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The document summarizes the key changes and structure of ISO/IEC 17025:2017 compared to the 2005 version. Major changes include an expanded scope to include sampling and a process-based approach. It adopts a new high level structure with common clauses across standards. Key requirements include impartiality, confidentiality, personnel competence, facilities, equipment calibration, metrological traceability, and management of externally provided products and services. The standard aims to ensure laboratories consistently operate at a high level of technical competence and quality.
1) GLP embodies a set of principles that provides a frame work within which laboratory studies are planned performed, monitored, and archived and reported.
2) WHY WAS GLP CREATED? • In the early 70’s FDA became aware of cases of poor laboratory practice all over the United States. • They discovered a lot fraudulent activities and a lot of poor lab practices. • Examples of some of these poor lab practices found were 1. Equipment not been calibrated to standard form , therefore giving wrong measurements. 2. Incorrect/inaccurate accounts of the actual lab study. 3. Inadequate test systems.
3) Purpose of GLPs: • GLP is to certify that every step of the analysis is valid or Not. • Assure the quality & integrity of data submitted to FDA in support of the safety of regulated products. • GLPs have heavy emphasis on data recording, record & specimen retention.
4)GOOD LABORATORY PRACTICES PRINCIPLES. 1. Test Facility Organisation and Personnel. 2. Quality Assurance Programme(QAP). 3. Facilities. 4. Apparatus, Material and Reagents. 5. Test systems. 6. Test and Reference Substances. 7. Standard Operating Procedures(SOP). 8. Performance of The Study. 9. Reporting of Study Results. 10. Storage and Retention of Records and materials.
5) GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.
6) "Good Laboratory Practice", or GLP for short, refers to a quality assurance system that is applied during the pre-clinical stage of research and development. Its aim is to test active ingredients under specific environmental conditions and over a defined period of time.
This document is an ISO/IEC 17025:2017 audit checklist for laboratories. It contains requirements for laboratories to meet the standard in areas such as impartiality, confidentiality, organizational structure, personnel, facilities, equipment, metrological traceability, and externally provided products and services. The checklist provides the requirement, reference, status of implementation, and a comment section for each clause to help laboratories evaluate their conformance to the standard.
The document discusses the requirements of ISO/IEC 17025 for testing and calibration laboratories. Some key points:
1) It covers the competency requirements for laboratories to perform both testing/analysis and instrument calibration using standards, non-standards, and laboratory-developed methods.
2) Laboratories must have qualified personnel, validated methods, traceable standards, documented quality management systems, and procedures for audits, management reviews, corrective actions and control of records.
3) The standard addresses technical and administrative operations including method development, subcontracting, purchasing, customer complaints, nonconforming work, and management commitment to meet requirements.
The document is an audit checklist for assessing the adequacy of a laboratory based on ISO/IEC 17025 requirements. It lists the clause requirements from the standard and columns for the laboratory to specify comparable documents and implementation information. The checklist covers general requirements, structural requirements, resource requirements, process requirements and management system requirements. It contains over 20 pages of requirements to evaluate all aspects of the laboratory's management system and technical operations.
Key factors and main change over in iso 17025 2017Dr.Lenin raja
1. The document discusses changes to ISO 17025:2017 regarding general requirements for testing and calibration laboratories. It outlines key changes to requirements regarding impartiality, confidentiality, organizational structure, personnel competence, equipment, metrological traceability, externally provided products/services, and method selection/validation.
2. New standards specify that laboratories must be committed to impartiality and minimize risks to impartiality. Personnel must keep information confidential, unless legally required. Laboratories must define their organizational structure and personnel responsibilities.
3. Equipment must be suitable for intended measurements and calibrated when it impacts validity or traceability of results. Laboratories must establish traceability of measurements to SI units through an unbroken chain of calibrations.
This document provides information on auditing and inspections. It defines key terms like audit, auditor, and auditee. Consistent auditing standards can provide benefits like effective GMP compliance assessments, reduced costs, and improved performance. Audits can be internal or external. The audit process involves planning, structuring, performing, reporting, and following up on findings. Inspections focus on current conditions, while audits review records to ensure all requirements were met. Qualified auditors with training and experience are important. Proper planning and cooperation are needed to avoid issues.
Presentation on ISO-IEC 17025-2017.pptxMimmaafrin1
This document provides an overview of the key requirements of ISO/IEC 17025:2017 for testing and calibration laboratories. It discusses the standard's focus on impartiality, competence, consistent operations, and risk-based approaches. Some of the main changes from the previous version include an increased emphasis on performance-based requirements and flexibility. The standard specifies requirements for laboratory management systems, personnel, facilities, equipment, sampling, test and calibration methods, handling of test items, quality control, reporting, and customer complaints in order to ensure the reliability of test and calibration results.
The document summarizes the key changes and structure of ISO/IEC 17025:2017 compared to the 2005 version. Major changes include an expanded scope to include sampling and a process-based approach. It adopts a new high level structure with common clauses across standards. Key requirements include impartiality, confidentiality, personnel competence, facilities, equipment calibration, metrological traceability, and management of externally provided products and services. The standard aims to ensure laboratories consistently operate at a high level of technical competence and quality.
1) GLP embodies a set of principles that provides a frame work within which laboratory studies are planned performed, monitored, and archived and reported.
2) WHY WAS GLP CREATED? • In the early 70’s FDA became aware of cases of poor laboratory practice all over the United States. • They discovered a lot fraudulent activities and a lot of poor lab practices. • Examples of some of these poor lab practices found were 1. Equipment not been calibrated to standard form , therefore giving wrong measurements. 2. Incorrect/inaccurate accounts of the actual lab study. 3. Inadequate test systems.
3) Purpose of GLPs: • GLP is to certify that every step of the analysis is valid or Not. • Assure the quality & integrity of data submitted to FDA in support of the safety of regulated products. • GLPs have heavy emphasis on data recording, record & specimen retention.
4)GOOD LABORATORY PRACTICES PRINCIPLES. 1. Test Facility Organisation and Personnel. 2. Quality Assurance Programme(QAP). 3. Facilities. 4. Apparatus, Material and Reagents. 5. Test systems. 6. Test and Reference Substances. 7. Standard Operating Procedures(SOP). 8. Performance of The Study. 9. Reporting of Study Results. 10. Storage and Retention of Records and materials.
5) GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.
6) "Good Laboratory Practice", or GLP for short, refers to a quality assurance system that is applied during the pre-clinical stage of research and development. Its aim is to test active ingredients under specific environmental conditions and over a defined period of time.
This document is an ISO/IEC 17025:2017 audit checklist for laboratories. It contains requirements for laboratories to meet the standard in areas such as impartiality, confidentiality, organizational structure, personnel, facilities, equipment, metrological traceability, and externally provided products and services. The checklist provides the requirement, reference, status of implementation, and a comment section for each clause to help laboratories evaluate their conformance to the standard.
The document discusses the requirements of ISO/IEC 17025 for testing and calibration laboratories. Some key points:
1) It covers the competency requirements for laboratories to perform both testing/analysis and instrument calibration using standards, non-standards, and laboratory-developed methods.
2) Laboratories must have qualified personnel, validated methods, traceable standards, documented quality management systems, and procedures for audits, management reviews, corrective actions and control of records.
3) The standard addresses technical and administrative operations including method development, subcontracting, purchasing, customer complaints, nonconforming work, and management commitment to meet requirements.
The document is an audit checklist for assessing the adequacy of a laboratory based on ISO/IEC 17025 requirements. It lists the clause requirements from the standard and columns for the laboratory to specify comparable documents and implementation information. The checklist covers general requirements, structural requirements, resource requirements, process requirements and management system requirements. It contains over 20 pages of requirements to evaluate all aspects of the laboratory's management system and technical operations.
Key factors and main change over in iso 17025 2017Dr.Lenin raja
1. The document discusses changes to ISO 17025:2017 regarding general requirements for testing and calibration laboratories. It outlines key changes to requirements regarding impartiality, confidentiality, organizational structure, personnel competence, equipment, metrological traceability, externally provided products/services, and method selection/validation.
2. New standards specify that laboratories must be committed to impartiality and minimize risks to impartiality. Personnel must keep information confidential, unless legally required. Laboratories must define their organizational structure and personnel responsibilities.
3. Equipment must be suitable for intended measurements and calibrated when it impacts validity or traceability of results. Laboratories must establish traceability of measurements to SI units through an unbroken chain of calibrations.
This document provides information on auditing and inspections. It defines key terms like audit, auditor, and auditee. Consistent auditing standards can provide benefits like effective GMP compliance assessments, reduced costs, and improved performance. Audits can be internal or external. The audit process involves planning, structuring, performing, reporting, and following up on findings. Inspections focus on current conditions, while audits review records to ensure all requirements were met. Qualified auditors with training and experience are important. Proper planning and cooperation are needed to avoid issues.
Presentation on ISO-IEC 17025-2017.pptxMimmaafrin1
This document provides an overview of the key requirements of ISO/IEC 17025:2017 for testing and calibration laboratories. It discusses the standard's focus on impartiality, competence, consistent operations, and risk-based approaches. Some of the main changes from the previous version include an increased emphasis on performance-based requirements and flexibility. The standard specifies requirements for laboratory management systems, personnel, facilities, equipment, sampling, test and calibration methods, handling of test items, quality control, reporting, and customer complaints in order to ensure the reliability of test and calibration results.
The National accreditation Board for Testing and Calibration laboratories (NABL) is an independent organization operating under the supervision of the Department of Science and Technology, Government of India. Its primary objective is to provide certification to clinical labs in India for their testing and calibration activities.
This document discusses types of inspections, quality system approaches to GMP inspections, and the key elements of a quality system for pharmaceutical manufacturing. It covers internal and external inspections, pre-approval inspections, system-based inspections focusing on quality systems, facilities, equipment, utilities, materials, production, laboratory controls, packaging and labeling. Common regulatory observations and how to minimize risks of non-compliance are also summarized.
This document discusses the key requirements of ISO/IEC 17025 for testing and calibration laboratories. It covers management requirements, technical requirements, quality management systems, personnel requirements, accommodation and environmental conditions, test and calibration methods, equipment, measurement traceability, sampling, handling of test and calibration items, quality control, reporting of results, subcontracting, and opinions and interpretations. The main points are that ISO/IEC 17025 establishes the requirements for laboratories to demonstrate they are technically competent and able to produce valid results, laboratories must implement a quality management system, and personnel performing testing and calibrations must be qualified.
Here are the key responsibilities of the roles you asked about:
Quality Manager:
- Oversee implementation and maintenance of quality management system
- Lead internal audits and monitor corrective/preventive actions
- Ensure staff are trained and competent
- Compile and analyze quality indicators and trends
- Advise management on quality improvements
Quality Director:
- Establish quality policy and objectives with management
- Allocate resources needed for quality management
- Review quality system, audit reports and indicators at management reviews
- Ensure continual improvement of quality management system
Quality Officer:
- Assist quality manager in implementing quality systems
- Conduct internal audits and record non-conformities and actions
- Monitor day
This document discusses quality auditing in the pharmaceutical industry. It defines quality auditing and explains that it involves systematically examining quality systems to determine compliance. The document outlines different types of audits including internal, external, regulatory, product, process, and system audits. It discusses planning, conducting, and reporting on audits. The key objectives of audits are to ensure quality, assess effectiveness of quality assurance systems, and permit timely correction of any issues. Audits help build confidence in quality management practices and identify areas for improvement.
This document contains information about internal auditing basics, including the audit process, terminology, types of audits, and accepting an audit assignment. It discusses the key steps of an audit as plan, perform, report, and follow-up. It defines important terms like auditor, auditee, client, and internal vs external audits. It categorizes audits as product, process, and system audits. Finally, it outlines the questions an auditor should ask when accepting an assignment: availability, conflict of interest, and competence. The overall document provides foundational information and concepts to understand internal auditing.
This document contains questions and answers about auditing processes and quality systems. It discusses the different types of audits, defines audit evidence and lists factors that affect audit evidence reliability. It explains the audit process steps and defines nonconformities, classifying them into critical, major and minor types with examples. It also lists the elements of a quality system, discussing management responsibilities. Other questions cover cGMP regulations regarding premises, personnel, equipment and raw materials, packaging and labeling controls. Quality system elements like manufacturing operations and evaluation activities are also explained.
This document provides an overview of quality management tools and concepts. It discusses six common quality management tools: check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. It also discusses key quality management concepts like quality management, quality assurance, quality control, and good laboratory practice (GLP). The document is intended to help improve quality performance in a laboratory setting.
Introduction types, Objectives, Management of audit, Responsibilities, Planni...Kunal10679
Audit and regulatory Compliance M.pharmacy Quality Assurance department Sem. 2 Introduction types, Objectives, Management of audit, Responsibilities, Planning Process, Information Gathering, Classifications of Deficiencies of auditing
Good laboratory practices in a pharmaceutical lab 1Sabahat Ali
This document discusses good laboratory practices in a pharmaceutical lab. It outlines the members of a group project on this topic and provides an introduction to pharmaceutical lab testing. It then covers topics like GMP, GLP, quality control, quality assurance, reducing human errors, and the scope of QA and QC in a pharmaceutical lab. Key points include that pharmaceutical labs test raw materials, finished products, and conduct validation, stability, and analytical method development testing. GMP and GLP aim to minimize risks and ensure consistent quality production. QA and QC work to guarantee drug quality and safety at all stages from development to sales.
Accreditation of laboratories is a process through which an authorized body examines and certifies the competence and quality systems of a laboratory based on predefined standards. NABL is India's national accreditation body that specifies the requirements for testing and calibration laboratories to be considered technically competent. The accreditation process involves identifying standards, assessment procedures, training, documentation, internal audits, management reviews, and a final certification audit. Laboratories must prepare for accreditation by training personnel, documenting procedures, implementing quality control, participating in proficiency testing, and addressing any gaps before applying to NABL for assessment.
This webinar focuses on the importance of internal audits for quality control laboratories to ensure ongoing compliance with FDA regulations. Attendees will learn how to plan and execute effective laboratory audits, including developing an audit plan, assessing standards, executing the audit, writing a report, and conducting follow-up. The webinar is intended for quality managers, laboratory managers, internal auditors, and quality control scientists seeking to understand internal auditing best practices for assuring continual regulatory compliance.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, including that GLP was created by the FDA in the 1970s in response to cases of fraudulent laboratory practices. The key objectives of GLP are to ensure study data is accurate, traceable, and promotes international acceptance of tests. GLP establishes requirements for facilities, equipment, personnel, methods, records, and quality assurance programs. Laboratories must adhere to GLP in order to produce reliable results for regulatory submissions.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, explaining that GLP was created by the FDA in the 1970s after investigations found fraudulent activities and poor practices in toxicology labs. The objectives of GLP are to ensure data submitted are an accurate reflection of study results and that data is traceable. GLP provides a framework for planning, conducting, monitoring, recording and reporting laboratory studies while maintaining quality assurance.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, including that GLP was created by the FDA in the 1970s in response to cases of fraudulent laboratory practices. The key objectives of GLP are to ensure laboratory study data is accurate, traceable, and can be relied upon for regulatory decision making. GLP establishes requirements for facilities, equipment, personnel, methods, records, and management to ensure the integrity of all safety data generated during nonclinical health and environmental safety studies.
1. NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. It provides accreditation to technical testing, calibration, medical laboratories, and proficiency testing providers in India.
2. Accreditation through NABL has several benefits, including increased confidence in lab reports, better quality control, and potential business growth. It also allows easier access to both domestic and international markets for users of accredited labs.
3. The NABL accreditation process involves an application, scrutiny of documents, pre-assessment, assessment, and review before accreditation is granted. Laboratories must meet the technical requirements of ISO/IEC 17025 or ISO 15189 and undergo regular audits
OHSAS 18001 is an international occupational health and safety management system standard. It requires organizations to implement a management system to identify hazards and assess risks, put controls in place to mitigate risks, and continually improve occupational health and safety performance. The standard outlines requirements for policy, planning, implementation and operation, performance evaluation, and management review to drive continual improvement. Organizations can seek third-party certification to the standard to verify conformance with its requirements.
The National accreditation Board for Testing and Calibration laboratories (NABL) is an independent organization operating under the supervision of the Department of Science and Technology, Government of India. Its primary objective is to provide certification to clinical labs in India for their testing and calibration activities.
This document discusses types of inspections, quality system approaches to GMP inspections, and the key elements of a quality system for pharmaceutical manufacturing. It covers internal and external inspections, pre-approval inspections, system-based inspections focusing on quality systems, facilities, equipment, utilities, materials, production, laboratory controls, packaging and labeling. Common regulatory observations and how to minimize risks of non-compliance are also summarized.
This document discusses the key requirements of ISO/IEC 17025 for testing and calibration laboratories. It covers management requirements, technical requirements, quality management systems, personnel requirements, accommodation and environmental conditions, test and calibration methods, equipment, measurement traceability, sampling, handling of test and calibration items, quality control, reporting of results, subcontracting, and opinions and interpretations. The main points are that ISO/IEC 17025 establishes the requirements for laboratories to demonstrate they are technically competent and able to produce valid results, laboratories must implement a quality management system, and personnel performing testing and calibrations must be qualified.
Here are the key responsibilities of the roles you asked about:
Quality Manager:
- Oversee implementation and maintenance of quality management system
- Lead internal audits and monitor corrective/preventive actions
- Ensure staff are trained and competent
- Compile and analyze quality indicators and trends
- Advise management on quality improvements
Quality Director:
- Establish quality policy and objectives with management
- Allocate resources needed for quality management
- Review quality system, audit reports and indicators at management reviews
- Ensure continual improvement of quality management system
Quality Officer:
- Assist quality manager in implementing quality systems
- Conduct internal audits and record non-conformities and actions
- Monitor day
This document discusses quality auditing in the pharmaceutical industry. It defines quality auditing and explains that it involves systematically examining quality systems to determine compliance. The document outlines different types of audits including internal, external, regulatory, product, process, and system audits. It discusses planning, conducting, and reporting on audits. The key objectives of audits are to ensure quality, assess effectiveness of quality assurance systems, and permit timely correction of any issues. Audits help build confidence in quality management practices and identify areas for improvement.
This document contains information about internal auditing basics, including the audit process, terminology, types of audits, and accepting an audit assignment. It discusses the key steps of an audit as plan, perform, report, and follow-up. It defines important terms like auditor, auditee, client, and internal vs external audits. It categorizes audits as product, process, and system audits. Finally, it outlines the questions an auditor should ask when accepting an assignment: availability, conflict of interest, and competence. The overall document provides foundational information and concepts to understand internal auditing.
This document contains questions and answers about auditing processes and quality systems. It discusses the different types of audits, defines audit evidence and lists factors that affect audit evidence reliability. It explains the audit process steps and defines nonconformities, classifying them into critical, major and minor types with examples. It also lists the elements of a quality system, discussing management responsibilities. Other questions cover cGMP regulations regarding premises, personnel, equipment and raw materials, packaging and labeling controls. Quality system elements like manufacturing operations and evaluation activities are also explained.
This document provides an overview of quality management tools and concepts. It discusses six common quality management tools: check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. It also discusses key quality management concepts like quality management, quality assurance, quality control, and good laboratory practice (GLP). The document is intended to help improve quality performance in a laboratory setting.
Introduction types, Objectives, Management of audit, Responsibilities, Planni...Kunal10679
Audit and regulatory Compliance M.pharmacy Quality Assurance department Sem. 2 Introduction types, Objectives, Management of audit, Responsibilities, Planning Process, Information Gathering, Classifications of Deficiencies of auditing
Good laboratory practices in a pharmaceutical lab 1Sabahat Ali
This document discusses good laboratory practices in a pharmaceutical lab. It outlines the members of a group project on this topic and provides an introduction to pharmaceutical lab testing. It then covers topics like GMP, GLP, quality control, quality assurance, reducing human errors, and the scope of QA and QC in a pharmaceutical lab. Key points include that pharmaceutical labs test raw materials, finished products, and conduct validation, stability, and analytical method development testing. GMP and GLP aim to minimize risks and ensure consistent quality production. QA and QC work to guarantee drug quality and safety at all stages from development to sales.
Accreditation of laboratories is a process through which an authorized body examines and certifies the competence and quality systems of a laboratory based on predefined standards. NABL is India's national accreditation body that specifies the requirements for testing and calibration laboratories to be considered technically competent. The accreditation process involves identifying standards, assessment procedures, training, documentation, internal audits, management reviews, and a final certification audit. Laboratories must prepare for accreditation by training personnel, documenting procedures, implementing quality control, participating in proficiency testing, and addressing any gaps before applying to NABL for assessment.
This webinar focuses on the importance of internal audits for quality control laboratories to ensure ongoing compliance with FDA regulations. Attendees will learn how to plan and execute effective laboratory audits, including developing an audit plan, assessing standards, executing the audit, writing a report, and conducting follow-up. The webinar is intended for quality managers, laboratory managers, internal auditors, and quality control scientists seeking to understand internal auditing best practices for assuring continual regulatory compliance.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, including that GLP was created by the FDA in the 1970s in response to cases of fraudulent laboratory practices. The key objectives of GLP are to ensure study data is accurate, traceable, and promotes international acceptance of tests. GLP establishes requirements for facilities, equipment, personnel, methods, records, and quality assurance programs. Laboratories must adhere to GLP in order to produce reliable results for regulatory submissions.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, explaining that GLP was created by the FDA in the 1970s after investigations found fraudulent activities and poor practices in toxicology labs. The objectives of GLP are to ensure data submitted are an accurate reflection of study results and that data is traceable. GLP provides a framework for planning, conducting, monitoring, recording and reporting laboratory studies while maintaining quality assurance.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, including that GLP was created by the FDA in the 1970s in response to cases of fraudulent laboratory practices. The key objectives of GLP are to ensure laboratory study data is accurate, traceable, and can be relied upon for regulatory decision making. GLP establishes requirements for facilities, equipment, personnel, methods, records, and management to ensure the integrity of all safety data generated during nonclinical health and environmental safety studies.
1. NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. It provides accreditation to technical testing, calibration, medical laboratories, and proficiency testing providers in India.
2. Accreditation through NABL has several benefits, including increased confidence in lab reports, better quality control, and potential business growth. It also allows easier access to both domestic and international markets for users of accredited labs.
3. The NABL accreditation process involves an application, scrutiny of documents, pre-assessment, assessment, and review before accreditation is granted. Laboratories must meet the technical requirements of ISO/IEC 17025 or ISO 15189 and undergo regular audits
OHSAS 18001 is an international occupational health and safety management system standard. It requires organizations to implement a management system to identify hazards and assess risks, put controls in place to mitigate risks, and continually improve occupational health and safety performance. The standard outlines requirements for policy, planning, implementation and operation, performance evaluation, and management review to drive continual improvement. Organizations can seek third-party certification to the standard to verify conformance with its requirements.
Similar to Impartiality as per ISO /IEC 17025:2017 Standard (20)
This study Examines the Effectiveness of Talent Procurement through the Imple...DharmaBanothu
In the world with high technology and fast
forward mindset recruiters are walking/showing interest
towards E-Recruitment. Present most of the HRs of
many companies are choosing E-Recruitment as the best
choice for recruitment. E-Recruitment is being done
through many online platforms like Linkedin, Naukri,
Instagram , Facebook etc. Now with high technology E-
Recruitment has gone through next level by using
Artificial Intelligence too.
Key Words : Talent Management, Talent Acquisition , E-
Recruitment , Artificial Intelligence Introduction
Effectiveness of Talent Acquisition through E-
Recruitment in this topic we will discuss about 4important
and interlinked topics which are
Sri Guru Hargobind Ji - Bandi Chor Guru.pdfBalvir Singh
Sri Guru Hargobind Ji (19 June 1595 - 3 March 1644) is revered as the Sixth Nanak.
• On 25 May 1606 Guru Arjan nominated his son Sri Hargobind Ji as his successor. Shortly
afterwards, Guru Arjan was arrested, tortured and killed by order of the Mogul Emperor
Jahangir.
• Guru Hargobind's succession ceremony took place on 24 June 1606. He was barely
eleven years old when he became 6th Guru.
• As ordered by Guru Arjan Dev Ji, he put on two swords, one indicated his spiritual
authority (PIRI) and the other, his temporal authority (MIRI). He thus for the first time
initiated military tradition in the Sikh faith to resist religious persecution, protect
people’s freedom and independence to practice religion by choice. He transformed
Sikhs to be Saints and Soldier.
• He had a long tenure as Guru, lasting 37 years, 9 months and 3 days
Better Builder Magazine brings together premium product manufactures and leading builders to create better differentiated homes and buildings that use less energy, save water and reduce our impact on the environment. The magazine is published four times a year.
An In-Depth Exploration of Natural Language Processing: Evolution, Applicatio...DharmaBanothu
Natural language processing (NLP) has
recently garnered significant interest for the
computational representation and analysis of human
language. Its applications span multiple domains such
as machine translation, email spam detection,
information extraction, summarization, healthcare,
and question answering. This paper first delineates
four phases by examining various levels of NLP and
components of Natural Language Generation,
followed by a review of the history and progression of
NLP. Subsequently, we delve into the current state of
the art by presenting diverse NLP applications,
contemporary trends, and challenges. Finally, we
discuss some available datasets, models, and
evaluation metrics in NLP.
Sachpazis_Consolidation Settlement Calculation Program-The Python Code and th...Dr.Costas Sachpazis
Consolidation Settlement Calculation Program-The Python Code
By Professor Dr. Costas Sachpazis, Civil Engineer & Geologist
This program calculates the consolidation settlement for a foundation based on soil layer properties and foundation data. It allows users to input multiple soil layers and foundation characteristics to determine the total settlement.
2. This webinar is being recorded and will be available in it’s entirely
on the Perry Johnson Laboratory Accreditation Website.
www.pjlabs.com
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Duration of webinar is set for one hour.
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3. ISO/IEC 17025:2017 defines partiality
Impartiality - presence of objectivity
Note 1 to entry: Objectivity means that conflicts of interest do not
exist, or are resolved so as not to adversely influence subsequent
activities of the laboratory .
Note 2 to entry: Other terms that are useful in conveying the
element of impartiality include “freedom from conflict of
interests”, “freedom from bias”, “lack of prejudice”, “neutrality”,
“fairness”, “open-mindedness”, “even-handedness”,
“detachment”, “balance”
4. In earlier versions of ISO/IEC 17025 the issue of a laboratory´s
impartiality has not been a big issue. In ISO 17025:2005 ,
impartiality is only mentioned in notes and conflict of interest is
only mentioned once. However, ISO/IEC 17025:2017 there is a
new section 4.1 dealing with impartiality . It is therefore now
more important for laboratories to show how they have handled
the issue about impartiality.
5. Wikipedia defines as;
Impartiality is a principle of justice holding that decisions should
be based on objective criteria, rather than on the basis of bias,
prejudice, or preferring the benefit to one person over another for
improper reasons
6. ISO/IEC 17025:2017 requirements Sec 4.1 “Impartiality”
4.1.1 Laboratory activities shall be undertaken impartially and
structured and managed so as to safeguard impartiality.
• It is therefore now more important for laboratories to show
how they have handled the issue about impartiality
• The laboratory shall be responsible for the impartiality of its
laboratory activities
• Laboratories activities extend beyond the testing or calibration
activities. It also incorporates activities such as internal
auditing, procurement, or maintenance;
7. Shall be Structured and Managed as to Safeguard Impartiality
Laboratory operations should not be influenced by other areas of an organization that
may have a different agenda which may risk the integrity of the results produced by the
laboratory.
There should be a clear separation of the responsibilities of the laboratory personnel
from those of the personnel employed in the other functions. This should be
established by organizational identification and the reporting methods of the laboratory
operations within the parent organization.
The personnel involved in laboratory activities shall not engage in any activities that
may conflict with their independence of judgment and integrity in relation to their
laboratory duties In particular, they should not be engaged in the design, manufacture,
supply, installation, use or ownership of the items tested or calibrated.
8. Common Ownership
Risk may have to be reduced by the following:
• Producing a barrier showing how ownership has no influence on
results.
• Common ownership appointees on the boards or equivalent of the
organizations, except where these have functions that have no
influence on the outcome of laboratory results. This may be an
appointee to the board who will overview how the company is
managed but will not be involved in any decision-making regarding
laboratory operations.
• Directly reporting where this cannot influence the outcome of
laboratory results
9. 4.1.2 The laboratory management shall be committed to impartiality.
This may be demonstrated by:
• Have a special impartiality policy or involve a statement about
impartiality in the quality policy;
• Discuss impartiality on the management review and to include the
discussions and decisions in the minutes of meeting;
• Documented training and agreement of staff, including the top
management, on potential threats to impartiality;
10. 4.1.3 The laboratory shall be responsible for the impartiality of its
laboratory activities and shall not allow commercial, financial or
other pressures to compromise impartiality.
• Puts the responsibility on the laboratory;
• Safeguards should be put in place;
Safeguards may include prohibitions, restrictions, disclosures,
policies, procedures, practices, standards, rules, institutional
arrangements, and environmental conditions
11. 4.1.4 The laboratory shall identify risks to its impartiality on an
on-going basis. This shall include those risks that arise from its
activities, or from its relationships, or from the relationships of its
personnel. However, such relationships do not necessarily present
a laboratory with a risk to impartiality.
NOTE A relationship that threatens the impartiality of the
laboratory can be based on ownership, governance, management,
personnel, shared resources, finances, contracts, marketing
(including branding), and payment of a sales commission or other
inducement for the referral of new customers, etc
12. Identifying risks to impartiality
• The laboratory shall make a risk analyses.
• Should be incorporated in contract reviews (to identify if there
is risk connected to the customer or the activity)
• Management reviews, internal audits and performance review
can provide inputs to identify any potential risk to personnel.
• Since this shall be an ongoing activity it is important to
identify changes in the laboratories activities that may become
a risk. Even if there are no changes in the laboratories activities
the impartiality risk analyses should at least be reviewed during
the management review.
13. Create Awareness
Threats and inducements aimed at laboratory operations may
represent serious risks to impartiality. Threats and inducements
may originate from inside or outside the organization and may
happen at any time. All personnel having an influence on
laboratory results should be aware of the responsibility to act
impartially, be involved accordingly in the laboratory’s
impartiality measures and have appropriate access to provide
records as issues arise. The accredited laboratories analysis of
risks to impartiality should include details of the responses to
such risks
14. 4.1.5 If a risk to impartiality is identified, the laboratory shall be able to
demonstrate how it eliminates or minimizes such risk.
• Can eliminate or reduce to an acceptable level (risk mitigation);
• The laboratory should be able to show how it has handled the issue of
impartiality so these activities should be documented;
Examples may include:
• Change the personnel if the initial personnel are compromised
• Letting other parts of the laboratory perform the test if the initial part
is compromised
• Employment contract update
15. • Quarantine time ; For example In the instance that staff has received
additional payment for the recruitment of a new client, then they are
not permitted to be involved in testing or calibration within one year
of this additional payment for this client.
• Additional requirement specific to risk 8.5 “Actions to address risks
and opportunities;
RISK REVIEW EVALUATION AND DETAILS OF ANY NECESSARY MITIGATION
Does some impartiality risk exist? Yes No
If "No" then no further action required.
If "Yes" (some impartiality risk exists):
Can all the impartiality risks be mitigated? Yes No
If "no" - services cannot be offered until all impartiality risks are mitigated
If "yes" complete details of how the risks will be mitigated.
16. Impartiality also appears:
6.2 Personnel
6.2.1 All personnel of the laboratory, either internal or external,
that could influence the laboratory activities shall act impartially,
be competent and work in accordance with the laboratory's
management system.
8.2 Management system documentation
8.2.2 The policies and objectives shall address the competence,
impartiality and consistent operation of the laboratory.
17. Confidentiality can be though of as the state of keeping or being
kept secret or private;
18. General practices should include
• Store confidential information in locked file cabinets.
• Encrypt all confidential electronic information with firewalls
and passwords.
• Employees should keep their desks clear of any confidential
information.
• Employees should keep their computer monitors clear of any
confidential information
• Shed records or documents
• Employee Training
19. ISO/IEC 17025:2017 Requirements:
4.2.1 The laboratory shall be responsible, through legally
enforceable commitments, for the management of all information
obtained or created during the performance of laboratory
activities. The laboratory shall inform the customer in advance, of
the information it intends to place in the public domain. Except
for information that the customer makes publicly available, or
when agreed between the laboratory and the customer (e.g. for the
purpose of responding to complaints), all other information is
considered proprietary information and shall be regarded as
confidential.
Legally enforceable commitments can be, for example,
contractual agreements.
20. 4.2.1 highlights
• Requires that the laboratory shall legally commit itself to keep
information obtained or created during the performance of
assignment for client secret. “legally enforceable commitments
can be, for example, contractual agreements;
• Inform the customer in advance, of the information it intends to
place in the public domain., except when customer makes
publicly available, or when agreed with the customer;
• All other information is considered proprietary information and
shall be regarded as confidential
21. 4.2.2 When the laboratory is required by law or authorized by
contractual arrangements to release confidential information, the
customer or individual concerned shall, unless prohibited by law,
be notified of the information provided;
4.2.3 Information about the customer obtained from sources other
than the customer (e.g. complainant, regulators) shall be
confidential between the customer and the laboratory. The
provider (source) of this information shall be confidential to the
laboratory and shall not be shared with the customer, unless
agreed by the source;
22. 4.2.4 Personnel, including any committee members, contractors,
personnel of external bodies, or individuals acting on the
laboratory's behalf, shall keep confidential all information
obtained or created during the performance of laboratory
activities, except as required by law.
• Personnel shall keep customer information confidential. This
may be handled in the employment contract
• External bodies can be subcontractors.
23. This time is allocated for answering questions. You should have a
space provided for submitting questions.
Please keep questions related to the topic covered in this webinar;
24. Next Webinar
Thursday, May 27, 2021
A look at the requirements specified in PJLA Policy on
Proficiency Testing Requirements “PL-1”
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