Consultancy

Consultancy

Laboratory set-up and process management (Green field and Brown field).

  • Infrastructure Management: Layout design, construction, different departments, unidirectional work flow, BSL II / BSL III compliance, compliance with international, national and local guidelines..
  • Department Management: Suggestions pertaining to the necessary requirements mandatory for the laboratory and to customize the laboratory room size to occupy all the sections.
  • Instrument Selection: Guidance in Instrument selection & provide Techno-Commercial comparison of Instruments which gives an idea on which instrument will be suitable in terms of Quality, Cost, and Services etc. Which will help in final selection on instruments.
  • Instrument Validation: Guidance for Validation & Verification of instruments as per local, national and international guidelines, which will a baseline for the accreditation.
  • Staff Management: Guidance in the staff recruitment and training.
  • Process Flow Design: Guidance in designing the lab work process flow as per local, national and international guidelines.

ACCREDITATION CONSULTANCY

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.

Preparation of applicable documents required by accreditation body ( such as NABL - ISO 15189:2012 & NABL 112, NABH, CAP, RNTCP, ISO and JCI ) based on the detailed study of all activities of the laboratory.

  • Guidance in preparation of laboratory manuals
  • Guidance in preparation of Quality System Procedures.
  • Guidance in preparation of Standard Operating Procedures (SOPs) 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 accreditation application annexures
  • Guidance in preparation of “Test Scope” as per NABL formats.
  • Guidance in preparation of “Authorized Signatory” details as per accreditation body formats.
  • Guidance in preparation of “Organogram” as per accreditation body.
  • Guidance in preparation of “List of Staff” as per accreditation body.
  • Guidance in preparation of “List of Instruments” as per accreditation body.
  • Guidance in preparation of “List of Reference Materials” as per accreditation body.
  • Guidance in preparation of “EQAS, ILC Details” as per accreditation body.
  • Guidance in preparation of “List of CC” as per accreditation body.
  • Guidance in preparation of “Senior Management Details ” as per accreditation body

Start to end hand holding for getting accredited by accreditation bodies and guidance continuation of accreditation

  • Customer centric approach
  • Design and implementation of processes as per the requirements of customer which also address properly the requirements of accreditation bodies
  • Continuous support for maintaining requirements of accreditation bodies through out years on day to day basis

Accreditation body checklist (Like ISO 15189:2012 & NABL 112, NABH) 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
  • Quality Manager training for successfully facing the audits
  • 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 Receival, Work List, Processing, Report Entry, Validation, and Approval.
  • Post-Analytical: Report Generation, Report Printing, and Report Delivery
  • Quality Assurance
  • Inventory management
  • Financial management
  • Logistics management

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
  • Etc

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 as per accreditation body (Like NABL 112 & ISO 15189: 2012).
  • Conduct internal audit as per requirements of accreditation body (like 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 as per accreditation body (like ISO 15189:2012).
  • Guidance in submitting an application to accreditation body (NABL, NABH, CAP ISO, RNTCP, JCI) seeking accreditation.
  • Guidance in addressing the issues raised (if any) in application and quality manual adequacy report by accreditation body.
  • 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 accreditation body checklists

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