are looking for documentation for a full management system, then you might be interested in our Management System Packages which include a range of documents at a cost-effective price.
