nabl 180

NABL 180

NABL

NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES

APPLICATION FORM for PROFICIENCY TESTING PROVIDERS

ISSUE NO : 01 ISSUE DATE: 01.06.2011

AMENDMENT NO : 00 AMENDMENT DATE: -

AMENDMENT SHEET Sl no

Page No.

Clause No.

Date of Amendment

Amendment made

Reasons

Signature Signature QO Director

1 2 3 4 5 6 7 8 9 10

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 180 Issue No: 01

Application Form for Proficiency Testing Providers Issue Date: 01.06.2011 Amend No: 00 Amend Date: --

Page No: 1/ 13

CONTENTS Sl. No.

Title

Page

1

Information & Instructions for completing an Application Form

3

2

Application Form

6

3

Annexure A: Guidance for submitting and preparing documents for the Application for Proficiency Testing Provider Accreditation

12

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 180 Issue No: 01

Application Form for Proficiency Testing Providers Issue Date: 01.06.2011 Amend No: 00 Amend Date: --

Page No: 2/ 13

Information & Instructions for completing an Application Form 1. Application shall be made in the prescribed form only. PT Provider shall submit separate application form for each field of accreditation. The application shall consist of the following: • Three copies of completed application forms • Two copies of Quality Manual of PT Provider 2. Incomplete application and insufficient number of copies submitted may lead to rejection of application. In case the space provided is insufficient, please use additional pages clearly indicating to which section they relate to.

3. The applicant shall undertake to carry out its proficiency testing activities in such a way as to meet the requirement of ISO/IEC 17043:2010, additional requirements of NABL and the regulatory authorities, as applicable at all times. Applicants are advised to ensure that the latest versions of all documents including NABL documents are available with them.

4. The application fee and other necessary charges related to accreditation process will be applicable as per the details given below: Application Fee (for one scheme per field)

Rs. 25,000

(non-refundable, to be paid along with the application) Additional Proficiency Test Item (Matrix/Group/Field)

Rs. 10,000

Change in Name of PT provider

Rs. 3,000

Accreditation Fee (per year from the date of accreditation)

Rs. 25,000

Assessment Charges (payable after the completion of assessment visit)

Comprising of Travel, Boarding, Lodging, Honorarium for NABL Assessors, Overhead Charges

Travel, Boarding and Lodging expenditure

Travel to be made by Air in economy class (Apex fare) or by train in 2nd AC Class or by AC Bus. The PT provider will provide the tickets as per above entitlement. If the PT provider is not able to provide the tickets, NABL will reimburse the expenses incurred by the assessors as per above entitlement, on production of ticket/ receipt/ boarding pass. If the journey is made by own car, the re-imbursement will be restricted to 2nd AC class fare by train.

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 180 Issue No: 01

Application Form for Proficiency Testing Providers Issue Date: 01.06.2011 Amend No: 00 Amend Date: --

Page No: 3/ 13

The PT provider shall also make arrangements for boarding & lodging for the Assessment team. A single occupancy AC accommodation may be provided for each Assessor/ Observer in a reasonably good hotel/ guesthouse and arrangement for local transportation from temporary residence to the PT provider site and airport/ railway station/ bus stand.

Honorarium for NABL Assessors

Adequacy Audit of Quality Manual Rs. 1,000

by Lead Assessor

by Technical Assessor/ Expert

Rs. 2,500 (Per day) Rs. 2,000 (Per day)

Assessment, Surveillance, Verification, Supplementary Visit

Overhead Charges

by Lead Assessor

by Technical Assessor/ Expert

Rs. 2,500 (Per day)

For each assessment (including Desktop surveillance) irrespective of number of disciplines.

Rs. 7,000

Rs. 2,000 (Per day)

5. PT providers are advised to familiarize themselves with NABL 100 on Policy and Procedures for Assessment, Surveillance and Re-assessment for accreditation , NABL 216 on Procedures for Dealing with Adverse Decisions and NABL 131 on Terms and Conditions for Maintaining Accreditation and NABL-133 on Use of NABL symbol before filling up this form. The existing procedures for accreditation process and adverse decisions are applicable for Proficiency Testing providers also.

6. The applicant PT Provider shall provide photocopies of appropriate document in support of the legal status claimed (eg. Registration Certificate under Companies Act, approval from local bodies, etc.)

7. The applicant PT Provider shall intimate NABL about any change in the information provided in this application such personnel, location etc. within 15 days from the date of changes.

8. NABL expects applicant PT Provider(s) that are to be accredited by NABL to provide their documentation, access to their as well as subcontractors areas, equipment, records and personnel for purpose of assessment and resolution of complaints.

9. The PT Provider shall also inform NABL in advance about any reservation regarding appointment of Lead Assessor/ Assessor for the assessment.

10. The applicant PT Provider shall be given due notice of any intended changes relating to NABL accreditation criteria and will also be given such time, as in the opinion of NABL is reasonable to carry out the necessary adjustments to its procedure(s). The PT Provider shall inform NABL when such adjustments have been completed.

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 180 Issue No: 01

Application Form for Proficiency Testing Providers Issue Date: 01.06.2011 Amend No: 00 Amend Date: --

Page No: 4/ 13

11. The application must be filled up carefully to provide required information in such a manner that further correspondence for seeking clarifications are not required. Particularly the scope of accreditation (para 3.2) shall be complete to indicate unambiguously. Examples related to filling the scope is provided in Specific Criteria (NABL- 181) under Introduction section.

12. The PT Provider shall submit NABL 131 duly signed by the Chief Executive or his/ her Authorised Representative to NABL Secretariat along with this application form. By signing NABL 131 the PT Provider agrees to comply at all times with Terms and Conditions of NABL. Note: NABL-131 shall be signed by Chief executive of the organization. In case it is signed by any other person, an authority letter/copy of resolution from board of directors of limited organizations/trust/society authorizing the person to sign NABL-131 shall be available. For partnership firms, the resolution by all partners in favour of the signatory shall be made available.

13. The PT Provider shall extend cooperation to NABL or its representative in: a. undertaking any check to verify capability of the PT Provider. b. the PT Provider shall unambiguously provide names of all authorised signatories/Proficiency Testing Co-ordinator who are responsible for activities like preparation of sample (testing of homogeneity and stability) transportation and preservation of sample, use of statistical tools, issue of PT report. c. Access to relevant areas of the PT Provider or subcontractor for witnessing the activities being performed. d. examination of all relevant documentation and records. e. interaction with all relevant personnel.

14. The PT Provider shall take all necessary actions and discharge all non-conformities raised during the assessment within a maximum time of three months. The same shall be verified to the satisfaction of NABL. The final decision on accreditation shall rest with NABL. 15. The application shall be kept confidential by NABL and information obtained during the processing of application, assessment visit and grant of accreditation shall be safeguarded and dealt with impartiality.

16. Any conflict of interests shall be clearly defined with organization chart.

17. PT Provider shall have completed at least one Proficiency Testing round as per relevant international standard (eg. ISO/IEC Guide 43, ILAC G:13, ISO/IEC 17043, IUPAC Harmonised Protocol for Analytical Chemistry, etc) before submitting the application form.

18. The artifacts circulated in calibration PT programs shall have direct traceability from National Metrological Institute (e.g. NPL India, NIST USA etc.).

19. PT Provider shall have conducted at least one Internal audit and Management Review meeting prior to submitting the application form.

20. Please attach relevant documents with details required as per Annexure A ***

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 180 Issue No: 01

Application Form for Proficiency Testing Providers Issue Date: 01.06.2011 Amend No: 00 Amend Date: --

Page No: 5/ 13

Application Form for Accreditation of Proficiency Testing Provider Our organization wish to apply for NABL accreditation of Proficiency Testing provider as per details given below: First Accreditation

Renewal of Accreditation

1.0 Organisation Details 1.1 Name of the Proficiency Testing Provider ________________________________________________________________________________ (Permanent Facility)

Address _________________________________________________________________________ Telephone No. _____________________ Fax No. __________________ e-mail ________________ 1.2 Name of Parent Organisation ________________________________________________________ (If part of an larger organisation)

Telephone No. _____________________ Fax No. __________________ e-mail ________________ 1.3 Legal status and date of establishment _______________________________________________

(please give Registration No. and name of authority who granted the registration. Attach copy of relevant documents) _________________________________________________________________________________________________

1.4 (a) Other accreditation for eg: ISO/IEC 17025, ISO 15189, ISO/IEC 17020, ISO Guide 34, ISO Guide 35: _________________________________________________________________________________ 1.5 Indicate exactly how the name of the PT Provider and the address is to be printed on the certificate (the current bi-lingual system calls for this information)

In English ________________________________________________________________________ In Hindi __________________________________________________________________________

2.0 Proficiency Testing Scheme 2.1. Provide information of the PT Schemes designed and organized along with the standard used (eg. ISO/IEC Guide 43-1, ILAC G:13, ISO/IEC 17043, IUPAC Harmonised Protocol for Analytical Chemistry).

Sl. No.

Name of Program

Total Number of Participants

Standard Used

Statistical Technique Adopted

(If a similar program has been repeated please provide details individually with unique ID)

(Please submit a copy of report)

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 180 Issue No: 01

Application Form for Proficiency Testing Providers Issue Date: 01.06.2011 Amend No: 00 Amend Date: --

Page No: 6/ 13

2.2

Are you conducting proficiency testing activities a.

Independently at permanent facility

Yes

No

b.

With the help of sub-contractor

Yes

No

3.0 Scope for Application 3.1 Discipline in which accreditation is sought •

Testing

•

Calibration

•

Medical

•

Inspection

3.1 .1 Field of Testing for which accreditation is sought (includes sampling also) •

Biological

•

Mechanical

•

Chemical

•

Non-Destructive

•

Electrical

•

Optical Photometry

•

Electronic

•

Radiological

•

Fluid-Flow

•

Thermal

•

Forensic

3.1.2

Field of Calibration for which accreditation is sought •

Electro-Technical

•

Mechanical

• •

Fluid Flow Thermal

•

Optical

•

Radiological

3.1.3

Field of Medical for which accreditation is sought

•

Clinical Biochemistry Clinical Pathology Haematology and Immunohaematology Microbiology and Serology Histopathology Cytopathology Genetics

•

Nuclear medicine (in-vitro tests only)

• • • • • •

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 180 Issue No: 01

Application Form for Proficiency Testing Providers Issue Date: 01.06.2011 Amend No: 00 Amend Date: --

Page No: 7/ 13

3.1.4

Field of Inspection for which accreditation is sought • NDT

•

Forensic inspection

• Agriculture and agricultural products

•

Industrial equipment and machinery

• Manufactured goods

•

Natural resources and refined products

• IT products and services

•

Transport

• Tourism accommodation

•

Factory inspection

• Health inspection

•

Technical regulation inspection

• Building construction and maintenance

•

Environment & Environmental protection products

• Industrial and commercial construction & maintenance

•

Others

3.2 Desired Scope of Accreditation PT Scheme

Proficiency Test Item (Matrix/Group/Field)*

Analyte or Parameter

Range of Measurement (if applicable)

Periodicity (Minimum)

Remarks**

* Refer definition in ISO/IEC 17043:2010 section 3.8 ** Remarks can include Type of scheme, test method adapted, any other information deemed necessary by PT Provider

3.3 Description of sub-contractor Sl. Name of No. contractor

sub-

Address and Phone No

Whether the organization is accredited, Provide details

Description of subcontracted*

activity

* Subcontracting activities can include formal arrangement for production, testing, measurement, sampling, storage and distribution of PT materials/samples or measurement artifacts and data processing as in ISO/IEC 17043 :2010 section 5.5 ref 5.5)

4.0 Organisation 4.1 Senior Management (Name, Designation, Telephone, Fax, e-mail) 4.1.1 Chief Executive of the PT Provider __________________________________________________________ 4.1.2 Person(s) responsible for the Proficiency Testing Activities (PT Co-ordinator)*__________________________ 4.1.3 Person responsible for Quality Management ____________________________________________________ 4.1.4 Contact person for NABL ___________________________________________________________________ 4.1.5 Any other key personnel involved in the PT Activities____________________________________________ * There could be more than one person for different schemes National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 180 Issue No: 01

Application Form for Proficiency Testing Providers Issue Date: 01.06.2011 Amend No: 00 Amend Date: --

Page No: 8/ 13

4.2 Employees 4.2.1 Total number of employees in the organization ___________________________________________________ 4.2.2 Total number in employees involved in running PT schemes ________________________________________ 4.2.3 Details of staff (including contracted, part time, etc) having responsibility about any aspect of Proficiency Testing Scheme (please refer NABL 181) Sl. Name & Qualification with Experience in years No Designation of Specialization related to present work person

Relevant Training

Role & Responsibility in the specific PT scheme

4.2.4 Details of Authorised Signatory Sl. Name & Qualification with Experience in years No. Designation of Specialization related to present person work

Authorize for which field

Relevant Training

Specimen Signature

(Refer to annexure A of NABL 181

4.2.5 Details of Steering/Advisory Committee: Sl. No.

Name of Person

Qualification with Specialization

Experience in years related to present work

Relevant Training

Affiliation

Area of Responsibility

4.2.6 Information regarding any individual or organisation that has provided consultancy for preparing towards NABL Accreditation __________________________________________________________________________

4.3 Brief description of main activities of Parent organization 4.4 Organisation Chart 4.4.1. Indicate in an organisation chart the operating departments of the proficiency testing activities for which accreditation is being sought (please append) 4.4.2 Indicate how the proficiency department is related to external organizations and/or to its own parent organisation (where applicable)

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 180 Issue No: 01

Application Form for Proficiency Testing Providers Issue Date: 01.06.2011 Amend No: 00 Amend Date: --

Page No: 9/ 13

5.0 Equipment and Reference Materials/Standards 5.1 List of major equipments available for use (where applicable) Sl. No.

Name of equipment

Model/ type/Sl. No./ year of make

Receipt date & date placed in service

Range and accuracy

Date of last calibration

Calibration due on *

Traceability**

5.2 List of reference materials/reference standards (where applicable) available for use Sl. No

Name of reference material/standards strains/ cultures

Source

Date of expiry/ validity

Traceability**

* The PT Provider to decide the calibration interval based on ISO 10012 ** Please indicate the traceability to National/ International standards through unbroken chain of Accredited laboratories

6.0 Internal Audit and Management Review 6.1 Date of last Internal Audit _________________________________________________________ 6.2 Whether all requirements of ISO/ IEC 17043:2010 covering all activities of laboratory have been audited atleast once in last one year: Yes No 6.3 Date of last Management review____________________________________________________

7.0 Application fees 7.1 Number of schemes & proficiency test items (Matrix/Group/Field) applied for accreditation •

Number of Schemes

•

Number of PT items

7.2 Application fees (Rs. )___________________________________________________________ 7.3 DD / Cheque* number ___________________________________________________________

*NABL will accept at par cheques. All payments shall be made in favor of 'NABL'

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 180 Issue No: 01

Application Form for Proficiency Testing Providers Issue Date: 01.06.2011 Amend No: 00 Amend Date: --

Page No: 10/ 13

8.0 Willingness to undergo Assessment We declare that 8.1 We are familiar with the terms and conditions of maintaining accreditation (NABL 131), which is enclosed and will abide by them.

8.2 We agree to comply fully with ISO/IEC 17043:2010 for the accreditation of PT provider.

8.3 We agree to comply with accreditation procedures, pay all costs for pre-assessment, assessment, verification visit (if any), surveillance and reassessment irrespective of the result.

8.4 We agree to co-operate with the assessment team appointed by NABL for examination of all relevant documents by them and their visits to those parts of the PT Provider and subcontractor that are part of the scope of accreditation.

8.5 We shall maintain confidentiality of customer information and shall not disclose the identity of the participant to the third party without the prior permission of participant concerned.

8.6 We agree to maintain integrity for samples distributed to customers/participants and take effective measures to prevent any possible collusion and falsification of results.

8.7 We agree to conduct our operations in an impartial manner.

Signature of Chief Executive or his authorised representative ________________________________ Name & Designation_______________________________________________________________ Date & Place ______________________________________________________________________

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 180 Issue No: 01

Application Form for Proficiency Testing Providers Issue Date: 01.06.2011 Amend No: 00 Amend Date: --

Page No: 11/ 13

Annexure A Guidance for preparing and submitting documents for the Accreditation for Proficiency Testing Provider Purpose and Scope: This part is intended to give PT Provider(s) understanding for addressing major issues in the application process.

This guidance document applies to all applicants and accredited PT Provider(s).

Table 1: Checklist Sl. No.

Specific requirement/ document

1.

Legal Identity of your organisation

2

Identified the following with qualification, experience and specimen signature

Reference to Complete document

PT Co-ordinator(s), Management of PT Authorized signatories List of Staff involved in PT schemes.

3

Quality Manual (QM) addressing all clauses of ISO/IEC 17043:2010 with cross references (if applicable)

4

Master List of all Quality Documents.

5

Completed draft scope of accreditation

6

Completed organizational chart (including staff name, job titles & reporting relationship

7

Declaration of Independence in case of identified Potential Conflict of Interest

8*

Staff has signed declaration for maintaining confidentiality

9

Copy of at least one original version of proficiency testing report for each proficiency testing field

10*

Documentation for subcontracting (if applicable): • list of areas for subcontracting • list of subcontractors with field of activity • evidence of competence (e.g. copy of accreditation certificate, audit reports).

11

Written contract with the subcontractor along with Completed sub-contractor information sheet (if applicable)

12

Documentation on Advisory Committee/Steering group (if applicable): •

list of Advisory Committee/Steering group with fields of activity

•

lists of members with information on the background of persons

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 180 Issue No: 01

Application Form for Proficiency Testing Providers Issue Date: 01.06.2011 Amend No: 00 Amend Date: --

Page No: 12/ 13

(e.g. affiliation to companies, organizations) •

terms of reference of the Advisory Committee/Steering group

13

Read /understood and signed copy of NABL-131.

14*

Documentation of the procedure to carry out proficiency testing: •

planning

•

subcontracting (if applicable)

•

stability testing

•

homogeneity testing

•

selection of the statistical methods

determination of assigned values and evaluation criteria (standard deviation of proficiency assessment) 15*

Site plan showing the areas of operation Total built up area for PT Provider Activities Provide a layout diagram of the area (marking dimensions) under PT Provider/laboratory activities clearly highlighting access, emergency exists, area under different activities (the areas for incompatible activities for homogeneity and stability should be clearly highlighted as microbiology; chemical testing, mechanical testing) special areas as for storage, calibration, reception, dispatch,

16

Submitted fees of required amount payable to “ NABL”

17

List of certified reference materials used with traceability

18

List of equipment to be used with calibration status and traceability**

19*

Internal audit and Management Review reports

20

Completed Annexure 'A' (checklist) for the accreditation of PT Provider

(*These documents have to be kept ready during review at on-site assessment. Other documents should be submitted along with the Application form NABL-154. ** Artifacts circulated in calibration PT programs shall have direct traceability to NMI)

Place, Date

Signature of the Authorised Representative

Name and Designation The Authorised Representative confirms the completeness and correctness of all the above mentioned documents by signature. The listed documents shall be up-dated for each assessment.

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 180 Issue No: 01

Application Form for Proficiency Testing Providers Issue Date: 01.06.2011 Amend No: 00 Amend Date: --

Page No: 13/ 13

National Accreditation Board for Testing and Calibration Laboratories NISCAIR, 3rd Floor, 14 Satsang Vihar Marg New Delhi – 110 067 Tel.: +91-11 – 46499999 Fax: +91-11 – 26529716 www.nabl-india.org