Scope of the Lesson
The lesson will cover the requirements of the standard, how it is applied to calibration and test laboratories, and what a technician who works for an accredited lab needs to know. On completion, you will understand these topics and will understand what behavior and activities are required of you in order for your work to be conformant to the standard.
• Intro to documentary standards
• Quality systems and standards
• Prescriptive and non-prescriptive standards
• Accreditation, registration, and certification
• ISO/IEC 17025 and ISO/IEC Guide 58
• Accreditation bodies and ISO/IEC 17025
• Mutual agreement and mutual recognition Conformance and conformity assessment
• Requirements of the standard(s)
• Shalls, shoulds, and notes
• Normative references
• Additional requirements from accreditation bodies
• The assessment process
• Deficiencies, nonconformances, corrective action, responses
• Preassessment, reassessment, surveillance
Audits and Auditors
• ISO 10011
• Assessor qualifications
• Assessor training requirements
• Requirements for confidentiality
• Assessor roles – Lead, technical, associate
The Assessment Process
• Assignment
• Planning
• Desk audit, first round of deficiencies and corrective action
• Scheduling the assessment
• Agenda and assessor roles
• The opening meeting
• The tour
• Lead assessor roles and responsibilities
• Technical assessor roles and responsibilities
• Technical interviews and observations of tests/calibrations
• Daily meetings
• The closing meeting
After the Assessment
• The final report
• Typical documentation produced
• Deficiencies and Corrective action
• Proficiency testing and interlaboratory comparisons
• Review of laboratory submissions
• Review of entire final package
• Assessor revisits and continuing assignments
Internal Assessments
• The internal audit team
• Process and schedule
• Contents of the assessment
• Documentation
• Corrective action
Evaluation and Exam
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