IMDNA provides scientific, technical, and non-regulatory support for laboratories developing, updating, organizing, or harmonizing Standard Operating Procedures (SOPs) and related laboratory documents. Support can include SOP architecture, technical drafting, workflow mapping, procedure templates, method-specific instructions, equipment procedures, quality-control workflows, document-control tools, revision support, training materials, and implementation assistance.
An SOP should describe how work is actually performed in the laboratory. WHO laboratory-quality guidance emphasizes standardizing major laboratory processes through authorized procedures, while U.S. CLIA requires applicable nonwaived laboratories to maintain written procedures for tests, assays, and examinations performed. IMDNA can help translate technical workflows into practical documents while the laboratory retains responsibility for customization, review, approval, implementation, and ongoing control of its procedures.
SOP development is not simply rewriting a manufacturer's insert or copying a generic template. The procedure should accurately describe the laboratory's instrument, reagents, sample types, work sequence, controls, calculations, result workflow, troubleshooting, safety considerations, and local operating practices. WHO's quality-manual template specifically states that laboratories should customize templates to their local situation.
Define what process the SOP controls and which laboratory activity, instrument, method, or workflow it covers.
Identify where the SOP applies, which specimen or process it covers, and which staff or laboratory sections use it.
Write operational steps in clear language and in the same sequence that personnel perform the work.
Include the applicable controls, quality checks, calculations, troubleshooting actions, and documentation points needed for the process.
Maintain identifiable versions, effective dates, review history, approvals, revisions, and controlled access to the current procedure.
IMDNA can support a single assay procedure, a laboratory section, an instrument implementation project, or a broader SOP harmonization program.
Help identify which operational, technical, equipment, sample-handling, quality, and support procedures may be needed for the laboratory's intended workflow.
Develop a consistent SOP structure, numbering approach, header/footer format, required sections, revision table, approval fields, and writing conventions for laboratory use.
Prepare draft procedures from validated or established workflows, manufacturer instructions, laboratory information, assay protocols, instrument manuals, and customer-provided technical requirements.
Map the actual process before drafting so specimen handling, reagent preparation, instrument use, controls, analysis, troubleshooting, and handoffs are represented correctly.
Support assay procedures for qPCR/RT-qPCR, ELISA, multiplex immunoassay, flow cytometry, cell-based methods, extraction, sample preparation, and other laboratory workflows within IMDNA's technical capability.
Support operating, startup/shutdown, maintenance, cleaning, calibration-support, troubleshooting, and equipment-use procedures based on manufacturer information and laboratory workflow.
Help document control preparation, run acceptance workflow, review steps, troubleshooting pathways, and technical response to unacceptable control performance.
Support practical procedures for receipt, labeling, preparation, aliquoting, extraction, storage, retention, repeat testing, referral, and other specimen workflows.
Support technical documentation for result analysis, data review, calculations, instrument software, reporting handoffs, amended workflows, and data retention as appropriate.
Document technically justified actions for control failures, instrument issues, reagent problems, repeat testing, discordant results, inhibition, assay-performance concerns, or other defined technical events.
Update older documents, consolidate duplicate procedures, harmonize formatting and terminology, and align related SOPs across laboratory sections.
Provide technical orientation, workflow review, training-support materials, change summaries, and early implementation assistance after a new or revised SOP is introduced.
IMDNA's SOP-development model starts with the actual process and moves through drafting, laboratory review, controlled revision, approval by the responsible laboratory personnel, implementation, and ongoing maintenance.
A common structure makes procedures easier to write, review, train, retrieve, and maintain. The exact structure should be customized by the laboratory and may differ according to the procedure type.
| SOP Section | Typical Content | Development Consideration |
|---|---|---|
| Document Identification | Title, SOP number, version, effective date, department, pagination, author/reviewer/approver fields. | Use one consistent document-control structure across the laboratory. |
| Purpose | Why the procedure exists and what process it standardizes. | Keep it specific enough to distinguish this SOP from related procedures. |
| Scope | Applicable laboratory section, specimen, test, equipment, staff role, or workflow. | Define boundaries so users know when the SOP applies. |
| Responsibilities | Roles involved in performing, reviewing, maintaining, or supporting the procedure. | Responsibilities should reflect the laboratory's actual staffing model. |
| Definitions / Abbreviations | Technical terms, acronyms, symbols, or method-specific terminology needed to understand the procedure. | Avoid unnecessary definitions; include terms that improve clarity. |
| Safety / Precautions | Applicable hazards, PPE, chemical/biological precautions, equipment warnings, and waste considerations. | Safety content should align with the laboratory's own safety program and authoritative requirements. |
| Materials / Equipment | Reagents, consumables, instruments, controls, calibrators, reference materials, and supporting equipment. | Specify what is needed without creating unnecessary dependence on obsolete catalog details unless required. |
| Specimen / Input Requirements | Applicable specimen type, preparation, handling, storage, volume, quality, or other input criteria. | Use method-appropriate criteria and align with the laboratory's collection and acceptance processes. |
| Procedure | Step-by-step instructions in the order personnel perform the work. | Write clearly, avoid ambiguous verbs, and separate decisions from routine steps. |
| Quality Control / Acceptance | Control setup, expected performance, review workflow, technically justified acceptance or escalation instructions. | Final acceptance criteria remain the laboratory's responsibility. |
| Calculations / Analysis | Formulas, software steps, normalization, gating, thresholds, or interpretation workflow as applicable. | Include enough detail for reproducible execution and review. |
| Limitations / Troubleshooting | Known technical limitations, common failure modes, repeat actions, escalation, instrument/reagent issues. | Distinguish routine troubleshooting from issues requiring vendor, laboratory leadership, or other qualified review. |
| Records / Related Documents | Logs, forms, worksheets, QC records, instrument records, related SOPs, manuals, and references. | Link the SOP to the rest of the document system. |
| Revision History | Version, date, summary of changes, and applicable approvals. | Maintain traceability of significant changes over the document lifecycle. |
For U.S. laboratories performing applicable nonwaived testing, 42 CFR §493.1251 requires a written procedure manual for all tests, assays, and examinations performed by the laboratory. Manufacturer instructions may satisfy certain required elements when applicable, but information not provided by the manufacturer must be supplied by the laboratory. CMS interpretive guidance also states that procedures and procedure changes must be approved, signed, and dated by the current laboratory director before use.
IMDNA can help draft and organize technical content, but the receiving laboratory should ensure that each procedure reflects its own approved method, instruments, specimen workflow, staff responsibilities, quality practices, and local requirements.
WHO laboratory-quality guidance treats SOPs as one part of a broader document and quality-management system. A useful document hierarchy helps laboratories separate high-level policy from detailed work instructions and records.
Describe the laboratory's overall quality framework, organizational approach, responsibilities, and high-level policies.
Describe standardized laboratory processes and how defined activities should be performed.
Provide focused, task-specific instructions, diagrams, quick-reference steps, checklists, or equipment reminders where useful.
Capture evidence that procedures were performed, reviewed, maintained, and followed over time.
IMDNA can develop or support technical SOPs across laboratory areas where its scientific and technical team has relevant expertise.
Extraction, reagent preparation, assay setup, controls, amplification, analysis, multiplex workflows, troubleshooting, maintenance, and result-review support.
Sample dilution, plate preparation, controls, standards, incubation, washing, detection, reading, calculations, troubleshooting, and equipment workflow.
Bead/reagent preparation, sample dilution, calibrators, controls, incubation, washing, acquisition, analysis, and analyte-specific review.
Sample preparation, staining, controls, instrument setup, compensation/unmixing, acquisition, gating workflow, maintenance, and data review.
Cell handling, culture conditions, plating, stimulation/treatment, assay readout, controls, viability, equipment use, and workflow documentation.
Startup, shutdown, routine operation, cleaning, maintenance, qualification-support, calibration-support, troubleshooting, and service documentation.
Receipt, labeling, transport, aliquoting, preparation, storage, retention, repeat testing, referral preparation, and disposition workflow.
QC workflow, inventory, document control, change control, training records, temperature monitoring, workflow review, equipment logs, and related practical procedures.
Translate an established assay or method into the laboratory's routine operating procedure following technical review and laboratory-specific customization.
An SOP is useful only when users can identify the current approved version. WHO's quality-manual template includes SOP management, internal document management, and document control as dedicated processes.
Develop a practical naming and numbering convention by laboratory section, document type, workflow, or technology.
Support consistent recording of version numbers, approval dates, effective dates, review dates, and revision history.
Clearly document what changed and why so staff can understand revisions without comparing entire documents line by line.
Connect SOPs with forms, logs, worksheets, equipment manuals, validation documents, QC procedures, and associated workflows.
Support practical approaches for removing superseded versions from routine use while preserving records where required by the laboratory.
Help laboratories establish review lists, revision calendars, technical-review workflows, and document update priorities.
Publishing an SOP does not by itself ensure consistent execution. The procedure should be introduced to the personnel who use it and supported with appropriate training or orientation.
Develop slide decks, workflow diagrams, quick-reference guides, checklists, or other practical materials that support the SOP.
Provide technical walkthroughs to explain the sequence, controls, critical steps, troubleshooting, and workflow changes within the procedure.
Summarize important differences when a method, instrument, reagent, workflow, or document version changes.
Support early use of a new procedure by addressing technical questions and clarifying workflow or document issues as they arise.
Collect practical feedback from users and help revise unclear or inefficient sections after laboratory review.
Help keep related procedures aligned when laboratory workflows, assays, instruments, or supporting documents change.
IMDNA provides general scientific, technical, laboratory-documentation, SOP-development, workflow, validation-support, and non-regulatory implementation support based on the needs of each laboratory organization. Support may include assistance with SOP inventories, master SOP and template development, technical drafting, workflow mapping, method-specific procedures, equipment procedures, QC and control procedures, troubleshooting procedures, document-control tools, revision support, training materials, and implementation assistance.
Where appropriate, IMDNA may prepare draft procedures using information supplied by the laboratory, manufacturer instructions, technical manuals, established assay workflows, published scientific information, and IMDNA's own technical experience. Draft documents should be reviewed and customized by the receiving laboratory before use.
IMDNA is not a regulatory, licensing, accreditation, certification, legal, or governmental authority. IMDNA does not approve a laboratory's SOPs on behalf of a regulatory or accreditation body and does not replace the laboratory director, quality-management personnel, safety personnel, manufacturer, or other responsible authorized individuals.
Each laboratory is responsible for determining which procedures are required for its own activities; ensuring that procedures accurately reflect its methods, instruments, specimens, personnel, safety practices, and applicable requirements; and completing the required review, approval, implementation, training, change control, retention, and ongoing maintenance of its documents.
Any SOP, template, technical document, workflow, or guidance provided by IMDNA is intended to support the laboratory's own documentation process and should not be interpreted as regulatory approval, certification, accreditation, legal determination, reimbursement determination, or a guarantee of regulatory acceptance.
References to governmental, regulatory, standards-development, scientific, or professional organizations are provided for general informational purposes only and do not imply endorsement, approval, affiliation, certification, or sponsorship of IMDNA or its services.
The following official and internationally recognized resources support the general concepts of laboratory procedure manuals, SOP standardization, document control, quality systems, and laboratory-specific customization. These resources are provided for independent educational use and do not imply endorsement of IMDNA or establish one universal SOP format for every laboratory.
Tell IMDNA about your laboratory section, assay or instrument, current workflow, existing documents, staff process, controls, technical challenges, and documentation goals. Our scientific and technical team can help organize a practical SOP-development program covering workflow mapping, technical drafting, templates, QC procedures, troubleshooting, document harmonization, training resources, and implementation support.