The ISO 9001 2000 Internal Audit Checklist

ISO 9001 standards require an internal audit of any quality management system. An effective audit needs to include a plan, schedule and document requirements.

An audit checklist provides an effective means of documenting process attributes.

How can you ensure externally provided processes, products and services meet specific requirements? Be ready to provide documented evidence of evaluation results, monitoring results and reevaluations.

Policy and Procedures

The Policy and Procedures Section of an Internal Audit Checklist consists of questions designed to assist auditors in assessing whether an organization is adhering to its written plans. Auditors examine items like quality manuals, policies, records of qualifications and training records as well as methods used for verifying employee skills.

Auditors need to perform this section of an audit properly in order to gauge employee compliance with procedures and standards. While an internal auditor cannot evaluate every process, document, and employee under their purview, he or she can use judgment when selecting samples to review. In general, samples will consist of areas which have been subject to previous audits or have shown areas of weakness; since the PDCA management method emphasizes continuous improvement it’s vitally important that past audits be reviewed to identify areas that need improving and guide future ones; it also allows auditors to focus more intently where improvements may be needed instead of trying to prove processes were perfect from day one.

Training and Awareness

ISO 9001 internal audits seek to compare business activities with broad management system requirements. Auditors use the Process Approach method of reviewing work activities and asking questions to ascertain if they are being implemented effectively. Depending on the audited department(s), additional documents or records may need to be shared with auditors for review.

Auditors should consider various factors when selecting processes for audit, including but not limited to:

Auditors should provide results of their audit findings to all parties as quickly and clearly as possible, starting with top managers and staff involved with audited areas. It would also be beneficial for auditors to include departments which met ISO 9001 standards most compliantly in this meeting so they may be recognized and encouraged for their efforts, helping reduce employee perception that internal audits are punitive activities.

Process Execution

ISO 9001 is designed to foster continuous business improvement. This can be accomplished through internal audits and corrective actions that investigate methods for meeting quality targets, with some business owners viewing internal audits as painful parts of maintaining their ISO certification while others view them as useful ways of optimizing operations.

An ISO internal audit involves conducting employee interviews, observation of actual work activities and reviewing documentation in order to ascertain if processes meet ISO 9001 standards. Questions on process approach could include:

The ISO 9001 internal audit checklist will also cover documenting the scope and establishment of your quality management system, procedures for identifying hazards and controlling processes as well as training, communication and participation procedures.

Process Improvement

As part of its process approach to quality, ISO 9001 mandates that processes are continuously improved. This requirement can be difficult for many organizations to fulfill as it necessitates an ongoing review of all activities and records, along with an internal audit checklist for reviewing how improvements affect overall quality management systems.

The process audit section of the checklist resembles that of supplier audit, featuring an audit question table and grading standards such as compliant, opportunities for improvement, minor non-conformance and major non-conformance. In addition, this audit reviews procedures, work instructions, policies, plans, organization charts and other documentation as part of its assessment process.

When conducting an internal audit, it’s essential that it remains impartial. Avoid singling out specific departments for scrutiny as this can create negative emotions among employees and discourage future internal audit participation.