InformationUpdate

Industry Information Updates – Healthcare Sector

NABL Announcement

CLARIFICATION ON UNIQUE LABORATORY REPORT (ULR) NUMBER

Accredited testing laboratories, calibration laboratories and Reference Material Producers may note the clarification on the use of ULR number released by NABL recently.

Key Highlights about the announcement :

Government electronic Marketplace (GeM) accepts test reports issued by NABL accredited laboratories along with the products which are uploaded on the GeM portal.

Similarly for product / equipment which is to be used after calibration, the calibration certificates issued by NABL accredited calibration laboratories are accepted. RM document from NABL accredited RMP is required to be uploaded along with any (certified) reference material on GeM portal.

To authenticate the test reports / calibration certificates / RM documents, GeM has sought the co-operation of NABL in getting the data on reports mapped with the claim of the sellers. To facilitate such mapping, an 18-digit ULR number has to be mentioned on all reports issued by testing & calibration laboratories and RMPs. This number will be in addition to the report number of the laboratory / RMP and will have to be mentioned in all reports issued with accredited scope only.

This system is not mandatory for test reports issued by bulk petroleum product manufacturer’s laboratories, test reports of non-commodities like air, waste water and similar environmental parameters and results related to veterinary testing, dope testing & forensic testing.

For testing and calibration laboratories, discipline (example- Biological / Mechanical) and group (example- Water /

Dimension) as applicable needs to be mentioned before the product and parameters in the reports. (Please refer NABL 120)

For RMP, category and sub-category needs to be mentioned before the product / parameters in the document. (Please refer NABL 191).

It is reiterated that the ULR system has to be followed in line with the current version of NABL 133.

This system is not to be used in reports containing parameters outside the scope of NABL accreditation.

Read the full notification issued by NABL here :

Announcement

Announcement from NABL on CABs

Sharing the recent announcement from NABL on CABs.

There is a fast track focus at the market place to seek Certifications fast. This trend is more visible at the market place now. Fast tracking , resorting to various acts as listed in the announcement is not a healthy sign for the industry.

Certificates , Certifications are of no use, of no relevance when the users, payers, for the services don’t experience “the showcased Quality of Service”. There is a structure , methodology that needs to be followed while seeking Quality Systems Certifications.

The sudden rush for Certificates must be driving businesses to resort to unhealthy practices is what is understood from the notification !

Sharing this here to as information update for industry to take cognizance of the notification.

NABL Announcement

NABL Announcement for Calibration Laboratories

Guidelines for Interlaboratory Comparison for Calibration Laboratories where Formal PT Programs are not available
Posted on 25.10.2021

NABL has released guidelines for ILC for Calibration Labs where PT Programs are not available.

The guideline is for the Calibration laboratories which are accredited and applicant to NABL. Calibration laboratories shall participate in Proficiency Testing Program of accredited Proficiency Testing Providers. This procedure is be used only as an alternative in the absence of formal Proficiency Testing programs to meet the requirements of NABL 163.

For more information, download the document here :

Source : https://nabl-india.org/

For Clarifications and guidance , reach out to :

A A Srinivasan, Principal Consultant – srinivasanaa@valueaddedin
Mobile – +91 98404 90368

NABL Training Programs

Training Programs from NABLAnnouncement

Training Programs from NABL

Download the Brochure here :

Registration Link :

Laboratory Excellence Award

Prof. S.K. Joshi Laboratory Excellence Award from QCI NBQP

Prof. S.K. Joshi – Laboratory Excellence Award has been instituted to promote Laboratory Quality and performance improvement in the country. The award has been incepted to ensure the laboratory’s commitment to achieve excellence in providing high precision testing and calibration services in line with the prevalent national/international quality systems legislations including Health, Safety, Environment (HSE).

The Award is to recognize Laboratories (Testing, Medical and Calibration) those have established outstanding achievements in the field of Quality in services and benchmarked in their domain for their best practices

Eligibility:

1.This award is open to all currently operational Laboratories pertaining to Testing, Calibration & Medical including their Proficiency Testing Providers & Reference Material Producers located in India.
2.Participating labs are required to operate the applicable Quality System according to the requirements as stipulated in ISO 17025/ISO 15189/ISO 17043/ISO 17034, regarding its implementation and monitoring.
3. The award require labs to operate with proper HSE measures.
4.The Laboratory should not have been convicted by any Court.
5.A Laboratory once awarded can be considered only after a period of 3 Years

The 5 stages of assessment by Technical Expert Committee (TEC) are as follows:-

Stage 1: Application Document Evaluation
Stage 2: Physical/Virtual Presentation
Stage 3: Site Assessment / verification
Stage 4: Evaluation through Reference check of customer in special case
Stage 5: Inputs to Jury for final evaluation

Assessment Criteria

The assessment of the application submitted by the laboratory is made on the basis of various parameters which have been identified by a team of experts from NBQP/QCI.

Primary Parameters:

  1. Management Commitment – Qualification, Experience, Training & Innovation, Quality Improvement and skill upgradation.
  2. Strategy – Accreditation for entire Laboratory activities (to ensure Sustainability).
  3. Processes – Standard Method (National/International), Validation/Verification, Equipment/Techniques used and Measurement Traceability to SI units.
  4. Infrastructure & Quality Control Resources – Facilities and Environmental Conditions (Innovation for enhancing Good Laboratories Practices) owned by Lab. Use of Certified Reference material, Proficiency Testing Program participation and Inter-Laboratory Comparison and other QC checks.
  5. Customer Complaints, Feedback and Improvement – Diagnosis of the problem (Root Cause Analysis & Quality tools deployed)
  6. Key Results/Satisfaction – Reports, Customer Results, Society Results and Employee Satisfaction. Tangible benefits, intangible benefits or socio economic and environmental benefits

Terms & Conditions Of The Award:

1. Non – disclosure and confidentiality
I. The names of the applicants, evaluation and scoring system developed for the assessment process will be regarded as proprietary and kept confidential. Such information shall be made available only to those individuals who will be directly involved in the assessment and administrative process and shall not be disclosed.
II. QCI will not disclose the details about the shortlisted/non-shortlisted laboratories at any stage of the assessment. The qualified laboratories will be notified via e-mail/call by the QCI office directly.
2. Any misinterpretation of facts will disqualify the laboratories from Awards.
3. Applications received with incomplete data will not qualify.
4. Any Award applicant and Awardee cannot use the NBQP and QCI logo in anyway that suggests that QCI is affiliated with, sponsors, approves or endorses you, your organization, your websites, your products or your services etc.

Application Fees

There is no Application Fees

Award Presenatation

The awards will be presented during a special Award Ceremony

Where to Apply ?

Award Details

check here to know more about various awards and details

When is the Last date for applying ?

Last date for submitting the application form is 16th November 2021

For any queries, contact :

Source – https://labexcellenceaward.qcin.org/Home.aspx

Fee Update from NABL

Revised Fee Structure effective for all applications received on/after 01.10.2021 Posted on 01.10.2021

NABL has released revised Fee Structure for all applications received on or after 1/10/2021 . This is applicable for all Testing and Calibration Labs.

All applicant labs and Accredited, Certified Labs have to make a note of the same.

Download the notification from here .

Clarification on the Role of NABL in Enforcing Regulations

Announcement from NABL – National Accreditation Board for Testing and Calibration Laboratories

Clarification on the Role of NABL in Enforcing Regulations

Accreditation is the independent evaluation of Conformity Assessment bodies against recognised normative documents like Standards, Regulations etc. to carry out specific activities to ensure their impartiality, consistency of operation and competence. Through the application of national and international Standards, Government, Procurers and Consumers can have confidence in the results of accredited Conformity Assessment Bodies.

Laboratories are accredited to the applicable international standards, ISO/IEC 17025 in case of testing and calibration laboratories, and ISO 15189 applicable to Medical Laboratories.

Laboratory Customers, Regulatory Authorities, Organizations and Schemes using peer assessment, Accreditation bodies, and others use these documents in confirming or recognizing the competence of laboratories.

The results from Accredited Laboratories are used extensively by regulators for the public benefit in the provision of services that promote an unpolluted environment, safe food, clean water, energy, health and social care services.

Many Government Agencies have recognised the importance of credible accreditation schemes that are developed against internationally recognised standards.

NABL Accreditation is increasingly being used by Regulators and Government to ascertain the Quality of Products. Accredited CABs can objectively state conformance of product or service to specified requirements.

NABL is a Voluntary Accreditation body and has no Regulatory powers. Checking of compliance to the regulatory requirements falls under the purview of respective/applicable Regulator.

In all cases, it is the responsibility of Laboratory to abide by the National & State Statutory requirements, Acts, Ordnance, Rules, Regulations, Legal orders, Court Decisions/ Orders issued by the Government, Statutory Bodies, Courts as applicable and in force from time to time.

Download the announceement from here

Source : https://nabl-india.org/

The above announcement from NABL clarifies its role as Accreditation body to various stakeholders at market place. Regulators , Governments normally rely on Accreditation Bodies for Conformity Assessment procedures. Accreditation bodies are not Regulators and can’t step into shoes of Regulators. This confusion is often seen at market place where Accreditation bodies and Regulators Roles are understood wrongly , get mixed up often. Frequent communication from Apex bodies , Accreditation bodies clarifying the role of ABs, CBs etc throws so much clarity to the industry, stakeholders too. Markets still mix up Accreditations and Certifications. Lot of confusion prevails between Voluntary Recognition Programs and Mandatory Recognition Programs. FAQs list is very long and apex bodies can release communication often on all the FAQs.

Improving Global Competitiveness of Indian businesses is the key focus of Govt of India and businesses need to show compliance to various Conformity Assessment Procedures of Importing Countries. Understanding all these matter as most of these protocols are International Protocols too.

Country is witnessing lot of FDI and many new global businesses are setting up shop in India. International businesses need clarity and clear communication on conformity assessment too as Technical Regulations are linked to International Accounting Standards as well.

Parakh – Unified Laboratory Network

Launched by DPIIT, Ministry of Commerce, Govt of India – National Network of Laboratories Infrastructure

What is #Parakh ?

#Parakh is a Government of India initiative for mapping of testing and laboratory infrastructure across the country on a unified network of testing laboratories. This is yet another significant step towards enhancing Ease of Doing Business. This portal incorporates all the accredited and recognised laboratories in the country on a Geographic Information System.

This is an interactive and user friendly system to find a Laboratories and Tests based on various parameters a user may require.

This program is a joint initiative of various boards, councils as mentioned below :

MSME
CSIR
DRDO
Textile Committee
NABL
Bureau of Indian Standards
FSSAI
Export Inspection Council, EIC India
APEDA

All types of Testing, Calibration Laboratories which are Recognised and Accredited are found in the portal.

This is an initiative which will benefit all citizens, user communities to have access to information related to various testing labs in the country that tests products or services.

Pandemic crisis has brought out this huge gap in the country’s lab infrastructure related information where no information was available about testing labs for PPEs, Ventilators, various other medical devices, Covid testing labs etc. All stakeholders were shunted from pillar to post hunting to testing labs information. Intense debates, discussions had taken place about lack of information about National Testing Labs Infrastructure. That’s how DPIIT has initiated the process to create the National Network of Laboratories which will immensely benefit not only domestic trade but International Trade as well.

Portal currently has a list of :

  • 6581 laboratories offering testing services related to
    • 60558 products and services
    • following 367209 Test Methods

All Laboratories in the country are open to get their laboratories listed in the portal.

Source – https://parakh.ncog.gov.in/indexpage

Customers Quality Systems – Supply Chain getting Trained

Orientation Program for IVD Manufacturers about Various Quality Systems Programs implemented by their User Industry – Hospitals, Med Labs , Other Healthcare Organisations

Supply Chain is showing interest to learn about various Quality Systems implemented by their Customers

Customers Quality Systems – Supply Chain getting Trained

Got a call from an IVD Manufacturer last week expressing interest to get his team trained on various Quality Management Systems followed by healthcare organisations.

I first thought I heard it wrong, I thought he was seeking training for his team on Med Dev QMS. When I asked the question, he said NO and his question is about getting his team members understand a little about various QMS Programs implemented by their customers like NABL, NABH , CAP, QAI Programs.

I was a little surprised and asked him for the reason for choosing a topic like this, though I could quickly guess where he would be heading to. He has mentioned that they are supplying their products to multiple categories of healthcare organisations . Each one comes up with some Certification, Accreditation program that they are implementing. Having implemented Med Dev QMS & Product Certification Programs in house, he felt that its appropriate for his team to acquire some basic knowledge about their Customers Quality Systems Programs and ensuring that as Vendors to the respective healthcare orgns, they would prefer to provide necessary inputs, information that are needed by these Healthcare Organisations (HCOs) during their Quality journey.

This is what is emerging across the globe. Many businesses / sectors are ensuring that their Supply Chain is also in sync with their Quality Systems Journey. When a Mfrer or a Service Provider delivers a Product or a Service to end user / customer, as a finished good, he/she has to doubly ensure that his supply chain also maintains high Quality Standards. It becomes imperative for the Vendors, Suppliers , Stakeholders who are part of the supply chain to be in sync, in alignment with the Quality Systems adopted by their customers.

Similarly, businesses that are seeking support from suppliers, should also make an effort to understand the Quality Systems – be it Product or Systems Certifications, implemented by the Suppliers in their respective organisations. This is the fundamental requirement of Vendor Evaluation in any business. Understanding the Suppliers Quality Systems Programs Matters for Businesses too ! Many Regulated Business Sectors, across the globe, have initiated this exercise of bringing the Supply Chain under some Quality Standards, Systems Programs. Automotive Sector was the 1st sector to introduce this almost 2 decades ago. Many other sectors which are under Regulatory Control are slowly introducing this concept.

This manufacturers/suppliers, being the suppliers to many healthcare organisations, come under the supplier category to these businesses. Healthcare Sector being regulated (be it Products or Services) in the country now, Supplier Quality Compliance will become a norm sooner or later.

We have customised a 3 day program for the IVD Mfrer’s team comprising of :
– Technical Team
– Sales Team
– Customer Support Team
– Management Team

The program was designed in such a manner to provide them a bird’s eye view on various Healthcare Certification, Accreditation Programs that are currently available in India for healthcare businesses to choose.

We have also designed a session on Minimum Standards that are adopted in the country as Regulatory spec which addresses basic QMS to be implemented by Med Labs in the country.

It was interesting session fielding questions from IVD Mfrers about Quality Systems Programs in HCOs.

  • Some interesting questions posed by them :
  • For a start up lab, Is there a bare minimum period required to get the accreditation, if all the criteria is met?
  • Is there any minimal number of parameters in scope of testing for applying certification ?
  • What is the difference betn Certification & Accreditation Program when most of the quality mgmt systems clauses are similar ?
  • Is it compulsory to do ILC ? Frequency ?
  • When there are multiple Certification , Accreditation Programs available for Med Labs, how to differentiate and choose a relevant, appropriate program for HCO

Matured Participants and the Quality of the interactions was highly invigorating .

Were actually surprised when they were asking questions related to :
– Voluntary withdrawal from Accreditations :
– Suspensions criteria
– Eligibility of the HCOs to reapply
– Normal scenarios , reasons for such actions taken by Accreditation Bodies
– Any penalties , punishments for non compliances

Some screen shots from the session :

3 days of orientation program came to a close today. Bird’s eye view of all National , International Certification, Accreditation Programs , Minimum Standards – Regulatory requirements were covered. Program was well received and appreciated by the participants.

Informative, customised content, pretty detailed, well explained, looking forward to detailed sessions

Some feedback received by the end of the session.

Moving forward, Quality Systems Implementation Programs become more inclusive in nature in near future. Businesses will ensure Quality of their Supply Chain and Suppliers will show more interest to learn about their Customers Quality Systems Implementation Programs. More inclusive it becomes, supply chain gets strengthened and end users will be assured of better Quality & Safe Products and Services.

Session was handled by :
Dr Srivatsan , Expert – Healthcare Quality Management Systems
A A Srinivasan – Principal Consultant
Chithambaranathan – Associate Consultant

Posted by :

Rama Venugopal
Executive Director
Value Added Corporate Services P Ltd
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