NIST Certification and Validation Services

 
NIST Certification

NIST Certification

Validation Services

Validation Services

 

NIST Certification

Use NIST traceable certificates
to maintain regulatory compliance.

Benefits of our NIST certification services:

• In house ISO 17025 certified lab
• NIST certificates valid for up to 2 years
• Custom temperature points for your application

What is NIST Traceability?

Traceability can be defined as an unbroken chain of measurements and associated uncertainties. A tested device will have traceability to NIST standards if the following conditions are met:

• An unbroken chain of measurements back to NIST standards is maintained.
• Each step of the chain has known and documented uncertainties.
• There is a quality system to ensure that the thermometers and associated measurement equipment maintain their measurement uncertainty (accuracy).

Information here sourced from the nist.gov website.

Validation Services

Our array of audit-quality validation services and documents help you meet and mitigate regulatory risk without adversely affecting your buisiness and lab requirements. We cover the three most commonly used types of validation protocols for systems and equipment.

Installation Qualification (IQ):

• Record critical information applicable to the equipment, including equipment attributes such as the manufacturer, serial number, model number, equipment asset or tag number, and the location where the equipment will be installed.
• Record the system instrument and valve information, including the manufacturer, model number, and calibration information (if applicable).
• Verify documentation specific to the equipment, such as operation and maintenance manuals, purchase orders, component specifications, and the required spare parts.

Operational Qualification (OQ):

• Demonstrate and document that the equipment operates within the stated limits when used under defined operating procedures.
• Test and record the all modes of operation to meet user requirements, equipment alarms,sequence of operations, and any other specific requirements of the equipment.
• Document the verification of all applicable equipment parameters.

Performance Qualification (PQ):

• Verify that the equipment, previously verified to be installed and operational per user requirements, is able to consistently perform in accordance with the predetermined acceptance criteria.
• Verify and document the equipment can operate consistently and repeatedly under normal, less than optimal, and worst case conditions.
• Verify the alarm functionality under operational conditions.

Validation FAQs

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