The key to a successful quality audit is selecting a highly qualified auditor. Since the quality of your organizational processes directly depends on the audit's effectiveness, it's imperative to choose the right professionals for the job.  Read More

Regular internal audits are a vital part of QMS maintenance and are in many cases a regulatory requirement. By collecting evidence and evaluating it objectively, a company can determine how well its quality management system is performing, and support an environment of continuous improvement.  An effective audit can identify areas of risk and opportunity. Even if the audit doesn't reveal any... Read More

Many executives only see internal audits as something that has to be done for compliance reasons. However, the reality is that an efficient and effective internal audit program can reduce redundancies, reduce risk, enhance customer satisfaction, and bring about cost savings. An effective internal audit will also improve efficiencies by identifying opportunities for improvement and eliminating... Read More

According to a recent survey by the Independent International Organization for Certification (IIOC), 38 percent of total audits (across 22 certification bodies) were delivered remotely in 2020. The year before, that number stood at a meager 1.75 percent.   Read More

Maintaining oversight and control of your supply chain is a critical part of your organization's quality management system.  Effective and efficient supplier audits can have significant impact on long-term compliance profile and profitability. The quality of the audit doesn't just depend on the auditor's skills – preparation, contribution, and support by the audit sponsor is also essential. Read More

A supplier audit is one of the most effective ways to ensure your suppliers adhere to quality standards while meeting required promise dates. In addition to uncovering nonconformities and opportunities for improvement, audits remind suppliers that they must continually strive to fully conform to applicable customer requirements, standards, and regulations.  Read More

Internal audits are an essential part of quality management. Working with external auditors ensures you avoid conflicts of interest and have an independent perspective.  But how should your team interact with the auditor? Read More

As the world continues to adjust to the COVID-19 pandemic's adverse disruptions, consideration must be given to how the medical device and pharma industries can best ensure business continuity of supply chain monitoring. A pandemic can impact most, if not all, suppliers, and prioritizing on-site audits can help reduce business disruptions going forward. Although it is essential to have ongoing... Read More

Increasing the efficiency of your Quality Management System (QMS) should be a no-brainer. When you invest in an efficient QMS, you discover new growth opportunities, improve customer satisfaction, and gain a competitive edge. Improving the efficiency of your QMS can help you achieve business and quality management goals.   Read More

The Medical Device Single Audit Program, better known by its acronym MDSAP, is designed to increase audit efficiency by allowing a single audit to cover the requirements for Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA, the U.S. Food and Drug Administration (FDA), and Japan Ordinance on Standards for... Read More