ISO 17025 modernization for the modern laboratory.

Keep track of laboratory compliance items and synchronize documentation with anyone, anywhere.

Automate workflow

QT9 QMS reduces staff time by eliminating manual processes.

Hassle-free compliance

QT9 QMS collects & prioritizes all your ISO & ISO 17025 compliance.

Connect & collaborate online

QT9 QMS lets you upload, publish & distribute documents.

Be more accurate & efficient

QT9 QMS helps you anticipate & address changes & problems.

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See how QT9™ QMS stacks up against the ISO 17025 standard.

QT9's ISO 17025 quality management system is your all-in-one ISO 17025 software solution.

Control of Documents

QT9™ QMS Document Control Module

Element 8.2 & 8.3

Purchasing Services & Supplies

QT9™ QMS Supplier Evaluation Module

Element 6.6

Customer Complaints

QT9™ QMS Customer Feedback Module

Element 7.9

Control of Nonconforming Testing

QT9™ QMS Nonconforming Product Module

Element 7.10

Calibration Work

QT9™ QMS Calibration Module

Element 7.4/7.5/7.6/7.7

Corrective Actions

QT9™ QMS Corrective Actions Module

Element 8.7

Preventive Actions

QT9™ QMS Preventive Action Module

Element 8.6

Internal Audits

QT9™ QMS Audit Management Module

Element 8.8

Management Review

QT9™ QMS Management Review Module

Element 8.9

Personnel/Training Training

QT9™ QMS Employee Training Module

Element 6.2

Infrastructure

QT9™ QMS Preventive Action Module

Element 6.4
Explore 25+ Modules Included

Frequently Asked Questions: ISO 17025

What is ISO 17025?

ISO 17025, also referred to as ISO/IEC 17025, is the international standard for testing and calibration laboratories. It sets out requirements for the competence, impartiality and consistent operation of laboratories, ensuring the accuracy and reliability of their testing and calibration results.

 

The standard is published by the International Organization for Standardization (ISO) in collaboration with the International Electrotechnical Commission (IEC). It is reviewed for relevancy every five years. The most current version is ISO/IEC 17025:2017.

Who does ISO 17025 apply to?

ISO 17025 is applicable to any size laboratory or facility that performs testing, sampling or calibration – any measurable result – and seeks to assure stakeholders of the competence of their systems and reliability of their results. Examples of industries covered by the rule include chemicals, forensics, automotive and food production.

 

Note that ISO 17025 does not apply to medical labs. Instead, ISO 15189 is the standard that specifies requirements for quality and competence in medical laboratories.

What are ISO 17025 requirements?

Requirements for ISO/IEC 17025 fall into five main categories:

  1. General Requirements – Centered around impartiality and confidentiality
  2. Structural Requirements – Covering management and employee involvement, and lab organization
  3. Resource Requirements – Requirements for personnel, facilities, equipment, systems and support needed to optimally perform lab activities
  4. Process Requirements – Core processes to improve efficiency, including selection, verification and validation of methods
  5. Management Systems Requirements – Including documentation, document control, risk assessment, continuous improvement and corrective actions

 

For detailed information about ISO 17025 visit ISO/IEC 17025

How do I get ISO 17025 certified?

Companies can be certified to ISO 17025 by an authorized, third-party accrediting body. Certification is not mandatory, however many organizations require this certification as a prerequisite to doing business.

 

Obtaining official certification shows customers and stakeholders that your lab resources and practices are competent and your results are trustworthy. Start by examining the standard and comparing it to your lab's current activities. Create a gap analysis and work on improving in necessary areas.

How does ISO 17025 compare to ISO 9001?

Both ISO 9001 and ISO 17025 are quality management systems. The biggest difference is that ISO 17025 is specific to testing and calibration laboratories. ISO 17025 and ISO 9001 have many similarities, including requirements for document control, risk management, resource management and corrective actions. Testing labs often use ISO 9001 alongside ISO 17025 to ensure that all aspects of quality management are addressed.

How can QT9 QMS help with ISO 17025 compliance?

QT9 QMS offers 23-plus standard modules that help streamline and centralize ISO 17025 compliance, including document control, risk management, audit management and employee training. Our highly rated QMS is cost effective, easy to use and offers full customer support, an available ERP integration and Business Intelligence tool.

 

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Track all your ISO 17025 information in one place.

QT9's easy-to-use ISO 17025 quality management system makes laboratory traceability and transparency simple.

Built-In Dashboard

Quickly see the status of ISO 17025 items with real-time reports from the QT9 dashboard. You can even personalize the view specific to your needs.

Electronic Signatures

Make approvals electronically with electronic signature capturing built-in. QT9's ISO 17025 quality management system is 21 CFR Part 11 compliant.

Software Validation

QT9 QMS is validated after each release, and it is in line with FDA QSRs to keep you in compliance with FDA quality system requirements.

QT9™ QMS is flexible for your business.

QT9 lets you choose modules based on what's best for your organization.

Modules for any business size

With multiple modules to choose from, there's solutions for nearly anyone.

A solution that scales with you

Whether you are a large corporation or a small start-up you can use as many modules as you want.

Cross-Platform Support

Whether you use Android, iOS or Windows, QT9 works from virtually any web browser.

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