Micro-level survey for each and every test parameter of the laboratory and preparation of detail “Gap Analysis Report”.
  • Guidance in preparation of available records list.
  • Guidance in preparation of required records list.
  • Guidance in setting laboratory operations according to NABL requirements.
  • Identify processes/ areas where there is lack of technical expertise, the requirement of staff training etc.
Guidance in preparation of laboratory manuals as per ISO 15189:2012.
  • Guidance in preparation of laboratory quality manual as per ISO 15189:2012.
  • Guidance in preparation of laboratory safety manual.
  • Guidance in preparation of laboratory purchase manual.
  • Guidance in preparation of laboratory staff manual.
  • Guidance in preparation of laboratory software manual.
  • Guidance in preparation of laboratory primary sample collection manual.
Preparation of applicable documents required by ISO 15189:2012 & NABL 112 checklist based on the detail study of all activities of the laboratory, such as:
  • Guidance in preparation of Quality System Procedures (Mandatory laboratory procedures required by the ISO 15189:2012 standard).
  • Guidance in preparation of Standard Operating Procedures (SOPs) (for the tests covered under the scope) to control identified activities having risk potential to the test parameter.
  • Guidance in preparation of Form Formats to establish the objective evidence of implementation and to ensure control over all the activities.
  • Guidance in preparation of “Test Scope” as per NABL formats.
  • Guidance in preparation of “Authorized Signatory” details as per NABL formats.
  • Guidance in preparation of “Organogram” as per NABL.
  • Guidance in preparation of “List of Staff” as per NABL.
  • Guidance in preparation of “List of Instruments” as per NABL.
  • Guidance in preparation of “List of Reference Materials” as per NABL.
  • Guidance in preparation of “EQAS, ILC Details” as per NABL.
  • Guidance in preparation of “List of CC” as per NABL.
  • Guidance in preparation of “Senior Management Details ” as per NABL
Guidance in preparation of below listed QSP’s (Quality System procedures)
  • Quality management system SOP for control of documents & records.
  • SoP for Amendment of Documents.
  • SoP to Access Medical Records.
  • SoP for Establishment & Review of Service Agreements.
  • SoP for Selection & Evaluation of Lab Referrals.
  • Resolutions of Complaints & Feedback.
  • SoP for Identification & Control of Non-Conformity.
  • SoP for Corrective Action.
  • SoP for preventive action on laboratory Risk Analysis & Intended Performance Level.
  • SoP or action plan for Review of Continual Improvement.
  • SoP for management review.
  • List of quality indicators, document control log.
ISO 15189:2012 & NABL 112 checklist awareness training to all levels of employees within the laboratory.
  • Training on ISO 15189:2012
    1. All 15 sub-clauses of management requirements.
    2. All 10 sub-clauses of technical requirements.
  • Training on NABL 112
  • Training on assessor checklist 1

    1. Clause-wise requirement of documents.
    2. Clause-wise implementation.
  • Training on assessor checklist 2
    1. Clause-wise requirement of documents.
    2. Clause-wise implementation.
Guidance in development and effective implementation of processes in laboratory
  • Pre-Analytical: Patient Preparation, Sample Collection, Transportation, Accession, Cross Verification, and Separation.
  • Analytical: Sample Received, Work List, Processing, Report Entry, Validation, and Approval.
  • Post-Analytical: Report Generation, Report Printing, and Report Delivery
Guidance in preparation of all kind of form formats required for documentation
A) General:
  • Room temperature & humidity log
  • Microscope daily maintenance log
  • Daily maintenance log for CO2 incubator
  • Daily maintenance log for incubator
  • Incubator daily temp. record log
  • Daily maintenance log for water bath
  • Refrigerator temperature log
  • Freezer temperature log
  • Daily maintenance log for centrifuge
  • Daily maintenance log for barcode printer
  • Daily cleaning record of the working area
  • Daily cleaning record of washroom(s)
  • Sample rejection log
  • Critical value log
  • Software validation record log
  • Inter-lab comparison record log
  • Deep freezer defrost log
  • Carryover evaluation record log
  • Audit NC record log
  • Corrective action record log for IQC outlier
  • CA-PA log for errors
  • Instrument breakdown log
  • Inter-personnel validation record log
  • Read & understood record log
  • Result amendment record log
  • CA-PA log for EQAS/ILC outlier
  • CA-PA log for monthly CV% outlier
  • Inter-instrument / method comparison log
  • Lot verification record log
  • Monthly CV% record log
  • Training / CME attendance log
  • Daily temperature log for hot air oven
  • Instrument authorization record log
  • Maintenance log for water system
  • Competency assessment record log
  • Employee feedback record log
  • Split testing record log
  • Fumigation record log
  • Housekeeping record log
  • Vendor evaluation record log
  • Reagent usage record log
  • Adverse incident record for reagents log
  • Sample discard record log
  • Preparation of 1% sodium hypochlorite record log
  • LIMS request record log
  • Specimen label correction record log
  • Specimen of not received follow-up record log
  • Glassware residual checking record log
  • Verification of formula calculated test results record log
  • Slide discard record log
B) Department wise required logs will be prepared as required based on the final test scope.
  • Guidance in preparation of all kind of form formats required for documentation
  • Training to designated quality manager, deputy quality manager and department wise key personnel on facing the audits.
  • 1Step will provide a customized checklist for conducting an internal audit, which includes required details/records each clause mentioned in ISO 15189: 2012.
  • Conduct internal audit as per ISO 15189:2012 & NABL 112 to check readiness for the accreditation and provide details where there is scope for improvement (Non-conformances) and help in the closure of the same.
  • Guidance in Conducting management review meeting in presence of “laboratory top management” to guide the laboratory for effective implementation on all the issues related to management requirements and technical requirements of ISO 15189:2012.
  • Guidance in submitting an application to NABL seeking accreditation.
  • Guidance in addressing the issues raised (if any) in application and quality manual adequacy report by NABL.
  • Be present at the location at the time of pre-assessment and final audits and guidance on effective onsite closure of observations and Non-Conformances raised (wherever possible).
  • Training to designated safety officer to develop and continuously improve safety procedures and monitor the effective implementation of the same.
  • Training to designated lab persons on CAPA (Corrective Actions and Preventive Actions).
  • Guidance on closing the Non-Conformances raised (if any) during pre-assessment and final audits within the specified time.
  • Guidance on preparation & implementation of QMS as per NABL Accreditation checklist