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ISO 15189 Standards

ISO 15189:2012 is a regulatory standard for medical labs. Its criteria help labs develop quality management systems and assess their own competence. The standard is also used by regulators, accreditation bodies and customers to confirm or recognize a lab’s competence.

The common components of the standard include document control, internal audits, occurrence management, and risk management. Compliance with ISO 15189 improves the overall quality of a laboratory’s services and products, which directly affects the quality of health care.

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ISO 15189 Standards: For Medical and Clinical Laboratories

ISO 15189 Videos

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Free Resources

Select all the ISO 15189-related resources you’re interested downloading.

Case Study: ARUP Laboratories
Industry Brief: ISO 17025: What it Means for You and Your Laboratory
White Paper: Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory Should Avoid White Paper: 6 Must-Haves for a Quality Management System (QMS)

The Role of ISO 15189

The ISO 15189:2012 international standard is based on ISO/IEC 17025 and ISO 9001. It applies to all medical laboratories and is becoming the most widely accepted standard for accrediting the competence of clinical laboratories. ISO 15189 requirements are intended to help lab staff:

Establish systems that are as failure resistant as possible.
Reduce errors.
Catch mistakes before they turn into bigger issues.
Improve right-first-time metrics.
Identify continual improvement opportunities.
Enhance their problem-solving capabilities.

Optimize quality and competence in your laboratory.

See how your lab can achieve the highest level of safety, consistency and performance with a digital QMS.

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ISO 15189 Standards

ISO 15189 Videos

Free Resources

The Role of ISO 15189

Establish systems that are as failure resistant as possible.

Reduce errors.

Catch mistakes before they turn into bigger issues.

Improve right-first-time metrics.

Identify continual improvement opportunities.

Enhance their problem-solving capabilities.

Optimize quality in your laboratory with ISO 15189 software.

Optimize quality and competence in your laboratory.

ISO Quality Standards

Leveraging the Value of Quality in Your Business Through ISO

ISO Compliance Forms

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{{ content.title }}

ISO 15189 Standards

ISO 15189 Videos

Free Resources

The Value of ISO 15189 Compliance

The Role of ISO 15189

Establish systems that are as failure resistant as possible.

Reduce errors.

Catch mistakes before they turn into bigger issues.

Improve right-first-time metrics.

Identify continual improvement opportunities.

Enhance their problem-solving capabilities.

Optimize quality in your laboratory with ISO 15189 software.

MasterControl Simplifies ISO 15189 Compliance

Optimize quality and competence in your laboratory.

ISO Quality Standards

Leveraging the Value of Quality in Your Business Through ISO

ISO Compliance Forms

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