11 years of Experiences in

NABL ACCREDITATION PROGRAMME

MORE THAN 700+ NABL AUDIT, 200+ HAPPY CLIENTS

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WHAT IS NABL?

The National Accreditation Board for Testing & Calibration Laboratories (NABL) Standards is today the highest benchmark standard for Medical Laboratory in India and are considered prestigious acknowledgements of the Laboratory Quality as they substantially stimulate continuous improvement, enabling the Medical Laboratory in demonstrating commitment to quality care and raises the community confidence in the services provided by the Laboratory. They provide an opportunity to benchmark with
the best.

OUR CONSULTANCY SERVICES INCLUDES FOLLOWING NABL ACCREDITATION PROGRAMME

WHY NABL?

The concept of laboratory accreditation was developed to provide third-party certification that a laboratory is competent to perform the specific test or type of tests. Laboratory accreditation is a means to improve customer confidence in the test reports issued by the laboratory so that the clinicians and through them the patients shall accept the reports with confidence.

Accreditation is the single most important approach for improving the quality of LABORATORY. Happier patients & staffs.

supplies the leading-edge science and technology through the standard, benefiting the clinicians and patients who rely so heavily upon accurate laboratory testing.

As per The Insurance Regulatory and Development Authority of India (IRDA) guideline, it is mandatory to enroll in NABL for providing treatment under Cashless Insurance Schemes (CIS).

Get the Best Rates for CGHS (Central Government Health Scheme) and RSBY(Rashtriya Swasthya Bima Yojana) etc. health plans promoted by State / Central Govt.

Health Tourism is one of the key benefits in getting NABH Standards. Both Foreign and Domestic tourist looking for health services , search for Hospitals and Clinics with Trust values like NABH Accreditation.

The infrastructure, facilities and maintenance are certified and reliable to be accessed along with the level of care and safety.

HOW QualityKonnect WILL HELP YOU TO GET NABL ACCREDITATION?

Once your Organization determines to go for NABL Accreditation, QualityKonnect Consultants shall guide you in each and every step of the process, starting from 'CONCEPTION' to "REALIZATION'.

Preparing the Organization for NABL Accreditation

The Organization should have implemented the NABL Standard (ISO 15189 for Medical Laboratory and ISO/IEC 17025 for Testing and Proficiency laboratory) before applying to NABL. QualityKonnect Consultants with their expertise shall help your organization to understand the standard and train your staffs and implement at your organization.

Preparing your organization will cover the following activities:

GAP Analysis report of entire Organization as per NABL guidelines and suggest changes in Infrastructure, Personnel or any Regulatory or Statutory compliances if required.

Preparation of various Quality Documents like Quality Manual, Departmental SOPs, Files, Formats etc.

Training of staffs on NABL standard.

Formation of Core Quality Team and guide them implementing NABL standard throughout the organization.

Conducting Internal Audit and Management review meeting.

Statutory Compliance Guidelines.

Providing guidelines for various displays.

Implementing policies for capturing Quality Indicators.

Filling Application process in NABL web portal.

The laboratory are required to apply through NABL Web Portal (‘Apply Now’ option on website www.nablindia.org) to NABL in prescribed application form (NABL 151, NABL 152, NABL 153) for Testing laboratories, Calibration laboratories or Medical laboratories respectively along with associated Sample Collection Centre/ Facilities (SCF). The applicant laboratory should describe the management system in accordance with ISO/IEC 17025: 2017 or ISO 15189: 2012. Once the laboratory is ready for Application, QualityKonnect shall help you to fill the application as per the instructions given in the online application portal. Application may be rejected in case information provided in the application and Management System Document/ Quality Manual uploaded are not relevant to NABL accreditation. This is why you need the expertise, and we have inevitable experiences in this domain for more than a decade.

Application Document review by Lead Assessor

The preliminary document review of the application and management system document/ quality manual submitted by the laboratory is carried out by NABL whereas the detailed review is carried out by Lead Assessor. The lead assessor informs NABL regarding the document review, indicating inadequacies (if any). In case receiving of any inadequacies, QualityKonnect shall help the Laboratory amending the relevant documents and make changes in the management system accordingly within seven days.

Implantation of NABH standard

In the mean time, when your application is being scrutinized by the NABL authorities and plan your pre-assessment date, QulaityKonnect Consultants shall be guiding you to implement the ISO standard throughout your organization by conducting training of Staffs, Internal Audit, various Mock drill and other implementation process. Before the pre-assessment, it is important to check the readiness of your organization. Our experts shall conduct the Mock audit just the way it is done by NABL to ensure the preparedness of the organization to face the actual assessment.

Support during Pre-Assessment of your organization

In case there are no inadequacies in the document review or after satisfactory corrective action by the laboratory, a pre-assessment is conducted by lead assessor appointed by NABL (Date will be mutually agreed by Assessor & Organization).

The pre-assessment is conducted to:

a) evaluate quality management system.

b) assess the degree of preparedness of the CAB for the assessment

c) determine the number of assessors required in various fields based on the scope of accreditation, number of key locations to be visited etc.

During the Assessment, QualityKonnect shall be giving you entire assessment support from the backend. At the end of the assessment, our expert will guide you to take proper corrective and preventive action against the observations raises by the lead assessor and submits a report to NABL within fifteen days.

Final-Assessment of your organization

After reviewing the satisfactory corrective actions based on root cause analysis submitted by laboratory, NABL proposes constitution of an assessment team. The date(s) for assessment are decided in agreement with the laboratory. The assessment will be generally carried out for two days (the duration for integrated assessment is 05 days). The assessment team includes the lead assessor (generally the one who had conducted the pre-assessment), the technical assessor(s)/ expert(s) in order to cover the scope for which the accreditation has been sought. The number of technical assessor(s)/ expert(s) depend upon the type of assessment.

The assessment team verify laboratory's documented management system and check its compliance with the requirements of ISO/IEC 17025: 2017 or ISO 15189: 2012 or ISO/IEC 17043: 2010 or ISO 17034: 2016 whichever is applicable and relevant specific criteria (wherever applicable) and other NABL policies. The documented Management system, SOPs, work instructions, test methods etc. are assessed for their implementation and effectiveness. The CAB’s technical competence to perform specific tasks is also evaluated.

During the Final Assessment, QualityKonnect shall extend the entire assessment support from the backend. At the end of the assessment, our expert will guide you to make details assessment report along with proper corrective and preventive action against the Assessor's observations raised during the assessment and will submit to NABL portal within recommended timeline suggested by the assessors.

During assessment, if laboratory fails to demonstrate competence for applied scope of accreditation due to any reason then it will be constructed as falsification of information. Therefore, laboratories are required to apply for the scope for which they have competence in all respect (personal, facilities, procedures etc.). Our expertise in this domain will help you to fill actual scope of services.

Once your submitted corrective/ preventive action against the observations raised by the assessor is accepted by the NABL, you will receive the NABL Accreditation certificate with validity of 3 years.

Surveillance and Re assessment:

Accreditation to the hospital shall be valid for a period of three years. NABL shall conduct surveillance before completion of 18 months since the date of accreditation. QualityKonnect is always there for you to maintain your NABL Accreditation and support at various assessment.