The Basic Elements of a Lab Quality Management System

All labs require a quality management system (QMS). Some labs choose to implement an internal QMS that is driven by the local needs and maintained to the company’s quality standards. Many labs choose to build a QMS that is aligned with international standards and can be accredited by a qualified external organization. Perry Johnson Consulting, Inc. can provide consulting and accreditation services for labs interested in adopting ISO 9001 or ISO 17025 QMS systems.

ISO 9001

ISO 9001:2015 is a QMS that demonstrates a company’s commitment to quality that is understood and accepted globally. ISO 9001 generates a QMS that focuses on prevention of quality issues, risk management, a continuous review of critical process points, corrective actions and outcomes, consistent communication, and thorough documentation. Its implementation in a lab tends to improve customer satisfaction, management decision making, and profitability.

ISO 9001 is based on seven key quality management principles:

• Customer focus: labs need to understand customer needs and strive to exceed their expectations
• Leadership: leaders need to create and maintain a lab environment that enables staff to be fully engaged in meeting the organization’s objectives
• Engagement of people: enable competent, empowered, and engaged staff to create and deliver value
• Process approach: labs need to manage processes through a coherent system
• Improvement: labs need to support ongoing improvement of overall performance
• Evidence-based decision making: data-driven decisions are more likely to deliver the desired results
• Relationship management: the lab and its external interested parties are interdependent and share in each other’s success

Download the ISO 9000 Resource Guide
 

ISO 17025

ISO 17025:2017 builds upon ISO 9001 and is the international basis for a QMS for calibration and testing labs. An ISO 17025 QMS will drive acceptance of a lab’s testing and calibration results and efficiency of their operational processes. The standards of the ISO 17025 QMS will directly assess the competence of the lab staff and their ability to deliver accurate and appropriate results for the accredited test methods. Because of the rigor of ISO 17025 accreditation, there is a high rate of failure for first time applicants for the accreditation. It is good practice to seek the help of an experienced consulting group to help the lab navigate the requirements of the standards.

Some of the key requirements of ISO 17025:2017 include the following:

• Impartiality
• Confidentiality
• Competent and trained lab staff
• Appropriate and calibrated lab equipment
• Appropriate and validated lab methods
• Retention of technical records
• Evaluation of measurement uncertainty
• Procedures to ensure test validity
• Mechanisms to make improvements and to take corrective action

Download the ISO 17025 Resource Guide