Maintaining ISO 17025 Accreditation: Surveillance, Reassessment, and Continual Improvement

Getting ISO/IEC 17025 accreditation is a major achievement for any laboratory. But the real work starts after you receive your certificate. Maintaining ISO 17025 accreditation requires ongoing effort through regular surveillance audits, periodic reassessments, and a commitment to continual improvement. Many labs treat accreditation like a finish line when it’s actually the starting point of a long-term relationship with your accreditation body.

Three professionals discussing charts and documents in a modern laboratory office focused on quality control and accreditation processes while maintaining ISO 17025 accreditation

Your accreditation body, whether it’s UKAS, A2LA, PJLA, or another organization, will check in regularly to make sure your lab still meets all requirements. These check-ins come in the form of surveillance assessments and re-accreditation assessments. Between these visits, you need to keep your quality system active, your equipment calibrated, your staff trained, and your records up to date. If you let things slip, you risk findings that could suspend your accreditation.

This guide walks you through everything you need to maintain your accreditation without stress. You’ll learn what surveillance and reassessments involve, what your accreditation body expects between visits, how to build continual improvement into your daily work, and what common mistakes to avoid. Whether you’re managing one standard like ISO/IEC 17025 or multiple standards like ISO 14001 and ISO 9001, these practices will help you stay compliant and keep your lab running smoothly.

Key Takeaways

ISO/IEC 17025 Implementation Masterclass

Complete documentation + step-by-step training to get your lab accreditation-ready with confidence.

What you get (features)

  • Customizable Quality Manual aligned to ISO/IEC 17025
  • All required policies & procedures with matching forms/templates
  • 7 training modules (Clauses 4–8, internal audit & management review)
  • 20-question quiz + certificate of completion
  • Clear instructions on tailoring documents to your lab

Why it matters (benefits)

  • Implement faster with proven, audit-ready templates
  • Train your team consistently and reduce nonconformities
  • Show competence to assessors with documented training & certificate
  • Confidently prepare for internal & external audits
  • Move from “paper compliance” to a working quality system
Explore the Masterclass Includes documentation, training modules, and internal auditor certificate.
  • Re-accreditation assessments happen every 2 years and during the odd years’ surveillance assessments occur to verify your lab still meets ISO/IEC 17025 requirements
  • Keeping your quality system active year-round makes audits easier than scrambling to prepare at the last minute
  • Building continual improvement into your daily work helps you maintain compliance and strengthen your lab’s performance

It should be noted that ISOIEC 17025 assessment bodies conduct “assessments”, not “audits” and they are referred to as “assessors” and not “auditors”.

What “Maintaining ISO 17025 Accreditation” Really Means

Laboratory professionals collaborating around a table with documents and laptops in a modern lab filled with scientific equipment while maintaining ISO 17025 accreditation

Maintaining ISO 17025 accreditation means you must actively demonstrate ongoing compliance and competence with ISO/IEC 17025:2017 standards every day. It’s not a one-time achievement that you earn and forget about.

Your lab needs to keep its quality management system working properly at all times. This includes following all management requirements and technical requirements outlined in the standard. You can’t let procedures slide or skip documentation just because you already have your certificate.

Key activities you must continue doing include:

  • Running regular internal audits of your QMS
  • Calibrating equipment on schedule
  • Training staff and keeping competency records current
  • Monitoring measurement uncertainty
  • Participating in proficiency testing programs
  • Documenting all nonconformities and corrective actions
  • Keeping up with Management Review including the input and outputs requirements

Your accreditation body will conduct surveillance assessments between full reassessments. These typically happen every year or two, depending on your accrediting organization. During these visits, assessors check that you’re still meeting quality standards and following your documented procedures.

Lab accreditation requires you to manage changes carefully. When you update test methods, purchase new equipment, or hire personnel, you must evaluate how these changes affect your ISO/IEC 17025 compliance. Major changes, such as moving into a new building, need to be reported to your accreditation body before implementation.

You also need to track your laboratory’s performance through quality control measures. This means analyzing QC data, reviewing customer complaints, monitoring nonconformities, and identifying areas where you can improve. The ISO/IEC17025:2017 standard expects you to continually improve your operations, not just maintain the status quo. You also want to ensure compliance and maintain accreditation through the structured ISO 17025 management review and participate in risk-based thinking.

If you fail to maintain compliance, your accreditation can be suspended or withdrawn. Here is a step-by-step guide to getting and keeping ISO 17025 accreditation, you can review to help keep you on track.

Surveillance Vs Reassessment Vs Scope Changes

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ISO/IEC 17025 accreditation requires different types of assessments at specific intervals throughout your accreditation cycle. Each assessment serves a distinct purpose and has unique requirements.

Surveillance Assessments

Your first surveillance assessment occurs between your initial accreditation and re-accreditation assessment. Most accreditation bodies then perform off-site surveillance assessments on the years in-between your re-accreditation assessments which occur every two years. This means that your accreditation certificate is good for two years before needing to be renewed.

These surveillance assessments verify that your lab continues to meet ISO/IEC 17025 requirements. The assessment is narrower than your initial assessment, but still covers critical areas like corrective actions, equipment calibration, and staff competence.

Surveillance assessments typically last 1 to 2 days depending on the size of your scope of work. Your accreditation body may conduct these as on-site visits, remote visits, or off-site documentation reviews.

You’ll receive advance notice, usually 8 to 12 weeks before the scheduled date. The assessor will review representative samples of your work rather than your entire accreditation scope.

If you fail to address findings from a surveillance audit properly, your accreditation can be suspended.

ISO/IEC 17025 Re Accreditation Assessment

A re-accreditation assessment is a complete assessment that occurs at the end of your accreditation cycle. Most accreditation bodies operate on a 2-year cycle.

This assessment covers all of the ISO/IEC 17025 clause requirements and your entire scope of accreditation. It’s essentially like going through initial accreditation again.

The reassessment process takes longer than surveillance assessments. You should expect multiple assessor days depending on your lab’s size and complexity.

Your accreditation body will evaluate your entire management system and technical operations. They’ll review documentation, observe testing procedures, and verify all equipment calibration and metrological traceability records.

You must complete reassessment successfully to maintain your accredited status for another cycle.

Scope Extensions and Reductions

Your accreditation scope defines which tests, calibrations, or measurements your lab can perform under accreditation. Changes to this scope require formal assessment.

Scope extensions happen when you add new test methods, measurement ranges, or equipment. Your accreditation body will schedule a special assessment to verify competence in these new areas. This can occur during a surveillance or reaccreditation assessment, or as a separate visit.

Scope reductions occur when you remove methods from your accreditation. You must notify your accreditation body in writing. They’ll update your certificate and scope documents.

Most accreditation bodies charge additional fees for scope extension assessments. The assessment depth depends on how different the new methods are from your existing scope.

So, it is a good idea for the laboratory to be continually preparing for the ISO 17025 accreditation audit, including surveillance and reassessment expectations

Maintaining ISO/IEC 17025 accreditation isn’t just about passing each visit—it’s how your lab stays trusted under the international ILAC MRA framework. Accreditation bodies that are ILAC MRA signatories
are peer-evaluated to ensure they continually check that accredited laboratories meet ISO/IEC 17025 and that their results can be accepted worldwide.

What Accreditation Bodies Expect Between Assessments

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Accreditation bodies don’t just check your lab during scheduled assessments They expect you to maintain your system actively between assessments through internal audits, management reviews, proficiency testing, corrective actions, and ongoing staff training and the maintenance of records.

Routine Internal Audits

Your internal audit program proves you’re monitoring your own system before assessors arrive. Accreditation bodies expect you to conduct internal audits that cover all ISO/IEC 17025 clauses over a defined cycle—typically annually.

Each internal audit should examine both management requirements and technical operations. That means reviewing your quality manual, SOPs, calibration records, and how staff actually follow procedures in daily work. The internal audit should also include an audit of how you meet the requirements of each of the clause elements of the ISO/IEC 17025 standard.

Your internal auditor should be trained and competent to identify gaps. They don’t need to be external—many labs successfully rotate staff as auditors for different areas. Just make sure auditors don’t audit their own work and that they have training records indicating they are trained to perform internal audits.

Document every finding, even minor observations. Then track corrective actions through to closure with evidence. Accreditation bodies will review these audit reports during surveillance and reaccreditation assessments to verify you’re maintaining the system between their visits.

Key documentation:

  • Audit schedules and plans
  • Completed audit reports with findings
  • Corrective action records with closure evidence
  • Internal auditor competence records

Regular Management Review

Management review shows leadership is engaged with your quality system. Accreditation bodies expect you to conduct formal management reviews at planned intervals—at least annually, though many labs do them more frequently.

Your management review must cover specific topics: internal audit results, corrective actions, proficiency testing outcomes, customer feedback, quality objectives, resource needs, and process effectiveness. These aren’t optional discussion points—they’re requirements as listed in section 8.9 of the ISO/IEC 17025 standard.

Document decisions made during the review. If management identifies needed resources, process improvements, or policy changes, record those decisions and track implementation. Assessors will look for evidence that management reviews drive real action, not just paperwork.

Don’t wait until right before surveillance to hold your review. Schedule it regularly so you have time to implement decisions and show progress.

Proficiency Testing and Ongoing Technical Monitoring

Proficiency testing demonstrates your technical competence remains valid between assessments. Testing and calibration laboratories must participate in an ISO 17025 proficiency testing plan aligned with ILAC P9 and ISO/IEC 17043 proficiency tests or interlaboratory comparisons for methods within their scope.

Accreditation bodies expect you to:

  • Participate in relevant proficiency tests at appropriate intervals
  • Analyze results and compare them to acceptance criteria
  • Document corrective actions when results fall outside acceptable limits
  • Monitor trends across multiple proficiency tests
  • Maintain a proficiency testing plan (usually a four-year plan covering your scope of work)

If suitable proficiency tests aren’t available for your specific methods, you need alternative technical monitoring. This might include measurement comparisons with reference materials, secondary standards verified by another lab, or split-sample testing with a reference laboratory. These types of proficiency testing protocols usually require preapproval by your accreditation body.

NIST-traceable standards and calibration traceability also fall under ongoing technical monitoring. Keep calibration certificates current and verify reference standards according to your schedule. Also make sure you are not using expired reference standards. This is a common finding.

Track all proficiency test results in one location. Make them available during management review and surveillance assessments.

Corrective Actions and Preventive Thinking

Corrective action proves you identify problems and fix them permanently. Accreditation bodies expect you to have an active corrective action system that addresses issues from internal audits, proficiency tests, customer complaints, and daily operations.

Every corrective action should include:

  • Clear description of the nonconformity
  • Root cause analysis (not just symptoms)
  • Corrective action plan with specific steps
  • Implementation evidence
  • Verification that the action was effective

Don’t just fix individual problems—look for patterns. If multiple calibration certificates expire late or staff repeatedly make the same procedural errors, your corrective action plan should address the underlying system weakness.

Preventive thinking means catching potential issues before they become actual nonconformities. When you identify risks during internal audits or process monitoring, document preventive actions taken.

Keep a centralized corrective action log. Assessors will review it to verify you’re maintaining system integrity between their visits.

Training, Competence, and Records

Staff competency must be maintained continuously, not just verified once. Accreditation bodies expect you to keep training records current and ensure personnel competence is evaluated regularly for all technical procedures.

Your competency system should include:

  • Initial training for new staff on relevant SOPs
  • Ongoing training when procedures change
  • Periodic competence checks for existing staff
  • Documentation of authorization for specific methods

Training records should show who was trained, when, by whom, and how competence was verified. This applies to technical staff performing testing and calibration work, internal auditors, and anyone responsible for quality system implementation.

Update your competence matrix regularly. If someone hasn’t performed a specific calibration or test in months, their authorization may need reverification before they resume that work.

Technical competence isn’t just about certificates. Document on-the-job evaluations, proficiency test participation, and technical reviews. These practical demonstrations matter more than classroom hours.

Store training records where they’re easily accessible during surveillance. Assessors will ask for proof that staff performing observed work are qualified and current.

Building a Continual Improvement Mindset

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Accreditation survives on evidence of progress, not promises. Labs that track meaningful data, analyze failures honestly, and apply risk-based thinking to daily work create systems that improve naturally instead of scrambling before audits.

Using Data and KPIs

Your lab generates data constantly—calibration results, turnaround times, equipment drift, proficiency test outcomes. The question is whether you’re actually using it to improve.

Start by identifying key performance indicators (KPIs) that reflect what matters most to your operation. Examples include equipment calibration overdue rates, customer complaint frequency, internal audit findings per quarter, or method validation success rates.

Track these metrics monthly and review them during management meetings. If measurement uncertainty increases for a specific parameter, investigate why. If customer feedback mentions delays, examine your workflow bottlenecks.

Pro tip:
Keep KPIs visible. A simple dashboard showing trending data helps staff recognize patterns and stay engaged with quality goals. Also, make sure your quality objectives and KPIs are measurable and realistic.

Data integrity matters here. If your records are incomplete or inconsistent, your metrics will mislead you. Make sure your data collection process is documented and followed every time.

Learning from Nonconforming Work and Complaints

Every nonconformity and complaint is a chance to strengthen your system. Labs that treat these as problems to hide miss the point entirely.

When nonconforming work happens—like an out-of-tolerance calibration or failed method verification—dig into the root cause. Was it equipment drift? Staff error? An unclear procedure? Document your investigation and the corrective action taken.

Customer feedback works the same way. If a client questions your measurement uncertainty or turnaround time, don’t dismiss it. Log the complaint, investigate whether it reveals a gap in your process, and follow up with documented changes.

Example:
A lab receiving repeated complaints about report clarity revised its template and trained staff on technical writing. Complaint rates dropped, and customer satisfaction improved.

Assessors look for evidence that you close the loop—not just record issues but actually learn from them. Keep a complaint and nonconformity register that shows trends and corrective actions.

Risk-Based Thinking in Daily Operations

Risk management isn’t a separate task—it’s how you approach every decision. ISO/IEC 17025 requires you to identify risks that could affect impartiality, data integrity, or the validity of your results.

Apply risk-based thinking when planning method validation, assigning staff to critical calibrations, or introducing new equipment. Ask yourself: What could go wrong? How likely is it? What’s the impact if it happens?

Common risk areas:

  • Staff competence gaps affecting measurement quality
  • Equipment failures impacting traceability
  • External pressures compromising impartiality
  • Incomplete method verification leading to invalid results

You don’t need formal risk assessments for every task. Simple checks work—like verifying that backup instruments are calibrated before primary equipment goes down, or rotating staff responsibilities to reduce dependency on one person.

Document significant risk assessments and review them regularly. When risks change—like adding a new test method or relocating your lab—update your analysis and controls accordingly.

Common Pitfalls That Lead to Problems at Surveillance

Many labs pass their initial accreditation only to struggle during surveillance because they fall into predictable patterns. These issues usually come down to treating compliance as a once-a-year event, letting systems drift between audits, ignoring previous findings, or failing to document changes.

“Audit Season Only” Behavior

Some labs treat ISO/IEC 17025 as something that only matters when an external audit is scheduled. Staff rush to update records, complete overdue calibrations, and finalize internal audits weeks before the surveillance visit. This creates obvious gaps that assessors notice immediately.

Your documentation should reflect real-time activities, not last-minute catch-up work. When calibration dates cluster right before the audit or training records all show the same signature date, it signals weak surveillance audit readiness. Assessors look for consistent patterns throughout the year, not sudden bursts of activity.

Signs you’re in “audit season mode”:

  • Equipment calibrations all dated within 30 days of the audit
  • Internal audits scheduled right before surveillance instead of quarterly
  • Training records completed in bulk rather than as ongoing activities
  • Document review comments that reference rushed updates

The fix is simple but requires discipline. Build system maintenance into weekly routines so your lab stays ready year-round, not just during external audits.

Letting Documentation Drift Out of Date

Your procedures should match what actually happens in the lab. But many teams update their processes without updating the corresponding documents. When assessors compare your quality manual to real-world practice, inconsistencies become nonconformities.

This happens most often with method changes, equipment replacements, or staff role updates. You might switch to a new reference standard or update a calculation method, but if the procedure still references the old approach, you’ve created a non-conformity.

Common documentation gaps:

  • Procedure versions that don’t reflect current methods
  • Quality manuals missing recent scope changes
  • Forms that no longer match updated processes
  • Staff authorization lists showing employees who left months ago

Keep a simple change log and review your key documents quarterly. When something changes in practice, update the document immediately. Waiting until audit preparation leads to rushed updates that miss critical details.

Weak Follow-Up on Previous Nonconformities

Your corrective actions from the last audit are the first thing assessors review during surveillance. If findings weren’t properly closed or if the same issue reappears, expect a more serious non-conformity this time.

Many labs address the immediate problem but skip the root cause analysis. You might recalibrate the equipment that was overdue, but if you didn’t fix the tracking system that let it expire, the problem will return. Assessors look for evidence that your corrective action prevented recurrence, not just fixed one instance.

What assessors want to see:

  • Root cause analysis documented for each previous finding
  • Corrective actions that address the system, not just the symptom
  • Verification evidence showing the fix worked over time
  • Management review records discussing effectiveness of corrections

Track every finding from your last external audit in a central register. Include the clause reference, root cause, action taken, person responsible, and verification date. Update it as you gather evidence of effectiveness so you’re ready when surveillance arrives.

Ignoring Changes in Scope, Methods, or Equipment

Your accreditation covers specific methods and equipment. When you add new test parameters, replace instruments, or modify procedures without notifying your accreditation body, you risk major audit findings.

Some labs assume minor changes don’t require documentation or approval. But assessors need to verify that any scope expansion includes proper validation, staff training, and uncertainty analysis. If you’ve been performing new tests for months without updating your accreditation scope, that’s a significant non-conformity.

Changes that require documentation and notification:

  • New methods or parameters added to your scope
  • Replacement of reference standards or critical equipment
  • Facility relocations or environmental control changes
  • Updates to software used for data analysis or reporting

Create a change control process that flags when modifications need accreditation body approval. Review your scope of accreditation quarterly against what you’re actually offering clients. Document validation studies, staff competency checks, and uncertainty calculations for any additions before you report results under your accreditation.

Practical Maintenance Calendar for an ISO 17025 Lab

A structured calendar keeps your lab audit-ready without last-minute stress. Breaking maintenance into annual and shorter-term tasks ensures nothing slips through the cracks between surveillance visits.

Annual Cycle Overview

Your annual cycle should align with your audit schedule and accreditation body’s surveillance timeline. Plan your internal audit 3-4 months before the expected surveillance date to give yourself time to close any findings.

Schedule your management review at least once per year, ideally after your internal audit so you can discuss findings and system performance together. If you run calibration laboratories, align your reference standard calibrations with this annual planning to avoid any lapsed certificates during assessments.

Plan proficiency testing enrollment at the start of each year. Most PT providers publish schedules early, so you can budget and register before deadlines pass.

Use this annual overview to map out:

  • Internal audit dates (with assigned auditors)
  • Management review meetings
  • Major equipment calibrations for reference standards
  • Staff competency evaluations and requalifications
  • Proficiency testing participation deadlines

Many labs use spreadsheets or LIMS systems to track these dates automatically. Set alerts 30 days before each deadline.

Monthly/Quarterly Check-Ins

Monthly or quarterly reviews catch problems early and keep your system active between audits. Pick a consistent day each month to review key records and processes.

Monthly tasks should include:

  • Verify equipment maintenance logs are current
  • Check calibration due dates for the next 60 days
  • Review any customer complaints and corrective actions
  • Update training records for completed sessions

Quarterly tasks work well for broader system checks:

  • Review internal audit progress and corrective action status
  • Verify environmental monitoring records (temperature, humidity)
  • Check staff competency matrices for gaps
  • Audit document control for outdated procedures

If your lab uses automation tools or a LIMS, configure recurring reports that flag overdue calibrations, pending training, or unresolved corrective actions. This removes guesswork and keeps your team accountable without manual tracking.

Tools and Resources to Make Maintenance Easier

The right tools and resources can reduce the burden of maintaining ISO 17025 accreditation by organizing tasks, tracking compliance activities, and keeping your team competent. Structured templates and ongoing training programs help laboratories stay prepared for surveillance visits and reassessments.

Templates, Checklists, and Standard Forms

You can streamline your maintenance activities by using templates for common ISO 17025 tasks. Standard forms for equipment calibration records, internal audit reports, and corrective action logs save time and reduce errors. These documents ensure you capture all required information consistently.

Checklists help you prepare for surveillance visits and reassessments. Create checklists that cover document reviews, equipment verification, and staff competency checks. You can use these before a lead auditor arrives to identify gaps in your system.

Common templates you should maintain:

  • Equipment calibration and maintenance logs
  • Internal audit schedules and reports
  • Training records and competency assessments
  • Nonconformance and corrective action forms
  • Method validation worksheets
  • Measurement uncertainty calculations

Digital templates work better than paper forms because you can update them quickly and track changes. Many laboratories store templates in their quality management system so all staff members access the same current versions.

Training and Coaching for Your Team

Your staff needs regular training to maintain their competency and understand new requirements. Schedule training sessions that cover ISO 17025 changes, technical procedures, and quality management principles. This keeps everyone aligned with your laboratory’s standards.

Coaching from experienced professionals helps you address specific compliance challenges. You can hire consultants who specialize in ISO 17025 to review your processes and train your internal auditors. Some organizations bring in a lead auditor to conduct mock assessments and identify weaknesses before official surveillance visits.

Effective training approaches include:

  • Monthly quality meetings to discuss compliance updates
  • Hands-on workshops for new equipment or methods
  • Online courses for ISO 17025 fundamentals
  • Shadowing programs for new staff members
  • External seminars on measurement uncertainty and validation

Document all training activities with attendance records and competency assessments. This evidence demonstrates to assessors that you maintain qualified personnel.

When to Ask for Help

Some labs can maintain accreditation on their own, but many reach a point where external expertise saves time, prevents findings, and keeps the system strong.

Warning Signs You May Need External Support

If your lab is falling behind on internal audits or consistently running late on corrective actions, that’s a red flag. These delays often signal resource shortages or gaps in understanding how to close findings effectively.

Another warning sign is confusion about how to handle new scope additions or method validations. If your staff can’t clearly explain measurement uncertainty or traceability for a new test, assessors will notice during surveillance.

Repeated findings in the same areas across multiple audits also suggest deeper problems. You’re not just missing a step — you might be missing the underlying requirement.

Finally, if preparing for surveillance feels overwhelming or takes weeks of scrambling, your system isn’t working the way it should. Accreditation maintenance should feel routine, not frantic.

How a Consultant Can Support Maintenance

Consultants bring focused expertise when you need it most. They can conduct gap analyses before your surveillance audit to identify weak spots early, giving you time to fix issues before assessors arrive.

They also help with specific technical challenges like updating uncertainty budgets, validating new methods, or training staff on competency requirements. This targeted support often costs less than hiring full-time quality staff.

Consultants can also perform mock internal audits using the same approach your accreditation body uses. This gives your team realistic practice and builds confidence.

Next Steps – Strengthen Your Post-Accreditation Plan

Your lab needs a structured approach to stay ready between assessments. Regular reviews and proactive maintenance prevent rushed preparations when the next surveillance notice arrives.

Review Your Current Maintenance Practices

Start with a gap analysis of your existing system. Compare your current practices against ISO/IEC 17025 requirements and identify areas where documentation has slipped or procedures need updates.

Check these core areas every quarter:

  • Equipment calibration schedules – Verify all instruments have valid certificates and no due dates are approaching
  • Staff competency records – Confirm training matrices reflect current authorizations and recent evaluations
  • Internal audit coverage – Ensure all clauses get reviewed within your planned cycle
  • Corrective action status – Track open items from previous audits and verify closure evidence exists

Document what you find during each review. If your management review meetings happen only once per year, consider adding shorter check-ins every three to six months. These brief sessions catch problems early when fixes are simple.

Create a simple tracking system that shows calibration due dates, training expirations, and audit schedules in one place. Your quality manager should be able to see system health at a glance without digging through multiple files.

Take Action Before the Next Visit

Don’t wait for the surveillance notification to start preparing. Build maintenance into your daily operations so your system stays audit-ready without extra effort.

Set up recurring tasks for key activities:

  • Monthly equipment list reviews to catch expired calibrations
  • Quarterly competency assessments for staff performing technical work
  • Regular proficiency test participation with documented follow-up
  • Ongoing procedure updates whenever processes change

Test your readiness by conducting internal audits that mirror surveillance assessments. Focus on areas that had findings before or where your processes have changed significantly. Train your internal auditors to ask the same questions external assessors will ask.

Keep your corrective action records organized with clear evidence of implementation and effectiveness. When assessors return, you should be able to pull up any closed finding within minutes and show exactly what you did to resolve it.

Update your quality manual and technical procedures as changes occur, not months later. If you add new test methods or equipment, document the validation and training immediately. This approach eliminates the pre-audit scramble and proves your system functions in real conditions.

Frequently Asked Questions

Labs often have similar questions about keeping their accreditation active and meeting ongoing requirements. The answers below address common concerns about surveillance timing, quality system elements, improvement practices, and specific ISO 17025 clauses.

What steps are involved in the ISO 17025 surveillance process?

The surveillance process starts when your accreditation body sends a notification 8 to 12 weeks before your scheduled audit date. You’ll receive an audit plan, assessor names, and a list of documents they need to review beforehand.

Your accreditation body may conduct a remote document review first. They’ll check your quality manual updates, calibration records, and management review results. This gives you time to fix any concerns before the on-site visit.

The on-site assessment typically lasts 1 to 3 days, depending on your lab size. Assessors focus on corrective actions from your last audit, internal audits, management reviews, equipment calibration, staff competence, and any changes to your scope.

After the visit, you’ll get a report listing any nonconformities or observations. You have 30 to 60 days to close these findings and submit proof of corrective actions. Once accepted, your accreditation continues without interruption.

How frequently should a laboratory reassess its compliance with ISO 17025 standards?

Your accreditation body conducts surveillance assessments every other year after your initial accreditation. The exact timing depends on your specific accreditation body and any significant changes to your lab operations.

A full reassessment happens at the end of a 2-year cycle. This is a complete system audit similar to your initial accreditation, and it renews your accreditation for another cycle.

You should also conduct internal audits throughout the year. Most labs cover all ISO 17025 clauses annually, either through one comprehensive audit or several smaller audits spread across quarters.

Management reviews should occur at planned intervals, typically once or twice per year. These reviews assess your quality system’s effectiveness and identify areas needing improvement or resources.

What are the key elements of a quality management system required for ISO 17025 accreditation?

Your quality management system must include documented policies and procedures that cover all ISO 17025 requirements. This includes your quality manual, process procedures, work instructions, and forms.

You need an organizational structure that clearly defines roles, responsibilities, and authorities. Each staff member should know what they’re authorized to do and who they report to.

A document control system ensures your procedures stay current and accessible. This system tracks document versions, approval processes, and distribution to relevant staff.

Records management is critical. You must maintain records of all technical activities, calibrations, staff training, equipment maintenance, complaints, and corrective actions. These records prove your ongoing compliance.

Internal audits and management reviews form the backbone of your system monitoring. They help you catch problems early and make informed decisions about resources and improvements.

Risk management must be addressed throughout your operations. You need to identify risks to impartiality and technical quality, then implement controls to manage those risks.

What practices should be implemented for continual improvement to maintain ISO 17025 accreditation?

Regular internal audits help you spot weaknesses before external assessors do. Schedule these audits throughout the year and rotate auditors when possible to get fresh perspectives on your processes.

Track and analyze quality indicators like turnaround times, complaint rates, and proficiency testing results. Use this data to identify trends and prioritize improvement efforts.

Conduct root cause analysis when problems occur. Don’t just fix symptoms. Figure out why something went wrong and implement corrective actions that prevent recurrence.

Participate in proficiency testing and interlaboratory comparisons. When results fall outside acceptable limits, investigate immediately and document your corrective actions.

Encourage staff feedback about procedures and equipment. Your technicians often spot inefficiencies or safety concerns that management might miss.

Review customer feedback regularly and address complaints promptly. Even positive feedback can reveal opportunities to streamline services or improve communication.

Keep your staff trained on new methods, equipment updates, and changes to ISO 17025 requirements. Competent staff perform better work and identify improvement opportunities more effectively.

What documentation is necessary for maintaining compliance with ISO 17025?

You must maintain current calibration certificates for all measurement equipment. These certificates need to show traceability to national or international standards and include measurement uncertainty.

Equipment maintenance logs document routine servicing, repairs, and verification checks. These logs prove your equipment stays in proper working condition between calibrations.

Staff competence records include training plans, qualification evidence, competency evaluations, and authorization matrices. These records show who is qualified to perform each test or calibration method.

Internal audit reports and corrective action records demonstrate your system monitoring efforts. Keep reports from all internal audits plus evidence that findings were properly addressed.

Management review minutes show leadership involvement in your quality system. Document attendance, topics discussed, decisions made, and action items assigned.

Method validation records prove your test methods produce reliable results. This includes validation protocols, raw data, uncertainty calculations, and approval documentation.

Quality control records track your ongoing method performance. Keep proficiency testing results, control charts, duplicate sample results, and reference material checks.

Customer complaints and feedback logs must be maintained even when no formal complaints exist. Document both complaints and how you resolved them.

Contract review records show you verified requirements before accepting work. Keep records of customer communications, capability assessments, and any agreed modifications.

How does Clause 7.1 ‘Review of Requests, Tenders, and Contracts’ impact laboratory operations in ISO 17025:2017?

Clause 7.1 requires you to review every customer request before accepting work. You must confirm you have the capability, resources, and qualified staff to meet the customer’s requirements.

This review process protects both you and your customer. It prevents you from accepting work you can’t complete properly and ensures customers understand what you’ll deliver.

You need to document each review, even for routine or repeat work. The documentation can be simple, but it must show you considered the requirements and confirmed your ability to meet them.

When customer requirements are unclear or differ from what you typically offer, you must resolve these differences before starting work. Document any agreements or clarifications in writing.

If you need to deviate from standard methods or add special requirements, get customer approval first. These changes must be documented and communicated to all affected staff.

The review extends to subcontractors too. When you outsource any portion of testing or calibration, verify the subcontractor is competent and inform your customer about the arrangement.

Changes to existing contracts trigger a new review. If a customer modifies their requirements mid-project, reassess your capability and communicate any impacts on timelines or costs.

Conclusion

Maintaining ISO/IEC 17025 accreditation is not a one-time achievement. It requires ongoing commitment to quality, competence, and improvement.

Surveillance assessments keep your accreditation active between cycles. They verify that your lab still meets requirements and that your system works in daily practice. These assessments happen every other year and focus on key areas like corrective actions, equipment calibration, and staff competence.

Reassessment occurs every two years. This is a full audit similar to your initial accreditation. It renews your certificate and confirms your lab’s continued technical ability.

Continual improvement ties everything together. It means your lab doesn’t just maintain standards but actively looks for ways to do better. This includes:

  • Conducting regular internal audits
  • Reviewing management system performance
  • Training staff and updating procedures
  • Fixing problems before they become findings
  • Learning from customer feedback and proficiency testing

Your accreditation proves your competence to clients and regulators. Maintaining it proves your consistency. Both matter equally in building trust and credibility for your laboratory’s work.

Stay organized, stay proactive, and your accreditation will remain secure.

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