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Quality Auditing

By definition, a quality audit is an independent and systematic examination to establish whether quality activities and related results comply with planned arrangements. An internal or external quality audit is useful in the maintenance of quality control and looks at effective implementation of quality arrangements and whether they are suitable for the achievement of objectives. It is an integral part of working toward a quality standard. It may be used to determine whether or not the subject of the audit is operating in compliance with governing source documentation such as corporate directives, federal and state laws and regulations, etc.

Once relegated to corporate-risk cop, the role of quality auditors is changing. Like their colleagues in the finance department, quality auditors in the healthcare industry are leveraging their regulatory knowledge of, for example, nonclinical and clinical testing, to expand their internal consulting activities and, ultimately, add greater value. Quality auditors are working with business unit managers to identify areas where efficiency can be improved, and the insight gained may shape how the organization handles future product safety and development challenges and programs.

Internal auditing, quality auditing and other internal assurance/control functions are being reinvented. Many assurance functions including security, safety, environment, quality, customer-supplier evaluations and internal auditing may be subsumed into a risk management, risk assurance or internal auditing organization. Instead of fighting these developments, Walker Downey & Associates, Inc. quality professionals and auditors advise that you understand what's occurring with internal auditing standards and be prepared.

Walker Downey & Associates, Inc. clients are diverse. Some do not have an internal audit function, believe they do not need one, and feel that the cost of internal audit far outweighs the benefits. Other clients have an internal audit function but are somewhat unaware of what it does, felt internal audit provided little value, or that it existed only to appease an outside party such as an audit committee or regulators. Finally (and thankfully), most of our clients have an internal audit department and believe the function is valuable and necessary to sustain the business. In this larger group, executive management is involved in setting the scope of the internal audit program and the scope is linked into company strategy. Take the challenge. Contact us at to see what group you fit, or let us improve upon your existing programs with our experienced staff.

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