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Module 1: Introduction about ISO 17025:2017 and Process Approach
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Introduction to ISO 17025 Awareness training
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Objectives of the Course
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Scope of training
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About ISO
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General requirements of ISO 17025
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Reminder of principles
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Applying Principles
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Module 2: Laboratory Management System Principles
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Main changes in approach Vs 17025
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Main changes in approach Vs 17025
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Main changes in approach Vs 17025
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Comparison of 2005 & 2017
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Why Restructure 17025
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Management System Options
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The New Structure
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Headlines of changes
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Other Changes
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ISO 17025 Timeline
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|Introduction steps to accreditation
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ISO 17025 Applicability
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ISO 17025 Accreditation benefits
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Benefits- ISO 17025
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Overview of Requirements
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Module 3: Overview of clause 1-3
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10 steps to implementation of ISO 17025
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ISO/IEC 17025 comparison clause regroup
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Main changes compared to 2005
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Introduction to ISO 17025:2017
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Overview of Clause
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1.0 Scope
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2.0 Normative Ref
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3.0 terms and definition
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3.0 terms and definition
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3.0 terms and definition
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Module 4: General Requirements
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4.0 General Requirements
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Clause 4.1 Impartiality (4.1.1 - 4.1.3)
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Clause 4.1 Impartiality (4.1.4 - 4.1.5)
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4.2 Confidentiality 4.2.1
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4.2 Confidentiality 4.2.2
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4.2 Confidentiality 4.2.3 & 4.2.4
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Module 5: Structural Requirements
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5.0 Structural requirements
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5.0 Structural requirements (5.1 & 5.2)
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5.0 Structural requirements 5.3
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5.0 Structural requirements 5.4
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5.0 Structural requirements 5.5
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5.0 Structural requirements 5.6
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5.0 Structural requirements 5.7
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Clause 4.0 & 5.0 Summary
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Assignment -1- ISO 17025 AW
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Section Quiz 4 & 5
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Module 6: Resource requirements
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6.0 Resource requirements
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6.1 General
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6.2 Personnel 6.2.1 & 6.2.2
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6.2 Personnel 6.2.3 & 6.2.4
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6.2 Personnel 6.2.5 & 6.2.6
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6.3 facilities and environmental conditions 6.3.1, 6.3.2 & 6.3.3
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6.3 Facilities and environmental conditions 6.3.4 & 6.3.5
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6.4 Equipment 6.4.1 & 6.4.2
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6.4 Equipment 6.4.3 & 6.4.4
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6.4 Equipment 6.4.5 & 6.4.6
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6.4 Equipment 6.4.7 & 6.4.8
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6.4 Equipment 6.4.9
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6.4 Equipment 6.4.10, 6.4.11 & 6.4.12
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6.4 Equipment 6.4.13
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6.5 Metrological traceability 6.5.1 & 6.5.2
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6.5 Metrological traceability 6.5.3
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6.6 Externally Provided Products and services 6.6.1
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6.6 Externally Provided Products and services 6.6.2 & 6.6.3
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Clause 6.0 Summary
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Assignment -2- ISO 17025 AW
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Section Quiz 6
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Module 7: Process Requirements
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7.0 Process Requirements
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7.1 Review of requests, tenders and contracts 7.1.1 & 7.1.2
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7.1 Review of requests, tenders and contracts 7.1.3 & 7.1.4
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7.1 Review of requests, tenders and contracts 7.1.5 & 7.1.6
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7.1 Review of requests, tenders and contracts 7.1.7 & 7.1.8
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7.2 Selection, verification and validation of methods 7.2.1
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7.2 Selection, verification and validation of methods 7.2.1
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7.2 Selection, verification and validation of methods 7.2.1
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7.2 Selection, verification and validation of methods 7.2.1
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7.2.2 Validation of methods
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7.2.2 Validation of methods
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7.2.2 Validation of methods
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7.3 Sampling 7.3.1 & 7.3.2
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7.3 Sampling 7.3.3
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7.4 Handling of test or calibration items 7.4.1 & 7.4.2
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7.4 Handling of test or calibration items 7.4.3 & 7.4.4
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7.5 Technical records 7.5.1 & 7.5.2
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7.6 Evaluation of measurement uncertainty 7.6.1 & 7.6.2
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7.6 Evaluation of measurement uncertainty 7.6.3
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7.7 Ensuring the validity of results 7.7.1
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7.7 Ensuring the validity of results 7.7.2 & 7.7.3
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7.8 Reporting of results 7.8.1 General
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7.8 Reporting of results 7.8.2 Common requirements for reports
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7.8 Reporting of results 7.8.2 Common requirements for reports
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7.8.3 Specific requirements for test reports
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7.8.4 Specific requirements for calibration certificates 7.8.4.1
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7.8.5 Reporting sampling - specific requirements
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7.8.6 Reporting statements of conformity
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7.8.7 Reporting opinions and interpretations
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7.8.8 Amendments to reports
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7.9 Complaints 7.9.1 & 7.9.2
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7.9 Complaints 7.9.3, 7.9.4 & 7.9.5
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7.9 Complaints 7.9.6 & 7.9.7
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7.10 Nonconforming work 7.10.1
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7.10 Nonconforming work 7.10.2 & 7.10.3
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7.11 Control of data and information management
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7.11 Control of data and information management
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7.11 Control of data and information management
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Clause 7.0 Summary
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Assignment -3- ISO 17025
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Section Quiz 7
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Module 8: Management system requirements
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8.0 Management system requirements
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8.1 Options 8.1.1 General 8.1.2 Option A
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8.2 Management System documentation (Option A)
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8.2 Management System documentation (Option A)
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8.3 Control of Management System documentations (Option A)
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8.4 Control of records (Option A)
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8.5 Actions to address risks and opportunities (Option A)
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8.5 Actions to address risks and opportunities (Option A)
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8.6 Improvement (Option A)
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8.7 Corrective actions (Option A)
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8.9 Management reviews (Option A)
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8.8 Internal Audits (Option A)
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8.9 Management reviews (Option A)
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RECAP
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ISO 17025 124
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Section Quiz 8
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Module 9: Internal Audit based on ISO 19011
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Introduction to ISO 19011- Internal audit
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Audit definition
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Audit Terms and Definitions
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Planning and preparation of audit - different stages in an audit cycle
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Audit Management
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Internal Audits
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Planning and preparation for an audit
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Planning and preparation for an audit- Initiating the audit
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Audit criteria Vs audit scope
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Planning & Preparation of an Audit Selection of an audit team
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Planning & Preparation of an Audit - Document review
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Planning & Preparation for an Audit Preparation for on-site audit
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Performing an audit- Audit Management
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Performance of an Audit
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Performing an Audit – From collecting information to audit conclusions
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Audit team - Participants
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Key qualities of an auditor
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Performing an Audit – Audit Approach – Attitude of Auditor
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Audit approach - Communication process
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Audit approach - Communication process
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Audit approach - Communication process
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Audit approach - Communication process
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Audit approach - Communication process
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Audit approach - Communication process
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Audit approach - Communication process
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Audit Approach – Questioning techniques
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Audit Approach – Questioning techniques
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Audit approach - Communication process- clarifying questions
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Documentary evidence and follow up actions
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Performing an Audit – How do auditors find evidence ?
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Time management - Preparing a Checklist Format
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Preparing a Checklist Format
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Purpose of checklists
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Visit the field – Move around
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Performing an Audit -Observe Operational Control
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Performing an Audit -Observe Operational Control
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Follow Audit trials
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Audit Management - reporting an audit
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Audit reporting
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Audit reporting – Writing Non-conformity reports
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NCR’s & Corrective actions Concepts relating to requirements
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Audit reporting – Writing Non-conformity reports
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NCR’s and Corrective actions -Examples of Objective Evidence
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Audit reporting – Writing Non-conformity reports
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Audit reporting – Writing Non-conformity reports
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NCR’s and Corrective action
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Writing Non-conformity reports Do and donts
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Writing Non-conformity reports- matrix
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Writing Non-conformity reports- auditor and auditee
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Writing Non-conformity reports- corrective action
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Difficulties encountered during internal audits
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A piece of counsel
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THANK you
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Final Assessment- ISO 17025 Awareness
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Final Assessment ISO 17025 Awareness
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