Transition to ISO/IEC 17025:2017

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2000/day

(2 Days)

Benefits

Clarify the main changes between ISO/IEC 17025:2005 and ISO/IEC 17025:2017, which is covered scope of the standard, defined range of activities for laboratory, process orientation, information technology, metrological traceability and decision rules.

Understand the new standard requirements that are more emphasized on performance-based requirements rather than prescriptive requirements.

Describe the new requirements relating to impartiality and confidentiality

Appreciate the significance of a risk-based approach.

Understand the decision rules for statements of conformity (pass or fail) that is based on the specification, measured value and its measurement uncertainty.

Understand the key terminologies used in the laboratory.

Learn how to transition from previous standard to new standard

Identify areas that need to change in your current Quality management system

Prepare transition plan that is requested by Standards Malaysia.

Implement the new standard to your organization.

Audience

· To all who need to discover the requirements about transitioning to the new ISO/IEC 17025:2017 standard, You will learn more about the changes from ISO/IEC 17025:2005 to ISO/IEC 17025:2017 and how these will affect your organization, and then able to effectively arrange the deadlines' schedule of the transition plan by laboratory for ISO/IEC 17025:2017, which is required by Standards Malaysia.

· Individuals directly involved in the planning, implementing, maintaining or auditing of an ISO/IEC 17025: 2017, general requirements for the competence of testing and calibration laboratories.

· Anyone with ISO/IEC 17025 responsibility, including new implementation of ISO/IEC 17025, IATF 16949 organizations, internal and external management system auditors and anyone interested in finding out how ISO/IEC 17025:2017 differs from its 2005 version

Methodology

This stimulating program will maximize understanding and learning through training slides, review questions, exercises, case study and Q&A.

Module 1: General Information

· Introduction to ISO/IEC 17025

· Structure and Rearrangement

· The Major Changes in New Standard

· The Key Terms and Definitions

· Review Questions

Module 2: FAQs on Laboratory Quality

· Calibration

· Testing

· Inspection

· Measurement

· Traceability

· Measurement Uncertainty

· Quality Control in the Laboratory

· Verification and Validation

· Review Questions

Module 3: Main Clauses in ISO/IEC 17025: 2017

· General Requirements (Clause 4)

o Impartiality

o Confidentiality

· Structural Requirements (Clause 5)

o Legal Operation

o Management Identification

o Documentation of the Range of laboratory Activities

o Fulfilment of Laboratory Facilities

o Define, Conduct and Document Management System

o Implement, Maintain and Effective Management System

o Ensure Effectiveness and Integrity of Management system

· Resource Requirements (Clause 6)

o General

o Personnel

o Facilities and Environmental Conditions

o Equipment

o Metrological Traceability

o Externally Provided Products and Services

· Process Requirements (Clause 7)

o Review of Requests, Tenders and Contracts

o Selection, Verification and Validation of Methods

o Sampling

o Handling of Test or Calibration Items

o Technical Records

o Evaluation of Measurement Uncertainty

o Ensuring the Validity of Results

o Reporting of Results

o Complaints

o Nonconforming Work

o Control of Data and Information Management

· Management System Requirements (Clause 8)

o Options

o Management System Documentation (Option A)

o Control of Management System Documents (Option A)

o Control of Records (Option A)

o Actions to Address Risks and Opportunities (Option A)

o Improvement (Option A)

o Corrective Action (Option A)

o Internal Audits (Option A)

o Management Reviews (Option A)

· Annex A (Metrological Traceability)

o General

o Establishing Metrological Traceability

o Demonstrating Metrological Traceability

· Annex B (Management system options)

o Introduction

o Option A

o Option B

o Summary of Option Selection

o Schematic of the Operational Processes of a Laboratory

· Review Questions

Module 4: Gap Analysis of ISO/IEC 17025 between Version 2005 and 2017

· Cross Checking

· Requirements and Action Plan

· General Requirements

· Structural Requirements

· Resource Requirements

· Process Requirements

· Management System Requirements

· Review Questions

Module 5: Requirement Lists in ISO/IEC 17025: 2017

· List of Policies

· List of Procedures

· List of Activities

· Programs

· Documented Process

· Plan and planning

· List of Identify

· List of Define

· List of Documents

· List of Records

· Review Question

Module 6: SAMM Circular 4/2017

· Introduction

· Objective

· Standards Malaysia Requirements for Transition to ISO/IEC 17025: 2017

· Validity of ISO/IEC 17025: 2005

· Specific Exceptions

Module 7: Review Questions
Module 8: Exercise
Module 9: Appendix
Module 10: References

Trainers