ISO/IEC 17025 Audit: Common Non-Conformities & Solutions

Discover common ISO/IEC 17025 audit non-conformities and expert solutions from 4CPL, India’s leading ISO & NABL certification consultant.

1. ISO/IEC 17025 Audit: Common Non-Conformities &
Solutions

Testing and calibration laboratories play a critical role in industries such as pharmaceuticals,
automotive, aerospace, power and food safety. For these organizations, NABL accreditation is more
than a certificate it demonstrates technical competence, impartiality and reliability of test and
calibration results.
Many laboratories face ISO 17025 audit non-conformities during assessments. These often include
incomplete documentation, outdated calibration records, insufficient evidence of staff competence
or weak ISO 17025 internal audits. In some cases, laboratories treat this certification as a paperwork
requirement rather than a living management system, resulting in recurring compliance issues and
failed outcomes.
Every non-conformity has consequences. It can undermine credibility, weaken customer trust and
even jeopardize contracts with regulators, certification bodies or global clients. By understanding the
common non-conformities in ISO 17025 and adopting corrective measures, laboratories can reduce
risks, improve audit readiness and achieve accreditation with greater confidence.
This blog highlights frequent ISO/IEC 17025 compliance issues, explains why such audit findings
occur and shares practical strategies to overcome these audit challenges.

WHAT IS ISO/IEC 17025?
ISO/IEC 17025 is the internationally recognized standard for testing and calibration laboratories. It
specifies the general requirements for competence, impartiality and consistent operations, ensuring
that laboratory results are valid, traceable and globally accepted.

2. Unlike ISO 9001, which focuses on quality management at an organizational level, ISO/IEC 17025
goes deeper into the technical requirements that directly influence laboratory outcomes. These
include method validation, equipment calibration, staff competency, risk management and data
integrity all of which are evaluated during ISO 17025 audits.
For organizations, achieving ISO/IEC 17025 accreditation brings several
advantages:
 Recognition of technical competence by regulators, accreditation bodies and customers
worldwide.
 Greater reliability of test and calibration results, minimizing disputes, re-testing and costly
compliance failures.
 Support for regulatory compliance across critical industries such as pharma, food,
environment and manufacturing.
 Enhanced customer confidence and market competitiveness both domestically and
internationally.
ISO/IEC 17025 framework provides a structured compliance framework that helps laboratories
reduce ISO 17025 audit non-conformities and operate with transparency, accuracy and credibility.
This is why ISO/IEC 17025 compliance issues are taken so seriously they directly reflect whether a lab
is audit-ready and able to meet global expectations.

Key Reasons to Implement ISO/IEC 17025
Organizations Implement ISO/IEC 17025 not only for recognition but also in response to increasing
industry pressures, regulatory requirements and client expectations. The key drivers for
implementation include:
 Integration with Global Supply Chains: As supply chains become increasingly international,
only results from accredited laboratories are widely accepted. Implementation of ISO/IEC
17025 ensures laboratory outputs are recognized across border enabling global market
participation.
 Commitment to Impartiality and Integrity: Beyond technical competence, laboratories must
demonstrate impartiality and transparency. ISO/IEC 17025 introduces safeguards to prevent
conflicts of interest and reinforce trust in laboratory practices.
 Customer and Stakeholder Demands: Global clients, regulators and certification bodies
increasingly expect laboratories to operate in line with ISO/IEC 17025 standards.
Accreditation often becomes a mandatory requirement for contracts, approvals and long-
term partnerships.
 Consistency Across Operations: In the absence of a standardized framework, laboratories
often struggle with variations in methods, record-keeping and reporting. This certification
introduces a unified system that ensures results remain consistent, regardless of personnel
changes or equipment variations.

3.  Mitigation of Non-Compliance Risks: Unplanned equipment failures, inadequate staff
training or poor documentation can disrupt laboratory operations and create compliance
gaps. Implementing ISO 17025 establishes structured processes to minimize these risks
before they result in major non-conformities.
 Competitive Advantage: In highly regulated industries such as pharmaceuticals, food and
aerospace organizations prefer working with accredited laboratories. Without NABL ISO
17025 laboratories risk losing business opportunities to competitors that demonstrate
stronger compliance and reliability.
By adopting ISO 17025 certification standards laboratories move beyond basic compliance to build a
robust framework for quality assurance, risk management and sustainable market leadership.

COMMON NON-CONFORMITIES IN ISO/IEC 17025 AUDIT AND THEIR
FINDINGS

Personnel (Clause 6.2), competence is frequently not demonstrated, as technical staff may not be
evaluated for competence, ISO 17025 training records can be incomplete, and there is often no
evidence of periodic skill assessments. For Equipment (Clause 6.4), calibration and equipment gaps
are common, including the use of equipment without valid calibration certificates, lack of traceability
to national or international standards, and incomplete preventive maintenance records.
In Purchasing & External Services (Clause 6.6), weaknesses in supplier and external provider
management are identified, such as missing evaluation records for external calibration providers and
insufficient evidence that subcontracted services comply with ISO/IEC 17025 requirements. Sample
Management (Clause 7.4) often reveals gaps in sample handling and traceability, including
incomplete sample labelling, unrecorded chain-of-custody, poor storage practices, and lack of
traceability from receipt to reporting.
Issues related to Records & Data (Clauses 7.5 / 7.11) include improper handling of data and results,
such as unarchived raw data, reliance on uncontrolled spreadsheets, and inadequate data validation
or access control. Under Methods (Clause 7.2) and Measurement Uncertainty (Clause 7.6), non-
conformities include use of test methods without validation, missing or inadequately documented
uncertainty evaluations, and lack of justification for method selection.
For Complaints & Corrective Actions (Clauses 7.9 / 8.7), poor complaint handling and ineffective
corrective actions are observed, with customer complaints not formally recorded, delayed corrective
actions, or repeated non-conformities across audits. In Document Control (Clause 8.3),
documentation issues arise, such as an outdated quality manual, SOPs, and test methods, absent
version control, or uncontrolled document copies in circulation.
Finally, Risk & Impartiality (Clauses 8.5 / 4.1) often shows weak risk management and impartiality
oversight, including missing risk registers, undocumented impartiality threats, and absent preventive
actions. In Internal Audit and Management Review (Clauses 8.8 / 8.9), deficiencies are seen in
audits not conducted per schedule, unresolved findings, and management reviews lacking inputs like
risk assessment, impartiality, or customer feedback.

4. STRATEGIES TO ADDRESS NON-CONFORMITIES IN ISO 17025 STANDARDS
 Competence Not Demonstrated: Auditors frequently raise NCs when staff training records
are incomplete or when competence evaluations are missing. For instance, in a audit of a
pharma laboratory technicians operating GC instruments could not provide evidence of
method-specific training. The NC was closed only after the lab implemented a competence
matrix, linked ISO 17025 training to each analytical method and documented periodic
performance checks. This ensured auditors could trace skills directly to responsibilities.
 Calibration and Equipment Gaps: This common finding is of instruments without valid
calibration. In one automotive calibration lab torque wrenches were in active use despite
expired calibration certificates making all results for that period unreliable. The lab corrected
the NC by introducing a master calibration calendar with automated alerts and by tagging
equipment to prevent use when certificates lapse. This practice now ensures audit readiness
at all times.
 Supplier and External Provider Weakness: Many labs outsource calibration or testing
without verifying the supplier’s accreditation. In a food testing lab, a subcontracted
microbiology test provider was found to be non-accredited leading to rejection of
outsourced reports. By creating a supplier evaluation checklist (including NABL/ISO 17025
scope review) the lab established evidence-based approval of external providers preventing
recurrence of this NC.
 Sample Handling & Traceability Gaps: One materials testing lab was cited for poor sample
traceability when auditors found multiple samples stored without unique identifiers. This
created uncertainty about which results belonged to which client. The corrective action
involved implementing barcode labelling, logging samples into a chain-of-custody register
and defining storage protocols. This system not only satisfied auditors but also reduced
internal mix-ups.
 Improper Handling of Data and Results: Data integrity issues are a major NC. In an
environmental testing lab, auditors flagged uncontrolled Excel files used for recording water
quality parameters formulas could be edited without authorization. The lab addressed this
by migrating to a validated Laboratory Information Management System (LIMS), locking
historical records and introducing access controls. This not only resolved the NC but
strengthened client trust in data reliability.
 Method Validation & MU Weakness: Auditors often find that methods are applied without
documented validation. In one pathology lab, a new PCR test was introduced without
validation or uncertainty estimation. The NC was closed after the lab developed a validation
protocol aligned with ISO/IEC 17025, performed inter laboratory comparisons and prepared
a documented uncertainty budget. This gave confidence in method reliability during
surveillance audits.
 Poor Complaint Handling & CAPA: A calibration lab received multiple client complaints
about delayed reports but had no formal complaint log. During audit this was flagged as a
repeat NC. The lab established a complaint register, linked it to CAPA workflows and
reviewed trends in management meetings. Within 6 months, complaint closure times
improved, demonstrating continual improvement to auditors.

5.  Incomplete / Uncontrolled Documentation: Document control is one of the most common
NCs. In a power sector testing lab, auditors discovered technicians using outdated SOPs that
conflicted with the current Quality Manual. The NC was closed after the lab implemented
electronic document control with restricted access, version tracking and quarterly document
reviews. This gave auditors confidence that only approved documents were in use.
 Weak Risk Management & Impartiality Oversight: In a recent audit, a laboratory director
was found to be both managing client relations and approving test results for the same client
a clear impartiality risk. The NC was resolved by introducing impartiality declarations,
maintaining a risk register and assigning result approvals to independent technical staff. This
demonstrated transparent governance to auditors.
 Deficient ISO 17025 Internal Audits and Reviews: One food testing lab had skipped internal
audits for two consecutive years, resulting in multiple hidden NCs being discovered during
external assessment. Corrective action included preparing an annual audit calendar ISO
17025 internal auditors training and ensuring management reviews addressed risks,
customer feedback and audit outcomes. Subsequent audits showed significantly fewer NCs

BENEFITS OF IMPLEMENTATION ISO/IEC 17025 CERTIFICATION
 Holistic Quality Culture: Implementing ISO/IEC 17025 goes beyond technical compliance; it
fosters a culture where quality is everyone’s responsibility. Staff at all levels become aligned
with principles of accuracy, impartiality and transparency. This shift ensures that good
practices are consistently applied, not just during audits. Over time, laboratories build an
environment where excellence is embedded in day-to-day operations.
 Transparent Decision-Making: Reliable decisions depend on validated data, documented
competence and controlled processes all central to ISO/IEC 17025. With evidence-based
insights, management can make confident choices about methods resources and
investments. This transparency also provides clarity for regulators and clients reviewing the
lab’s operations. The result is stronger governance backed by traceable, defensible records.
 Strengthened Global Credibility: Accreditation under ISO/IEC 17025 signals international
recognition of competence. Test reports and calibration certificates gain acceptance across
borders without the need for revalidation. This credibility facilitates easier entry into global
supply chains and collaborations with multinational clients. It positions laboratories as
trusted world-class service providers.
 Streamlined Collaboration: Implementation brings structure to how teams share data,
manage samples and communicate findings. Standardized documentation and reporting
reduce misunderstandings and delays in multi-disciplinary projects. External stakeholders
such as suppliers or clients also benefit from this consistency. As a result, collaboration
becomes smoother and more productive strengthening professional partnerships.
 Future-Ready Operations: ISO/IEC 17025 promotes continual improvement and adaptation
to change. Laboratories are encouraged to adopt digital tools such as LIMS, align with
evolving industry standards and anticipate regulatory shifts. This future oriented approach
ensures the lab remains competitive and compliant in dynamic industries. Instead of reacting
to changes the organization stays prepared for them.

6.  Talent Retention and Attraction: Professionals value working in structured environments
where competence is recognized and career growth is supported. ISO/IEC 17025 provides
clear role definitions, training pathways and performance evaluations. This clarity helps
retain skilled staff while also attracting new talent seeking stability and growth opportunities.
Over time, the lab benefits from a motivated and capable workforce.
 Reputation for Reliability: Consistent implementation of ISO/IEC 17025 builds a reputation
that extends beyond certification. Clients, regulators and partners begin to associate the
laboratory with reliability and technical excellence. This reputation becomes a powerful
differentiator in competitive markets, where credibility often drives contract decisions. Long-
term, it reinforces the lab’s position as a preferred and trusted partner.

ISO/IEC 17025 is not just about passing an audit; it is about building a laboratory culture rooted in
accuracy, impartiality and continual improvement. While common non-conformities such as
incomplete documentation, calibration gaps, weak internal audits or data integrity issues can delay
accreditation, addressing them with structured strategies strengthens both compliance and
credibility. By effectively implementing ISO/IEC 17025 laboratories can reduce risks, enhance
customer trust and position themselves as reliable, globally recognized partners in highly regulated
industries.

HOW 4C CONSULTING HELPS YOU IMPLEMENT ISO/IEC 17025 IN YOUR
ORGANIZATION?
At 4C Consulting, we bring 20+ years of expertise in testing and calibration environments to simplify
ISO/IEC 17025 implementation. 10,000+ training hours and 50+ workshops into a structured end-to-
end approach covers gap assessments, documentation support, competence management,
equipment calibration schedules, risk registers, training and internal audits all tailored to your
laboratory’s needs. By identifying potential non-conformities early and integrating best practices into
daily operations, we ensure your systems are audit-ready, reliable and aligned with global
expectations. Partnering with 4C means smoother NABL accreditation stronger client trust and long-
term operational excellence. Book your Free ISO/IEC 17025 Gap Assessment today.