LQMS - Laboratory Quality Management System

LQMS - Laboratory Quality Management System

Quality Objectives

• Specific, measurable, achievable, relevant, and time-bound (SMART) goals that support the quality policy
• Derived from the quality policy and aligned with the laboratory's mission and vision
• Examples: reduce turnaround time, improve accuracy, increase customer satisfaction
• Reviewed and updated regularly to ensure they remain relevant and achievable

Quality Policy

• A statement that outlines the laboratory's commitment to quality
• Defines the laboratory's quality objectives and guiding principles
• Communicates the laboratory's quality commitment to stakeholders
• Typically includes statements on:
  • Commitment to quality
  • Customer focus
  • Continuous improvement
  • Regulatory compliance
  • Employee involvement

Management Review

• A regular review of the laboratory's quality management system (QMS)
• Conducted by top management to ensure the QMS is effective and aligned with the laboratory's objectives
• Review of:
  • Quality policy and objectives
  • Audit results
  • Corrective actions
  • Customer feedback
  • Opportunities for improvement
• Output: decisions and actions to improve the QMS

Corrective Action

• A process to identify, contain, and correct deviations from the QMS
• Initiated in response to:
  • Nonconforming test results
  • Customer complaints
  • Audit findings
  • Internal audits
• Corrective action process:
  1. Identify and contain the issue
  2. Determine the root cause
  3. Implement corrective action
  4. Verify effectiveness
  5. Document and close the corrective action

Audit Management

• A process to evaluate the laboratory's QMS and ensure compliance with regulatory requirements
• Two types of audits:
  • Internal audits: conducted by the laboratory to evaluate its own QMS
  • External audits: conducted by external organizations to evaluate the laboratory's QMS
• Audit process:
  1. Planning and preparation
  2. Conducting the audit
  3. Reporting and follow-up
  4. Corrective action and closure

LQMS - Laboratory Quality Management System

Quality Objectives

• Quality objectives are specific, measurable, achievable, relevant, and time-bound (SMART) goals that support the quality policy.
• They are derived from the quality policy and aligned with the laboratory's mission and vision.
• Examples of quality objectives include reducing turnaround time, improving accuracy, and increasing customer satisfaction.
• Quality objectives are reviewed and updated regularly to ensure they remain relevant and achievable.

Quality Policy

• A quality policy is a statement that outlines the laboratory's commitment to quality.
• It defines the laboratory's quality objectives and guiding principles.
• The quality policy communicates the laboratory's quality commitment to stakeholders.
• A quality policy typically includes statements on:
  • Commitment to quality
  • Customer focus
  • Continuous improvement
  • Regulatory compliance
  • Employee involvement

Management Review

• A management review is a regular review of the laboratory's quality management system (QMS).
• It is conducted by top management to ensure the QMS is effective and aligned with the laboratory's objectives.
• The review covers:
  • Quality policy and objectives
  • Audit results
  • Corrective actions
  • Customer feedback
  • Opportunities for improvement
• The output of the management review is decisions and actions to improve the QMS.

Corrective Action

• A corrective action is a process to identify, contain, and correct deviations from the QMS.
• It is initiated in response to:
  • Nonconforming test results
  • Customer complaints
  • Audit findings
  • Internal audits
• The corrective action process involves:
  • Identifying and containing the issue
  • Determining the root cause
  • Implementing corrective action
  • Verifying effectiveness
  • Documenting and closing the corrective action

Audit Management

• Audit management is a process to evaluate the laboratory's QMS and ensure compliance with regulatory requirements.
• There are two types of audits:
  • Internal audits: conducted by the laboratory to evaluate its own QMS
  • External audits: conducted by external organizations to evaluate the laboratory's QMS
• The audit process involves:
  • Planning and preparation
  • Conducting the audit
  • Reporting and follow-up
  • Corrective action and closure