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  The sampler shall endorse the relevant records of complete Assortment/ Batch/ shipment/ consignment/ Lot as the case may be, maintained at the place of sampling. The laboratory is liable to maintain confidentiality of samples and information thereof. The laboratory shall keep the remnants of the sample after testing for a minimum period of three months and reference sample for a period of six months in stipulated storage conditions before they are disposed off or returned to the customer. In case of samples tested for Biological parameters the sample shall be retained for reasonable period as per lab’s policy based on importing country’s requirement. The mode of disposal of sample after test shall be recorded and indicated in the test request as well. The testing under the scope for approval shall be in compliance to the methods of validation as per the requirements of the importing countries if any. The Laboratory shall be audited for the harmonized methods of sampling, samp

  “The  laboratory  shall report on the statement of conformity, such that the statement clearly identifies: a) to which results the statement of conformity applies; b) which specifications, standards or parts thereof are met or not; c) the decision rule applied. A conformity statement or a statement of conformity is an expression that clearly describes the state of compliance or non-compliance to a specification, standard, or requirement. Type of statements of conformity While we are on the topic of statements of conformity, it is important to review the three most common types of conformity used in accredited test and calibration reports. The three most common types of conformity are:- a.      Compliance b.      Non-Compliance c.       Indeterminate Below is a list of commonly used statements of compliance: a.      Compliance b.      Pass c.       In spec d.      Within Specification e.      In Tolerance Below is a list of commonly used statements of non-c

  The top management of the CAB shall periodically conduct a review of the CAB’s management system and technical activities to ensure their suitability and effectiveness and to introduce any necessary changes or improvements. Management review should also take note of changes that have taken place in the organisation, facilities, equipment, procedures and/ or activities of the CAB and ensure (through quality manager) that management system continues to conform to the requirements of relevant standard. The need for changes to the system may also arise as a result of findings from internal or external quality audits, inter-laboratory comparisons or proficiency tests, surveillance or reassessment visits by NABL / regulatory bodies, complaints from customers or change in policies of NABL. The top management of the CAB should be responsible for conducting reviews of the management system The quality manager should be responsible for ensuring that all reviews are conducted in a syste

An internal audit is  a formal laboratory activity that must be performed in accordance with a documented procedure and on a regular schedule . Laboratories may choose to conduct a full laboratory audit annually or biannually, or to audit parts of their system every month. The internal audits should also ensure that the defined management system fulfils the requirements of ISO/ IEC 17025:2005 or ISO 15189:2012 or ISO/IEC 17043:2010 or ISO Guide 34:2009. The audit should also ensure whether or not the requirements of the CAB’s quality manual and related documents are applied at all levels of work. The non-conformities found during the internal audit should give valuable information for the improvement of the CAB’s management system and technical competence, which is to be used as a input to management reviews. The quality manager may delegate the task of performing audits to personnel who are having sufficient technical knowledge with respect to the operations of the CAB, traine

  Proficiency Testing (PT) or External Quality Assessment (EQA) is a program in which multiple specimens are periodically sent to a group of laboratories for analysis. The purpose of such a program is to evaluate the laboratory performance with regard to the testing quality of patient samples. ​Verifying that our technology works correctly can identify potential testing issues. Proficiency testing is a part of a quality assurance program that reassures the accurate performance of our products. It's an effective tool because it not only tests our analyzers, but the testing process itself. Proficiency Testing (PT) is the evaluation of participant performance against pre-established criteria by means of inter laboratory comparisons. For the purposes of ISO/IEC 17043:2010, the term “proficiency testing” is taken in its widest sense and includes.           The accreditation services to Proficiency Testing Providers (PTP) is currently given in the following disciplines Proficiency Testin

To calculate the uncertainty of your measurements, you'll need to find the best estimate of your measurement  and consider the results when you add or subtract the measurement of uncertainty. After measuring the individual uncertainty due to type A and type B, the combined uncertainty (U c ) is calculated as follows; U c  = √ (U 1 2  + U 1 2  + U 1 2 +……) Where; U 1,  U 2,  U 3  etc are uncertainties calculated with same units        Another method of combining uncertainty with different units of measure is fractional uncertainty. 1.      Identify the equation 2.      Calculate the fractional uncertainty for each contributor 3.      Calculate the combined uncertainty 4.      Convert the result to the desired unit of measure. The quantities that affects the measurand may not have a direct one to one relationship with it. Indeed they may be entirely different unit altogether. For example a dimensional laboratory may use Steel gauge block for calibrating measuring tools. A significan

  Accredited CAB(Conformity Assessment Body) may undergo certain changes which may affect its operations / functions. This procedure addresses the procedure to implement the various changes in a CAB and also specifies the process by NABL on such matters. These changes may include change in ownership / legal identity, premises, authorised signatory, key personnel, scope of accreditation, change / addition of major equipment within the valid accreditation period etc. 1.        Dealing with change in Name / Legal Identity If an accredited CAB desires to change its name under the same ownership; the following procedure shall be followed. (a)    Inform NABL about the name change in writing along with relevant documents (such as legal identity / resolution etc.) and applicable fee for name change (refer NABL 100 for information on applicable fee). (b)      If the documents are found satisfactory; NABL will issue the accreditation certificate with new name but with same accreditation

                  The sole purpose of the NABL-ISO 17025 is  to provide third-party assessment to ensure          excellent quality and technical competence of testing and calibration laboratories , which enables the  government and the industry to streamline and maintain the standardized quality environment. ISO/IEC 17025:2017 describes two options for fulfilling the management system requirements, Option A & Option B. Besides meeting the requirements of Clause 4 to clause7 of ISO/IEC 17025:2017, the laboratory shall also implement a management system according to Option A or B. Option A Laboratory shall address the requirements of as a bare minimum. Option B If a laboratory has established and maintains management system in accordance with the requirements of ISO 9001:2015, these may be referred against the requirements of clause of ISO/IEC 17025:2017 in the laboratory’s quality management system. Compliance to these requirements shall be verified during on-site assessm

  Defining the scope of work in terms of facility to be developed for the calibration of which disciplines as well as type of equipment. In this stage, the detail discussion is done with the customer and list of equipment to be calibrated is prepared with the details of name, range, resolution / least count etc. All automated Instruments such as cell counters, Clinical Biochemistry automated analysers, automated coagulometers and ELISA readers shall be calibrated by manufacturer at least once a year and be verified for calibration after preventive maintenance.   The calibration certificate shall contain raw data; just a certificate that the apparatus has been calibrated is not sufficient. All raw data or machine printout / screen shots should be captured and documented for future use. The calibration should be as per manufacturer’s recommendations and criteria for acceptance of verification.   During calibration of autoanalysers verification of power supply, photometer / Illumino

Environmental Requirement means  any Environmental Law, agreement or restriction , as the same now exists or may be changed or amended or come into effect in the future, which pertains to any Hazardous Material or the environment including ground or air or water or noise pollution or contamination, and underground. The laboratory shall ensure any anomalies and deficiencies are recorded, upon receipt of the sample. These anomalies and deficiencies may vary from: i.                     Damaged sample, ii.                   Insufficient sample for testing & iii.                 Deficiencies pertaining to filtration, chemical preservation, sample container, temperature on arrival, elapsed time subsequent to sampling, etc. If the sample deficiencies may affect the validity of the result, the customer shall be informed in advance. The laboratory shall have adequate space for efficient functioning, a pleasant ambience and conditions to avoid cross contamination. The laborato

The technical requirements have been sub-divided into two sections. The first section includes the general requirements applicable to most of the disciplines and the second section includes discipline wise requirements. Personnel As per the latest Notification issued by Ministry of Health & Family Welfare (MoHFW) dated 18th May, 2018 notifying Clinical Establishment (Central Government) Amendment Rules, 2018, all laboratories are required to comply with it as applicable. Note 1 : If the above notification is not applicable, laboratory may give valid justification by producing evidence of alternate applicable rules and regulations. In all cases, it is the responsibility of laboratory to abide by the National/ Regional/ State/ Local regulatory requirements/ Acts/ Rules/ Legal orders/ Court Decisions/ Orders issued by Government/ Statutory Bodies as applicable and effective from time to time. Laboratory Director/Head of Laboratory/Technical Head (Howsoever named) shall have

                          National Accreditation Board for Testing and Calibration Laboratories (NABL)  provides accreditation to Conformity Assessment Bodies (Laboratories)  in India. ... In addition, NABL offers accreditation for Proficiency testing providers & Reference Material producers for which it has APLAC MRA. Enhance Customer Satisfaction & Confidence Benefits of NABL Accredited  Calibration Laboratory Certificate .  Potential increase in business due to enhanced customer confidence and satisfaction . Savings in terms of time and money due to reduction or elimination of the need for retesting of products. Standard Quality The sole purpose of the NABL-ISO 17025 is to  provide third-party assessment to ensure excellent quality and technical competence of testing and calibration laboratories , which enables the government and the industry to streamline and maintain the standardized quality environment. Work Accuracy Laboratory accreditation benefits laborator