Quality management audits

Quality Management system priorities to consider are management responsibility, quality system principles, auditing, contract review, design control, corrective action, document control, quality records, training, product safety and liability, and statistical techniques, because these are critical aspects of the Quality Management system where Xmple Inc. already has some systems in place. 

Audits may differ. Some concentrate on particular facets, e.g. waste minimization, energy conservation. A management audit will probably cover organizational structures and relationships, communications, procedures acceptance and implementation, training and quality assurance. A technical audit will consider the performance of plant and equipment, monitoring and inspection programmes. Items for inclusion in auditing are listed in Table 17.12. 

To understand the difference between auditing a quality management system and conducting a quality system review. 

A laboratory must have a defined quality management system, which is described in the Quality Manual. The procedures for auditing and reviewing... 

A system for auditing and reviewing quality procedures is a specific requirement of ISO/IEC 17025, ISO 9001 and GLP. This is a critically important aspect of any quality management system so we will consider these activities in some detail. The first, and most important, thing to realize about Quality Audit and Management Review is that they are two completely different activities. This section deals with auditing while Section 9.5 deals with management review. 

Quality Audit is the only option available to them. It is therefore vital that, to ensure standards of quality are maintained, a laboratory must operate its own internal audits to test its quality management system. If the internal system of audits is not operating adequately, external assessment visits are liable to be traumatic experiences, awaited with trepidation and producing unexpected and embarrassing nonconformities in several areas of operation. 

The report form should be completed by the auditor and passed to the Quality Manager immediately after the audit. 

This confirmation is often provided by an external audit or assessment (u.s.). Quality management systems are often certified for conformation with ISO 9000. Probably the most common term with respect to our topic here is certified reference materiaT (CRM). 

The laboratory should ensure the establishment of an effective and efficient internal audit process to assess the strengths and weaknesses of the quality management system. The internal audit process provides an independent tool for obtaining objective evidence that the existing requirements have been met, since the internal audit evaluates the effectiveness and efficiency of the laboratory. 

During the audit process the auditors inspect the effective and efficient implementation of the laboratory processes, the capability of processes, the performance results, the improvement activities and they are also looking for opportunities for improvement. The aim of the internal audit is to determine whether the quality management system conforms to the planned arrangements and if it is effectively implemented. 

The laboratory shall continnally improve the effectiveness of the qnality management system throngh the nse of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review. Improvements can range from small-step ongoing continnal improvement activities to strategic breakthrough improvement projects. 

A manufacturer must apply an appropriate conformity assessment procedure to their device in order to ensure that it complies with the essential requirements, after which they must certify this fact by completing a declaration of conformity. There is usually a choice of conformity assessment procedures open to a manufacturer, depending on a risk-based classification of the class into which the device falls. The two main approaches to conformity assessment are based either on an approved total quality management system audited to ISO 9000 series standard, as customised for medical devices with EN 46 000 series standard, or individual product assessment. 

Nonconformance arises when any aspect of the work of a laboratory does not conform to its procedures, to the standard, or the agreed-upon requirements of the customer. These are detected by customer complaints, internal quality control measures, management audits and reviews, and by observations of staff. They must be dealt with under the appropriate part of the management system and fully investigated and reported. 

An Auditor who is qualified and authorized to manage a quality system audit is called a lead auditor. 

The organization has ensured continual improvement in the effectiveness of the quality management system through management review (measurement and analysis), internal and external audits, and corrective actions. 

Company name) conducts internal audits at specified intervals to determine whether the quality management system ... 

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