NABL 218NABL NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES Desktop Surveillance Issue No. 02 Issue date: 29.05.2013 Amendment No.01 Amendment date: 11.03.2014 No: NABL 218 Desktop Surveillance Issue No: 02 Issue Date: 29. No. Amendment 2/4 2 (k) & 3.2 11.05.2013 Amendment No: 01 Amendment Date: 11.03.03.AMENDMENT SHEET Sl 1 Page Clause Date of No.2014 Page i Director .2014 Amendment made Reasons Signature Signature QO Summary of NCs of last internal audit & CPAIC Minutes of MRM recommendations 2 3 4 5 6 7 8 9 10 National Accreditation Board for Testing and Calibration Laboratories Doc. it is mandatory that the laboratory continues to comply with the requirements of ISO/IEC 17025: 2005 or ISO: 15189: 2007 (whichever is relevant) and NABL policies. Once a laboratory has been accredited for the first time. Any wrong information provided may lead to adverse decision by NABL. The information provided by the laboratory is evaluated at NABL secretariat and if the information is conforming to the requirements.2013 Amendment No: 00 Amendment Date: -- Page ii . In the subsequent accreditation cycles of 2 years. instead of onsite surveillance visits. The laboratories are therefore advised to provide the desired information accurately as per the format. For this purpose the laboratory should provide the information as per this document and the same will be considered to verify the continued compliance for maintaining accreditation.PREFACE For an accredited laboratory to maintain its accreditation status.05. an onsite surveillance visit may be conducted or NABL may call for further additional evidences to fulfil the requirements for continuation of accreditation. if the information provided is insufficient to establish the continued compliance. However. The information provided is subject to verification at onsite surveillance (if conducted) or in subsequent reassessment visit. No: NABL 218 Desktop Surveillance Issue No: 02 Issue Date: 29. National Accreditation Board for Testing and Calibration Laboratories Doc. NABL conducts onsite surveillance visit within the first year of accreditation to verify the continued compliance. NABL has evolved a monitoring system for verifying the continued compliance of the laboratory by conducting desktop surveillance. the laboratory is allowed to continue its accreditation status based on desktop surveillance. No: NABL 218 Desktop Surveillance Issue No: 02 Issue Date: 29.2013 Amendment No: 00 Amendment Date: -- Page 1 of 4 .. mobile.. Status of implementation and monitoring the effectiveness of corrective actions(s) taken on non-conformities raised during last re-assessment: (please provide details in tabular format) Non-conformities raised during last Brief Summary of corrective actions Evidence of continued compliance assessment taken of corrective actions (as on date) 2. collection centres etc) were covered in the audit Yes / No h) Whether the all the requirements of ISO/IEC 17025 (or) ISO 15189 were covered in audit Yes/ No i) Number of NCs raised. address & ID: Field: Testing/ Calibration/ Medical Discipline(s): Accreditation validity period: Period of the report: 1... j) Whether NCs are monitored for its closure as agreed time frame Yes / No National Accreditation Board for Testing and Calibration Laboratories Doc...INFORMATION TO BE FURNISHED BY LABORATORY FOR DESKTOP SURVEILLANCE Laboratory's name. Summary of last internal audit findings and corrective actions taken on non-conformities raised during the audit a) Availability of audit scope and plan/schedule b) Frequency of internal audit as per procedure for internal audit.._____________________________________ c) Dates of last two internal audit conducted _____________________________________________________ d) Particulars of persons who have conducted last internal audit Name(s) ofQualification auditors(s) & Affiliation (Internal/ External) designation Yes/No Training status Details of training organization & duration (whether trained as of training per ISO/IEC 17025 / ISO 15189) e) Comment on independence of activities audited_________________________________________________ f) Whether all the activities (as required by standard) were covered in the audit Yes / No g) Whether various locations (including site testing / calibration.05.... . Details of internal quality control (IQC) checks practiced by the laboratory a) Which of the following quality control measures are used by the laboratory.. Non-conformities raised No. Replicate calibration using same or different method vi.. Recalibration of retained items. vii. Brief Summary of corrective actions taken during last Internal audit Status (Closed/Open) 3..03. Please specify.2014 Yes/ No Page 2 of 4 ..2 Minutes of last Management Review Meeting Yes/No Yes/ No (Annexure.1 Summary of last Management Review a) Date of last Management Review____________________________________________________________ b) Whether all the agenda points as required by the relevant standard (ISO/IEC 17025 / ISO 15189) were discussed including quality policy and objectives Yes/ No c) Whether minutes of the meeting and with actions points thereon were recorded d) Whether the action plan implemented as targeted 3.. b) Details of IQC plans of the laboratory as per accredited scope mentioning frequency of IQC checks (Annexure: _______________) c) Whether the compliance criterion is defined. Management Review Meeting 3.05.. please tick appropriate column(s). ii. Retesting of retained item v. met and corrective actions taken if required National Accreditation Board for Testing and Calibration Laboratories Doc.) 4.2013 Amendment No: 01 Amendment Date: 11..k) Sl. Any other technique(s). Replicate testing using same or different method. iv.. Use of control charts using check standards ix. & date Complaint details Investigation findings Corrective action Status settled/ taken unsettled 5. i. Summary of complaints received and status of their resolutions S. Correlation of results for different characteristics of an item x.. Use of control charts using control samples viii. Complaint No. No: NABL 218 Desktop Surveillance Issue No: 02 Issue Date: 29. No. Use of internal quality control material iii. Use of Certified reference material/reference material. 05. give details thereof) d) Key Laboratory Personnel : Yes/No (If yes. give details thereof) g) Laboratory Premises : Yes/No (If yes. The above declarations cannot be considered as an application for change National Accreditation Board for Testing and Calibration Laboratories Doc. give details thereof) b) Ownership : Yes/No (If yes.2013 Amendment No: 00 Amendment Date: -- Page 3 of 4 . reference standard/ CRM/ equipments (Make Date of calibration (reference Metrological & Model No. Reference standards details shall be given separately wherever applicable 8. give details thereof) c) Top Management : Yes/No (If yes. Details of Training provided to laboratory personnel since last assessment a) Does the laboratory identify training needs of its employees and prepare an annual training plan Yes/No b) Whether the training plan implemented c) Please provide clarifications of lapses in implementation (if any) __________________________________ d) Whether the effectiveness of training is evaluated and records are maintained Yes/ No Yes/ No 9. No: NABL 218 Desktop Surveillance Issue No: 02 Issue Date: 29.No. held by the laboratory S.6. if applicable) standard/ equipments)/ Date of traceability/ calibration validity (CRM) agency Note: Equipments. give details thereof) Note: For any of above stated changes. Details of participation in EQAS/ PT/ ILC and initiation of ILC by the laboratory a) Availability of EQAS/ PT/ ILC plan as per requirements of NABL163 Yes/ No b) Whether the ILC/PT activities complied as per the plan submitted Yes/ No c) Please provide clarifications of lapses in implementation (if any) ____________________________________ Results of EQAS/ PT/ ILC participation EQAS/ PT providers PT programme No. CRM. Has there been a change in the following aspects of the laboratory operations since last assessment? a) Legal Status : Yes/No (If yes. Please furnish detail of the reference standards. equipments. give details thereof) f) Resources : Yes/No (If yes. laboratory should have informed NABL within 15 days of its change as defined in NABL 131. CRM. give details thereof) h) Major Test/ Calibration equipment : Yes/ No (If yes. Parameter Z (or) ILC/ coordinating Score/ En Details of root cause analysis Value / SDI in case of unsatisfactory laboratory performance 7. give details thereof) i) Authorised signatories : Yes/ No (If yes. give details thereof) e) Policies : Yes/No (If yes. . (b) In case the laboratory has enhanced the periodicity of calibration of any equipment(s).. The declaration should also focus on compliance to metrological traceability policy as given in NABL 142.. Does the laboratory want a change/ addition in authorised signatories? If yes please furnish bio data of proposed authorised signatories along with signatures in NABL Form 71 Note: Approval of authorised signatories is subject to verification of competence by NABL 11..10. please give detailed technical justification for the same.2 Please furnish a self declaration by the head of the laboratory/ laboratory director for continued compliance of the laboratory to ISO/IEC 17025: 2005 or ISO 15189: 2007 (whichever is applicable) and relevant NABL specific criteria (s) (to be specified) since last on site assessment... Annexure. Desktop surveillance fee details: __________________________________________________________ Note: Provide the DD number/ bank details along with the amount paid.. Annexure.. All payments shall be payable at New Delhi 12.. All information provided above is true and I am aware that any wrong information / declaration given therein may lead to adverse actions by NABL Signature of Laboratory Head/ Laboratory Director__________________________________________________________ Name& Designation__________________________________________________________________________________ Date & Place _______________________________________________________________________________________ . Note: The self declaration to be given by a competent authority on laboratory’s letter head 12. Self declarations 12. Note: The self declaration to be given on laboratory’s letter head 13. Annexure.1 (a) Please give a self declaration confirming the valid calibration status of various equipments and reference standards held by the laboratory. Sector 44. No: NABL 218 Desktop Surveillance Issue No: 02 Issue Date: 29. India Tel.2013 Amendment No: 01 Amendment Date: 11.2014 Page i . Gurgaon .05.122002. no. 45.org National Accreditation Board for Testing and Calibration Laboratories Doc.nabl-india.03. Haryana.National Accreditation Board for Testing and Calibration Laboratories NABL House Plot No.: 91-124-4679700 (30 lines) Fax: 91-124-4679799 Website: www.