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

  1. Course Overview
  2. 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]

  1. Organizational Structure to ensure impartiality
    1. Management commitment to impartiality
    2. Legally enforceable commitments
    3. Customer information
    4. 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

  1. Defining Organizational Structure and the legal entity of the Organization [5.1, 5.2]
  2. Documenting the range of activities, excluding externally provided laboratory activities [5.3]
  3. Meeting the requirements of ISO 17025 and relevant regulatory bodies [5.4]
  4. Defining Organizational Structure [5.5] and personnel [5.6]
  5. 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]

  1. Personnel and competence [6.2.1 – 6.2.4] and relevant records required [6.2.5]
    1. Specific activities of personnel [6.2.6]
    2. Infrastructure and Work Environment [6.3]
    3. Testing equipment [6.4.1 – 6.4.5] and calibration [6.4.6 – 6.4.13]
    4. 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]

  1. Auditing by Process and Auditing by Objectives
  2. 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

  1. Infrastructure and Work Environment [6.3]
  2. 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

  1. Traceability of results – documenting the chain of events [6.5.1]
  2. Traceability to the International System of Units (SI) [6.5.2]
  3. 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]

  1. Choosing suppliers [6.6.1]
  2. Procedures and records required [6.6.2]
  3. 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]

  1. Determining requirements and the Lab’s capabilities [7.1.1]
  2. Appropriateness of customer’s suggested method, if applicable [7.1.2]
  3. Statement of conformity [7.1.3]
  4. Differences, deviations and amendments [7.1.4 – 7.1.6]
  5. Clarifying customer’s request and monitoring performance [7.1.7]
  6. 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]

  1. Choosing appropriate methods and procedures [7.2.1.1]
  2. Maintaining methods, procedures and associated documentation [7.2.1.2, 7.1.2.3]
  3. Choosing an appropriate method [7.2.1.4]
  4. Verification of methods [7.2.1.5]
  5. Developing a method [7.2.1.6]
  6. Documenting deviations if required [7.2.1.7]

Validation of Methods [7.2.2]

  1. 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]

  1. 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]

  1. Procedure for handling samples including precautions and disposal [7.4.1]
  2. Identification and traceability [7.4.2]
  3. Determining suitability of samples [7.4.3]
  4. Storage [7.4.4]

Technical Records [7.5]

  1. Ensuring technical records contain required information [7.5.1]
  2. 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]

  1. Procedure for monitoring the validity of results (11 subclauses) [7.7.1]
  2. Interlaboratory comparison activities [7.7.2]
  3. 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]

  1. Common requirements for reports [7.8.2]
  2. Specific requirements for test reports [7.8.3]
  3. Specific requirements for reporting sampling [7.8.5]
  4. Reporting opinions and interpretations [7.8.7]
  5. Amendments to reports [7.8.7]

Complaints [7.9]

  1. Documenting the complaint handling process [7.9.1]
  2. Interested parties and the complaint process [7.9.2]
  3. Specific requirements for handling complaints [7.9.3 – 7.9.7]

Non-conforming work [7.10]

  1. Documenting the non-conformance handling process [7.10.1]
  2. Records of non-conformances [7.10.2]
  3. 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]

  1. Data for performing activities [7.11.1]
  2. Validating functionality for data collection, processing, recording, reporting, storage and retrieval [7.11.2]
  3. Maintaining data integrity [7.11.3]
  4. Access to support documentation [7.11.5]
  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]

  1. Option A – organizations that do not have ISO 9001 in place [8.1.2]
  2. Option B – organizations that have ISO 9001 in place [8.1.3]
  3. Documentation – Option A [8.2]
  4. Control of Documents – Option A [8.3]
  5. Control of Records  – Option A [8.4]
  6. Actions to address risks and opportunities [8.5]
  7. Improvement – Option A [8.6]
  8. Corrective actions – Option A [8.7]
  9. Internal Audits – Option A [8.8]
  10. 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

  1. All elements of the system have been audited
  2. Conclusions recorded
  3. 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