NABL NATIONAL ACCREDITATION

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1 NABL 160 NABL NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES GUIDE for PREPARING A QUALITY MANUAL ISSUE NO. : 05 AMENDMENT NO : 00 ISSUE DATE: AMENDMENT DATE: --

2 Amendment Sheet Sl Page No. Clause No. Date of Amendment Amendment made Reasons Signature QO Signature Director Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 1/ 59

3 Contents Sl. Contents Page No. Amendment sheet 1 Contents 2 1. Introduction 3 2. Process for preparing a Quality Manual 4 3. Structure and format of Quality Manual 7 4. 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 58 Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 2/ 59

4 1. 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. One of the pre-requisite for seeking NABL Accreditation is that applicant laboratory shall submit its Quality Manual, describing its policies, the structure of management system documentation and compliance to ISO/IEC or ISO 15189, as applicable & relevant NABL Specific Criteria. In preparing the Quality Manual, it should not be restricted to the contents of this guide. However, all elements of ISO/IEC or ISO as applicable must be addressed in the intended Quality Manual. As an illustration this document provides guidance to Testing and Calibration laboratories for addressing the requirements of ISO/IEC in their Quality Manual. Similarly, the requirements of ISO can be addressed by Medical Testing laboratories in their Quality Manual. The amount of details to be provided in the manual will vary depending upon the size, field of activities, and nature of testing / calibration performed by the laboratory. The Quality Manual shall include or make reference to other documents such operational procedures, work instructions, forms etc. For preparing the Quality Manual, the laboratory may also get its technical personnel trained in NABL s training program on management system for laboratory personnel. A calendar of such training courses is regularly published in the NABL News/ web-site. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 3/ 59

5 2. 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, having a background of Management Systems. This group should get fully acquainted with all NABL documents and understand the assessment procedure & methodology of making an application. Relevant requirements for NABL accreditation should be discussed amongst concerned staff of the laboratory. The team should collectively make the effort to prepare the Quality Manual with the guidance of the Quality Manager. Laboratory needs to ascertain the status of its existing management system and its competence. For that all existing policies, objectives, procedures, work instruction whether documented or otherwise are required to be listed and compared with the requirements of ISO/IEC or ISO as applicable, relevant NABL Specific criteria and other requirements. The laboratory should examine that the existing management system is appropriate or it needs modification or it needs to be built from scratch. The laboratory will be able to decide. However, it is advisable that the laboratory writes the manual afresh, as the elements of ISO/ IEC or ISO are quite different from other Quality Management System standards, even though the system elements are similar. It must be remembered that Quality Manual is a policy document, which has to be supplemented by a set of other documents like procedure manuals, work instructions, forms, reports etc. to align the management system in accordance with ISO/IEC or ISO 15189, as applicable and relevant NABL specific criteria. Therefore, the management system of the laboratory needs to be structured. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 4/ 59

6 The management system of the laboratory can be structured in many ways. A typical structure of management system document hierarchy, generally followed, is given below: Quality Manual (Level A) Management system Procedures (Level B) Other quality documents (Work instructions, forms, reports, etc.) (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 or ISO as applicable in brief. This is the apex document or Level A document termed as the Quality Manual. The Quality Manual has to be supplemented by a set of management system procedures, Level B documents, which describe the detailed procedures of the activities of individual function units needed to implement the management system. All procedures are cross referred in the Quality Manual. Management system procedures may further be supplemented with detailed work instructions, forms, reports etc. termed as Level C documents. In some hierarchy systems, forms and reports may be grouped as Level D documents. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 5/ 59

7 The quantity of documented procedures, work instructions, forms, reports etc. and the nature of their format and presentation are to be determined by the individual functional units. However, 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 or ISO as applicable. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 6/ 59

8 3. Structure and Format of Quality Manual There is no required structure or format for a Quality Manual. However, any Quality Manual should convey accurately, completely and concisely the Quality Policy, objectives, address or reference to the next level of documentation and management responsibilities of the laboratory. 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 or ISO as applicable. 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. This guide is not intended to define a unique structure, format, content or method of presentation for the Quality Manual, which can be applied to all (or even some) laboratories. It is unique to each laboratory. However, it is recommended that the first few pages of the Quality Manual should address to the sections of general information like title, authority under which it is issued, scope of the Quality Manual, amendment record of the manual, contents of the manual, references to other documents, definitions and abbreviations used, distribution record, brief description of the laboratory and the management system. After these pages, should place the section on Quality Policy and Objectives of the laboratory. The Quality Policy is required to be stated under clause 4.2 of management requirements. It is preferred that it is placed after the introductory pages, since this is the basic objective, the laboratory s management system is designed to meet. The remaining sections of the Quality Manual should describe all applicable elements of the ISO/IEC or ISO The description of these sections of the Quality Manual should be in a sequence similar to that of ISO/IEC or ISO 15189, as applicable. Other sequencing or cross-referencing, as appropriate to the laboratory, is acceptable. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 7/ 59

9 Thereafter the list of documents, records and forms maintained by the laboratory should be placed. Any supportive data, to be provided should be annexed at the last. A brief explanation of these sections has been given below. These sections, 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. It should also indicate the issue number, issue date, holders name and the copy number. A typical title page is shown at page 11. Release Authorisation The section on release authorisation should indicate the authority under which the Quality Manual has been released. The management responsible for the implementation of Quality Manual, normally the Head of the laboratory should authorise its release for usage. Each copy should bear evidence of this release. A typical release authorisation is shown at page 12. 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. The numbering system of sections, subsections, pages, figures, exhibits, diagrams, tables, etc., should be clear and logical. A typical table of contents is shown at page 14. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 8/ 59

10 Scope and field of application This section of the Quality Manual should clearly mention the compliance to the applicable standard(s) and NABL documents. It should also define the field(s)/ discipline(s)/ area(s) and the section(s)/ division(s) department(s) of the laboratory, to which the Quality Manual is applicable. To ensure clarity and avoid confusion, the use of disclaimers (eg. what is not covered by the Quality Manual and situations where it should not be applied) may also be mentioned. Use of references Wherever appropriate, and to avoid unnecessary document volume, reference to existing recognised standards or documents available with the Quality Manual user should be incorporated. Definitions Although it is recommended, when practical, to use standard definitions and terms which are referenced in recognised quality terminology documents or in general dictionary usage, 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 references to existing concepts, terminology, definitions and standards (eg. ISO 8402) is highly recommended. Abbreviations Whenever the abbreviations are used, its expanded form should be defined in this section. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 9/ 59

11 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, for example, by serialisation of copies for recipients. Management should ensure that individuals are familiar with those contents of the manual appropriate to each user within the laboratory. A typical distribution record is shown at page 15. Introduction The introductory pages of a Quality Manual should provide general information about the laboratory concerned and the Quality Manual itself. The minimum information about the laboratory should be its name, site, location and means of communication. Additional information about the laboratory, such as its line of business, a brief description of its background, history or size, may also be included. The information about the Quality Manual itself should include: a The current issue number, date of issue and identification of amended contents b c A brief description of how the Quality Manual is revised and maintained, who reviews its content and how often, who is authorised to change the Quality Manual, and who is authorised to approve it, this information may also be give under the system element concerned; a method for determining the history of any change in procedure may be included, if appropriate A brief description of the documented procedures used to identify the status and to control the distribution of the Quality Manual, whether or not is contains confidential information, whether it is used only for the laboratory s internal purposes, or whether it can be made available externally Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 10/ 59

12 d Evidence of approval by those responsible for authorisation of the contents of the Quality Manual. 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 4.2 of ISO/IEC or ISO 15189, as applicable. This is where the laboratory commitment to quality is presented and where the laboratory s objectives for quality are outlines. This section should also describe how the Quality Policy is made known to, and understood by, all employees and how it is implemented and maintained at all levels. Elements of the Management system The subsequent sections of the Quality Manual should describe all the elements of the ISO/IEC or ISO as applicable. The format or method of presentation for the description of management system elements, which can be applied, is unique to each laboratory. However it is recommended that the description of the elements of the management system be in a sequence similar to that of ISO/IEC or ISO 15189, as applicable. Further the description of each element should be divided into logical sub-sections revealing a well-coordinated management system. This may be done by inclusion of policy and objectives with respect to the element or reference to the policy, scope, person(s)/ position responsible for executing that policy, documented management system procedures and reference to records for each element. The management system procedure of each element of Quality Manual, wherever applicable, should be briefly outlined, covering the major aspects of respective clause of ISO/IEC or ISO The actual process/ procedure may be covered in separate procedure document and cross referred in the Quality Manual. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 11/ 59

13 List of documents, records and forms All documents which are maintained by the laboratory and the records & forms, which are used by the laboratory should be listed in these sections. These must find reference in the Quality Manual or the associated document. Annexure for supportive information Whenever it appears in this document, that supportive data has to be provided, 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, each page within the manual should have a page footer, similar to the given on the typical pages shown in the next few pages. Page footer shows the Issue status, amendment status, page no. etc. As and when the manual is amended, the relevant pages where amendment takes place are replaced by new pages and is cross referred in the amendment record. A typical amendment record is shown at page 13. It also gives the copy number. As and when each holder is issued a Quality Manual, a copy no. is allotted to him/ her and this is indicated in the distribution record, page 15. The signatures of the persons/ position who have prepared, approved and issued the Quality Manual are also placed in the page footer. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 12/ 59

14 TITLE PAGE The title page of the Quality Manual should normally contain the following: QUALITY MANUAL of (Name & Address of Laboratory) Issue No. : Issue Date : Copy No. : Holder s Name : Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 13/ 59

15 QUALITY MANUAL RELEASE AUTHORISATION Immediately after the title page, this page should be placed. 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, Name & Designation) Name of Laboratory: Document No.: Document Name: Quality Manual Issue No.: Issue Date: Copy No.: Section No. Page No.: Amend No.: Amend Date Prepared by: Approved by: Issued by: Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 14/ 59

16 AMENDMENT PAGE An amendment page should be inserted immediately after the title page. 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. To ensure that each copy of the Quality Manual contains a complete record of amendments, this amendment page should be updated and issued with each set of amended/ new pages of the Quality Manual. A typical amendment page should normally contain the following: AMENDMENT RECORD Sl Page No. Section/ Clause/ Para/ line (as applicable) Date of Amendment Amendment made Reasons of Amendment Signature of person authorising Amendment Name of Laboratory: Document No.: Document Name: Quality Manual Issue No.: Issue Date: Copy No.: Section No. Page No.: Amend No.: Amend Date Prepared by: Approved by: Issued by: Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 15/ 59

17 CONTENT PAGE For the ease of reference, the manual should contain a table of contents listing the major sections, sub-sections and their page numbers. A list of the Annexures should also be included. A typical table of contents should normally contain the following: CONTENTS Section Contents Page Quality Manual release authorisation 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 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.: Document Name: Quality Manual Issue No.: Issue Date: Copy No.: Section No. Page No.: Amend No.: Amend Date Prepared by: Approved by: Issued by: Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 16/ 59

18 DISTRIBUTION LIST The distribution record should list the holders of the controlled copies of Quality Manual with their allotted copy numbers. Copies of Quality Manual distributed as uncontrolled copies, should not be listed. A typical distribution list should normally contain the following: DISTRIBUTION LIST The following are the authorised holders of the controlled copy of Quality Manual. Controlled copy No. Name/ Designation of the holder of controlled copy Name of Laboratory: Document No.: Document Name: Quality Manual Issue No.: Issue Date: Copy No.: Section No. Page No.: Amend No.: Amend Date Prepared by: Approved by: Issued by: Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 17/ 59

19 4. Management Requirements 4.1 Organisation Give the name, address, type of corporate structure and whether or not an affiliate of a larger organisation and any other information required to identify the laboratory, including its legal status, such as Government, a registered society or under company s act. The date of incorporation may also be mentioned 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, the needs of its customer, the regulatory authorities or the organisations providing recognition, at all times. The names and details of the regulatory bodies and the organisations providing recognition may also be mentioned Describe the laboratory and its operations to convey a true picture of the organisation such as location, size, whether permanent/ part of permanent/ independent site/ mobile, branches, type of services offered, major fields of activity etc If the laboratory is a part of larger organisation which also performs other activities, other than testing and/ or calibration, 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, commercial, marketing or finance shall be clearly defined in order to identify the potential conflict of interest with the laboratory personnel, which might adversely effect the judgement & integrity of staff and quality of work. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 18/ 59

20 4.1.5 a A statement that the laboratory has adequate number of staff both managerial and technical, 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. 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, financial and other pressures which might influence their technical judgement. c Describe the procedure which the laboratory uses to protect the proprietary right and confidential information of the customer. Under no circumstances the results of test and/ or calibration be made known to any third party without the written consent of the customer. No reports should be send by fax without customers prior permission. 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, competence, impartiality and integrity in relation to its testing and/ or calibration. e Describe the organisation and management structure of the laboratory with the help of a chart showing Quality Management, Technical Management and other support services alongwith their linkages. The relationship with its parent organisation (if any) should be stated. 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. Provide an organisation chart to show the interrelationship of the laboratory staff. Copies of job descriptions be issued to all personnel to ensure that they are aware of both their responsibility and authority. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 19/ 59

21 g State the laboratory s arrangement for providing supervision to laboratory staff. The supervision has to be provided by persons familiar with methods and procedures, purpose of each test and/ or calibration and assessment of the test and/ or calibration results. h i 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. Include a statement that the Quality Manager (however named) is responsible for ensuring that the management system related to quality is implemented and followed, at all times. 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, commensurate with the organisation chart. j k Describe arrangements in the event of absence of key laboratory staff, including Quality Manager and Technical Manager. 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 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. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 20/ 59

22 4.2 Management System General Describe the documentation, implementation and maintenance of the management system of the laboratory. 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. A statement also to be made that the management system documentation of the laboratory is communicated to, understood by, available with and implemented by those personnel who are responsible for maintaining the quality of test and/ or calibration results. The Quality Manual of a laboratory is the basic document to describe its management system. Associated documents like operating procedures, work instructions, forms, report etc. also form a part of the management system. The management system of the laboratory need not be complex. Much will depend on the size of the laboratory and the scope of testing/ calibration requiring accreditation Quality Policy The laboratory must define its management system policies related to quality, including Quality Policy statement and objectives, 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. 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 Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 21/ 59

23 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, at all times e commitment to compliance with ISO/IEC 17025:2005 and to continually improve the effectiveness the management. 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. It may also include that the laboratory gives emphasis in producing reliable and accurate tests and/ or calibration results. When test and/ or calibration laboratory is part of a larger organisation, some quality policy elements may be in other documents Describe arrangements that top management provides evidence of commitment to the development and implementation of the management system and continually improving its effectiveness Describe arrangements that top management communicates to the organisation the importance of meeting customer as well as statutory and regulatory requirements Documentation Structure Describe the structure of documentation used in the management system. It shall include or make reference to the supporting procedures, including technical procedures, i.e., reference to supporting documents such as operating procedures etc. Pyramid structure for documentation may also be described here or referred. It shall include or make references to the supporting documents such as operating procedures, work instructions, forms, reports etc. This may also be described by a pyramid structure of management system document hierarchy. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 22/ 59

24 4.2.6 Responsibility The person(s)/ position responsible for implementing and monitoring programs and policies to achieve laboratory s quality objectives shall be identified. The role and responsibility of the Technical Management and the Quality Manager for ensuring compliance to ISO/IEC 17025:2005, should be clearly defined. Generally the responsibilities of key personnel are defined in Quality Manual and others having different responsibilities within the management system at appropriate position, in the second/ third level of documentation 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. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 23/ 59

25 4.3 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, both internally generated or from external source such as policy statements, procedures, specification, calibration tables, charts, text books, posters, notices, memoranda, software, drawings, plans, regulations, standards and other normative documents etc. and maintain a master list or equivalent document control procedure, which identifies the revision status and distribution. All documents generated by the laboratory shall be uniquely identified, which shall include document number, issue number, date of issue, amendment/ revision number, date of amendment/ revision, page numbering, total number of pages, approving authority and issuing authority Document approval and issue Procedure Describe the document approval and issue procedure. It shall atleast include the following information: a availability of authorised edition of appropriate documents at all locations b periodic review of documents c removal of obsolete documents from all locations d retention of a copy of obsolete document. Responsibility The person(s)/ position responsible for review and approval of documents shall be identified for all level of documentation. The laboratory shall ensure that all documents are reviewed and approved by authorised personnel prior to issue. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 24/ 59

26 4.3.3 Document changes Procedure The laboratory shall state the procedure to identify the altered or new text, in the amended document. Where documentation control system allows the amendments of documents by hand pending re-issue, the procedure and authority for such amendment shall be defined. Where the laboratory maintains the amendments to documents in a computerised system, procedures to describe the changes and its control shall be defined. 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. Responsibility The person(s)/ position authorised to review and approve changes/ amendments shall be identified. It should be preferably be the same person who performed the original review. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 25/ 59

27 4.4 Review of requests, tenders and contracts Policy State the laboratory s policy for the review of requests, tenders and contracts including subcontracted work. Responsibility The person(s)/ position responsible for review of request/ indent of new, repetitive/ routine, special work, tenders and contracts may be identified. Procedure Briefly outline the procedure for review of requests and tenders which shall include: a defining, documenting and understanding customer requirements before commencing work b assessment of laboratory s capability and resources c appropriate method selection d work that is subcontracted by the laboratory. The details of how the review is actually done, may be covered separately in a procedure cross referred herein. Records Make a reference to the document, where the records are maintained. The records of reviews, any significant changes, pertinent discussions with the customer etc., during the execution of contract and during the amendment to the contract shall be maintained. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 26/ 59

28 4.5 Subcontracting of tests and calibrations Policy State the laboratory s policy for subcontracting of test and/ or calibration work. The NABL policy for subcontracting by the laboratories is that the work shall be placed with an accredited laboratory. Responsibility The person(s)/ position responsible for subcontracting the works may be identified. Procedure Briefly outline the procedure for subcontracting, which should include advising customer of such arrangements in writing, seeking customers approval and accepting the responsibility for the subcontracted work. The actual process 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 subcontractors that are used and record of evidence of compliance with ISO/IEC 17025:2005 for the work in question, shall be maintained. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 27/ 59

29 4.6 Purchasing, services and supplies Policy State the laboratory s policy for purchasing, services and supplies which affect the quality of test and/ or calibration. Responsibility The person(s)/ position responsible for authorising purchases may be identified. Procedure Briefly outline the procedure for the selection and purchase of services and supplies, evaluation of suppliers of critical items, receipt and storage of reagents/ consumables, inspection & verification. Also briefly outline the procedure for review and approval of purchase documents for technical contents. The actual process may be covered in separate procedure cross referred in the Quality Manual. The description in the purchase document may include types, class, grade, precise identification, specification, drawings, inspection instructions, other technical data including approval of test results, the quality required and the management system standard under which they were made. Where assurance of quality of outside support services or supplies is unavailable, the laboratory s policy of using the items may be stated (i.e. whether they should be inspected or otherwise verified for adequate quality). Records Make a reference to the document, where the records are maintained. The records of evaluation of supplies of critical consumables & services and the list of those approved shall be maintained. The records of action taken to check the compliance of supplies/ services used with specified requirements shall also be maintained. The records like purchasing documents may also be maintained. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 28/ 59

30 4.7 Service to the customer Policy State the laboratory s policy for service to the customer. The policy may address to the following: a maintenance of good communication b to clarify their request c 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 preparation, packaging and despatch of test(s)/ calibration(s) items f advice and guidance in technical matters g opinion and interpretation based on results h to maintain confidentiality to other customers during the monitoring i delays or major deviations in the performance of test(s)/ calibration(s). Responsibility The person(s)/ position responsible for authorising the customers for these services, if required shall be identified. Procedure Briefly outline the procedure for implementation. It may also include the procedure for obtaining feedback from the customers on laboratory s quality of 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 records of the customer feedback, both positive and negative from the customers shall be maintained. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 29/ 59

31 4.8 Complaints Policy State the laboratory s policy on resolution of complaints to improve the quality of services provided. Responsibility The person(s)/ position responsible for resolution of complaints shall be identified. Procedure Briefly outline the procedure for resolution of complaints received from customers or other parties. The procedure shall have a provision of promptly auditing those aspects, which are indicated by the complainant and conveying it for management review. 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 records of all complaints written or verbal shall be maintained. The records shall also, include the complainant s name/ organisation, the investigations carried out and the corrective action taken by the laboratory, shall be maintained. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 30/ 59

32 4.9 Control of nonconforming testing and/ or calibration work Policy State the laboratory s policy on control of nonconforming work, when any work and results do not confirm to its own procedures or the agreed requirements of the customers. Responsibility The person(s)/ position responsible for management of nonconforming work and actions such as halting of work, withholding of test reports/ calibration certificates & resumption of work shall be identified. Procedure Briefly outline the procedure for control of nonconforming work, which shall include: a authority for halt of work, if necessary b an evaluation of the significance of the non-conforming work c Corrections and decision about the acceptability of nonconforming work to be taken d notification to the customer and work recall, if necessary e authorising the resumption of work f action taken to prevent future occurrence. The actual process 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 non-conformities and action taken for correcting the non-conformities shall be maintained. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 31/ 59

33 4.10 Improvements Policy State the laboratory s policy on improvement of the effectiveness of its, management system. The policy may include use of quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews. Responsibility Designate the management persons(s)/ position responsible for improvements shall be identified. Procedure Briefly outline the procedure of identification, implementation and monitoring the improvements. The actual process 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 improvements implemented shall be maintained. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 32/ 59

34 4.11 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. Responsibility The person(s)/ position responsible for planning, implementing and monitoring appropriate corrective action shall be identified. Procedure Briefly outline the procedure for implementing corrective action which shall include: a sources of information for identification of problems b cause analysis c selection and implementation of corrective actions d monitoring of corrective actions e additional audits where non-conformities/ departures cast doubt. The actual process 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 corrective actions taken shall be maintained. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 33/ 59

35 4.12 Preventive action Policy State the laboratory s policy on preventive actions for needed improvements and identification of potential sources of non-conformities, technical as well as concerning the management system. Responsibility The person(s)/ position responsible for taking preventive actions shall be identified. Procedure Briefly outline the procedure for preventive action and action plan to implement & monitor to reduce the likelihood of the occurrence of nonconformities. The procedure for preventive action shall include initiation of such actions and application of controls to ensure they are effective. The sources for identification of areas for implementing preventive action may include feedback from staff and customers, internal quality checks, management review, proficiency testing, results, customer feedback, analysis of data, trend/ risk analysis, etc. 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. Records Make a reference to the document, where the records are maintained. Records of identification of potential sources of non-conformities, investigations carried out, required improvements and preventive measures taken shall be maintained. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 34/ 59

36 4.13 Control of records Policy State the laboratory s policy to maintain and control record pertaining to quality and technical activities. Also state policy on confidentiality, protection and security of records, especially computer records. Scope List all quality and technical records maintained by the laboratory and give a unique identification record number. Responsibility State the person(s) responsible for maintaining and controlling each record. Procedure Briefly outline the procedure for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records. The quality records shall include reports of internal audit, management review, corrective action, preventive action etc. The technical records shall include original observations, derived data, calibration records, staff records, a copy of each test report or calibration certificate, personnel responsible for sampling, participation in proficiency testing etc. Briefly describe the procedure for control and time period for retention of records, especially the test and/ or calibration worksheet, raw data and test report/ calibration certificate. Briefly describe the procedure for corrections, if mistakes occur. The actual process may be covered in a separate procedure cross referred in the Quality Manual. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 35/ 59

37 4.14 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 of laboratory s management system and ISO/IEC 17025:2005. Scope State the activities of the management system including testing and/ or calibration activities, which will be audited to cover all elements of the laboratory s management system and ISO/IEC 17025:2005. Responsibility State the person/ position responsible for planning, organising internal audits and coordinating the corrective action. Normally this activity is the responsibility of the Quality Manager. Procedure Briefly outline the procedure for conduct of internal audit. The procedure shall take account of: a the frequency of conducting the internal audit at regular intervals b training and qualification criteria of personnel conducting the internal audit, that they are independent of the activity to be audited to the extent possible. The procedure shall also include the procedure for the corrective action(s) to be taken and its verification including notifying customers in writing, if the findings of internal audit cast doubt on the effectiveness of operations or on the correctness/ validity of test and/ or calibration results. The detailed process may be covered in a separate procedure cross referred in the Quality Manual. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 36/ 59

38 Records Make a reference to the document, where the records are maintained. The records of the activities covered; the audit findings including the areas audited, records verified, 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; corrective actions that arise from them, implementation, its verification and the effectiveness of the corrective action taken shall be recorded. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 37/ 59

39 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 the suitability of policies and procedures b reports from managerial and supervisory personnel c the outcome of recent internal audits d corrective and preventive actions e assessments by external bodies f the results of inter-laboratory comparisons or proficiency testing g changes in the volume and type of the work h customer feedback i complaints j recommendations for improvement k 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. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 38/ 59

40 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. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 39/ 59

41 5. Technical Requirements 5.1 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 human factors b accommodation and environmental conditions c test and calibration methods and method validation d equipment e measurement traceability f sampling g 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. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 40/ 59

42 5.2 Personnel Policy State the laboratory s policy on ensuring personnel competence and with regard to training needs, relevant to the present and anticipated tasks of the laboratory. Formulate and state goals with respect to education, training and skills of the laboratory personnel. Job Description Provide job description of the laboratory staff which shall include atleast the following: a name b qualification c training attended d management duties e expertise f responsibilities g further expertise/ training required. This data may be maintained by the personnel department and be also annexed with the procedural manual of relevant sections. 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. 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. Other staff members may only assist in performing that test under close supervision of a competent staff member. Issue No: 05 Issue Date: Amend No: 00 Amend Date: -- Page No: 41/ 59

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