Laboratory Compliance & Quality
The regulatory and quality frameworks governing laboratory work: GxP, data integrity and validation, accreditation and calibration, biosafety, chemical safety, waste and shipping, and facility requirements.
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Laboratory compliance is frequently encountered as a series of disconnected obligations — an accreditation audit here, a chemical hygiene plan there, a shipping rule discovered only when a sample is rejected. In practice these frameworks overlap heavily and share a common logic: define what you will do, do it consistently, record it contemporaneously, and be able to demonstrate all three to an auditor.
This section covers those frameworks as a connected system, written for researchers, lab managers and quality staff who need to act on them rather than merely cite them.
How this section is organised
- GxP and quality management systems — Good Laboratory Practice, Good Clinical Practice and Good Manufacturing Practice, and the SOP, deviation, CAPA and change-control machinery around them.
- Data integrity and validation — 21 CFR Part 11, computer system validation, audit trails, and the ALCOA+ principles.
- Accreditation and calibration — ISO/IEC 17025, CLIA and CAP, proficiency testing, and NIST-traceable calibration.
- Biosafety and containment — biosafety levels 1 to 4, institutional biosafety committee review, select agents, and biosafety cabinet classes.
- Chemical safety and hazard communication — GHS labelling, safety data sheets, the OSHA Laboratory Standard, chemical hygiene plans and inventory control.
- Waste, shipping and transport — waste stream segregation, dry ice shipping, and IATA dangerous goods requirements.
- Facility and environmental controls — cleanroom classification, ventilation and fume hood face velocity, eyewash and safety shower requirements.
- Device and diagnostics quality — ISO 13485, design controls, IVDR, pharmacovigilance and regulatory affairs practice.
- Compliance fundamentals — how these frameworks relate to one another.
Which framework applies to you
The frameworks are not alternatives; they stack according to what the work is and what it supports. Academic bench research is typically governed by institutional biosafety and chemical hygiene requirements. Work supporting a regulatory submission adds the relevant GxP framework and, where electronic systems hold that data, 21 CFR Part 11. A laboratory selling testing services adds accreditation under ISO 17025 or, for human specimens in the United States, CLIA. Determining the applicable stack before designing a quality system is considerably cheaper than retrofitting one after an audit finding.
See also EPA Method 200.8, 200.7, and 6020 — EPA Method 200.8 (ICP-MS), 200.7 (ICP-OES), and 6020 (SW-846 ICP-MS) are the trace-metals testing methods most often specified in water-quality permits and contracts.
Related sections
For the instruments and consumables these requirements apply to, see Laboratory Equipment & Instrumentation. For clinical trial conduct specifically, see Clinical Research Administration. For day-to-day bench operations, see Laboratory Operations.
Further reading: common GCP violations — The GCP violation categories that recur most often in FDA and EMA inspections — informed consent deficiencies, protocol deviations, inadequate source documentation, drug/investigational-product accountability, and IRB no.
Related reading: CLIA Quality Control Requirements — What CLIA actually requires for quality control on non-waived test systems: the default two-levels-per-day schedule, the IQCP and EQC alternatives, proficiency testing, and how to size QC-material procurement including third-party control material.
More guides in this cluster
Showing 31 of 188 guides directly — the rest are organised into the topic hubs above.
Combination Products: How PMOA Determines the Lead FDA Center
How FDA’s primary mode of action (PMOA) test assigns combination products to CDER, CDRH, or CBER, and how to use the Request for Designation process when jurisdiction is unclear.
Sealed Source Leak Testing: Frequency, Method and Action Level
How often sealed radioactive sources must be leak tested, the wipe-test method, the 0.005 microcurie (185 Bq) action level, and which sources are exempt under 10 CFR 39.35.
Health Canada Medical Device Licence (MDL) and MDALL
How Health Canada’s Medical Device Licence (MDL) system works: the four device classes, the MDSAP certification requirement, how the MDALL public database differs from an Establishment Licence (MDEL), and how licences are amended and post-market reporting works.
Laboratory Safety Inspection Programme: Frequency, Scoring, and Corrective-Action Tracking
How to design a lab safety inspection programme: setting inspection frequency against the OSHA 1910.1450(e)(4) annual-review floor, scoring findings by severity, routing them into CAPA tracking, escalating repeat findings, and evidencing corrective-action closure to an inspector.
Shock-Sensitive Chemicals in the Laboratory: Identification and the Do-Not-Touch Boundary
Dried picric acid, concentrated peroxide-forming solvents, and metal azides formed in plumbing are the three real sources of shock-sensitive chemical incidents in a lab. Here is how to spot the age and condition cues, and why the correct response is to stop and call EHS, not to handle the container yourself.
Laboratory Safety Self-Inspection Checklist: What to Check and the Rule Behind Each Line
A citation-mapped checklist for a routine lab safety self-inspection: chemical hygiene, fire, eyewash stations, fume hoods, biosafety cabinets, gas cylinders, hazardous waste, PPE, and labeling, with the exact OSHA/ANSI/RCRA rule behind every line.
eSTAR: FDA’s Structured Submission Template for Medical Devices
eSTAR replaced free-form 510(k) and De Novo submissions with a structured, logic-checked interactive PDF. Here is what it covers, how technical screening differs from Refuse to Accept, and the attachment mistakes that actually trigger a hold.
Radiation Survey Meter Calibration and Daily Response Checks
Calibration and the daily response check are two different obligations under 10 CFR 20.1501/35.61 and ANSI N323AB — what each establishes, who performs it, and what documentation an inspector expects for both.
Laboratory Safety Committee Charter: Membership, Quorum, and Authority
A model charter for a general laboratory safety committee that resolves its overlap with the IBC, IACUC, and Radiation Safety Committee instead of merging their statutory approval authority.
MDSAP: The Medical Device Single Audit Program, Explained
How MDSAP actually works: the three membership tiers and what each one really accepts, the seven-process audit model auditors follow in sequence, and the 1-5 nonconformity grading scale (with its separate escalation step) that decides how serious a finding becomes.
EU MDR Compliance: What Changed from the MDD
A delta view of EU MDR (2017/745) against the Medical Device Directive it replaced: the PRRC role, EUDAMED, UDI, new Annex VIII classification rules, the narrowed clinical-evidence equivalence route, and the Regulation (EU) 2023/607 extended transition deadlines by device class.
Laboratory Safety Manual: Required Contents and How It Relates to the CHP
A laboratory safety manual and a Chemical Hygiene Plan are often the same document, but OSHA only regulates the CHP part. This guide walks through the eight CHP-required elements under 29 CFR 1910.1450(e)(3), what institutions typically add beyond them, and a section-by-section checklist for reviewing a combined manual.
EU MDR Classification Rules: The 22 Annex VIII Rules That Set a Device’s Class
How EU MDR 2017/745 actually classifies a device: the 22 Annex VIII rules across four rule groups, the transient/short-term/long-term duration bands, and the strictest-rule-governs principle behind the classification rationale.
What Is Joint Commission Accreditation?
A plain-language guide to what Joint Commission accreditation is, how it relates to CMS deemed status, and how it differs from CLIA/CAP laboratory certification.
What Is Calibration?
A plain-language guide to what calibration means for lab and scientific equipment: NIST traceability, why it matters for data integrity and accreditation, and how it differs from verification and IQ/OQ/PQ qualification.
What Is an Investigational Device Exemption (IDE)?
A plain-language guide to what an Investigational Device Exemption (IDE) is, why it exists, how significant-risk vs. nonsignificant-risk device studies differ, and how IDE relates to IND, 510(k), and PMA.
Respirator Medical Clearance: The OSHA Appendix C Questionnaire and PLHCP Evaluation
What the OSHA Appendix C medical questionnaire covers, mandatory vs. voluntary-use triggers, PLHCP follow-up and re-evaluation triggers, and why medical clearance must precede fit testing for lab respirator wearers.
RAC Exam Preparation: Domains, Question Types, and Study Timing
The RAC exam is 120 questions in 2.5 hours, but RAC-Drugs and RAC-Devices test different domains at different weightings. This guide breaks down both content outlines, the three question formats, and how to build a study plan and timeline around RAPS’s own 2026 candidate guides.
Respiratory Protection Program for Laboratories: OSHA 1910.134 Applied to Bench Work
How OSHA 29 CFR 1910.134’s respiratory protection program applies to a laboratory: the nine written-program elements, when voluntary use under Appendix D is enough, medical evaluation and fit testing, and how to set a defensible cartridge/canister change schedule for chemical work.
Sharps Injury Log: What OSHA Requires and How It Differs from the 300 Log
The OSHA sharps injury log (29 CFR 1910.1030(h)(5)) is a separate Bloodborne Pathogens Standard requirement from the OSHA 300 Log, with its own device-type/brand, location, and confidentiality rules.
Regulatory Affairs in the Pharmaceutical Industry
What the pharma regulatory affairs function actually does across the product lifecycle: strategy, FDA submissions, agency meetings, labeling, and post-approval change control.
Near-Miss Reporting in the Laboratory: Definitions and Programme Design
What separates a near-miss from an incident, how to design a blameless lab reporting programme staff actually use, and the two failure patterns — fear of blame and no visible follow-up — that kill most near-miss programmes.
OSHA-Reportable Laboratory Injuries: The 8-Hour and 24-Hour Clocks, and What Recordable Means Instead
Reporting a laboratory injury to OSHA and recording it on the 300 Log are two different duties with two different triggers. This guide separates 29 CFR 1904.39 from the recording criteria at 1904.4 through 1904.12, works the 8-hour and 24-hour clocks from the incident rather than the medical outcome, and shows why most laboratory establishments keep no 300 Log at all yet still owe every report.
Written Hazard Communication Program for a Laboratory: Who Actually Owes One, and How It Nests Inside the Chemical Hygiene Plan
A laboratory under 29 CFR 1910.1450 owes a Chemical Hygiene Plan, not a written hazard communication program — but the stockroom, machine shop and pilot-plant suite in the same building do owe one under 1910.1200(e). Here is the scoping test, every required element of the written program, the two things the CHP does not contain, and a cross-walk showing where each obligation lives.
ISO 17025 Calibration Certificates: Interpretation Guide
How to read an ISO/IEC 17025:2017 calibration certificate rather than just file it: the mandatory elements, what expanded uncertainty and the coverage factor k mean, how decision rules produce a pass or fail statement, test uncertainty ratio, and handling an out-of-tolerance result.
CAP Proficiency Testing: How the College of American Pathologists’ PT/EQA Program Works
How CAP proficiency testing actually works: the difference between CAP Surveys (a CMS-approved PT provider) and CAP’s own accreditation requirement, plus alternative performance assessment, enrollment, and what happens after an unsuccessful result.
AABB Certification: What AABB Accreditation Is and How to Get It
AABB accreditation explained: what it covers, who needs it, the on-site assessment process, and how it differs from AABB membership and CLIA certification.
Calibration Certificates and Metrological Traceability: What “NIST-Traceable” Actually Means
What a compliant calibration certificate must contain, what metrological traceability (VIM) actually requires, why “NIST-traceable” is widely misused, and how calibration, verification, and adjustment differ.
Proficiency Testing & External Quality Assessment (EQA) for Accredited Labs
How proficiency testing (PT) and external quality assessment (EQA) schemes work under ISO/IEC 17043 and CLIA, including how PT samples must be handled and tested in duplicate, where labs source them, z-score interpretation, and what unsuccessful performance triggers.
CLIA Certification: Certificate Types, Complexity Categories, and Whether Your Lab Needs One
A guide to CLIA certification under 42 CFR Part 493: the five certificate types, waived/moderate/high complexity categories, and the research-lab exemption that determines whether CLIA applies at all.
ISO/IEC 17025: What It Actually Accredits and How It Differs from ISO 9001
ISO/IEC 17025:2017 accredits a laboratory’s technical competence for a defined scope of tests or calibrations — it does not certify the organization as a whole, and it is not the same thing as ISO 9001. This guide covers the clause structure (general, structural, resource, process, and management-system requirements), how accreditation bodies differ from certification bodies, exactly what an accreditation scope does and doesn’t cover, and what a procurement or QA reviewer should verify before qualifying a calibration or testing supplier.
