PECB Webinar: Understanding the basics of laboratory management with ISO/IEC 17025

PECB Webinar|September 2015 ISO/IEC 17025:2005
Content:
 Introduction
 History of ISO 17025
 Important Terminology
 ILAC Mutual Recognition
Arrangement
 GLP: Conformance Vs
Compliance
 Relationship between ISO
17025 9001
 Structure of ISO 17025
 Process Approach: Deming
Cycle
 Laboratory Management System
(LMS)
 Implementation of LMS
 Documentation Requirements
 Technical Requirements
 ISO 17025 Implementation Plan

INTRODUCTION:
The purpose of this webinar is to
introduce to each participant the
concept of Laboratory
Management System and how
to initiate such based on
ISO/IEC 17025:2005.

ISO/IEC 17025:
 Basic requirements necessary for a laboratory to be
able to implement and operate to demonstrate it is
competent
– They are not “super” requirements
– Cost (of compliance and/or Accreditation) is cost of achieving
consistently good results
– Cost of not having consistently good results could be much higher
 17025 focus is on:
– Management requirements and Technical requirements
– Annex A Cross reference to ISO 9001
– Annex B Guidelines for establishing application for sector fields

ILAC MLA (Mutual Recognition Arrangement)ISO 17025: 1999 VS 2005
 Insistence on a demonstrated commitment to
continually improve the quality management system and
identified mechanisms for achieving this. ƒ
 Greater emphasis of the need to communicate with
customers and, especially, to actively solicit feedback on
service quality and ensure the resulting information is used
as the basis of action to improve the management system. ƒ
 Greater emphasis of the need to use information from
quality control data to evaluate the performance of the
quality system and to identify opportunities for improvement.

ILAC MLA (Mutual Recognition Arrangement)The ‘tion’ Words:
Registration: Procedure by which a registration body
indicates relevant characteristics of a product, process of
service, or particulars of a body or person, on an appropriate
publicly available list OR procedure used to give written
assurance that a system conforms to specified requirements
Accreditation: Procedure by which an authoritative body
gives formal recognition that a body or person is competent
to carry out specific tasks
Certification: Procedure used to provide written assurance
that a product, process, service, or person’s qualifications
conform to specified requirements

ILAC MLA (Mutual Recognition Arrangement)
Peer Evaluation Process (ISO/IEC
17040)
Accreditation Body in country A
(ISO/IEC 17011)
Accreditation Body in country B
(ISO/IEC 17011)
Recognition
Laboratory in country A
(ISO/IEC 17025)
Test/Calibration
Results
Recognition of
Equivalence
Laboratory in Country
B
(ISO/IEC 17025)
Test /Calibration
Results
ILAC MRA (Mutual Recognition Arrangement)

ILAC MLA (Mutual Recognition Arrangement)GLP: Conformance Vs Compliance
At the heart of ISO 17025 Implementation lies the
commitment to Good Laboratory Practice.
 Conformance: Doing what you say you are
doing and being able to prove it i.e Standard
requirements
 Non-Conformance results in a written audit
deficiency statement and requires corrective action
 Non-compliance, on the other hand,
suggests fines or legal/regulatory action i.e Legal
requirements

ILAC MLA (Mutual Recognition Arrangement)Thoughts on Laboratory Best Practice:
 Does the laboratory ‘say’ what they do?
Do they have written documents(policies, procedures,
arrangements) that meet the requirements of ISO 17025
 Does the laboratory ‘do’ what they say?
Are they in compliance with their own quality system and ISO
17025?
 And can they ‘prove’ it with their records?
From training records to standards preparation to work books
to client reports to audit reports and more
Conformance does not always require best practices (but
optimum practices)

Relationship between ISO 17025 &
9001:

ILAC MLA (Mutual Recognition Arrangement)Structure of ISO 17025 Standard:
Technical Requirements:
5.1 General
5.2 Personnel
5.3 Accommodation / Environmental
conditions
5.4 Test methods & method
validation
5.5 Equipment
5.6 Measurement Traceability
5.7 Sampling
5.8 Handling of test items
5.9 Assuring the quality of test
results
5.10 Reporting the results
4.1 Organization
4.2 Management System
4.3 Document Control
4.4 Review of requests,
tenders and contracts
4.5 Sub-contracting of
tests or calibrations
4.6 Purchasing services
and supplies
4.7 Service to the customer
4.8 Complaints
4.9 Control of
nonconforming testing work
4.10 Improvement
4.11 Corrective Action
4.12 Preventive Action
4.13 Control of Records
4.14 Internal Audits
4.15 Managements reviews
Management Requirements:

Deming-circle
DO
Implement QMS
PLAN
Establish a QMS
ACT
Maintain &
Improve QMS
CHECK
Monitor &
Review QMS
PROCESS APPROACH:

22
Broadly, all
documents relating to
quality fall in to the
following categories:
Quality Manual
Procedures
Supporting
Documents or
Work
Instructions
Records
Quality Records
Supporting Documents
or Work Instructions
Quality
Procedures
Quality
Manual
Tiers of Documentation:

Initiating the LMS Implementation

How to manage LMS Implementation Project:
Plan-Do-Check-Act Cycle

• 1-2 Months
– Training
– Define OHSMS
– Gap analysis
– Planning
• 3-4 Months
– Establishing practices and
documentation
– Certification body selection
– Implementation
• 5-6 Months
– Implementation
– Operation
– Evidence
• 7-8 Months
– Pre-assessment
– Internal Audit
– Management Review
– Corrective Actions
• 9-10 Months
– Stage 1 audit
– Stage 2 audit
– Corrective Actions
– Certification (if desired)
• 12+ Months
– Audit Follow-up
– Surveillance audits
30
Develop Implementation Plan-
Typical Schedule:

PECB Webinar: Understanding the basics of laboratory management with ISO/IEC 17025

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PECB Webinar: Understanding the basics of laboratory management with ISO/IEC 17025