Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of organization's quality management system and is a key element in the ISO quality system standard, ISO 9001.
Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly defined internal system monitoring procedures linked to effective action. This can help determine if the organization complies with the defined quality system processes and can involve procedural or results-based assessment criteria.
With the upgrade of the ISO9000 series of standards from the 1994 to 2008 series, the focus of the audits has shifted from purely procedural adherence towards measurement of the actual effectiveness of the Quality Management System (QMS) and the results that have been achieved through the implementation of a QMS.
Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined target levels, to provide evidence concerning reduction and elimination of problem areas. For the benefit of the organization, quality auditing should not only report non-conformance and corrective actions, but also highlight areas of good practice. In this way other departments may share information and amend their working practices as a result, also contributing to continual improvement. Quality audits can be an integral part of compliance or regulatory requirements.
Several countries have adopted quality audits in their higher education system (New Zealand, Australia, Sweden, Finland, Norway and USA),Initiated in the UK, the process of quality audit in the education system focused primarily on procedural issues rather than on the results or the efficiency of a quality system implementation.
Audits can also be used for safety purposes. Evans & Parker (2008) describe auditing as one of the most powerful safety monitoring techniques and 'an effective way to avoid complacency and highlight slowly deteriorating conditions', especially when the auditing focuses not just on compliance but effectiveness
The processes and tasks that a quality audit involves can be managed using a wide variety of software and self-assessment tools. Some of these relate specifically to quality in terms of fitness for purpose and conformance to standards, while others relate to Quality costs Cost of poor quality. In analyzing quality costs, a cost of quality audit can be applied across any organization rather than just to conventional production or assembly processes or, more accurately, to the
Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly defined internal system monitoring procedures linked to effective action. This can help determine if the organization complies with the defined quality system processes and can involve procedural or results-based assessment criteria.
With the upgrade of the ISO9000 series of standards from the 1994 to 2008 series, the focus of the audits has shifted from purely procedural adherence towards measurement of the actual effectiveness of the Quality Management System (QMS) and the results that have been achieved through the implementation of a QMS.
Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined target levels, to provide evidence concerning reduction and elimination of problem areas. For the benefit of the organization, quality auditing should not only report non-conformance and corrective actions, but also highlight areas of good practice. In this way other departments may share information and amend their working practices as a result, also contributing to continual improvement. Quality audits can be an integral part of compliance or regulatory requirements.
Several countries have adopted quality audits in their higher education system (New Zealand, Australia, Sweden, Finland, Norway and USA),Initiated in the UK, the process of quality audit in the education system focused primarily on procedural issues rather than on the results or the efficiency of a quality system implementation.
Audits can also be used for safety purposes. Evans & Parker (2008) describe auditing as one of the most powerful safety monitoring techniques and 'an effective way to avoid complacency and highlight slowly deteriorating conditions', especially when the auditing focuses not just on compliance but effectiveness
The processes and tasks that a quality audit involves can be managed using a wide variety of software and self-assessment tools. Some of these relate specifically to quality in terms of fitness for purpose and conformance to standards, while others relate to Quality costs Cost of poor quality. In analyzing quality costs, a cost of quality audit can be applied across any organization rather than just to conventional production or assembly processes or, more accurately, to the
Types of Quality Assurance Audits
Quality assurance audit is performed in order to ensure that the systems are in place and
being followed religiously to provide good quality to the customers. It also highlights the
need for any improvement in the systems in order to consistently deliver good quality
products or services. The audits are also performed to make sure that the organization is
following the legal and regulatory requirements. Some audits are conducted by internal
auditors whereas some are performed by external ones.
Various Quality Assurance Audit Types Are:
System Audit
The organization has various systems which when put together make a whole system. A system audit is an audit performed on any of these systems. Any non-conformity during a system audit is critical, since if the system itself is wrong, the output is likely to be wrong.
Product or Service Audit
The product or service audit is performed on the product or service to find out if the product or service meets the requirements of the customers and the standards set by the
organization. There are various stages at which this can be performed. It could be during
the process of product manufacturing, after the product has been manufactured, or even
after the product is packed and ready to be delivered to the customer.The nonconformities found during this quality assurance audit are taken very seriously, since all
these nonconformities are equivalent to customer complaints.
Department Audit
As the name suggests, the department audit is performed with a focus on a given department. The scope of the audit covers all the activities performed, all the procedures followed and all the systems available in the department. This audit highlights the areas for improvement in that department.
Process Audit
Various processes are critical for the smooth running of an organization. Actually speaking, all the activities from order inquiry to delivery of products follow a defined process in any organization. Hence, an audit of such processes is performed to identify the areas for improvement. Process audit also covers the audit of some special manufacturing processes that are critical for the quality of the end product. These processes may be in-house or at the suppliers place, the one to whom that process has been outsourced to.
Conformance Audit
The external parties normally perform this QA audit. It is a form of third party audit where the auditing party evaluates if the organization does meet the requirements as are supposed to by the systems. This could also be for any kind of system certifications that organizations wish to apply for. The certificate-awarding agency also conducts the conformance audit periodically to make sure that the organization is meeting the certification requirements.
Compliance Audit
Compliance audit is performed by regulatory agencies to confirm if the organization is meeting the legal and regulatory requirements. In case of any non-conformity, a re-audit may be required. The purpose of the re-audit is to ensure the effectiveness of the corrective actions taken.The output of the audit is an audit report that is circulated to all the concerned people. The purpose of any type of QA audit is not to find mistakes, but to find the areas for improvements. If it is taken by the auditor and the audited party in this spirit, the organization can be sure that it is on the path to improvement and will be able to consistently meet all customers, system, legal or regulatory requirements.
