2. Presentation Overview
Management Systems
Continual Improvement Cycle
Common Themes
ISO/IEC 17025:1999
Alignment of Management Systems
Benefits
3. What is a Management System?
A set of interrelated elements used to establish
policy and objectives and to achieve those
objectives.
Elements include
Organizational structure
Planning activities
Responsibilities
Practices
Procedures
Processes
Resources
ANSI/ISO/ASQ E14001-2004, 3.8 Note 1 & 2
4. Management System Models
Environment
ISO 14001: 2004
Quality USEPA NEIC 2001
ISO 9001: 2000
ISO/IEC 17025: 1999
Health and Safety
OSHAS 18001: 1999
ANSI/AIHA Z10: 2005
5. Process Approach
Processes versus Procedures
Identify processes needed for the Management
System
Demonstrate the ability of processes to achieve
planned results
Develop information on characteristics and
trends of processes
Top management review
6. Why Use a Standard or a Guide
Minimize re-inventing the wheel
Capitalize on shared experiences
Improved recognition
7. PDCA Cycle in Management Systems
Act
Make
improvements
Check Plan
Did things What to do
happen How to do it
according
to plan?
Do
Do what was
planned
8. Common Management System Themes
Theme Critical Success Factors
Policy Management Impetus/ Alignment
with Business Strategy
Plan Needs to be done/ Process
Approach
Implementation
Awareness and Training
Evaluation and Corrective Actions
Check
Multiple perspectives
Management Review
Improvement Opportunities
10. ISO/IEC 17025:1999
General Requirements for the Competence
of Testing and Calibration Laboratories
Grew out of and replaces ISO/IEC Guide 25 and EN
45001
Incorporates elements of ISO 9001 relevant to
laboratories
Clause 4 specifies MANAGEMENT REQUIREMENTS
Clause 5 specifies TECHNICAL REQUIREMENTS
11. ISO/IEC 17025 Management Requirements
4.1 Organization and Management
4.11 Preventive action
4.2 Quality Policy
4.12 Records
4.3 Document control
4.13 Internal audits
4.4 Request and tender review
4.14 Management reviews
4.5 Sub-contracting of tests
4.6 Purchasing services and
supplies
4.7 Service to Clients
4.8 Complaints
4.9 Control of nonconforming work
4.10 Corrective action
12. ISO/IEC 17025 Technical Requirements
5.1 General
5.6 Measurement Traceability
5.2 Personnel
5.3 Accommodation and 5.7 Sampling
environmental conditions
5.4 Test and calibration 5.8 Handling and
methods including sampling transportation of test samples
5.5 Equipment
5.9 Assuring the quality of test
results
5.10 Reporting the results
13. ISO/IEC 17025; 4.3 Document Control
Maintain procedures to control all
documents that form part of its quality
system. Includes
Regulations and normative documents as
well as policy statements, procedures,
software, drawings and plans
Authorization and availability of documents
Unique identification
Change management
14. ISO/IEC 17025;
5.6.3 Reference Standards and Materials
Laboratory must have a program and
procedure for calibration of reference
standards and materials
Traceable to International System of Units
(SI) or to certified reference materials
through an unbroken chain of calibrations or
comparisons
Use of intermediate checks to maintain
confidence in calibrations
Handling and storage shall be sufficient to
maintain integrity of materials
15. National Environmental Laboratory
Accreditation Committee (NELAC)
Established (1995) as a standards setting body,
supported by EPA, to support a National
Environmental Laboratory Accreditation Program
(NELAP)
Foster cooperation among accreditation activities
of different states or governmental agencies
Unify state and federal standards at minimum costs
2002: amended constitution to become standards
adoption body
Requirements organized according to ISO/IEC
17025
16. Alignment of Management Systems
Systems with similar focus; for example
quality
– Align technical operations with other
business units
– Take advantage of processes to achieve
the same objective
17. Systems Cross Walk:
Similar Focus - Quality
ISO ISO/IEC NELAC
9001: 17025: 1999 2003 1
Policy 2000
4.2.1 4.2.2 5.4.2.2
Control of Records 4.2.4 4.12 5.4.12
Management Reviews 5.6 4.14 5.4.14
8.5.1
Measurement 7.5.3 5.6 5.5.6
Traceability 7.6
Reporting Results 7.5.1 5.10 5.5.10
(Product Delivery) 7.5.4
8.2.4
1 Effective July 2005
18. Alignment of Management Systems
Systems with similar processes across
differing foci; for example document
control for quality and environmental
management
– Align processes across business units
– Take advantage of processes to achieve
the same objective
– Organizational synergy
– Maximized awareness
19. Systems Cross Walk:
Similar Elements
EMS QMS
ISO 14001: ISO/IEC 17025:
2004 1999
Policy 4.2 4.2.2
Document Control 4.4.5 4.3
Control of Records 4.5.4 4.12
Management Reviews 4.6 4.14
20. Systems Cross-walks
EMS OHS
ISO 14001:2004 ANSI/AIHA Z10 1
Policy 4.2 3.1.2 Policy
Environmental Aspects 4.3.1 4.1.1 Initial Review
4.2 Assessment
Competence, Training 4.4.2 5.2 Education, Training and
and Awareness Awareness
Management Review 4.6 6.5 Feedback to Planning
7.1 Management Review
1 Draft September 2004
21. Management Systems:
Benefits to be Realized
Work within a Recognized Framework
Provides for Systematic Development
Beyond Compliance - Sustainability
Management Support
Participation at All Levels
Improved Recognition
(Certification/Accreditation)
22. Management System Alignment
Benefits
Align Laboratory Operations among
Business Operations
Take Advantage of Prior Efforts -
Efficiency
Improved Collaboration
Alignment of Processes with Overall
Business Strategy
23. Summary
Use of Management
Systems
Common Themes
Continual Improvement
Cycle
ISO 17025:1999
Alignment of Management
Systems
Benefits
