Constancy Services Laboratory NABL, CAP& NABH Accreditation Includes:
1. Micro-level survey for each and every test parameter of the laboratory and preparation of detail “gap analysis report”.
- Guidance in preparation of available record list
- Guidance in preparation of required record list
- Guidance in setting laboratory operation according to NABL requirements.
- Identify processes/ areas where there is lack if technical expertise, requirement of staff training etc.
2. Guidance I preparation of laboratory manuals as per ISO 15189:2012
- Guidance in preparation laboratory Quality Manual as per 15189:2012
- Guidance in preparation laboratory safety manual
- Guidance in preparation laboratory purchase manual
- Guidance in preparation laboratory staff manual
- Guidance in preparation laboratory software manual
- Guidance in preparation laboratory primary sample collection manual
3. Preparation of applicable documents required by ISO 15189:2012 based on details study of all activities of the laboratory, such as:
- Guidance in preparation 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 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 format
- Guidance in preparation of “authorized” as per NABL.
- 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 material” 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.
4. Guidance in preparation of all kind of form formats required for documentation.
5. ISO15189:2012 and NABL 112 awareness training for all levels of employees within the laboratory.
- All 15 sub-clauses of management requirements
- All 10 sub-clauses of technical requirements
- Clauses-wise requirement of documents
- Clauses-wise implementation
6. Guidance in development and effective implementation of processes in laboratory
- Pre-analytical- patients preparation, sample collection, transportation, accession, cross verification and separation.
- Analytical- Sample receival, work list, processing, report delivery
- Post Analytical- Report Generation, Report Printing, Report Delivery.
7. Training to designated quality manager and deputy quality manager on taking internal audits and then effective closure of the NCs.
8. Training to designated quality manager and deputy quality managerand department wise key personnel on facing the audits.
9. 1step will provide customized checklist for conducting internal audit which includes required details/ records each clause mentioned in ISO 15189:2012
10. Conduct internal audit as per ISO 15189:2012 & NABL 112 to check readiness for the accreditation and provides details where there is scope for improvement(Non-conformance) and help in closure of the same.
11. Guidance in conduction 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
12. Guidance in submitting application to NABL seeking accreditation.
13. Guidance in addressing the issues raised (if any) in application and quality manual adequacy report by NABL.
14. Be present at location at the time of pre-assessment and final audits and guidance on effective onsite closure of observations and non-conformances raised (wherever possible)
15. Training to designated safety officer to develop and continuously improve safety procedures and monitor the effective implementation of the same
16. Training to designated lab persons on CAPA Corrective actions and preventive actions).
17. Guidance on closing the non-conformances raised (if any) during pre-assessment and final audits within specified time.