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17025:2005 Implementation guide

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Pravin Mali
Pravin Mali

The document outlines the 10 step process for a laboratory to achieve ISO 17025 accreditation. The steps include: 1) awareness training, 2) developing a quality policy and objectives, 3) conducting a gap analysis, 4) designing documentation and processes, 5) implementing documentation and processes, 6) conducting internal audits, 7) management reviews, 8) a shadow audit, 9) corrective and preventive actions, and 10) the final certification audit where accreditation is awarded upon compliance with ISO 17025 requirements.

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Pravin Mali ISO 17025-2005 NABL Awareness, Implementation & Accreditation Methodology ISO 17025 Implementation Steps
Pravin Mali What is ISO 17025:2005 or NABL? What is ISO/IEC 17025? ISO/IEC 17025 was first issued in 1999 by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). It is the single most important standard for calibration and testing laboratories around the world. Laboratories that are accredited to this international standard have demonstrated that they are technically competent and able to produce precise and accurate test and/or calibration data. ISO/IEC 17025:2005 / NABL specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods
Pravin Mali What is Accreditation? Accreditation is a voluntary, third party-reviewed process. As part of accreditation, a laboratory's quality management system is thoroughly evaluated on a regular basis to ensure continued technical competence and compliance with ISO/IEC 17025. Laboratory accreditation can only be granted by an accreditation body, In India there is a government body formed for accreditation of the laboratory i.e. NABL (National Accreditation Board for Testing and Calibration Laboratories )
Pravin Mali Scope of ISO 17025 It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.
Pravin Mali Application of ISO 17025 ISO/IEC 17025:2005 / NABL is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. ISO/IEC 17025:2005 / NABL is not intended to be used as the basis for certification of laboratories.
Pravin Mali Who should go for ISO 17025 ? ISO/IEC 17025:2005 /NABL is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025:2005 / NABL, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.
Pravin Mali Requirements of ISO 17025 The standard is divided into five major sections, as follows: 1. General requirements for the competence of testing and calibration laboratories 2. Normative references 3. Terms and definitions 4. Management requirements 5. Technical requirements As is the case with other ISO standards, sections 1, 2 and 3 are for guidance only, and not auditable.
Pravin Mali 10 Step Approach to ISO 17025 Accreditation Awareness Training Quality Policy & Objectives Finalization Gap Analysis Documentation / Process Design Documentation / Process Implementation Internal Audit Management Review Meeting Shadow Audit Corrective Preventive Actions Final Certification Audit
Pravin Mali Step 1: Awareness Training Deliverables Organization wide awareness about Quality and ISO 17025. Separate training sessions for top management, middle management and junior level management. Creates a motivating environment throughout the organization for ISO 17025 implementation.
Pravin Mali Step 2:- Quality Policy & Objectives Deliverables Development of Quality Policy & Quality Objectives for the organization considering vision, mission and goal . Work shop with top management on development of quality policy. Work shop with top management and middle level functional management on development of quality objectives.
Pravin Mali Step 3:- Gap Analysis Deliverables Identification of degree of compliance of existing system with requirements of ISO 17025:2008 standard. Understanding of all the operations of the organization. Development of process map for the activities of the organization. Comparing existing operations with requirements of ISO 17025:2005 standard.
Pravin Mali Step 4:- Documentation / Process Design Deliverables Documentation of the entire process as per requirements of ISO 17025:2008 Quality Management System. Quality Manual Functional Procedures Work Instructions System Procedures Formats Workshop on design and development of documents as per ISO 17025 requirements
Pravin Mali Step 5:- Documentation / Process Implementation Deliverables Processes / Documents developed in the last module implemented across the organization covering all the departments and activities. Workshop on process / document implementation as per ISO 17025 requirements. Departmental / Individual assistance in implementing the new processes / documents.
Pravin Mali Step 6:- Internal Audit Deliverables A robust internal audit system for the organization. Internal Audit Training & Examination (Optional). Successful employees / we carry out internal audit of the organization covering all the departments and operations. Suggest corrective and preventive actions for improvements in each of the audited departments.
Pravin Mali Step 7:- Management Review Meeting Deliverables A formal system of top management reviewing various business critical aspects of the organization. Review the following: Quality Policy & Objectives Results of internal audit Results of supplier evaluation Results of customer complaints Results of customer feed-back etc. .and develop action plan
Pravin Mali Step 8:- Shadow Audit Deliverables A formal Pre Certification audit conducted to assess effectiveness of ISO implementation in the organization. A replica of final certification audit. Finds degree of compliance with ISO 17025 standard. Gives an idea to the employees about the conduct of the final certification audit.
Pravin Mali Step 9:- Corrective Preventive Actions Deliverables Organization ready for final accreditation audit. On the basis of shadow audit conducted in the last step, all the non-conformities will be assigned corrective and preventive actions. A check will ensure that all the NCs are closed and the organization is ready for the final certification audit.
Pravin Mali Step 10:- Final Certification Audit Deliverables: Organization awarded ISO 17025:2005 accreditation . Upon completion of various stages of accreditation audit, the audit, your organization will be awarded ISO 17025:2005 accreditation.
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17025:2005 Implementation guide

  • 1. Pravin Mali ISO 17025-2005 NABL Awareness, Implementation & Accreditation Methodology ISO 17025 Implementation Steps
  • 2. Pravin Mali What is ISO 17025:2005 or NABL? What is ISO/IEC 17025? ISO/IEC 17025 was first issued in 1999 by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). It is the single most important standard for calibration and testing laboratories around the world. Laboratories that are accredited to this international standard have demonstrated that they are technically competent and able to produce precise and accurate test and/or calibration data. ISO/IEC 17025:2005 / NABL specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods
  • 3. Pravin Mali What is Accreditation? Accreditation is a voluntary, third party-reviewed process. As part of accreditation, a laboratory's quality management system is thoroughly evaluated on a regular basis to ensure continued technical competence and compliance with ISO/IEC 17025. Laboratory accreditation can only be granted by an accreditation body, In India there is a government body formed for accreditation of the laboratory i.e. NABL (National Accreditation Board for Testing and Calibration Laboratories )
  • 4. Pravin Mali Scope of ISO 17025 It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.
  • 5. Pravin Mali Application of ISO 17025 ISO/IEC 17025:2005 / NABL is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. ISO/IEC 17025:2005 / NABL is not intended to be used as the basis for certification of laboratories.
  • 6. Pravin Mali Who should go for ISO 17025 ? ISO/IEC 17025:2005 /NABL is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025:2005 / NABL, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.
  • 7. Pravin Mali Requirements of ISO 17025 The standard is divided into five major sections, as follows: 1. General requirements for the competence of testing and calibration laboratories 2. Normative references 3. Terms and definitions 4. Management requirements 5. Technical requirements As is the case with other ISO standards, sections 1, 2 and 3 are for guidance only, and not auditable.
  • 8. Pravin Mali 10 Step Approach to ISO 17025 Accreditation Awareness Training Quality Policy & Objectives Finalization Gap Analysis Documentation / Process Design Documentation / Process Implementation Internal Audit Management Review Meeting Shadow Audit Corrective Preventive Actions Final Certification Audit
  • 9. Pravin Mali Step 1: Awareness Training Deliverables Organization wide awareness about Quality and ISO 17025. Separate training sessions for top management, middle management and junior level management. Creates a motivating environment throughout the organization for ISO 17025 implementation.
  • 10. Pravin Mali Step 2:- Quality Policy & Objectives Deliverables Development of Quality Policy & Quality Objectives for the organization considering vision, mission and goal . Work shop with top management on development of quality policy. Work shop with top management and middle level functional management on development of quality objectives.
  • 11. Pravin Mali Step 3:- Gap Analysis Deliverables Identification of degree of compliance of existing system with requirements of ISO 17025:2008 standard. Understanding of all the operations of the organization. Development of process map for the activities of the organization. Comparing existing operations with requirements of ISO 17025:2005 standard.
  • 12. Pravin Mali Step 4:- Documentation / Process Design Deliverables Documentation of the entire process as per requirements of ISO 17025:2008 Quality Management System. Quality Manual Functional Procedures Work Instructions System Procedures Formats Workshop on design and development of documents as per ISO 17025 requirements
  • 13. Pravin Mali Step 5:- Documentation / Process Implementation Deliverables Processes / Documents developed in the last module implemented across the organization covering all the departments and activities. Workshop on process / document implementation as per ISO 17025 requirements. Departmental / Individual assistance in implementing the new processes / documents.
  • 14. Pravin Mali Step 6:- Internal Audit Deliverables A robust internal audit system for the organization. Internal Audit Training & Examination (Optional). Successful employees / we carry out internal audit of the organization covering all the departments and operations. Suggest corrective and preventive actions for improvements in each of the audited departments.
  • 15. Pravin Mali Step 7:- Management Review Meeting Deliverables A formal system of top management reviewing various business critical aspects of the organization. Review the following: Quality Policy & Objectives Results of internal audit Results of supplier evaluation Results of customer complaints Results of customer feed-back etc. .and develop action plan
  • 16. Pravin Mali Step 8:- Shadow Audit Deliverables A formal Pre Certification audit conducted to assess effectiveness of ISO implementation in the organization. A replica of final certification audit. Finds degree of compliance with ISO 17025 standard. Gives an idea to the employees about the conduct of the final certification audit.
  • 17. Pravin Mali Step 9:- Corrective Preventive Actions Deliverables Organization ready for final accreditation audit. On the basis of shadow audit conducted in the last step, all the non-conformities will be assigned corrective and preventive actions. A check will ensure that all the NCs are closed and the organization is ready for the final certification audit.
  • 18. Pravin Mali Step 10:- Final Certification Audit Deliverables: Organization awarded ISO 17025:2005 accreditation . Upon completion of various stages of accreditation audit, the audit, your organization will be awarded ISO 17025:2005 accreditation.
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