Question 1

What is ISO 17025 accreditation and why does it matter?

Accepted Answer

ISO/IEC 17025 is the international standard for testing and calibration laboratories. It demonstrates that a laboratory operates a quality management system, is technically competent, and can produce precise and accurate test results. ISO 17025 accreditation matters because it ensures your calibration certificates are recognized globally, meets regulatory requirements (FDA, GMP, EPA), provides legally defensible documentation for audits, and guarantees traceability to national standards like NIST. For pharmaceutical, biotech, and research facilities, ISO 17025 accreditation is often required for regulatory compliance and is considered the gold standard for calibration quality.

Question 2

How often should laboratory equipment be calibrated?

Accepted Answer

Calibration frequency depends on several factors: manufacturer recommendations, regulatory requirements (FDA, USP, ISO), equipment usage intensity, criticality to quality processes, and historical performance data. Common intervals include: pipettes every 6-12 months, analytical balances every 12 months or quarterly for critical applications, temperature monitoring equipment quarterly or annually, pH meters every 3-6 months, and spectrophotometers annually. High-use or critical equipment may require more frequent calibration. Your quality management system should define calibration intervals based on risk assessment, and intervals should be reviewed annually based on equipment performance trends.

Question 3

What is NIST traceability and why is it required?

Accepted Answer

NIST traceability means that calibration measurements can be traced back through an unbroken chain of comparisons to standards maintained by the National Institute of Standards and Technology (NIST), the U.S. national metrology institute. Each step in the traceability chain must have documented measurement uncertainty. NIST traceability is required because it ensures measurement accuracy and consistency across all laboratories, meets FDA 21 CFR Part 11 and GMP requirements, provides legal defensibility for quality documentation, enables global recognition of test results, and supports regulatory compliance during audits. All ISO 17025 accredited calibrations must demonstrate valid NIST traceability.

Question 4

What is included in a calibration certificate?

Accepted Answer

A comprehensive ISO 17025 calibration certificate includes: unique certificate number and date, customer and equipment identification details, description of calibration procedure and standards used, environmental conditions during calibration (temperature, humidity), as-found and as-left measurement data showing equipment performance before and after adjustment, measurement uncertainty calculations, NIST traceability statement with reference standard information, pass/fail status against specified tolerances, next calibration due date, technician signature and accreditation body logo, and any deviations or limitations. This documentation provides complete audit trails required for FDA, GMP, and ISO quality systems.

Question 5

How long does the calibration process take?

Accepted Answer

Typical calibration turnaround times vary by service type: on-site calibration is usually completed within 1-2 hours per equipment type on the scheduled visit day; mail-in service typically takes 5-7 business days including shipping; local pick-up and delivery takes 3-5 business days; and urgent or emergency service can be arranged within 24-48 hours for critical needs. Actual calibration time depends on equipment type complexity, number of test points required, environmental stabilization needs, and whether adjustments or repairs are needed. We provide estimated timelines during quote preparation and offer expedited service for urgent situations to minimize your equipment downtime.

Question 6

How often should pipettes be calibrated?

Accepted Answer

Pipettes should typically be calibrated every 6-12 months, though this varies based on usage and regulatory requirements. High-volume laboratories or GLP/GMP environments often require quarterly calibration for frequently used pipettes. Single-channel pipettes used daily should be calibrated every 6 months, while low-use pipettes may extend to 12 months. Multi-channel pipettes require more frequent calibration (every 6 months) due to their complexity. Regulatory frameworks like USP <1058> and FDA guidelines recommend risk-based calibration intervals. Additionally, pipettes should be calibrated immediately if dropped, showing visible damage, or producing inconsistent results. Maintaining calibration records helps establish optimal intervals for your specific laboratory operations.

Question 7

What causes pipette drift and accuracy loss?

Accepted Answer

Pipette accuracy degrades over time due to several factors: mechanical wear from repeated use causing seal deterioration and piston degradation, chemical exposure to corrosive samples or harsh cleaning agents, improper handling including dropping or overtightening, temperature fluctuations affecting internal components, contamination from sample residue or dust, and lack of regular maintenance. Environmental factors like humidity and temperature variations also impact performance. Single-channel pipettes typically experience seal wear, while multi-channel pipettes face channel-to-channel variation issues. Regular calibration identifies drift early, preventing out-of-specification results. Proper pipette care including using correct tips, regular cleaning, proper storage, and avoiding extreme temperatures significantly extends accuracy between calibrations.

Question 8

What is the difference between calibration and validation?

Accepted Answer

Calibration verifies instrument accuracy by comparing measurements against NIST-traceable standards and documents any deviation, typically performed on individual sensors or probes. Validation is a comprehensive process that evaluates the entire system performance under actual operating conditions, demonstrating that equipment consistently operates within specified parameters. For example, incubator calibration tests individual temperature probes, while validation maps temperature distribution throughout the chamber under loaded and unloaded conditions, tests door opening recovery, and verifies alarm functionality. Validation includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). FDA and GMP regulations require both calibration of measuring instruments and validation of critical equipment to ensure process reliability and product quality.

Question 9

Do freezers and refrigerators need calibration or validation for FDA compliance?

Accepted Answer

For FDA compliance, pharmaceutical-grade freezers and refrigerators require both calibration and validation. Temperature monitoring sensors must be calibrated against NIST-traceable standards every 6-12 months to ensure measurement accuracy. The storage unit itself requires thermal mapping validation to demonstrate uniform temperature distribution, verify all locations remain within specification, confirm recovery time after door openings, and validate alarm systems. Initial validation (IQ/OQ/PQ) is required upon installation, after relocation, following major repairs, and periodically (annually or per risk assessment). 21 CFR Part 11 compliance requires documented calibration certificates, validation protocols and reports, continuous temperature monitoring, and deviation investigation procedures. Proper validation protects product integrity and ensures regulatory compliance during FDA inspections.

Question 10

Do you install monitoring systems or just calibrate them?

Accepted Answer

We specialize in calibration and validation of environmental monitoring systems rather than installation. Our services include calibrating temperature and humidity sensors, particle counters, differential pressure gauges, and data loggers against NIST-traceable standards. We validate system performance after installation by others, ensuring accuracy across all monitoring points, verifying alarm functionality, and confirming data integrity for 21 CFR Part 11 compliance. We provide comprehensive calibration certificates, validation reports with IQ/OQ/PQ documentation, and ongoing periodic calibration services. For installation services, we can recommend qualified partners who integrate monitoring systems. Our focus on calibration and validation ensures your monitoring equipment provides accurate, reliable data for regulatory compliance and quality assurance.

Question 11

What is 21 CFR Part 11 compliance for environmental monitoring?

Accepted Answer

21 CFR Part 11 is FDA regulation governing electronic records and signatures, critical for automated environmental monitoring systems. Compliance requires that electronic monitoring data has the same legal standing as paper records through validated systems with audit trails, secure access controls with unique user identification, time-stamped electronic signatures, and data integrity protection preventing unauthorized changes. For environmental monitoring, this means your system must generate accurate, tamper-evident records of temperature, humidity, or other parameters, maintain complete audit trails of all data access and changes, provide secure electronic signatures for record approval, and undergo validation demonstrating system reliability. Calibration plays a crucial role by ensuring sensor accuracy and documenting traceability. Our calibration certificates support Part 11 compliance by providing validated documentation required during FDA inspections.

Question 12

Can you calibrate oscilloscopes and multimeters on-site?

Accepted Answer

Yes, we provide on-site calibration for most oscilloscopes, digital multimeters (DMMs), and electrical test equipment using portable NIST-traceable standards. On-site calibration offers significant advantages: zero downtime from shipping, immediate return to service, elimination of backup equipment needs, and reduced risk of damage during transport. Our technicians bring calibrated reference standards and perform comprehensive testing of all functions including voltage (AC/DC), current, resistance, frequency, and capacitance for multimeters, and bandwidth, vertical accuracy, timebase accuracy, and trigger functions for oscilloscopes. We provide same-day calibration certificates and can calibrate multiple instruments during a single visit for efficiency. Some complex electrical equipment requiring specialized laboratory conditions may need in-lab calibration, which we will identify during the quote process.

Question 13

How often should electrical test equipment be calibrated?

Accepted Answer

Electrical test equipment calibration frequency depends on manufacturer recommendations, industry standards, and usage patterns. General guidelines include: digital multimeters (DMMs) every 12 months for standard use or every 6 months for critical measurements, oscilloscopes annually, power supplies every 12 months, thermometers and temperature controllers every 6-12 months, and data acquisition systems annually. High-accuracy equipment used for quality control or manufacturing may require more frequent calibration. ISO 17025, ISO 9001, and industry-specific standards often mandate annual calibration as a minimum. Risk-based approaches consider measurement criticality, historical performance, manufacturer specifications, and regulatory requirements. Maintaining documented calibration intervals and trends helps optimize your calibration schedule while ensuring compliance.

Question 14

How do I know if my torque wrench needs calibration?

Accepted Answer

Torque wrenches require calibration when showing signs of inaccuracy or at scheduled intervals. Warning signs include inconsistent fastener tension, visible damage or dropping, difficulty achieving specified torque, unusual sounds during use, and failed verification checks. For preventive maintenance, calibrate torque wrenches every 12 months for general use, every 6 months for critical applications, every 3 months in high-volume production, and after every 5,000 cycles for frequently used tools. Critical torque applications in aerospace, automotive, and medical device manufacturing demand rigorous calibration schedules. ISO 6789 standards provide calibration requirements for torque tools. Regular calibration prevents product failures, ensures assembly quality, meets safety requirements, and satisfies ISO 9001 and industry-specific quality standards. Our calibration certificates document torque accuracy across the full range.

Question 15

What is the difference between balance calibration and verification?

Accepted Answer

Balance calibration is a comprehensive procedure performed by qualified technicians using certified reference weights traceable to NIST, involving adjustment of the balance internal calibration settings, testing at multiple points across the weighing range, documenting as-found and as-left performance, and calculating measurement uncertainty. Verification (or routine testing) is a simpler user-performed check using calibrated check weights to confirm the balance still operates within acceptable limits between calibrations. USP Chapter <41> requires both calibration by trained personnel (annually or per risk assessment) and routine verification (daily or before each use for critical applications). Calibration requires specialized equipment and expertise, while verification uses check weights near your typical use range. Both are essential: calibration ensures NIST traceability and compliance, while verification provides ongoing assurance of accuracy.

Question 16

Can you calibrate spectrophotometers and pH meters?

Accepted Answer

Yes, we provide comprehensive calibration services for spectrophotometers, pH meters, and general laboratory analytical instruments. For spectrophotometers, we calibrate wavelength accuracy, photometric accuracy, stray light, and baseline stability using NIST-traceable standards including holmium oxide filters and neutral density filters. Our pH meter calibration includes electrode testing at multiple buffer points (pH 4, 7, 10), slope verification, response time testing, and temperature compensation verification. We calibrate UV-Vis, visible-only, and IR spectrophotometers across their full wavelength range. All calibrations follow manufacturer specifications and USP requirements where applicable. We provide detailed calibration certificates documenting all test points, measurement uncertainty, and NIST traceability. Both on-site and mail-in service options are available depending on equipment portability and your operational requirements.

Question 17

What is the turnaround time for general laboratory equipment?

Accepted Answer

Turnaround times for general laboratory equipment calibration vary by service option. On-site calibration is completed during the scheduled visit, typically within 1-3 hours depending on equipment quantity and complexity, allowing immediate return to service. Mail-in service averages 5-7 business days from receipt to shipment back, including calibration and documentation. Local pick-up and delivery takes 3-5 business days. Expedited service is available for urgent needs with 24-48 hour turnaround for an additional fee. Complex equipment requiring extensive testing or equipment needing repairs may require additional time, which we communicate upfront. We recommend scheduling regular calibration during planned downtime to minimize operational impact. Batch calibration of multiple instruments during a single on-site visit provides the fastest total turnaround. Contact us for specific timeframes based on your equipment list and service preference.

Question 18

What industries do you serve?

Accepted Answer

We serve diverse industries requiring ISO 17025 accredited calibration services, with particular expertise in pharmaceutical manufacturing and QC laboratories, biotechnology research and development, medical device manufacturing, university research laboratories, hospital and clinical laboratories, food and beverage testing facilities, environmental testing laboratories, chemical and petrochemical industries, aerospace and defense, and contract research organizations (CROs). Our calibration services support compliance with FDA 21 CFR Part 11, GMP, GLP, ISO 13485, ISO 9001, and industry-specific regulations. We understand the unique requirements of regulated industries including validation protocols, audit documentation, and rapid turnaround needs. Our NIST-traceable certifications are accepted worldwide for regulatory submissions, quality audits, and accreditation requirements. We serve clients throughout San Diego, California, and nationwide through our comprehensive service delivery options.

Question 19

Do you offer emergency or urgent calibration services?

Accepted Answer

Yes, we understand that equipment failures and urgent calibration needs occur. Our urgent services include same-day or next-day on-site calibration for local clients, expedited 24-48 hour turnaround for mail-in service, weekend and after-hours service by appointment, and priority scheduling for critical equipment. Urgent service is available for production line shutdowns, regulatory audit preparation, equipment failure investigations, and time-sensitive projects. We maintain emergency contact lines and can often accommodate last-minute requests. While urgent service carries premium pricing due to scheduling prioritization and potential technician overtime, the cost is minimal compared to extended production downtime or failed audits. Contact us immediately when urgent needs arise, and we will work to accommodate your timeline. For the fastest response, on-site service is typically available within 24 hours for the San Diego area.

Question 20

What are your service delivery options?

Accepted Answer

We offer three convenient calibration service delivery options to meet your operational needs. On-site calibration brings our technicians and portable NIST-traceable standards to your facility, offering zero shipping risk, immediate equipment return to service, calibration in your actual operating environment, and efficient multi-equipment calibration in one visit. Local pick-up and delivery provides free collection of decontaminated equipment, calibration in our state-of-the-art laboratory, and return delivery with certificates, ideal for San Diego area clients. Nationwide mail-in service allows you to ship equipment securely to our lab for the same expert calibration with tracked return shipping, perfect for portable instruments and clients outside our local service area. All options provide identical ISO 17025 accredited quality and NIST-traceable certificates. Choose based on equipment portability, downtime tolerance, and location. Contact us to discuss the best option for your specific needs.

Question 21

How do I prepare equipment for calibration?

Accepted Answer

Proper equipment preparation ensures efficient calibration and technician safety. For all equipment, complete required decontamination following your facility SOPs and provide a decontamination certificate or tag, remove samples and materials, ensure equipment is clean and accessible, and gather any specific calibration requirements or tolerances. For mail-in service, additionally use original packaging when possible or provide adequate cushioning, include equipment identification and return shipping information, remove batteries from battery-operated devices if required by shipping regulations, and maintain insurance for valuable equipment. For on-site service, ensure adequate workspace with proper lighting and power access, provide equipment manuals if special procedures are needed, and notify us of any access requirements or safety protocols. Inform us in advance if equipment is not functioning properly or has visible damage, as this may affect the calibration approach or timeline.

Question 22

What happens if equipment fails calibration?

Accepted Answer

When equipment fails calibration (exceeds acceptable tolerance limits), we follow a structured process to protect your quality system. We document as-found condition showing specific out-of-tolerance measurements, immediately notify you before proceeding with adjustments, investigate the failure extent and potential impact period, and provide detailed reporting for deviation investigations. You have several options: authorize adjustment and recalibration to bring equipment into specification, reject adjustment to investigate root cause first, repair or replace the equipment if adjustment cannot achieve compliance, or retire equipment that cannot be economically restored. Our calibration certificates document both as-found (failed) and as-left (adjusted) conditions. This data helps you assess potential impact on prior test results and supports CAPA investigations. We can provide guidance on manufacturer repair services when needed. Failed calibrations are a normal quality system function that identifies problems before they affect product quality. This is why regular calibration is critical for compliance and quality assurance.

Frequently Asked Questions

General Calibration

What is ISO 17025 accreditation and why does it matter?

How often should laboratory equipment be calibrated?

What is NIST traceability and why is it required?

What is included in a calibration certificate?

How long does the calibration process take?

Pipette Calibration

How often should pipettes be calibrated?

What causes pipette drift and accuracy loss?

Thermal Calibration & Validation

What is the difference between calibration and validation?

Do freezers and refrigerators need calibration or validation for FDA compliance?

Environmental Monitoring

Do you install monitoring systems or just calibrate them?

What is 21 CFR Part 11 compliance for environmental monitoring?

Electrical Calibration

Can you calibrate oscilloscopes and multimeters on-site?

How often should electrical test equipment be calibrated?

Mechanical & Force Metrology

How do I know if my torque wrench needs calibration?

What is the difference between balance calibration and verification?

General Laboratory Equipment

Can you calibrate spectrophotometers and pH meters?

What is the turnaround time for general laboratory equipment?

Business & Service Questions

What industries do you serve?

Do you offer emergency or urgent calibration services?

What are your service delivery options?

How do I prepare equipment for calibration?

What happens if equipment fails calibration?

Still Have Questions?

Frequently Asked Questions

General Calibration

What is ISO 17025 accreditation and why does it matter?

How often should laboratory equipment be calibrated?

What is NIST traceability and why is it required?

What is included in a calibration certificate?

How long does the calibration process take?

Pipette Calibration

How often should pipettes be calibrated?

What causes pipette drift and accuracy loss?

Thermal Calibration & Validation

What is the difference between calibration and validation?

Do freezers and refrigerators need calibration or validation for FDA compliance?

Environmental Monitoring

Do you install monitoring systems or just calibrate them?

What is 21 CFR Part 11 compliance for environmental monitoring?

Electrical Calibration

Can you calibrate oscilloscopes and multimeters on-site?

How often should electrical test equipment be calibrated?

Mechanical & Force Metrology

How do I know if my torque wrench needs calibration?

What is the difference between balance calibration and verification?

General Laboratory Equipment

Can you calibrate spectrophotometers and pH meters?

What is the turnaround time for general laboratory equipment?

Business & Service Questions

What industries do you serve?

Do you offer emergency or urgent calibration services?

What are your service delivery options?

How do I prepare equipment for calibration?

What happens if equipment fails calibration?

Still Have Questions?