ISO 17025 Testing and Calibration Labs – Implementation Training
The Training Program runs for 16 weeks with two 1/2 day sessions each week. The training covers all the clauses of ISO 17025:2017 in detail so the participants will gain a thorough knowledge of the Standard and how they can implement the requirements into their organization.
Participants earn 2 Certificates:
- Certified Internal Auditor
- Certified Management System Specialist
Program Overview
Session #1 – Intro and Overview
- 1 Week Case Work
- One-on-One Coaching Session
Session #2 – General Requirements: Impartiality and Confidentiality
- 1 Weeks Case Work
- One-on-One Coaching Session
Session#3 – Management System Organizational Structural Requirements
- 1 Week Case Work
- One-on-One Coaching Sessions
Session#4 – Resource Requirements – Personnel & Infrastructure
- 1 Week Case Work
- One-on-One Coaching Sessions
Session#5 – Internal Auditor Training
- 1 Week Case Work – auditing and recording results
- One-on-One Coaching Sessions
Session#6 – Facilities and Environmental Conditions, Equipment
- 1 Week Case Work – auditing and recording results
- One-on-One Coaching Sessions
Session#7 – Metrological Traceability
- 1 Week Case Work
- One-on-One Coaching Sessions
Session#8 – Process Management – Purchasing
- 1 Week Case Work
- One-on-One Coaching Sessions
Session#9 – Requests, Tenders and Contracts
- 1 Week Case Work
- One-on-One Coaching Sessions
Session#10 – Selection, Verification and Validation of Test Methods
- 1 Week Case Work
- One-on-One Coaching Sessions
Session#11 – Handling Test or Calibration Items
- 1 Week Case Work
- One-on-One Coaching Sessions
Session#12 – Evaluation of Measurement Uncertainty & Validity of Results
- 1 Week Case Work
- One-on-One Coaching Sessions
Session#13 – Reporting of Results, Complaints & Non-conforming Work
- 1 Week Case Work
- One-on-One Coaching Sessions
Session#14 –Management System Requirements
- 1 Week Case Work
- One-on-One Coaching Sessions
Session#15 –Review of effectiveness of Management System, Management Review
- 1 Week Case Work
- One-on-One Coaching Sessions
Session#16 – Review of system and choosing Accrediting Body
- SCC – CAEL
- A2LA Laboratory Accreditation
Total Course Calendar – 16 weeks (this can be modified to meet your requirements, but the content will still be covered)
Module 1 – ISO 17025:2017Introduction and Overview
- Course Overview
- ISO 17025 Management System as a framework for ensuring accurate test results
Case Work
- Define Processes
- Define which tests will be within the Scope of the System
- Define Stakeholders and Expectations
Learning Outcomes
- Clear Understanding of intent and strategy for the System
- Defined Stakeholders, Requirements and Scope of the System
Module 2 – Impartiality and Confidentiality
Impartiality and Confidentiality Requirements [4.1, 4.2]
- Organizational Structure to ensure impartiality
- Management commitment to impartiality
- Legally enforceable commitments
- Customer information
- Personnel and confidentiality
Case Work
- Assess whether current organizational structure can support the impartiality and confidentiality requirements
- Identify kinds of Client and Organizational information where confidentiality must be maintained
- Draft legally enforceable commitments
- Identify sources of Customer information that must be protected
- Ensure that there is a process in place to inform personnel of impartiality and confidentiality requirements
Learning Outcomes
- Recognition of requirements for Impartiality and Confidentiality
- Understanding the relationship between information and required protection
- Ability to create legally enforceable commitments
- Assessment of risk of not meeting impartiality and confidentiality requirements
Module 3 – Management System Structural Requirements
- Defining Organizational Structure and the legal entity of the Organization [5.1, 5.2]
- Documenting the range of activities, excluding externally provided laboratory activities [5.3]
- Meeting the requirements of ISO 17025 and relevant regulatory bodies [5.4]
- Defining Organizational Structure [5.5] and personnel [5.6]
- Inter-lab communication [5.7]
Case Work
- Define organizational structure
- Define Process flow of tests within the scope of the system
- Identify relevant Regulatory requirements
- Create organizational chart
- Determine whether the communication flow will support the requirements for Impartiality and Confidentiality
Learning Outcomes
- Understanding the organizational structure
- Understanding the workflow of tests within the scope of the System
- Relevant regulatory bodies will be identified and documented
- Recognition of each process purpose and risks/controls in place for each test within the scope of the system
- Assessment of the effectiveness of the communication paths within the organization
Module 4 – Resource Requirements – Personnel and Infrastructure
Personnel [6.2]
- Personnel and competence [6.2.1 – 6.2.4] and relevant records required [6.2.5]
- Specific activities of personnel [6.2.6]
- Infrastructure and Work Environment [6.3]
- Testing equipment [6.4.1 – 6.4.5] and calibration [6.4.6 – 6.4.13]
- Information Management
Case Work
- Complete Applicability Matrix
- Identify Gaps in Current Activities
Learning Outcomes
- Clear understanding of ISO 17025:2017 clauses and requirements
- Recognition of the alignment between your organization’s processes and ISO 9001:2015
requirements
- Identification of ISO 17025:2017 requirements not currently addressed by your organization’s processes
Module 5 – Internal Auditor Training
Internal Audits [8.8]
- Auditing by Process and Auditing by Objectives
- Auditing by Risk/Objective/Performance
Case Work
- Define Internal Audit Process for your organization
- Schedule Internal Audits for each process
Learning Outcomes
- Understanding of the objectives of Internal Auditing based on Risks/Performance/Results
- Creation of schedule to carry out Internal Audits – next 4 months
- Skills to perform an Internal Audit for your organization for identified participants
Module 6 – Infrastructure and Equipment
Performing Tests
- Infrastructure and Work Environment [6.3]
- Testing equipment [6.4.1 – 6.4.5] and calibration [6.4.6 – 6.4.13]
Case Work
- Review Current Infrastructure and assess capability of equipment used for testing that falls within the scope of the System
- Review current active equipment and assess the strength of the current calibration program
- Identify Gaps in equipment and calibration activities
Learning Outcomes
- Understanding of the resources required to perform tests and report results accurately
- Recognition of capabilities both in testing and maintaining test equipment
- Awareness capabilities of tracking tools for calibration activities
Module 7 – Metrological Traceability
Traceability
- Traceability of results – documenting the chain of events [6.5.1]
- Traceability to the International System of Units (SI) [6.5.2]
- When traceability to SI is not possible [6.5.3]
Case Work
- Review traceability requirements as they apply to the tests within the scope of the Lab
- Demonstrate traceability to the International System of Units
- Create a method to demonstrate metrological traceability when traceability to SI is not possible, if required
Learning Outcomes
- Understanding of traceability requirements
- Awareness of conditions when traceability to SI is not technically possible and what references to use
- Implementation of alternate method to demonstrate traceability where applicable
Module 8 – Procurement
Externally provided products and services [6.6]
- Choosing suppliers [6.6.1]
- Procedures and records required [6.6.2]
- Sending requirements to suppliers [6.6.3]
Case Work
- Assess whether current procurement activities meet the requirements of the Standard
- Identify procedures and records required
- Determine whether current communication methods with External Providers are effective
Learning Outcomes
- Recognition of the requirements for dealing with external providers of goods and services
- Understanding the relationship between information sent to suppliers and resulting order completion and goods and services provided
Module 9 – Requests, Tenders and Contracts
Requests, tenders and contracts [7.1 – 7.8]
- Determining requirements and the Lab’s capabilities [7.1.1]
- Appropriateness of customer’s suggested method, if applicable [7.1.2]
- Statement of conformity [7.1.3]
- Differences, deviations and amendments [7.1.4 – 7.1.6]
- Clarifying customer’s request and monitoring performance [7.1.7]
- Review records [7.1.8]
Case Work
- Assess whether current organizational structure can support the customer request review requirements
- Determine if current methods for stating conclusions meets requirements
- Evaluate current practices regarding deviations
- Ensure that there is a process in place to retain approptiate documented information
Learning Outcomes
- Recognition of requirements around reviewing customer requirements and assessing the Lab’s capabilities
- Understanding the information required and retention of documented information
- Assessment of risk of deviations – identifying, assessing and reporting
Module 10 – Selection, Verification and Validation of Test Methods
Selection and Verification [7.2.1]
- Choosing appropriate methods and procedures [7.2.1.1]
- Maintaining methods, procedures and associated documentation [7.2.1.2, 7.1.2.3]
- Choosing an appropriate method [7.2.1.4]
- Verification of methods [7.2.1.5]
- Developing a method [7.2.1.6]
- Documenting deviations if required [7.2.1.7]
Validation of Methods [7.2.2]
- Validating non-standard methods, laboratory developed methods and standard methods used outside their scope [7.2.2.1]
- Managing changes to methods [7.2.2.2]
- Performance characteristics [7.2.2.3]
- Validation records required [7.2.2.4]
Sampling [7.3]
- Sampling plans and methods [7.3.1, 7.3.2]
- Sampling records [7.3.3]
Case Work
- Assess whether current organizational structure can support the choice of a proper method
- Identify requirements related to choosing a method or developing one
- Ensure that there is a process in place to retain appropriate documented information related to choosing, developing, verifying and validating methods including deviations
Learning Outcomes
- Recognition of requirements for choosing methods
- Understanding the requirements for developing and validating methods
- Ability to document all activities relevant to choosing, developing and validating methods
Module 11 – Handling Test or Calibration Items and Technical Records
Test Items [7.4]
- Procedure for handling samples including precautions and disposal [7.4.1]
- Identification and traceability [7.4.2]
- Determining suitability of samples [7.4.3]
- Storage [7.4.4]
Technical Records [7.5]
- Ensuring technical records contain required information [7.5.1]
- Amendments [7.5.2]
Case Work
- Assess whether current methods for handling samples and retaining documented information meet the requirements of this Standard
- Determine whether current identification methods are adequate
- Review incoming inspection of samples for effectiveness
- Consider storage facilities and determine suitability
- Assess effectiveness of Technical Record management
Learning Outcomes
- Recognition of requirements for handling samples including identification, traceability, storage and disposal
- Assessment of risk of not meeting handling requirements and technical record management requirements
Module 12 – Evaluation of Measurement Uncertainty & Validity of Results
Measurement of uncertainty [7.6]
- Identifying contributions to uncertainty [7.6.1]
- Evaluation of uncertainty of calibrations of all test equipment [7.6.2]
- Uncertainty of test results [7.6.3]
Validity of results [7.7]
- Procedure for monitoring the validity of results (11 subclauses) [7.7.1]
- Interlaboratory comparison activities [7.7.2]
- Using comparison activities to improve the effectiveness of the Lab’s Management System and prevent incorrect results from being sent to the customer [7.7.3]
Case Work
- Assess whether current methods meet the requirements for uncertainty of measurement and validity of results
- Identify opportunities to improve the accuracy of the calculation of uncertainty of measurement
- Identify labs that can be used for interlaboratory comparison, if any exist
- Ensure that there is a process in place to identify results outside the expected range and act appropriately if they occur
Learning Outcomes
- Understanding of the existence of uncertainty of measurement
- Assessment of risks related to measurements, uncertainty and actions needed if results are outside the expected range
Module 13 – Reporting of Results, Complaints & Non-conforming Work
Reporting of results [7.8, 7.8.1]
- Common requirements for reports [7.8.2]
- Specific requirements for test reports [7.8.3]
- Specific requirements for reporting sampling [7.8.5]
- Reporting opinions and interpretations [7.8.7]
- Amendments to reports [7.8.7]
Complaints [7.9]
- Documenting the complaint handling process [7.9.1]
- Interested parties and the complaint process [7.9.2]
- Specific requirements for handling complaints [7.9.3 – 7.9.7]
Non-conforming work [7.10]
- Documenting the non-conformance handling process [7.10.1]
- Records of non-conformances [7.10.2]
- Requirements for corrective actions [7.10.3]
Case Work
- Assess whether current organizational structure can support the reporting requirements
- Identify gaps in current reporting methods and propose improved methods for reporting
- Ensure that there is a robust process in place to manage complaints
Learning Outcomes
- Recognition of requirements for reporting
- Understanding the relationship between complaints and non-conformances
- Assessment of risk of weaknesses in the system that could lead to a non-conformance
Module 14 – Control of Data and Information Management
Access to data [7.11.1, 7.11.2]
- Data for performing activities [7.11.1]
- Validating functionality for data collection, processing, recording, reporting, storage and retrieval [7.11.2]
- Maintaining data integrity [7.11.3]
- Access to support documentation [7.11.5]
- Integrity of calculations and data transfers [7.11.6]
Case Work
- Assess whether current organizational structure can meet the data handling requirements
- Identify gaps in current data handling methods and propose improvements to methods
- Ensure that there is access to relevant information for lab activities
Learning Outcomes
- Recognition of requirements for data handling
- Assessment of access to relevant reference material to carry out laboratory activities
Module 15 – Management System Requirements
Determination of applicability of Option A or Option B for Management System requirements [8.1]
- Option A – organizations that do not have ISO 9001 in place [8.1.2]
- Option B – organizations that have ISO 9001 in place [8.1.3]
- Documentation – Option A [8.2]
- Control of Documents – Option A [8.3]
- Control of Records – Option A [8.4]
- Actions to address risks and opportunities [8.5]
- Improvement – Option A [8.6]
- Corrective actions – Option A [8.7]
- Internal Audits – Option A [8.8]
- Management reviews – Option A [8.9]
Case Work
- Assess whether current organizational should use Option A or Option B
- Identify gaps in the management system
- Create a plan to finalize the system and prepare for accreditation steps
Learning Outcomes
- Recognition of ‘state of readiness’ for accreditation
- Evaluation of the completeness and applicability of the management system
- Ability to maintain and improve the effectiveness of the system moving forward
Module 16 – Review of effectiveness of Management System, Management Review
Completion of Internal Audit activities and Review of System by Management
- All elements of the system have been audited
- Conclusions recorded
- Management Review has been conducted and recommendations recorded
Case Work
- Complete the internal audit – full system will be audited
- Determine sources of data for Management Review
- Record results of Internal Audit and Management Review
- Prepare for Accreditation audit
Learning Outcomes
- Understanding of ‘state of readiness’ for Accreditation activities
Review of system and choosing an Accreditation Body
- Evaluate proposals from Accrediting bodies
- Determine next steps toward accreditation – create timeline and project plan