NABL 160 Quality Manual Guide

NABL 160NABL NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES GUIDE for PREPARING A QUALITY MANUAL ISSUE NO. : 04 ISSUE DATE: 24.03.2008 AMENDMENT NO : 00 AMENDMENT DATE: -- Amendment Sheet Sl 1 Page Clause No. No. Date of Amendment Amendment made Reasons Signature Signature QM Director 2 3 4 5 6 7 8 9 10 National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.03.2008 Amend No: 00 Amend Date: -Page No: i Contents Sl. Contents Amendment sheet Contents 1. 2. 3. 4. 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15 5. 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 Introduction Process for preparing a Quality Manual Structure and format of Quality Manual Management Requirements Organisation Management System Document Control Review of requests, tenders and contracts Subcontracting of tests and calibrations Purchasing, Services and Supplies Service to the customer Complaints Control of nonconforming testing and/ or calibration work Improvements Corrective action Preventive action Control of records Internal Audit Management review Technical Requirements General Personnel Accommodation and Environmental Conditions Test and Calibration Methods and method validation Equipment Measurement Traceability and Calibration Sampling Handling of Calibration and Test items Assuring the quality of test and calibration results Reporting the results 38 39 41 43 47 49 52 53 54 56 16 19 22 24 25 26 27 28 29 30 31 32 33 34 36 Page No. i ii 1 2 5 National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.03.2008 Amend No: 00 Amend Date: -Page No: ii No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. As an illustration this document provides guidance to Testing and Calibration laboratories for addressing the requirements of ISO/IEC 17025 in their Quality Manual. and nature of testing / calibration performed by the laboratory. it should not be restricted to the contents of this guide. decided to publish this document as a help to applicant laboratories. field of activities. One of the pre-requisite for seeking NABL Accreditation is that applicant laboratory shall submit its Quality Manual.2008 Amend No: 00 Amend Date: -Page No: 1/ 57 . all elements of ISO/IEC 17025 or ISO 15189 as applicable must be addressed in the intended Quality Manual. For preparing the Quality Manual. forms etc. describing its policies. the requirements of ISO 15189 can be addressed by Medical Testing laboratories in their Quality Manual.1. Similarly. work instructions. the laboratory may also get its technical personnel trained in NABL’s training programme on management system for laboratory personnel. National Accreditation Board for Testing and Calibration Laboratories Doc. as applicable & relevant NABL Specific Criteria. The amount of details to be provided in the manual will vary depending upon the size. In preparing the Quality Manual. The Quality Manual shall include or make reference to other documents such operational procedures. However. A calendar of such training courses is regularly published in the NABL News.03. NABL therefore. the structure of management system documentation and compliance to ISO/IEC 17025 or ISO 15189. Introduction Testing and Calibration laboratories are required to comply with the requirements of ISO/IEC 17025:2005 ‘General Requirements for the Competence of Testing and Calibration Laboratories’ and Medical Testing laboratories have to comply with the requirements of ISO 15189:2007 ‘Medical laboratories – Particular requirements for quality and competence’. However. The laboratory should examine that the existing management system is appropriate or it needs modification or it needs to be built from scratch. even though the system elements are similar. Relevant requirements for NABL accreditation should be discussed amongst concerned staff of the laboratory. to align the management system in accordance with ISO/IEC 17025 or ISO 15189. procedures. This group should get fully acquainted with all NABL documents and understand the assessment procedure & methodology of making an application.03.2008 Amend No: 00 Amend Date: -Page No: 2/ 57 . Process of preparing a Quality Manual The management should nominate individuals from one or more functional area/ section of the laboratory and a Quality Manager. it is advisable that the laboratory writes the manual afresh. having a background of Management Systems. reports etc. For that all existing policies.2. required to work be instruction listed and whether documented with the or otherwise are of compared requirements ISO/IEC 17025 or ISO 15189 as applicable. objectives. work instructions. relevant NABL Specific criteria and other requirements. forms. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. It must be remembered that Quality Manual is a policy document. the management system of the laboratory needs to be structured. The team should collectively make the effort to prepare the Quality Manual with the guidance of the Quality Manager. National Accreditation Board for Testing and Calibration Laboratories Doc. Laboratory needs to ascertain the status of its existing management system and its competence. The laboratory will be able to decide. as applicable and relevant NABL specific criteria. Therefore. which has to be supplemented by a set of other documents like procedure manuals. as the elements of ISO/ IEC 17025 or ISO 15189 are quite different from other Quality Management System standards. is given below: Quality Manual (Level A) Management system Procedures (Level B) Other quality documents (Work instructions. Management system procedures may further be supplemented with detailed work instructions. etc. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. termed as Level C documents.03.) (Level C) The order of development of a hierarchy for an individual laboratory usually starts with the development of the laboratory’s Quality Policy & objectives followed by the implementation plan of the various elements of ISO/IEC 17025 or ISO 15189 as applicable in brief. forms. reports etc. forms. which describe the detailed procedures of the activities of individual function units needed to implement the management system. forms and reports may be grouped as Level D documents. generally followed. Level B documents. The Quality Manual has to be supplemented by a set of management system procedures. This is the apex document or Level A document termed as the ‘Quality Manual’. A typical structure of management system document hierarchy. reports. All procedures are cross referred in the Quality Manual.2008 Amend No: 00 Amend Date: -Page No: 3/ 57 . National Accreditation Board for Testing and Calibration Laboratories Doc. In some hierarchy systems.The management system of the laboratory can be structured in many ways. 03. However. and the nature of their format and presentation are to be determined by the individual functional units. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. work instructions. forms.2008 Amend No: 00 Amend Date: -Page No: 4/ 57 . reports etc. it is preferred that each of these set of documents are arranged in the same structure and format so that the users become familiar with the consistent approach applied to each requirement and to improve the likelihood of systematic compliance with ISO/IEC 17025 or ISO 15189 as applicable.The quantity of documented procedures. National Accreditation Board for Testing and Calibration Laboratories Doc. should place the section on ‘Quality Policy and Objectives’ of the laboratory. The remaining sections of the Quality Manual should describe all applicable elements of the ISO/IEC 17025 or ISO 15189. as applicable. This guide is not intended to define a unique structure. The Quality Policy is required to be stated under clause 4. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. amendment record of the manual. as appropriate to the laboratory.2008 Amend No: 00 Amend Date: -Page No: 5/ 57 . contents of the manual. which can be applied to all (or even some) laboratories. However. since this is the basic objective.03. is acceptable. content or method of presentation for the Quality Manual. However.3. It is preferred that it is placed after the introductory pages. Other sequencing or cross-referencing. definitions and abbreviations used. The description of these sections of the Quality Manual should be in a sequence similar to that of ISO/IEC 17025 or ISO 15189. format. completely and concisely the Quality Policy. scope of the Quality Manual. Structure and Format of Quality Manual There is no required structure or format for a Quality Manual. authority under which it is issued. Other approaches. such as structuring the manual to reflect the nature of the laboratory or nature of work carried out by the laboratory are equally acceptable. address or reference to the next level of documentation and management responsibilities of the laboratory. any Quality Manual should convey accurately. objectives. the laboratory’s management system is designed to meet. After these pages. brief description of the laboratory and the management system. references to other documents. distribution record.2 of management requirements. National Accreditation Board for Testing and Calibration Laboratories Doc. One of the methods of assuring that the subject matter is adequately addressed and located would be to align the sections of the Quality Manual to the elements of the ISO/IEC 17025 or ISO 15189 as applicable. It is unique to each laboratory. it is recommended that the first few pages of the Quality Manual should address to the sections of general information like title. A typical ‘table of contents’ is shown at page 14. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.. National Accreditation Board for Testing and Calibration Laboratories Doc. subsections.2008 Amend No: 00 Amend Date: -Page No: 6/ 57 . pages. diagrams. A typical ‘release authorisation’ is shown at page 12. holders name and the copy number.Thereafter the list of documents. The management responsible for the implementation of Quality Manual. issue date. The numbering system of sections. A typical ‘title page’ is shown at page 11. A brief explanation of these sections has been given below.03. Each copy should bear evidence of this release. It should also indicate the issue number. records and forms maintained by the laboratory should be placed. Table of contents The table of contents of a Quality Manual should show the titles of the sections within it and how they can be located. Release Authorisation The section on ‘release authorisation’ should indicate the authority under which the Quality Manual has been released. exhibits. figures. to be provided should be annexed at the last. etc. should preferably be sequenced in the manner as given below: Title The title of the Quality Manual should clearly indicate the name of the laboratory to which the manual belongs. Any supportive data. These sections. normally the Head of the laboratory should authorise its release for usage. tables. should be clear and logical. National Accreditation Board for Testing and Calibration Laboratories Doc. Definitions Although it is recommended. ISO 8402) is highly recommended. this section of the Quality Manual should contain the definitions of terms and concepts that are uniquely used within the Quality Manual. the use of disclaimers (eg. and to avoid unnecessary document volume. its expanded form should be defined in this section. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. terminology. Abbreviations Whenever the abbreviations are used. To ensure clarity and avoid confusion. definitions and standards (eg. what is not covered by the Quality Manual and situations where it should not be applied) may also be mentioned. when practical. Use of references Wherever appropriate.03.2008 Amend No: 00 Amend Date: -Page No: 7/ 57 . reference to existing recognised standards or documents available with the Quality Manual user should be incorporated. to use standard definitions and terms which are referenced in recognised quality terminology documents or in general dictionary usage. It should also define the field(s)/ discipline(s)/ area(s) and the section(s)/ division(s) department(s) of the laboratory. The use of references to existing concepts. to which the Quality Manual is applicable.Scope and field of application This section of the Quality Manual should clearly mention the compliance to the applicable standard(s) and NABL documents. who reviews its content and how often. whether or not is contains confidential information. this information may also be give under the system element concerned. and who is authorised to approve it.2008 Amend No: 00 Amend Date: -Page No: 8/ 57 .Distribution of the manual The method of distribution of the authorised manual should provide assurance that all users have appropriate access. Proper distribution and control can be aided. date of issue and identification of amended contents b A brief description of how the Quality Manual is revised and maintained.03. The information about the Quality Manual itself should include: a The current issue number. location and means of communication. Additional information about the laboratory. a method for determining the history of any change in procedure may be included. Management should ensure that individuals are familiar with those contents of the manual appropriate to each user within the laboratory. who is authorised to change the Quality Manual. Introduction The introductory pages of a Quality Manual should provide general information about the laboratory concerned and the Quality Manual itself. if appropriate c A brief description of the documented procedures used to identify the status and to control the distribution of the Quality Manual. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. The minimum information about the laboratory should be its name. A typical ‘distribution record’ is shown at page 15. for example. whether it is used only for the laboratory’s internal purposes. by serialisation of copies for recipients. a brief description of its background. such as its line of business. or whether it can be made available externally National Accreditation Board for Testing and Calibration Laboratories Doc. may also be included. site. history or size. covering the major aspects of respective clause of ISO/IEC 17025 or ISO 15189. as applicable. which can be applied. and understood by. This may be done by inclusion of policy and objectives with respect to the element or reference to the policy. This section should also describe how the Quality Policy is made known to. The actual process/ procedure may be covered in separate procedure document and cross referred in the Quality Manual. The management system procedure of each element of Quality Manual. Elements of the Management system The subsequent sections of the Quality Manual should describe all the elements of the ISO/IEC 17025 or ISO 15189 as applicable. wherever applicable. National Accreditation Board for Testing and Calibration Laboratories Doc.2008 Amend No: 00 Amend Date: -Page No: 9/ 57 . scope.03. documented management system procedures and reference to records for each element. all employees and how it is implemented and maintained at all levels. Quality Policy and Objectives This section of a Quality Manual should state the laboratory’s Quality Policy and objectives. which should be in line with the requirements of clause 4. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. This is where the laboratory commitment to quality is presented and where the laboratory’s objectives for quality are outlines. Further the description of each element should be divided into logical sub-sections revealing a well-coordinated management system. However it is recommended that the description of the elements of the management system be in a sequence similar to that of ISO/IEC 17025 or ISO 15189.2 of ISO/IEC 17025 or ISO 15189. as applicable. is unique to each laboratory. should be briefly outlined. person(s)/ position responsible for executing that policy. The format or method of presentation for the description of management system elements.d Evidence of approval by those responsible for authorisation of the contents of the Quality Manual. A typical ‘amendment record’ is shown at page 13. the relevant pages where amendment takes place are replaced by new pages and is cross referred in the amendment record. As and when the manual is amended. As and when each holder is issued a Quality Manual. is allotted to him/ her and this is indicated in the distribution record. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. Annexure for supportive information Whenever it appears in this document. each page within the manual should have a page footer. etc. National Accreditation Board for Testing and Calibration Laboratories Doc. These must find reference in the Quality Manual or the associated document. that supportive data has to be provided. a copy no.List of documents. Page footer shows the Issue status.2008 Amend No: 00 Amend Date: -Page No: 10/ 57 . records and forms All documents which are maintained by the laboratory and the records & forms. It also gives the copy number.03. The signatures of the persons/ position who have prepared. it should be attached as an annexure at the end. Page Footer It is recommended that to facilitate ease of handling and updating of the Quality Manual. page no. which are used by the laboratory should be listed in these sections. amendment status. page 15. approved and issued the Quality Manual are also placed in the page footer. similar to the given on the typical pages shown in the next few pages. Issue Date Copy No. : : : Holder’s Name : National Accreditation Board for Testing and Calibration Laboratories Doc.03. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.2008 Amend No: 00 Amend Date: -Page No: 11/ 57 .TITLE PAGE The title page of the Quality Manual should normally contain the following: QUALITY MANUAL of (Name & Address of Laboratory) Issue No. Name & Designation) Name of Laboratory: Document No. A typical authorization should normally contain the following: RELEASE AUTHORISATION This Quality Manual is released under the authority of (name and designation of the Head of the laboratory) and is the property of (name of the laboratory with address). (Signature.: Amend No.: Prepared by: Section No.QUALITY MANUAL RELEASE AUTHORISATION Immediately after the title page. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.: Issue No. Approved by: Page No.: Document Name: Quality Manual Issue Date: Amend Date Copy No.2008 Amend No: 00 Amend Date: -Page No: 12/ 57 .03.: Issued by: National Accreditation Board for Testing and Calibration Laboratories Doc. this page should be placed. 6.AMENDMENT PAGE An amendment page should be inserted immediately after the title page. 9.: Issued by: National Accreditation Board for Testing and Calibration Laboratories Doc.: Prepared by: Section No. 5. Name of Laboratory: Document No. 3. Specific instructions to each holder of the Quality Manual as to the amendment procedure to be followed to maintain each copy upto date should be included. Approved by: Page No.: Amend No. 10. 8. A typical amendment page should normally contain the following: AMENDMENT RECORD Sl Page No.03. 7.: Document Name: Quality Manual Issue Date: Amend Date Copy No. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. 2. Section/ Clause/ Para/ line ( as app li ca b le ) Date of Amendment Amendment made Reasons of Amendment Signature of person authorising Amendment 1. this amendment page should be updated and issued with each set of amended/ new pages of the Quality Manual.2008 Amend No: 00 Amend Date: -Page No: 13/ 57 . 4. To ensure that each copy of the Quality Manual contains a complete record of amendments.: Issue No. A typical table of contents should normally contain the following: CONTENTS Section Amendment sheet Contents Scope References (if any) Definitions (if any) Abbreviations (if any) Distribution List Introduction ( Brief description of the Laboratory & management system ) Quality Policy and Objectives Contents Quality Manual release authorisation Page Management Requirements Organisation Management system Document Control Technical Requirements General Personnel List of all documents maintained by the laboratory List of all records List of all forms Annexures (if any) Name of Laboratory: Document No.: Issued by: National Accreditation Board for Testing and Calibration Laboratories Doc.CONTENT PAGE For the ease of reference.: Document Name: Quality Manual Issue Date: Amend Date Copy No.: Amend No. sub-sections and their page numbers.2008 Amend No: 00 Amend Date: -Page No: 14/ 57 . No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.: Issue No.03.: Prepared by: Section No. Approved by: Page No. A list of the Annexures should also be included. the manual should contain a table of contents listing the major sections. : Document Name: Quality Manual Issue Date: Amend Date Copy No. should not be listed.2008 Amend No: 00 Amend Date: -Page No: 15/ 57 .: Issued by: National Accreditation Board for Testing and Calibration Laboratories Doc.03.: Amend No. Approved by: Page No.: Prepared by: Section No. A typical distribution list should normally contain the following: DISTRIBUTION LIST The following are the authorised holders of the controlled copy of Quality Manual. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.DISTRIBUTION LIST The distribution record should list the holders of the controlled copies of Quality Manual with their allotted copy numbers. Name/ Designation of the holder of controlled copy Name of Laboratory: Document No. Controlled copy No.: Issue No. Copies of Quality Manual distributed as uncontrolled copies. 1.1. including its legal status.2008 Amend No: 00 Amend Date: -Page No: 16/ 57 . major fields of activity etc.4 If the laboratory is a part of larger organisation which also performs other activities. 4.1. a registered society or under company’s act. the regulatory authorities or the organisations providing recognition. whether permanent/ part of permanent/ independent site/ mobile. address. size. other than testing and/ or calibration.3 Describe the laboratory and its operations to convey a true picture of the organisation such as location. such as Government. the needs of its customer. The names and details of the regulatory bodies and the organisations providing recognition may also be mentioned. branches.1.2 The laboratory shall make a compliance statement that it carries out its testing/ calibration activities in accordance with the requirements of ISO/IEC 17025:2005.03. type of services offered. National Accreditation Board for Testing and Calibration Laboratories Doc. The date of incorporation may also be mentioned. which might adversely effect the judgement & integrity of staff and quality of work. marketing or finance shall be clearly defined in order to identify the potential conflict of interest with the laboratory personnel. 4. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. commercial. type of corporate structure and whether or not an affiliate of a larger organisation and any other information required to identify the laboratory. 4.1 4. 4. at all times.4. the responsibility of the key personnel in the organisation that have an involvement or influence on the testing and/ or calibration activities such as production.1 Management Requirements Organisation Give the name. Technical Management and other support services alongwith their linkages.5 a A statement that the laboratory has adequate number of staff both managerial and technical. The relationship with its parent organisation (if any) should be stated. competence. e Describe the organisation and management structure of the laboratory with the help of a chart showing Quality Management.2008 Amend No: 00 Amend Date: -Page No: 17/ 57 . b Describe the procedure that is followed to ensure that the laboratory’s management and personnel are free from any undue internal and external commercial. f Describe the arrangement whereby written instructions and information are given to members of staff to ensure that every employee is aware of the extent and limitations of his areas of responsibility and authority. d State policy and describe procedure that the laboratory is not engaged in any activity that may diminish its trust in its independence of judgement.4. Under no circumstances the results of test and/ or calibration be made known to any third party without the written consent of the customer. Provide an organisation chart to show the interrelationship of the laboratory staff.1. National Accreditation Board for Testing and Calibration Laboratories Doc. impartiality and integrity in relation to its testing and/ or calibration. financial and other pressures which might influence their technical judgement. appropriate to the scope of work being carried out. Define the duties/ responsibilities of the managerial and technical personnel to carry out their duties and to identify the occurrence of departures from management system or procedures. No reports should be send by fax without customers prior permission. c Describe the procedure which the laboratory uses to protect the proprietary right and confidential information of the customer. Copies of job descriptions be issued to all personnel to ensure that they are aware of both their responsibility and authority. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.03. k Describe arrangements to ensure that laboratory personnel are aware of the relevance and importance of their activities and how they contribute to the achievements of the objectives of the management system. commensurate with the organisation chart. The supervision has to be provided by persons familiar with methods and procedures. at all times.1. j Describe arrangements in the event of absence of key laboratory staff.6 Describe the arrangement whereby top management ensures that appropriate communication process are established within the laboratory and that communication takes place regarding the effectiveness of the management system.g State the laboratory’s arrangement for providing supervision to laboratory staff.2008 Amend No: 00 Amend Date: -Page No: 18/ 57 . h Include a statement that the Technical Manager (however named) has an overall responsibility of technical operations of the laboratory as a whole or its sub-section their off and provision of resources to ensure the required quality. including Quality Manager and Technical Manager. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.03. National Accreditation Board for Testing and Calibration Laboratories Doc. purpose of each test and/ or calibration and assessment of the test and/ or calibration results. Also include a statement that the Quality Manager has direct access to the highest level of management at which decisions are made for laboratory policy and resources. i Include a statement that the Quality Manager (however named) is responsible for ensuring that the management system related to quality is implemented and followed. 4. The statement must include atleast the following: a commitment of the laboratory management in relation to quality of its testing and calibration services and to provide its customers at all times with a service complying with recognised standards of practice b c standard of services given to its customers the purpose of the management system related to Quality National Accreditation Board for Testing and Calibration Laboratories Doc.03. Much will depend on the size of the laboratory and the scope of testing/ calibration requiring accreditation. forms. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. preferably in the beginning of the Quality Manual. The quality policy statement shall be signed by the Chief Executive or any person of the top management who takes decisions on the laboratory’s policy and resources.2 Quality Policy The laboratory must define its management system policies related to quality. Include a statement that the management system is appropriate to the scope of its activities and in accordance with ISO/IEC 17025:2005 and NABL documents.2 4. also form a part of the management system.1 Management System General Describe the documentation.2. implementation and maintenance of the management system of the laboratory. The Quality Manual of a laboratory is the basic document to describe its management system. available with and implemented by those personnel who are responsible for maintaining the quality of test and/ or calibration results. including Quality Policy statement and objectives.2. 4.2008 Amend No: 00 Amend Date: -Page No: 19/ 57 . Associated documents like operating procedures. The management system of the laboratory need not be complex.4. report etc. work instructions. understood by. A statement also to be made that the management system documentation of the laboratory is communicated to. at all times e commitment to compliance with ISO/IEC 17025:2005 and to continually improve the effectiveness the management.4 Describe arrangements that top management communicates to the organisation the importance of meeting customer as well as statutory and regulatory requirements.2. 4. Pyramid structure for documentation may also be described here or referred. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. some quality policy elements may be in other documents. reference to supporting documents such as operating procedures etc. forms. work instructions.2008 Amend No: 00 Amend Date: -Page No: 20/ 57 . This may also be described by a pyramid structure of management system document hierarchy.2. including technical procedures.2.03.d all staff shall familiarise themselves with the content of the Quality Manual and comply with the Policies and Procedures laid down in the Manual and associated documentation. It shall include or make reference to the supporting procedures.. National Accreditation Board for Testing and Calibration Laboratories Doc.3 Describe arrangements that top management provides evidence of commitment to the development and implementation of the management system and continually improving its effectiveness. 4. It shall include or make references to the supporting documents such as operating procedures. The quality policy statement should be concise and may include the requirement that tests and/ or calibrations shall always be carried out in accordance with stated methods and customers requirements. i. 4. reports etc. It may also include that the laboratory gives emphasis in producing reliable and accurate tests and/ or calibration results.5 Documentation Structure Describe the structure of documentation used in the management system. When test and/ or calibration laboratory is part of a larger organisation.e. Generally the responsibilities of key personnel are defined in Quality Manual and others having different responsibilities within the management system at appropriate position. 4.4.2. in the second/ third level of documentation. National Accreditation Board for Testing and Calibration Laboratories Doc.03.2008 Amend No: 00 Amend Date: -Page No: 21/ 57 .7 Describe arrangements that top management ensures that the integrity of the management system is maintained when changes to the management system are planned and implemented. The role and responsibility of the Technical Management and the Quality Manager for ensuring compliance to ISO/IEC 17025:2005. should be clearly defined.2. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.6 Responsibility The person(s)/ position responsible for implementing and monitoring programmes and policies to achieve laboratory’s quality objectives shall be identified. notices. page numbering. date of amendment/ revision. which shall include document number. All documents generated by the laboratory shall be uniquely identified. The laboratory shall ensure that all documents are reviewed and approved by authorised personnel prior to issue. calibration tables. amendment/ revision number. memoranda. drawings.3. and maintain a master list or equivalent document control procedure. Responsibility The person(s)/ position responsible for review and approval of documents shall be identified for all level of documentation.2 Document approval and issue Procedure Describe the document approval and issue procedure.4. issue number.2008 Amend No: 00 Amend Date: -Page No: 22/ 57 . plans. procedures.03. specification.3. which identifies the revision status and distribution. text books. approving authority and issuing authority. It shall atleast include the following information: a availability of authorised edition of appropriate documents at all locations b c d periodic review of documents removal of obsolete documents from all locations retention of a copy of obsolete document. 4. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. standards and other normative documents etc. National Accreditation Board for Testing and Calibration Laboratories Doc. regulations. both internally generated or from external source such as policy statements. date of issue. total number of pages. charts.1 Document Control General Describe the system to uniquely identify all documents generated by the laboratory and the procedure to control these documents The laboratory must list all documents that form part of its management system. posters. software.3 4. the procedure and authority for such amendment shall be defined. procedures to describe the changes and its control shall be defined.3 Document changes Procedure The laboratory shall state the procedure to identify the altered or new text. Policy with respect to all above may be given in Quality Manual and the actual process may be covered in a separate procedure referred in the Quality Manual. National Accreditation Board for Testing and Calibration Laboratories Doc.2008 Amend No: 00 Amend Date: -Page No: 23/ 57 . in the amended document. Where documentation control system allows the amendments of documents by hand pending re-issue.4. Responsibility The person(s)/ position authorised to review and approve changes/ amendments shall be identified.3. Where the laboratory maintains the amendments to documents in a computerised system. It should be preferably be the same person who performed the original review. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.03. where the records are maintained. Records Make a reference to the document. repetitive/ routine. documenting and understanding customer requirements before commencing work b c d assessment of laboratory’s capability and resources appropriate method selection work that is subcontracted by the laboratory.2008 Amend No: 00 Amend Date: -Page No: 24/ 57 .4 Review of requests. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. tenders and contracts may be identified.. tenders and contracts including subcontracted work. Responsibility The person(s)/ position responsible for review of request/ indent of new. The records of reviews.4. any significant changes. during the execution of contract and during the amendment to the contract shall be maintained. special work. Procedure Briefly outline the procedure for review of requests and tenders which shall include: a defining. tenders and contracts Policy State the laboratory’s policy for the review of requests.03. National Accreditation Board for Testing and Calibration Laboratories Doc. The details of how the review is actually done. may be covered separately in a procedure cross referred herein. pertinent discussions with the customer etc. shall be maintained. which should include advising customer of such arrangements in writing. National Accreditation Board for Testing and Calibration Laboratories Doc. Responsibility The person(s)/ position responsible for subcontracting the works may be identified. The actual process may be covered in a separate procedure cross referred in the Quality Manual. Records of all subcontractors that are used and record of evidence of compliance with ISO/IEC 17025:2005 for the work in question.2008 Amend No: 00 Amend Date: -Page No: 25/ 57 . No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.03.4.5 Subcontracting of tests and calibrations Policy State the laboratory’s policy for subcontracting of test and/ or calibration work. seeking customers’ approval and accepting the responsibility for the subcontracted work. where the records are maintained. The NABL policy for subcontracting by the laboratories is that the work shall be placed with an accredited laboratory. Procedure Briefly outline the procedure for subcontracting. Records Make a reference to the document. class. The actual process may be covered in separate procedure cross referred in the Quality Manual.6 Purchasing. other technical data including approval of test results. whether they should be inspected or otherwise verified for adequate quality). The records like purchasing documents may also be maintained. inspection & verification.2008 Amend No: 00 Amend Date: -Page No: 26/ 57 . services and supplies which affect the quality of test and/ or calibration. evaluation of suppliers of critical items. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. where the records are maintained. grade.4. Responsibility The person(s)/ position responsible for authorising purchases may be identified. precise identification. The records of action taken to check the compliance of supplies/ services used with specified requirements shall also be maintained. receipt and storage of reagents/ consumables. the laboratory’s policy of using the items may be stated (i. drawings. National Accreditation Board for Testing and Calibration Laboratories Doc. The records of evaluation of supplies of critical consumables & services and the list of those approved shall be maintained. the quality required and the management system standard under which they were made. specification. Procedure Briefly outline the procedure for the selection and purchase of services and supplies.e. Where assurance of quality of outside support services or supplies is unavailable. inspection instructions. Also briefly outline the procedure for review and approval of purchase documents for technical contents. Records Make a reference to the document. The description in the purchase document may include types. Services and Supplies Policy State the laboratory’s policy for purchasing.03. 7 Service to the customer Policy State the laboratory’s policy for service to the customer.2008 Amend No: 00 Amend Date: -Page No: 27/ 57 . It may also include the procedure for obtaining feedback from the customers on laboratory’s quality of services.03. if required shall be identified. both positive and negative from the customers shall be maintained. Procedure Briefly outline the procedure for implementation. The policy may address to the following: a b c maintenance of good communication to clarify their request monitor the laboratory’s performance in relation to the work performed d provide reasonable access to relevant areas of the laboratory for the witnessing of test(s)/ calibration(s) performed for the customer e f g h i preparation. packaging and despatch of test(s)/ calibration(s) items advice and guidance in technical matters opinion and interpretation based on results to maintain confidentiality to other customers during the monitoring delays or major deviations in the performance of test(s)/ calibration(s). National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. The records of the customer feedback.4. Responsibility The person(s)/ position responsible for authorising the customers for these services. The actual process may be documented separately and cross referred in the Quality Manual. Records Make a reference to the document. where the records are maintained. The actual process may be documented separately and cross referred in the Quality Manual. include the complainant’s name/ organisation. Procedure Briefly outline the procedure for resolution of complaints received from customers or other parties. shall be maintained. which are indicated by the complainant and conveying it for management review.8 Complaints Policy State the laboratory’s policy on resolution of complaints to improve the quality of services provided. The procedure shall have a provision of promptly auditing those aspects.2008 Amend No: 00 Amend Date: -Page No: 28/ 57 . The records shall also.4. Responsibility The person(s)/ position responsible for resolution of complaints shall be identified. the investigations carried out and the corrective action taken by the laboratory. The records of all complaints written or verbal shall be maintained. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. where the records are maintained. National Accreditation Board for Testing and Calibration Laboratories Doc. Records Make a reference to the document.03. Records Make a reference to the document.03. which shall include: a b c authority for halt of work. Procedure Briefly outline the procedure for control of nonconforming work. where the records are maintained. when any work and results do not confirm to its own procedures or the agreed requirements of the customers.9 Control of nonconforming testing and/ or calibration work Policy State the laboratory’s policy on control of nonconforming work.4. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.2008 Amend No: 00 Amend Date: -Page No: 29/ 57 . National Accreditation Board for Testing and Calibration Laboratories Doc. Responsibility The person(s)/ position responsible for management of nonconforming work and actions such as halting of work. if necessary authorising the resumption of work action taken to prevent future occurrence. Records of all non-conformities and action taken for correcting the non-conformities shall be maintained. withholding of test reports/ calibration certificates & resumption of work shall be identified. if necessary an evaluation of the significance of the non-conforming work Corrections and decision about the acceptability of nonconforming work to be taken d e f notification to the customer and work recall. The actual process may be covered in a separate procedure cross referred in the Quality Manual. Records of all improvements implemented shall be maintained. The actual process may be covered in a separate procedure cross referred in the Quality Manual. audit results. corrective and preventive actions and management reviews.03. National Accreditation Board for Testing and Calibration Laboratories Doc.4. Procedure Briefly outline the procedure of identification. Records Make a reference to the document. Responsibility Designate the management persons(s)/ position responsible for improvements shall be identified. analysis of data. quality objectives. The policy may include use of quality policy. management system.2008 Amend No: 00 Amend Date: -Page No: 30/ 57 . No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. implementation and monitoring the improvements. where the records are maintained.10 Improvements Policy State the laboratory’s policy on improvement of the effectiveness of its. 4. Records Make a reference to the document.2008 Amend No: 00 Amend Date: -Page No: 31/ 57 . Procedure Briefly outline the procedure for implementing corrective action which shall include: a b c d e sources of information for identification of problems cause analysis selection and implementation of corrective actions monitoring of corrective actions additional audits where non-conformities/ departures cast doubt. National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. Responsibility The person(s)/ position responsible for planning.03. implementing and monitoring appropriate corrective action shall be identified. The actual process may be covered in a separate procedure cross referred in the Quality Manual. where the records are maintained. Records of all corrective actions taken shall be maintained.11 Corrective action Policy State the laboratory’s policy on corrective action when nonconforming work or departures from policies and procedures in the management system or technical operations are identified. 2008 Amend No: 00 Amend Date: -Page No: 32/ 57 .12 Preventive action Policy State the laboratory’s policy on preventive actions for needed improvements and identification of potential sources of non-conformities. internal quality checks. Records of identification of potential sources of non-conformities. technical as well as concerning the management system. trend/ risk analysis. Records Make a reference to the document. National Accreditation Board for Testing and Calibration Laboratories Doc. results. etc. Procedure Briefly outline the procedure for preventive action and action plan to implement & monitor to reduce the likelihood of the occurrence of nonconformities. Such feedback serves as controls and based on these an action plan to identify the potential sources of non-conformities and required improvement & preventive measures can be drawn for implementation. The actual process may be covered in a separate procedure cross referred in the Quality Manual. management review. proficiency testing. customer feedback. Responsibility The person(s)/ position responsible for taking preventive actions shall be identified.03. where the records are maintained. required improvements and preventive measures taken shall be maintained. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. investigations carried out. The sources for identification of areas for implementing preventive action may include feedback from staff and customers. The procedure for preventive action shall include initiation of such actions and application of controls to ensure they are effective.4. analysis of data. if mistakes occur. storage. personnel responsible for sampling. indexing. The actual process may be covered in a separate procedure cross referred in the Quality Manual. access.13 Control of records Policy State the laboratory’s policy to maintain and control record pertaining to quality and technical activities. protection and security of records. Briefly describe the procedure for corrections. Scope List all quality and technical records maintained by the laboratory and give a unique identification record number. derived data. a copy of each test report or calibration certificate. corrective action. calibration records. Also state policy on confidentiality. staff records. raw data and test report/ calibration certificate. Briefly describe the procedure for control and time period for retention of records. management review. Procedure Briefly outline the procedure for identification.2008 Amend No: 00 Amend Date: -Page No: 33/ 57 . filing. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. collection. maintenance and disposal of quality and technical records.4. especially the test and/ or calibration worksheet. preventive action etc. especially computer records.03. The quality records shall include reports of internal audit. National Accreditation Board for Testing and Calibration Laboratories Doc. participation in proficiency testing etc. Responsibility State the person(s) responsible for maintaining and controlling each record. The technical records shall include original observations. that they are independent of the activity to be audited to the extent possible. The procedure shall take account of: a b the frequency of conducting the internal audit at regular intervals training and qualification criteria of personnel conducting the internal audit. National Accreditation Board for Testing and Calibration Laboratories Doc. Responsibility State the person/ position responsible for planning. The detailed process may be covered in a separate procedure cross referred in the Quality Manual.03. Normally this activity is the responsibility of the Quality Manager.4. Scope State the activities of the management system including testing and/ or calibration activities. organising internal audits and coordinating the corrective action. The procedure shall also include the procedure for the corrective action(s) to be taken and its verification including notifying customers in writing. which will be audited to cover all elements of the laboratory’s management system and ISO/IEC 17025:2005.2008 Amend No: 00 Amend Date: -Page No: 34/ 57 .14 Internal Audit Policy State the laboratory’s policy in respect to conduct internal audit of all activities to verify that the operations continue to comply with the requirements 17025:2005. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. if the findings of internal audit cast doubt on the effectiveness of operations or on the correctness/ validity of test and/ or calibration results. of laboratory’s management system and ISO/IEC Procedure Briefly outline the procedure for conduct of internal audit. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.Records Make a reference to the document. the audit findings including the areas audited.2008 Amend No: 00 Amend Date: -Page No: 35/ 57 . where the records are maintained. implementation. National Accreditation Board for Testing and Calibration Laboratories Doc. its verification and the effectiveness of the corrective action taken shall be recorded.03. records verified. corrective actions that arise from them. objective evidence gathered for verifying compliance with the requirements of ISO/IEC 17025:2005 & the laboratory’s management system and the gaps/ non conformities observed if any. The records of the activities covered. 4.15 Management review Policy State laboratory’s policy for the conduct of Management Review to ensure the continuing suitability and effectiveness of laboratory’s management system and its testing and/ or calibration activities and to introduce necessary changes and improvements. It is expected that the top management (chief executive) of the laboratory who has the executive responsibility for running the laboratory, undertakes the management review. The members of senior management having overall responsibility for design and implementation of laboratory’s management system for the Technical Management, may also be involved in the management review. Scope State the activities, the Management Review shall take account of, however they should not be limited to the following: a b c d e f g h i j k the suitability of policies and procedures reports from managerial and supervisory personnel the outcome of recent internal audits corrective and preventive actions assessments by external bodies the results of inter-laboratory comparisons or proficiency testing changes in the volume and type of the work customer feedback complaints recommendations for improvement other relevant factors, such as quality control activities, resources and staff training. Responsibility State the person/ position responsible to convene the Management Review meeting and the person who shall implement the decisions of the meeting. National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.03.2008 Amend No: 00 Amend Date: -Page No: 36/ 57 Procedure Briefly outline the procedure for conduct of the Management Review covering all the aspects stated above and the frequency at which it is conducted. The procedure shall also include that any action identified during the review, is implemented within the agreed time limit. The detailed processes may be covered in a separate procedure cross referred in the Quality Manual. Records Make a reference to the document, where the records are maintained. Records of all management review, and the actions that arise from them shall be recorded. Records should also identify the personnel responsible for the actions and agreed time frame. It should also include report on the actions of previous reviews. National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.03.2008 Amend No: 00 Amend Date: -Page No: 37/ 57 5. 5.1 Technical Requirements General State the factors that determine the correctness and reliability of the tests/ calibrations performed by the laboratory. These factors should not be limited to: a b c d e f g human factors accommodation and environmental conditions test and calibration methods and method validation equipment measurement traceability sampling the handling of test and calibration items. The laboratory shall take account of the factors in developing the test and/ or calibration methods and procedures, in the training and qualification of personnel and in the selection and calibration of the equipment it uses. National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.03.2008 Amend No: 00 Amend Date: -Page No: 38/ 57 Job Description Provide job description of the laboratory staff which shall include atleast the following: a b c d e f g name qualification training attended management duties expertise responsibilities further expertise/ training required. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. National Accreditation Board for Testing and Calibration Laboratories Doc. Other staff members may only assist in performing that test under close supervision of a competent staff member.2008 Amend No: 00 Amend Date: -Page No: 39/ 57 . Include a statement that department/ section laboratory managers ensure that only staff members who have been assessed and found competent to perform a test and/ or calibration are allowed to perform only that test and/ or calibration independently.03. Supervision of Personnel Provide for each technical operating department/ section. information of the number of supervisory & non-supervisory personnel and the procedures used to ensure adequacy of supervision. Formulate and state goals with respect to education.5.2 Personnel Policy State the laboratory’s policy on ensuring personnel competence and with regard to training needs. training and skills of the laboratory personnel. This data may be maintained by the personnel department and be also annexed with the procedural manual of relevant sections. relevant to the present and anticipated tasks of the laboratory. 2008 Amend No: 00 Amend Date: -Page No: 40/ 57 .03. test and/ or calibration. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. skills and experience shall be maintained. issue of test report & calibration certificate. to perform specific tasks such as sampling. Also the records of their educational & professional qualification. relevant to the present and anticipated tasks of the laboratory. The laboratory shall also maintain records of persons who are competent/ authorised including date of authorization. to give opinion and interpretations and to operate particular types of equipment.Training and Assessment of Competence Describe the procedure for identifying the training needs and providing training of personnel. Each sectional laboratory manager may be responsible to maintain the manual and plan the training schedule of his section to satisfy these requirements. Also describe the evaluation procedure for the effectiveness of the training actions taken. National Accreditation Board for Testing and Calibration Laboratories Doc. The personnel competence requirements with respect to different task undertaken by laboratory shall be maintained. A procedure for assessing the competence/ skills of the personnel should also be described. training. where the records are maintained. Records Make a reference to the document. The details of the training and assessment programme of each section may be contained in the Training Manual of that section. performance Accommodation Briefly describe the building facilities. Describe measures to control access to any particular area of the laboratory and procedures to ensure laboratory security. energy & water sources and lighting.3 Accommodation and Environmental Conditions Policy State the laboratory’s facilitate policy correct with respect to of accommodation the tests and/ and or environments calibrations. Is there effective separation between neighboring areas in which there are incompatible activities? What measures have been taken to prevent cross contamination? Give instructions for laboratory staff to maintain good house keeping.03. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. as required by particular category of calibration or tests (giving a list if necessary). give a table listing the staff that is permitted access to the various areas and the position of staff responsible for security. A layout plan may be included.5. Environmental Conditions Give a brief description of the environmental conditions such as temperature and humidity. laboratories performing biological measurements shall specify biological sterility as environmental factor to be controlled and electo-technical laboratories shall monitor the mains voltage. If necessary. in the various sections of the laboratory. National Accreditation Board for Testing and Calibration Laboratories Doc.2008 Amend No: 00 Amend Date: -Page No: 41/ 57 . location. In addition to temperature and humidity. if necessary. Prepare/ document special procedures for specific areas. construction features. 03. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. where the records are maintained. wherever relevant. Records Make a reference to the document.2008 Amend No: 00 Amend Date: -Page No: 42/ 57 . The records of environmental conditions such as temperature and humidity. What if they break down? Briefly outline the procedure to monitor the environmental conditions. shall be maintained.Give a brief description of how to achieve the control of these environmental conditions. National Accreditation Board for Testing and Calibration Laboratories Doc. Test and Calibration Methods Briefly describe the procedure and instruction for use of appropriate methods and procedures for all tests and/ or calibrations within its scope. retrieving. storage and preparation of items to be tested and/ or calibrated. The methods published in national or international standards with latest valid edition shall be used. updating. handling. text books. This should include sampling. reviewing and approving of test and calibration methods. The procedure should include that in-house methods shall be validated and approved before issue. whether prescribed in national or international standards. transport.e. Designate the staff responsible for the above task. shall be validated. equipment operational manuals or laboratory developed methods etc.03. Each test or calibration procedure shall contain at least the following information: a b c d e appropriate identification scope description of the type of item to be tested or calibrated parameters or quantities and ranges to be determined apparatus and equipment. including technical performance requirements National Accreditation Board for Testing and Calibration Laboratories Doc. and where appropriate. Describe the procedure for writing laboratory developed and non-standard methods. Describe the general arrangements for issuing.2008 Amend No: 00 Amend Date: -Page No: 43/ 57 . published in reputed journals. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. Methods published in journals. amending. to meet the customer’s requirements. equipment manuals and laboratory developed methods or non-standard methods suggested by the customer. text books.4 Test and Calibration Methods and method validation Policy State laboratory’s policy with respect to selecting any particular test and/ or calibration method i.5. an estimation of measurement uncertainty as well as statistical techniques for analysis of tests and/ or calibration data. in-house methods. Procedure Manuals List the various categories of test and/ or calibration methods employed and make a cross-reference to the Test and/ or Calibration Procedure Manual(s) in the Quality Manual. including affixing of identification marks. Standard Specifications State the laboratory’s policy for referring to latest standards as the basis for test and/ or calibration methods. Regional or National Standard that contain sufficient and concise information on how to perform the tests and/ or calibrations do not need to be supplemented or rewritten as internal procedures if these standards are written in a way that they can be used as published by the operating staff in the laboratory. It may be necessary to provide additional documentation for optional steps in the method or addition details. whenever possible. guidance should be provided for amplifying standard specifications to make a step-by-step procedure. List the relevant standard specifications on which the test and/ or calibration procedures are based. where required. International. calibration and adjustment of the equipment before each use the method of recording the observations and results any safety measures to be observed i j k For criteria and/ or requirements for approval/ rejection data to be recorded and method of analysis and presentation the uncertainty or the procedure for estimating uncertainty. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. which is unambiguous to the staff concerned.2008 Amend No: 00 Amend Date: -Page No: 44/ 57 .f g h reference standards and reference materials required environmental condition required and any stabilization period needed description of the procedure. handling. storing and preparation of items checks to be made before the work is started checks that the equipment is working properly and. National Accreditation Board for Testing and Calibration Laboratories Doc.03. transporting. 03. the laboratory shall confirm the techniques used for the determination of the performance of a method.2008 Amend No: 00 Amend Date: -Page No: 45/ 57 . For calibration laboratories and testing laboratories performing their own calibrations shall estimate the uncertainty of measurement for all calibrations and types/ range of calibrations. a b c d e calibration using reference standards or reference materials comparison of results achieved with other methods Inter-laboratory comparisons systematic assessment of the factors influencing the result assessment of the uncertainty of the results based on scientific understanding of the theoretical principals of the method and practical experience f any other technique.Validation of Methods Where the laboratory is using the laboratory developed or non-standard methods. all uncertainty components which are of importance in the given situation shall be taken into account. National Accreditation Board for Testing and Calibration Laboratories Doc. The degree of rigor needed in an estimation of uncertainty of measurement depends on the requirements of test method. When estimating the uncertainty of measurement. For testing laboratories availing the services from calibration laboratories. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. One or combination of the following techniques may be used for the determination of performance of a method. which shall include but not be limiting to: a reference standards and reference materials with reported uncertainty in the calibration certificate b c d e method employed equipment used with reported uncertainty in the calibration certificate environmental conditions properties and condition of the item being tested/ calibrated. requirements of customer and the existence of narrow limits on which decisions on conformance to a specification are based. Estimation of Uncertainty of Measurement The laboratory shall state the procedure applied to estimate the uncertainty of measurement for all types/ ranges of calibration. and shall ensure that the form of reporting of the result does not give a wrong impression of the uncertainty. shall identify all the components of uncertainty and make a reasonable estimation for all test parameters. confidentiality and security of data. including software validation.2008 Amend No: 00 Amend Date: -Page No: 46/ 57 . No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. particularly when using computer processing. Describe the procedure to protect the integrity.Control of Data Describe the arrangement to ensure that all data transfer are subjected to appropriate checking by responsible staff.03. National Accreditation Board for Testing and Calibration Laboratories Doc. date of last calibration and date of next calibration.5. including both software invalidating the results.03. transport. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. Describe the procedure for safeguarding hardware and tests and/ or for calibration adjustment equipment. storage.2008 Amend No: 00 Amend Date: -Page No: 47/ 57 .5 Equipment Policy State laboratory’s policy on use of equipment and reference materials for complying to required specifications and capable of achieving the desired accuracy. Describe the procedure for commissioning new equipment including the criteria for acceptance and safeguarding from adjustments. The laboratory shall confirm that all equipment under the control of laboratory requiring calibration are identified and labeled to indicate the status of calibration. use and planned maintenance of measuring equipment to ensure proper functioning and prevent contamination or deterioration. reference standards and materials required by the laboratory. Procedures for test and calibration equipment Make a cross reference to the document where a list of major equipment are maintained and also make a statement to the effect that it has all the necessary equipment and reference material for meeting the stated policy. List the range of major test and/ or calibration equipment. Describe the procedure for safe handling. Describe a procedure for intermediate checks to maintain confidence status of the equipment. National Accreditation Board for Testing and Calibration Laboratories Doc. acceptance criteria. if available. type identification. malfunction. results and copies of reports and certificates of all calibrations. A record of their usage should be included. adjustments. and a procedure when it is repaired and brought back/ returned to service. modification or repair to the equipment. where appropriate the manufacturer’s instructions. giving suspected results or the equipment is declared defective or when equipment goes outside the direct control of laboratory. and the due date of next calibration g h the maintenance plan. where calibrations give rise to set of correction factors. date of the calibration and due date of next calibration. where the records are maintained. the expiry date should be indicated. For each equipment atleast the following data should be included: a b the identity of the item of equipment and its software the manufacturer’s name.Describe the procedure for equipment subjected to overloading or mishandling. where appropriate. The records for authorization of the technical staff for handling/ operating the equipments shall also be maintained. and a serial number or other unique identification c d e f checks that equipment complies with the specification current location. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. reference standards and reference materials requiring calibration which shall atleast include equipment name. National Accreditation Board for Testing and Calibration Laboratories Doc. in computer software) are correctly updated. and maintenance carried out to date any damage. calibration status. The laboratory shall maintain records of all major test and/ or calibration equipment.03. or reference to their location dates. The laboratory shall also maintain records of all test and/ or calibration equipment. Describe the procedure to ensure that copies (eg.2008 Amend No: 00 Amend Date: -Page No: 48/ 57 . For chemical reference materials. Equipment Records Make a reference to the document. The laboratory shall also make a commitment to use the services of accredited laboratories for external calibrations.2008 Amend No: 00 Amend Date: -Page No: 49/ 57 .5. The programme shall cover all measuring instrument/ equipment. to provide traceability to national/ international standards. reference standards and reference materials. for the calibration concerned is sufficient evidence of traceability of the calibration data reported. A calibration certificate bearing an accreditation body symbol from a calibration laboratory accredited in accordance with ISO/IEC 17025:2005. Where traceability to national/ international standards is not practicable. A detailed procedure for calibration may be given in a separate document and cross referred in the Quality Manual. For internal calibration. Calibration programme Describe the calibration programme operative in the laboratory which includes the scheduling & fixing of calibration due dates and fulfills the requirements of NABL 142. how does the laboratory provide the satisfactory evidence about the reliability of the measurement of result.03. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. given in NABL 142. describe calibration procedure including estimation of uncertainties of measurement and traceability to national/ international standards and acceptance criteria. National Accreditation Board for Testing and Calibration Laboratories Doc.6 Measurement Traceability and Calibration Policy The laboratory shall make a commitment to implement NABL policy on measurement traceability and calibration. Use of Reference Standard of Measurement Reference materials shall be. Responsibility The person(s)/ position responsible for implementing and monitoring the calibration programme shall be identified.6. where applicable. The measurements may be alternatively traceable to the calibration laboratories accredited by APLAC/ ILAC MRA partners. The calibration certificate shall also provide a statement on the uncertainty of measurement and standards used with their valid calibration. Describe the procedures and schedule for checks needed to maintain confidence in the calibration status of reference.03. transfer or working standards and reference materials. National Accreditation Board for Testing and Calibration Laboratories Doc. uncertainty & traceability. The laboratory shall make a statement that reference standards of measurement held by the laboratory shall be used for calibration only and for no other purpose. In case the same is not possible. be traceable to SI units or to Certified Reference Materials.2008 Amend No: 00 Amend Date: -Page No: 50/ 57 . Alternatively the measurement should be traceable to National Standards through an unbroken chain of NABL Accredited laboratories.2.1 and the same may be described by the laboratory. List of Reference Standard in use shall be maintained along with the details of its receipt and utilization.The overall programme of calibration and verification and validation of an equipment shall be so designed and operated to ensure that measurements made by the laboratory are directly traceable to National and International standard of measurement. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. if appropriate. the laboratory shall state the procedure to demonstrate that its performance as reference standards would not been invalidated. NABL will recognize the traceability of calibration to international metrology institutes such as NIST. it can provide traceability as prescribed in ISO/IEC 17025:2005 clause 5. where possible. In case the laboratory is using the reference standard for other purposes. NABL accredited laboratories are required to ensure that the calibration certificates in such cases indicate the traceability to National or International standards of Measurement. PTB etc. 03.Records Make a reference to the document.2008 Amend No: 00 Amend Date: -Page No: 51/ 57 . where the records are maintained. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. This record can be included with the equipment records like equipment name. calibration status. reference standard/ material. date of the calibration and due date of next calibration. National Accreditation Board for Testing and Calibration Laboratories Doc. The laboratory shall maintain records of all established traceability of calibrations performed on its own measuring instrument/ equipment. It shall atleast include sampling procedure used. where the records are maintained.7 Sampling Briefly outline the laboratory’s plan and procedures for sampling. The procedure should include the selection. The relevant data related to sampling shall be recorded. If customer requires deviation for documented sampling procedures. Records Make a reference to the document.03. diagrams to identify the sampling location and if appropriate. materials or products for subsequent testing. when sampling of substances.5. identification of the sampler. No sampling is to be done for calibration as the entire scope/ ranges need to be demonstrated. withdrawal and preparation of a sample to yield required information. thus two shall be recorded and included in all documents containing test and/ or calibration results. environmental conditions (if relevant). statistics principles upon which the sampling is based. sampling plan. National Accreditation Board for Testing and Calibration Laboratories Doc. is the responsibilities of the laboratory.2008 Amend No: 00 Amend Date: -Page No: 52/ 57 . No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. The actual process may be included in a separate procedure cross referred in the Quality Manual. storage. where the records are maintained.03. handling. Procedure Briefly outline the procedure for safe transportation.8 Handling of Calibration and Test items Policy State laboratory’s policy with respect to the handling of test and/ or calibration items to protect the integrity of test and/ or calibration item. security. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.2008 Amend No: 00 Amend Date: -Page No: 53/ 57 . retention and delivery/ disposal for items received by the laboratory for test and/ or calibration. throughout the life in the laboratory. protection. Records Make a reference to the document. receipt. Test/ Calibration item identification Describe the system for identification and recording of test and/ or calibration item. atleast the following information shall be recorded: a b c d e f g h laboratory identification number name of customer date of receipt sample description condition of receipt date of test/ measurement completed sample disposal date/ date on which sample collected by customer identity of assigned analyst. National Accreditation Board for Testing and Calibration Laboratories Doc. For each test and/ or calibration item. The actual process of handling to calibration and/ or test items may be detailed in a separate procedure cross referred in the Quality Manual.5. 03. The laboratories shall document a procedure to analyse the quality control data and where they find that their results/ analysis are outside the predefined criteria. The monitoring shall be planned & reviewed and shall include. one or more of the above measures shall be practiced. a planned action shall be taken to correct the problem and to prevent incorrect results from being reputed. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.2008 Amend No: 00 Amend Date: -Page No: 54/ 57 . Quality control measures The laboratory shall describe the quality control procedure for monitoring the validity of test and/ or calibration and the verification practices for checking the validity of test and/ or calibration results and for estimating the components of precision of test and/ or calibration results. Specify the management person responsible for reviewing the results and deciding on the appropriate investigation and corrective action.5. Responsibility Designate the person(s)/ position responsible for coordinating the verification practices. Describe or make cross reference to the document which contains the schedule and frequency with which such verification practices are carried out and the procedure for conduct and review of these activities.9 Assuring the quality of test and calibration results Policy State the laboratory’s policy for assuring the quality of test and calibration results. but not limited to the following: a regular use of certified reference materials and/ or internal quality control using secondary reference materials b c d e participation in inter-laboratory comparison or proficiency testing programme replicate tests or calibrations using the same or different methods retesting or recalibration of retained items correlation of results for different characteristics of an item. National Accreditation Board for Testing and Calibration Laboratories Doc. It is expected that depending upon the nature of test(s) and/ or calibration(s) performed and volume of work undertaken. in accordance with NABL 163. NABL shall keep the accredited laboratories informed about all such international programmes through NABL newsletter. All applicant laboratories are required to successfully participate in at least one Inter-laboratory Proficiency Testing in accordance with ISO/ IEC Guide-43 (I). Laboratories shall also participate (as far as available and practicable) in international Inter-laboratory Comparison/ Proficiency Testing Programmes conducted by APLAC. Records Make a reference to the document. This will of course not apply to those special areas where Inter-laboratory Proficiency Testing Programmes are not available. All NABL accredited testing and calibration laboratories are required to participate in Proficiency Testing Programmes conducted by NABL or the nodal organizations appointed by NABL. The records shall also include review of results and investigation/ analysis of deviations if observed and resulting corrective actions taken and verified. NABL is expected to enforce the requirements of APLAC MRA 001 and accordingly it will be essential for all its accredited laboratories to demonstrate technical competence of its accredited laboratories by satisfactory participation in International/ Regional/ National Proficiency Testing Programmes. internal quality checks and intermediate checks on reference standards shall be maintained.2008 Amend No: 00 Amend Date: -Page No: 55/ 57 . where the records are maintained. The records of all verification practices i. EA or equivalent organizations.e. National Accreditation Board for Testing and Calibration Laboratories Doc.03. Proficiency testing is one of the powerful method of checking the validity of the test and/ or calibration results. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. The records of proficiency testing and inter-laboratory comparisons shall be maintained.Proficiency Testing The laboratory shall make a statement that it follows NABL policy on Inter-laboratory Comparisons and/ or Proficiency Testing. including APLAC in a manner so that each major subareas of major disciplines of a laboratory’s scope of accreditation are covered in a cycle of 4 years.1996. 10 Reporting the results Policy The laboratory shall state its policy with respect to reporting of results of each test or calibration carried out by them so that they are reported accurately. as relevant may also be contained in the test report/ calibration certificates. the units of measurement the name(s). the condition of. the format may be made short. clearly.10.4. National Accreditation Board for Testing and Calibration Laboratories Doc. function(s) and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate k where relevant. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24.3 and 5. a statement to the effect that the results relate only to the items tested or calibrated.5. and unambiguous identification of the item(s) tested or calibrated g the date of receipt of the test or calibration item(s) where this is the validity and application of the results.03. and the location where the tests and/ or calibrations were carried out. which contains atleast the following information: a b a title (eg. if different from the address of the laboratory c unique identification of the test report or calibration (such as the serial number). where appropriate.2008 Amend No: 00 Amend Date: -Page No: 56/ 57 . However any requirement not reported to customer shall be readily available in the laboratory. and a clear identification of the end of the test report or calibration certificate d e f the name and address of the customer identification of he method used a description of. and the date(s) of performance of the test or calibration h reference to the sampling plan and procedures used by the laboratory or other bodies where these are relevant to the validity or application of the results i j the test or calibration results with. and on each page an identification in order to ensure that the page is recognized as a part of the test report or calibration certificate.10. “Test Report” or “Calibration Certificate”) the name and address of the laboratory. In case of internal customer or written agreement with the customer. In addition to the above any other information as stated in ISO/IEC 17025:2005 clause 5. unambiguously and objectively and in accordance with any specific instructions in the test or calibration methods. A standard format may be used by the laboratory. 03. uncertainty of measurement and the evidence of traceability of measurement c wherever required the opinions and interpretations are provided in the reports/ certificates d e all reports/ certificates bear NABL symbol as per NABL policy all reports/ certificates are signed by the authorised signatory.2008 Amend No: 00 Amend Date: -Page No: 57/ 57 . Describe the procedure for issuing and transmitting of reports/ certificates to the customers. National Accreditation Board for Testing and Calibration Laboratories Doc.The laboratory shall explicitly state that: a the results of test and calibration performed by the subcontractor are included in the report/ certificate and clearly identified b the calibration certificates also include environmental conditions. of any event that cast doubt on the validity of issued results. State the policy of the laboratory to notify to its customer. Describe the procedure for making amendments to Test Reports and Calibration Certificates. No: NABL 160 Issue No: 04 Guide for Preparing a Quality Manual Issue Date: 24. Also the procedure for issuing the amended or supplementary reports/ certificates shall be stated. : 91-11 26529718 – 20. Satsang Vihar Marg New Mehrauli Road New Delhi – 110 067 Tel. 26526864 Fax: 91-11 26529716 Website: www.nabl-india.org . NISCAIR 14.National Accreditation Board for Testing and Calibration Laboratories 3 rd Floor.