The Importance of a Good Quality Management System

McCrone Associates, Inc. (MA) has spent considerable time and effort over the last two years updating and improving its Quality Management System in an effort to provide increased quality assurance to clients and achieve ISO/IEC 17025:2005 accreditation. An existing culture of quality and staff pride in the MA brand, reputation, and services made management of the changes fairly easy and straightforward. The improvement process began from a solid platform because a majority of the key elements of the ISO 17025 standard requirements were already in place due to MA’s compliance with current good manufacturing practices.

Updates were made to the existing elements: the quality assurance manual, standard operating procedures, document and record management systems, personnel training programs, proficiency testing programs, equipment qualifications and calibrations, and systems for ensuring client confidentiality. These pieces were enhanced to meet or exceed the ISO standard requirements and client requirements for compliance with applicable cGMPs per 21 CFR Parts 210, 211 and 820. We improved our programs for change control, subcontract laboratory approvals, internal audits, external audits and complaint handling, and addressing non-conformances and deviations. New strategies and programs were developed for supplier approvals and management reviews. The result of all this effort was a very successful assessment by our ISO accreditation body and a swift accreditation process for MA. (Reference A2LA Certificate #3631.01).

Some of the benefits of the revised quality management system are improved efficiencies in decision making, documentation and record management. Introduction of risk assessments and risk-based decision making has ensured that tasks associated with change control, supplier approvals, internal/external audits and corrective actions are focused and appropriate to the magnitude of the situation. Standardization of some procedures, which is always a concern due to the unique nature of the services we provide and samples we analyze for clients, led to lively discussions on best practices and better understanding of the intricacies of the work we perform. In addition to serving our clients better, ISO accreditation may streamline the client auditing and approval process. Our ISO certificate and scope of accreditation should provide the information and confirmation a client requires regarding our quality program. These benefits will save time and money for our clients while ensuring the highest level of service. This accreditation will make it easier for our clients to approve and manage us as a supplier of laboratory services. Clients can rely on our accreditation because a recognized third-party has completed the assessment work for them.

In addition to ISO/IEC 17025:2005 accreditation (A2LA Certificate #3631.01), MA is also FDA registered (#1421090), GDUFA registered, DEA registered (#RM0182787) Schedule I-IV, and operates 2000 sq. ft. of ISO Class 5 cleanroom laboratory certified to the ISO 14644 standard.

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