ISO 9001 standard
An ISO 9001 audit checklist is a useful tool in assessing compliance with the ISO 9001 standard. There are 5 main sections that should be covered by the checklist, section 4 quality management system, section 5 management responsibility, section 6 resource management, section 7 product realization and section 8 measurement, analysis and improvement.
Due the nature of ISO 9001 an ISO 9001 audit checklist will concentrate on the requirements of the standard and not be industry specific. A skilled auditor will use such a checklist but will be knowledgeable in the area being audited such that they can assess if an organization has applied the requirements of the standard adequately for their processes.
Section 4 of ISO 9001 covers quality management system general requirements which include taking a process approach to implementing a quality management system and documentation requirements including a quality policy, quality objectives, a quality manual and controlled documented procedures and records.
Section 5 prescribes the expected responsibilities of Senior Management who should demonstrate commitment, customer focus and conduct reviews of the quality management system. A suitable quality policy should be documented, implemented and communicated by Senior Management. Senior Management should assume responsibility for the planning of the system including nomination of a Management Representative and communication of responsibilities. An ISO 9001 audit checklist will prescribe checks to see compliance in the form of documented policies, objectives and an organizational chart or job descriptions, all of which should be communicated. An auditor will check this is the case by looking at communication methods and interviewing staff to see if they have an understanding of company policies and their responsibilities.
Section 6 of the ISO 9001 standard covers management of resources including the provision of adequate resources including human resources, Infrastructure and Work environment. An audit checklist will include checks that personnel performing work with the potential to affect product quality are competent on the basis of appropriate education, training, skills and/or experience.
Section 7 is Product realization, an audit checklist should confirm that in planning product realization, the organization has established quality objectives and requirements for the product, implemented the relevant processes, records and documents, provided the necessary resources and implemented verification, validation, monitoring, measurement, inspection and test activities. Key elements of this section include customer-related processes, design and development, purchasing, production and service provision and control of monitoring and measuring equipment.
Section 8 the ISO 9001 standard covers measurement, analysis and improvement. An ISO 9001 audit checklist will include requirements for evidence of monitoring and measurement, control of nonconforming product, analysis of data and measures taken to improve the quality management system.
There are two stages to developing an IS0 9001 audit checklist, the first is Senior Management implementation. The checklist should ensure that the initial process has involved considering customer requirements in order determine the requirements for the quality management system and developing relevant policies and establishing establish objectives. Policies and objectives should be documented and refer to customer and legal requirements that the organization is committed to meeting. The audit checklist should cover how policies and objectives have been used to establish a documented quality management system.
The main part of the ISO 9001 audit checklist will cover how the quality management system meets the requirements of the standard. This can simply be done by listing each clause of the standard and using the list of requirements as an audit checklist. In doing this we have created a 75 point checklist that can be used to check compliance against the ISO 9001 standard.