Process Based Integration of ISO 9001:2000, ISO 14001,
and OHSAS 18001
David Barber, General ManagerOmnex Canada
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2000 - 2004, Omnex, Inc.3025 Boardwalk Suite 120
Ann Arbor, MI 48108734-761-4940
First EditionAugust 2004
This publication is protected by Federal Copyright Law, with all rights reserved. No part of this publication may be reproduced, stored in a retrieval system, translated, transcribed, or transmitted, in any form, or by any means manual, electronic, electro-magnetic, mechanical, chemical, optical, or otherwise, without prior
explicit written permission from Omnex, Inc.
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Course Objectives
• To provide an overview of the requirements of:
– ISO9001:2000
– ISO14001:1996
– OHSAS 18001:1999
• To provide a process-based approach to planning and implementation of an integrated Quality, Environmental and Health & Safety management system
• Demonstrate the use of proven quality tools to enhance the integration process
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Course Outline
1. Rationale for Integration
2. Brief Comparison of the Standards
3. Understanding the Requirements and their Relationships
4. The Process Approach - Strategies for Integration
5. Tools Used for Integration
Integrated Management Systems
A Rationale
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Management System Principles
• Customer focused organization• Leadership• Involvement of people• Process Approach• System Approach to management• Continual Improvement• Factual approach to decision making• Mutually beneficial supplier relationship
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Management System Process Model
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Rationale for Management Systems
ISO 9001:2000Customer Satisfaction & Competitive
Advantage
ISO 14001:1996Eliminate or Minimize Environmental Impact
OHSAS 18001:1999Eliminate or Minimize Physical Harm or
Damage
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Rationale for Integration
• Object of Each Standard is Reduction and Control of Variation in Processes Resulting in:– Product Non-Conformity and Waste– Injuries, Deaths and Property Damage– Environmental Impact and/or contamination
• System approaches to Management, Improvement and Control are the Same
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Benefits of Integration
• Focus– Integration of organization’s overall goals
and objectives
• Efficiency– Integration of Management planning,
realization & control processes
• Effectiveness– Application of proven quality management
tools to EMS and H&S
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Benefits of Integration
• Better Resource Management– Improve Resource utilization
• People, Equipment, Facilities, Materials, Energy
– Reduce Time Required• Minimal duplication of efforts
– Commonize Documentation• Integration & Simplification of procedures and instructions
– Cost avoidance/savings• Identification of cost reduction opportunities
– Employee empowerment• Easier to understand, follow and use
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Benefits of Integration
• Better Risk Management– Reduction, Prevention and Control of
• Quality failures• Accidents, injuries, illness, deaths• Property & equipment damage or loss• Environmental incidents and accidents• Potential prosecution and fines• Damage to Public image• Loss of Employee morale
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Benefits of Integration
• Competitive Edge–International markets
• Level playing field• Customer & Industry and Governmental standards
–Financial Performance–Insurance opportunities–Due diligence
Reduced Costs and Improved Profitability
Brief Comparison of the Standards
ISO 9001:2000
ISO 14001:1996
OHSAS 18001:1999
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BMS Stakeholders
• ISO 9001:2000: Customers, Suppliers
• EMS ISO14001: All interested parties– Employees, Customers, Suppliers & contractors,
public, regulatory authorities
• OHSAS 18001: Employees, contractors, visitors, regulatory authorities, trade/labor unions
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Shared Focus
Inputs/resources Organization Outputs Interested parties
equipmentsupplies
human resources
information resources
technology resources
natural resources
energy
financial resources
others
confidence
offered products
risks and effects onpeopleand environmentwastes, emissions
financial results
effects on employees
information
others
customers, society, owners
customers
customers, owners
society, customers, owners
owners, members/employees, suppliers
members/employees,ownerscustomers, society, owners
ISO 9001focus
Inputs/resources Organization Outputs Interested parties
equipmentsupplies
human resources
information resources
technology resources
natural resources
energy
financial resources
others
confidence
offered products
risks and effects onpeopleand environmentwastes, emissions
financial results
effects on employees
information
others
customers, society, owners
customers
customers, owners
society, customers, owners
owners, members/employees, suppliers
members/employees,ownerscustomers, society, owners
ISO 9001focus
ISO 9001
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Shared Focus
Inputs/resources Organization Outputs Interested parties
equipmentsupplies
human resources
information resources
technology resources
natural resources
energy
financial resources
others
confidence
offered products
risks and effects onpeopleand environmentwastes, emissions
financial results
effects on employees
information
others
customers, society, owners
customers
customers, owners
society, customers, owners
owners, members/employees, suppliers
members/employees,ownerscustomers, society, owners
OHSAS18001focus
Inputs/resources Organization Outputs Interested parties
equipmentsupplies
human resources
information resources
technology resources
natural resources
energy
financial resources
others
confidence
offered products
risks and effects onpeopleand environmentwastes, emissions
financial results
effects on employees
information
others
customers, society, owners
customers
customers, owners
society, customers, owners
owners, members/employees, suppliers
members/employees,ownerscustomers, society, owners
OHSAS18001focus
ISO 14001 & OHSAS 18001
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Structure of the Three Standards
• Part of overall Business Management System (BMS)
• All three standards, or systems follow the same management system process:– Plan (System, Processes and Resources)– Do (Operate Processes)– Check (Monitor, Measure and Analyze)– Act (Continually Improve)
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Structure of Three Standards
Policy (all require) Planning (identify)
• Continual improvement
• Meet requirements (customer or legal/other)
• Prevention (non-conforming product, pollution, accidents)
• Reference to objectives
• Customer and product requirements (9001)
• Environmental Aspects & Impacts (14001)
• Job Hazards and Risk assessment (18001)
Plan 4.2 Environmental Policy 4.2 OH&S Policy 5.3 Quality Policy
4.3.1 Environmental Aspects 4.3.1 Hazard identification & Risk assessment & control
4.3.2 Legal and Other Requirements
4.3.2 Legal and Other Requirements
4.3.3 Objectives and Targets 4.3.3 Objectives 5.4.1 Quality Objectives
4.3.4 Environmental Management Programs
4.3.4 OH&S Management Programs
5.4.2
8.5.1
Quality Management System PlanningContinual Improvement
14001 18001
5.27.2.17.2.2
Customer FocusDetermination of requirements related to productReview of requirements related to product
9001
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Structure of Three StandardsDo 4.4.1 Structure and Responsibility 4.4.1 Structure and Responsibility 5
6Management ResponsibilityResource Management
4.4.2 Training, Awareness, and Competence
4.4.2 Training, Awareness, and Competence
6.22 Competence, awareness & training
4.4.3 Communications 4.4.3 Consultation & Communication
5.5.37.2.3
Internal communicationCustomer communication
4.4.4 EMS Documentation 4.4.4 Documentation 4.2 Documentation requirements4.4.5 Document and Data Control 4.4.5 Document and Data Control 4.2.3 Control of documents4.4.6 Operational Control 4.4.6 Operational Control 7.1
7.27.37.47.5
Planning product realizationCustomer-related processesDesign & developmentPurchasingProduction & service provision
4.4.7 Emergency Preparedness and Response
4.4.7 Emergency Preparedness and Response
8.3 Control of nonconforming product
14001 18001 9001
Similarities Differences
• Management structure and resource allocation
• Training and communication
• Documentation and control of documents
• Process & operational controls
Emergency Response not directly addressed in 9001
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Structure of Three Standards
Check 4.5.1 Monitoring and Measurement 4.5.1 Performance Measurement & Monitoring
8.28.47.6
Monitoring & MeasurementAnalysis of dataControl of monitoring & measuring devices
4.5.2 Nonconformance and Corrective and Preventive Action
4.5.2 Accidents, Incidents, Nonconformance and Corrective and Preventive Action
8.38.5.28.5.3
Control of nonconforming productCorrective actionPreventative action
4.5.3 Records 4.5.3 Records & Record Management
4.2.4 Control of records
4.5.4 EMS Audit 4.5.4 Audit 8.2.2 Internal audit
14001 18001 9001
All share similar purpose and function in control, measurement &
Improvement
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Structure of Three Standards
Act 4.6 Management Review 4.6 Management Review 5.6 Management Review14001 18001 9001
All share similar purpose and function, and in all cases inputs & outputs
should be defined
Focus on Actions to Improve Results
3. Understanding the Requirements and their Relationships
Clause by clause analysis
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General Comments
• All three standards emphasize identification and compliance to regulatory and related requirements.
• ISO 9001 (Clauses 6.3 & 6.4) requires the provision of ‘infrastructure’, including proper management of the ‘work environment’.– This implies management of workplace health &
safety, and control of environmental impacts.
• The scopes ISO 14001 & OHSAS 18001 overlap:– ISO 14001 – ‘Environment’ includes Humans– OHSAS 18001 – ‘Hazard’ includes property damage &
damage to workplace environment.
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Potential for Integration
• We will now review the requirements of ISO 9001 by clause…
• and discuss/comment on the potential for integration of ISO14001 and OHSAS 18001 requirements within the Quality System structure. –ISO9000:2000 requirements are in BLACK
–ISO14001-96 requirements are in GREEN
–OHSAS18000 requirements are in BLUE
Note: The “checkmark” indicates comments regarding similarities and methods (best practices) for integration.
• Note: Within the three standards various comparison tables are available. However, caution must be taken as not to fall into the cross-reference table method trap only.
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ISO 9001- 4.0 Quality Management System
Intent– Describe the overall requirements of a
QMS• 4.1 General Requirements• 4.2 General Documentation Requirements
– Allows for some flexibility in extent of documentation
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ISO 9001 - 4.1 General Requirements
ISO 9001 - 4.1 • Outlines the overall requirements for a QMS. The
detailed requirements are contained in clauses 4.2, 5.0, 6.0, 7.0 and 8.0.
ISO14001 – 4.1• Overall requirements for an EMS.
Detailed requirements in clauses 4.2 through 4.6OHSAS 18001 – 4.1• Overall requirements for an OH&HSMS.
Detailed requirements in clauses 4.2 through 4.6
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ISO 9001- 4.2 Documentation Requirements
4.2.2 QualityManual
4.2.2 QualityManual
4.2.3 Control ofDocuments
4.2.3 Control ofDocuments
4.2.4 Control ofRecords
4.2.4 Control ofRecords
Quality ManualQuality Manual
List ControlledDocuments
List ControlledDocuments
ControlledDocuments
ControlledDocuments
List of RecordsList of Records
Records(in good
condition)
Records(in good
condition)
4.2DocumentationRequirements
4.2DocumentationRequirements
ISO14001 and OHSAS 18001 do not specifically require a Manual, but all other requirements apply
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ISO 9001 - 4.2.1 General Documentation Requirements
• Requirement for documented– quality policy (5.3) and quality objectives (5.4.1)– A quality manual– Documented procedures– Documents needed for the effective planning,
operation and control of processes – Records
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ISO 9001 - 4.2.2 Quality Manual• QMS Manual to include
– the scope of the QMS, and exclusions (see 1.2 Application);– documented procedures established for the QMS, or reference to
them; – description of the interaction between the processes of the QMS
• ISO 14001 & OHSAS 18001– Description of core elements of system & interaction (implies
scope)– Direction to related documentation– Policy Manual not specifically required– Some Elements require documented procedures or specific
records– OHSAS requires documentation to be kept to a minimum for
effectiveness and efficiency
All elements can be integrated into one manual
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ISO 9001 - 4.2.3 Control of Documents
• Documented procedure– Identification of required internal & external
documents– Approval, distribution controls, review & update– Retention requirements
• ISO14001[4.4.5] & OHSAS 18001[4.4.5]– Document control requirements are essentially
identical.– Documents maintained for legal purposes, identifiedAll required documents can be controlled via one
procedure or process.An enterprise-wide quality information software
system is the best approach
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ISO 9001 - 4.2.4 Control of Records
• Documented procedure– identification, storage, protection, retrieval, retention time
and disposition of records.– Records to be legible, readily identifiable and retrievable.
• ISO14001[4.5.3] & OHSAS 18001[4.5.3]– Record control requirements are essentially identical.
All required records can be controlled via one procedure or process.
An enterprise-wide quality information software system is the best approach
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Procedures / Processes to be Merged
Required Processes (Support Processes)1. Document Control*
2. Records*
3. Control of Nonconforming Product / Situations*
4. Corrective Action*
5. Preventive Action*
6. Internal Auditing*
7. Training & Competence
8. Management Review
*Organization shall have a documented procedure.
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Procedures / Processes to Merged
Possible Additional Procedures (Processes)1. Business Planning (BMS Control Plans)2. Objectives setting & review3. Quality Planning/Management Programs4. Identification of customer, regulatory and other
requirements5. New Product / Process Development6. Continual Improvement Process7. Measuring, Monitoring, Analysis of Data8. Equipment Maintenance, calibration and control 9. Contingency planning & Emergency preparedness &
response
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ISO 9001- 5.1 Management Commitment
• Evidenced by– Communicating importance of customer & legal
requirements– Establish Quality Policy– Establish Quality Objectives– Conduct Management Reviews– Ensure adequate resources.
• ISO14001 & OHSAS 18001– Corresponding requirements in
•Element 4.2 – Policy •Elements 4.3.3 – Objectives •Element 4.4.1 – Structure & Responsibility
Description of Management Responsibilities can be integrated for all three standards.
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ISO 9001- 5.2 Customer Focus
• Requirement to determine customer requirements– Details outlined in Clause 7.1 & 7.2 of Product
Realization– ISO14001
• Corresponding requirements in Element 4.3.1 – Environmental Aspects Element 4.3.2 – Legal & Other requirements
– OHSAS 18001• Corresponding requirements in
Element 4.3.1 – Hazard identification & risk assessmentElement 4.3.2 – Legal & Other requirements
Focus includes requirements of other stakeholders as well as those of customers.
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ISO 9001 – 5.3 Quality policy
• Requirement to develop & publish a Quality Policy– ISO14001 & OHSAS 18001 Corresponding requirements in Element 4.2
• Similar requirements for approval, communication, availability & review.
• Similar content requirements (improvement, meet requirements, prevent deficiencies, overall objectives)
Decision to publish separate policies or a combined policy should be based on ease of understanding by key stakeholders (employees)
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ISO 9001- 5.4.1 Quality Objectives
• Requirement to develop & review Quality Objectives– ISO14001 & OHSAS 18001 Corresponding requirements in Element 4.3.3
• Similar requirements for setting and reviewing objectives and measurable targets, considering established requirements and inputs.
Process for setting objectives and measurable targets should be integrated.
Some objectives may be linked.E.g. Scrap reduction (quality), Material/equipment damage (safety) and Waste reduction (environmental)
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ISO 9001- 5.4.2 Quality Planning
• Requirement to plan QMS & maintain integrity of QMS as result of changes to system– ISO14001 & OHSAS 18001
Corresponding requirements in Element 4.3.4 Environmental & OH&S management programmes
Process for planning and maintaining integrity is similar for all three standards.
Plans, arrangements and management programmes relating to all three standards should be developed and reviewed comprehensively.
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ISO 9001- 5.5.1 Responsibility & Authority
• Requirement to define and communicate responsibilities and authorities at all levels– ISO14001 & OHSAS 18001
Corresponding requirements in Element 4.4.1 Structure & Responsibility
Overall organizational structure and means of documenting/communicating responsibilities should be carefully coordinated to cover all three standards.
Consider a responsibility matrix. Include text and/or visual identifiers (symbols)
within the same document for each of the three systems
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ISO 9001- 5.5.2 Management Representative
• Requirement to appoint a management representative– ISO14001 & OHSAS 18001
Corresponding requirements in Element 4.4.1 Structure & Responsibility
Overall responsibilities are similar: “Implement, maintain and report”.
May or may not be the same individual.
Worker Representative (not necessarily related to implementation, reporting, etc.) required under OHSAS
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ISO 9001- 5.5.3 Internal communication
• Requirement establish internal communication process– ISO14001
Corresponding requirements in Element 4.4.3 Communication
– OHSAS 18001• Corresponding requirements in Element 4.4.3 Consultation
& CommunicationProcesses for communication from management to
employees about requirements, results, etc. should be integrated.
Processes for capturing communications from employees (concerns, suggestions, etc.) should also be integrated and documented.
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ISO 9001- 5.6 Management Review
• Requirement establish a Management Review process– Clauses 5.6.2 & 5.6.3 define both inputs and
outputs for review process.– ISO14001 & OHSAS 18001
Corresponding requirements in Element 4.6 Management Review
Management Review processes should be as integrated as possible, to enable more effective review of all relevant inputs, results, etc., and to enable more effective planning.
Top Management Reviews may derive from a series of low level meetings, but must be conducted by top management.
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ISO 9001- 6.1 Provision of resources
• Requirement determine and provide adequate resources to maintain and improve the system.
– ISO14001 & OHSAS 18001Corresponding requirements in Element 4.4.1 Structure & Responsibility
Resource planning, budgeting and allocation processes should be as integrated as possible.
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ISO 9001- 6.2 Competence, awareness & Training
• Requirement to determine training requirements, provide training, evaluate effectiveness and maintain records.– ISO14001 & OHSAS 18001
Corresponding requirements in Element 4.4.2 Training, Awareness & Competence.
All training requirements for the three standards should be managed under one training system.
All competencies can be defined and managed under one system.
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ISO 9001 – 6.3 Infrastructure requirements
• Requirement to provide and maintain buildings, workspace, utilities, equipment and support services.– ISO14001 & OHSAS 18001
Corresponding requirements in Element 4.4.1 Structure & Responsibility: provision of resources. Implies provision of infrastructure for fulfillment of the requirements of both standards.
Requirements under OHSAS (4.4.6) for process & equipment installation/design
The organization’s planning and budgeting processes should cover the requirements of all three standards.
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ISO 9001 – 6.4 Work environment
• Requirement to provide adequate work environment to satisfy the requirements.– ISO14001 & OHSAS 18001
Corresponding requirements in Element 4.4.1 Structure & Responsibility: provision of resources. Implies provision of suitable work environment.OHSAS 18001 specifically addresses planning and control of work environment (health, safety, ergonomics, etc.) – overall intent of the Specification
The organization’s planning and budgeting processes should cover the requirements of all three standards.
Implementation of the OHSAS 18001 requirements will assist in identification of work environment issues and controls.
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ISO 9001 – 7.1 Planning of product realization
• Requirement to plan and develop processes (procedures, documents, etc.) for product realization, monitoring schemes (measurements, sampling) and records.Linked to Quality objectives.– ISO14001 & OHSAS 18001
Corresponding requirements in Elements 4.3.1 Aspect/ Hazard Identification, 4.4.6 Operational Controls, 4.5.1 Monitoring & Measurement, and Element 4.5.3 Records.
Operational controls for EMS and OH&S shouldbe developed in concert with product realization processes to minimize duplication.
Operational controls for EMS and OH&S extend to all processes, not just product realization (e.g. building maintenance, cafeteria, landscaping, etc.)
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ISO 9001 – 7.2.1 Determination of product requirements
• Requirement to identify customer product specifications, and other related requirements, including regulatory requirements.– ISO14001 & OHSAS 18001
Corresponding requirements in Element 4.3.1 Environmental Aspects and impacts (Hazard identification, risk assessment and risk control) & Element 4.3.2 Legal and other requirements.
Includes applicable customer as well as other stakeholder requirements.
Process for identifying and maintaining the above requirements should be integrated.
The process planning section of this workshop provides a recommended method.
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ISO 9001 – 7.2.2 Review of Requirements Related to the Product
• Review process required to ensure product requirements are identified and current, including contract and order requirements.
• ISO14001 & OHSAS 18001Corresponding requirements in Element 4.3.1 Environmental Aspects and impacts (Hazard identification, risk assessment and risk control) & Element 4.3.2 Legal and other requirements.
These require a process for ongoing review of aspects and risks as a result of changes in requirements, products or processes.
Review and update of processes should be integrated to ensure all applicable requirements are systematically identified.
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ISO 9001 – 7.2.3 Customer Communication Requirements
• Process required to communicate with customers about product requirements, contract and order requirements, feedback & complaints.
• ISO14001 & OHSAS 18001Corresponding requirements in Element 4.4.3 Communications (external) (Consultation & Communication)
Some potential for integration of processes, keeping in mind that the scope of communications under ISO14001& OHSAS 18001 is broader than customers. (Government, community & other interested parties)
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ISO 9001 – 7.3 Design & Development
• Process consists ofPlanning (7.3.1) Inputs (7.3.2)Outputs (7.3.3) Review (7.3.4)Verification (7.3.5) Validation (7.3.6)Change control (7.3.7)
• ISO14001 & OHSAS 18001Corresponding requirements in Element 4.4.6 Operational controls to control environmental impacts and OH&S risks (includes design of process, equipment and installations to account for human factors).
Outputs from Aspects & Impacts (4.3.1), hazard identification & risk assessment (4.3.1) and identification of legal & other requirements (4.3.2) should be considered as inputs for design & development (7.3.2).
Conversely Outputs from design & development should provide for reevaluation of Aspects & Impacts and hazards & risks.
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ISO 9001 – 7.4 Purchasing
• Process consists of– Purchasing Process (7.4.1)– Purchasing Information (7.4.2)– Verification of Purchased Product (7.4.3)
• ISO14001 & OHSAS 18001Corresponding requirements in Element 4.4.6(c) Operational controls – communication to, and control of, suppliers & contractors to control environmental impacts and OH&S risks of purchased products or services.
Also the purchasing function should provide an input link to Aspects & Impacts (4.3.1), hazard identification & risk assessment (4.3.1) and identification of legal & other requirements (4.3.2).
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ISO 9001 – 7.5 Production & Service Provision
• Process consists of– Planning, Development and Provision of Product/Service– Control (7.5.1)– Validation (7.5.2)– Identification & Traceability(7.5.3)– Customer Property (7.5.4)– Preservation of product (7.5.5)
• ISO14001 & OHSAS 18001Corresponding requirements in Element 4.4.6 Operational controls control environmental impacts and OH&S risks relating to production & service provision.
Also outputs from Aspects & Impacts (4.3.1), hazard identification & risk assessment (4.3.1) and identification of legal & other requirements (4.3.2) should be considered as inputs for Production & Service controls (7.5.1).
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ISO 9001 – 7.6 Control of Monitoring & Measuring Devices/Technologies
• Process consists of– Processes for monitoring and sampling– Equipment calibration and safeguarding– Validation of measurement results
• ISO14001 & OHSAS 18001Corresponding requirements in Element 4.5.1 Monitoring & measurement (Performance measurement and monitoring) for– monitoring of activities and processes– Equipment Calibration
Monitoring and measurement processes may in some cases be common to all three systems.(e.g. a quality failure may also generate an environmental impact.)
Procedures for equipment calibration can be integrated.
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ISO 9001 – 8.2.1 Customer SatisfactionRequirements
• Requirement to monitor customer perception of satisfaction
• ISO14001 & OHSAS 18001No direct correspondence, although Element 4.4.3 – Communication (Consultation & Communication) provide a process for managing communications with internal & external stakeholders (complaints, concerns, etc.)
Some integration of processes for receiving and responding to relevant communications is possible, especially corrective and preventative action.
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ISO 9001 – 8.2.2 Internal Audit Requirements
• Requirement to conduct internal audits at planned intervals—audit effectiveness in practice
• ISO14001 & OHSAS 18001Corresponding requirements in Element 4.5.4 – EMS Audit (Audit)
Auditing methods, procedures and programs can be integrated.
Potential for cross-functional auditors (environmental & safety technical knowledge important)
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ISO 9001 – 8.2.3 Monitoring & Measurement of Processes
Requirement to monitor and measure QMS processes
• ISO14001 & OHSAS 18001Corresponding requirements in Element 4.5.1 – Monitoring &
Measurement (Performance measurement & monitoring)
Many of the processes involved would apply to all three standards. Planning of monitoring and measurement processes should be integrated.
Tracking of objectives & targetsMonitoring of critical activities & processes.
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ISO 9001 – 8.2.4 Monitoring & Measurement of Product
Requirement to monitor and measure characteristics of product towards conformity.
• ISO14001 & OHSAS 18001Corresponding requirements in Element 4.5.1 – Monitoring & Measurement (Performance measurement & monitoring), applicable where product or service itself presents either regulatory, environmental or H & S characteristics.
Planning of monitoring and measurement processes should be integrated.
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ISO 9001 – 8.3 Control of Nonconforming Product
• Requirement to identify and control nonconforming product.
• Linked to 8.5.2 – Corrective Action & 8.5.3 – Preventative Action
• ISO14001 & OHSAS 18001No direct correspondence, unless nonconforming product presents an environmental impact or an H & S hazard at the facility.
Element 4.5.2 – Nonconformance, corrective & preventative Action (Accidents, incidents, nonconformances & corrective & preventative action)
The processes for handling and resolving nonconformities are similar, and can be integrated.
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ISO 9001 – 8.4 Analysis of Data
• Requirement to collect and analyze data from monitoring and other sources to demonstrate effectiveness of QMS and identify opportunities for improvement.
• ISO14001 & OHSAS 18001Corresponding requirements in Element 4.5.1 – Monitoring & Measurement (Performance measurement & monitoring) (monitor key characteristics of it’s operations) and 4.6 (necessary information is collected for management review)
The processes for analysis of data are implied in ISO14001 & OHSAS 18001. Adoption of QMS methodology would strengthen effectiveness of all three systems.
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ISO 9001 – 8.5.1 Continual Improvement
• Requirement to continually improve the effectiveness of the QMS.
• ISO14001 & OHSAS 18001Corresponding requirements in Elements 4.3.3 – Objectives and Targets (Objectives), and Element 4.3.4 – Environmental Management Programmes (OH&S Management Programmes)
The processes are similar for all three standards: Use of the policy, objectives, audit results, analysis
of data, corrective and preventive actions and management review.
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ISO 9001 – 8.5.2 Corrective Action
Requirement identify and correct nonconformities.• Links to Clause 8.5.3 – Preventative Action
• ISO14001 & OHSAS 18001Corresponding requirements in Element 4.5.2 – Nonconformance,
corrective & preventative Action (Accidents, incidents, nonconformance’s & corrective & preventative action)
The processes and methodology are similar for all three standards, and can be fully integrated.
Proper root cause analysis is essential. OHSAS requirement to put proposed corrective
actions through the risk assessment process.
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ISO 9001 – 8.5.3 Preventive Action
• Requirement identify and prevent potential nonconformities.– Links to Clause 8.5.2 – Corrective Action
• ISO14001 & OHSAS 18001Corresponding requirements in Element 4.5.2 – Nonconformance, corrective & preventative Action (Accidents, incidents, nonconformance’s & corrective & preventative action)
The processes and methodology are similar for all three standards, and can be fully integrated.
Proper root cause analysis is essential. OHSAS requirement to put proposed preventative actions
through the risk assessment process.
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Requirements Not Incorporated into ISO 9001:2000
• 2 Requirements found in ISO14001 & OHSAS 18001 and not covered by ISO 9000:2000
• 4.4.7 – Emergency Preparedness & Response– Identification of potential incidents and emergency
situations, response plan, and investigation.
• 4.5.1 – Monitoring (auditing) compliance to applicable regulations
Both requirements can still be integrated into the overall system.
Strategies for Integration
The Process Approach
Establish the Processes
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Where to Start – The Process Approach
• The first step is to structure your QMS using the ISO 9001:2000 process approach model– Some organizations may already have completed
this fundamental shift from the old element based QMS to the process based system
– Breakdown department barriers– Identify and document your “Key Processes”– Understand there are different types of processes
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Different types of Processes
• OMNEX believes there are several types of processes– Customer Oriented Processes (COPs)
• COP’s can be within the other types of processes as well
– Management Oriented Processes (MOPs)– Support Processes (SOPs)– Product Realization Process– System Processes
• Types (names & categories) of process will vary from one organization to another
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Where to Start – The Process Approach
• Next, are all processes required by ISO 14001 and OHSAS 18001 effectively implemented?
• Identify customer, legal, and regulatory inputs and outputs within the various processes. These are sometimes called “Customer Related Processes (COP’s)”
• Analyze the processes:– Define Process– Eliminate redundancies– Eliminate waste– Improve effectiveness & efficiency
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Process Characteristics
• A process can be identified by a series of unique, but consistent, characteristics. There are six characteristics of a process that are mandatory for effective quality management.– A process owner exists
– The process is defined
– The process is documented
– The linkages of the process are established
– The process is monitored and improved
– Records are maintained
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Reminder
• Note, not all process have a direct impact on the quality of the product or service you provide.
• However they must be part of your integrated system. Some examples are:
– Building and property maintenance (internal and external), miscellaneous products, safety & fire systems (internal and external), disposal/recycling of non-production waste, biohazards, emergency response, disaster recovery, etc.
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Process Focus
Sequence and Interaction of Processes
Source: ISO 9000:2000 CD2
PROCESS AOutput A/Control B
PROCESS B PROCESS COutput B
Input C
Mechanism B
Output C
Control C
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Process Focus Vs. Department Focus
AccountingHumanResources
OperationsPurchasing Sales
Top Management
Result Measurables
Process Variation Outputs
Process A
Processes, not Departments, Drive Performance
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CleaningMarketing StampingDesign Finishing Packaging Shipping
Maintenance CompliancePurchasing Training
InternalAuditing
Corrective /Preventive
Action
QualityPlanning
ManagementReview
CustomerSatisfaction
QualityObjectives
DocumentControl
DataControl
Support Processes
Realization Processes
QMS Processes
CleaningMarketing StampingDesign Finishing Packaging Shipping
Maintenance CompliancePurchasing Training
InternalAuditing
Corrective /Preventive
Action
QualityPlanning
ManagementReview
CustomerSatisfaction
QualityObjectives
DocumentControl
DataControl
Support Processes
Realization Processes
QMS Processes
Sequence & Interaction of Processes –A Process Map Example
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Detailed Integration
• Address the detailed requirement of all three standards• As the processes are established, analyzed, and
improved, it is much easier to address all the requirements of all three standards
• Review the detailed comparison in the previous sections
• There are many tools to assist in understanding how to continuously analyze, monitor, measure, and improve these processes (following chapter)
• ALL PROCESSES SHOULD BE IMPROVED
Defining Quality Policy and Objectives
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Establishing Policy & Objectives
• All three standards require us to establish, implement, communicate, and continually improve through the use of Policies & Objective
• We must:• Describe the need and process for defining a
quality policy• Define the process for gathering and analyzing
customer, regulator, legal and stakeholder needs and expectations
• Identify a method for going from “expectations and needs” to objectives
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Customers
Customers
Managementresponsibility
Measurement,analysis andimprovement
Resourcemanagement
Requirements
Satisfaction
ProductProductrealization
Input Output
Continual improvement of thequality management system
Key
Value-adding activities
Information flow
Figure 1 - Model of a process-based quality management system
© ISO 2000
5.2 Customer Focus5.3 Quality Policy5.4.1 Quality Objectives
8.2.1 Customer Satisfaction
ISO 9001 Quality Policy & Objectives
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Customer Requirements
Quality/Business Objectives
Quality/Business Planning
Processes
Customer Requirements
Quality/Business Objectives
Quality/Business Planning
Processes
Links Between Customer Requirements and Processes
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Quality, Environmental and OHSAS Objectives & Measurables (example)
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• Who is the customer?– Product and service purchasers
– Product and service users
– Financial stakeholders
– Employees
– Government
• What is a Requirement?– Need or expectation of external entities– The key to stakeholder satisfaction– The focus of continual improvement activities
Interested Parties
Customer = Recipient of a product
Example: Consumer, End User, Retailer, Beneficiary, Purchaser
A customer can be internal or external to the organization
Determining Stakeholder Requirements
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Rate Customer Requirements (Example)
• Rate the Requirements to establish priorities– Rating criteria
5 Crucial: may result in near term loss of business, shutdown, business failure, etc.
4 Very Important: may become a “5” in 18 months to 2 years3 Important: not to be taken too lightly or to be ignored, but
lower priority2 Somewhat Important: be aware of these, particularly if they
are easy to satisfy1 Low Priority
• Evaluate from the Customer’s Perspective• Seek Additional Information• A more detailed analysis may be done, chapter 5.
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Objectives for All Areas of Performance
• Remember the differing focus and rationale of each of the three management standards:
• QMS deals mainly with:– Quality– Cost– Delivery– Some safety and controlled substances
• EMS deals with Environmental:– Aspects– Impacts
• HSMS addresses accident, injury and health:– Hazards– Risks
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Business Control Plan
• A simple method of gathering objective and deploying them throughout the organization in order to:– Identify the source of the requirement or expectation– Link objectives (QMS, BMS, HSMS) to key processes– Indicated the importance of the objective– Establish responsible and authority (Empowerment)– Set goals & targets– Reporting frequency– Show relationships between Quality, Environmental, OH&S– Improve communication– Establish control methods– Indicate improvement actions
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Business Management System Control Plan (ADD EMS & HSMS)
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The Shift to Empowerment
• In the quality field, the shift to empowerment is almost complete:– Quality is everyone’s responsibility, and – The quality professional is there to provide technical
assistance to the entire organization.
• This same empowerment shift must take place within the environmental & OHS field:– Top Management must drive quality, environmental
and OHS system (a true Business System).– All individuals must understand their role within this
new integrated system and be given the authority to improve all areas of their processes.
System Integration
Tools & Methodologies
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Process Planning Tools
• Now we must look at how we analysis and control our Production, Manufacturing, and/or Service processes in more detail.– The value add process– What we get paid to do– Product Realization & core business
• Cross-functional teams are established for:– New product/service development, and– On-going production/services
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Process Planning Tools
• Quality tools used mainly in manufacturing can now be used within the entire BMS
• Tools of most use are:– Fishbone Diagrams (Sources of Variation)– Process Flow Diagrams– Failure Mode & Effects Analysis– Control Plans
• These tools will integrate all three systems
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Fishbone Diagram – Sources of Variation
VariationInput
Equipment
Machine
Material Holding
Fixture
Tooling
Materials
Metallurgy
Chemistry
Dimensions
Ergonomics
PreventiveMaintenance
Set-up
Methods &Systems
MeasurementSystems
Instructions
Cleanliness
Humidity
Environment
AmbientTemperature
Lighting
OperationVariation
Teamwork
People
Training/Knowledge
Communications
Teamwork l Continual Improvement
Continual Improvement Loop
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Process Flow
Process Flow Diagram
11
05
10A
20-1 20-2
50
40
30-1 30-2 30-3
10B
35
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PFMEA Conceptual OverviewPart/
Process/Purpose
CurrentControl
CurrentControl
CurrentControl
CauseEffectsProcessFailure
Cause
CurrentControl
RecommendedAction
RecommendedAction
RecommendedAction
RecommendedAction
CurrentControl
CurrentControl
CurrentControl
CauseEffectsProcessFailure
Cause
CurrentControl
RecommendedAction
RecommendedAction
RecommendedAction
RecommendedAction
Risk
Risk
Risk
Risk
Risk
Risk
Risk
RiskPCIDChar
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Process Planning System Diagram
ProcessFlow
Requirements(ex: specifications,
designperformancespecification,
protoype requirementProcess parameters,Sources of variation,
Design matrixCustomer prints and/or CAD transmissions
In-process printsPlant layout
Problem reports andlogs
System and/or designFMEA
Process FMEA from asimilar product or
processContract review and
feasibilitySpecial product and
processcharacteristics matrix)
Associate PCswith Operational Steps
ProcessFMEA
IdentifyProcess
Characteristics(sources/causes
of variation)
8-D
Action Plan
IdentifyRoot Cause
ControlPlan
WorkInstructions
ISO/TS 16949Procedures
Identify Product Characteristics
OP10
OP20
OP30
Implement ControlStrategy
ImplementProcess
Improvements
SPC
Verify and Validate
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Example of a EMS Control PlanEMS Control Plan
Control Plan Number: Key Contact/Phone: Date (original): Date (Revised):
Location/Department: Core Team: Other Approval/Date (IF Required):
Process Name/Activity
Characterics/AspectsRegulatory
CharacteristicsClass*
Methods
Objective/Target
EvaluationMeasurement
Technique
SampleSize Freq.
ControlMethod
ReactionPlan
*R - RegulatoryS - SignificantM - Medium
FumesMelting aluminum
Storm drain pollution
RReduce
emissions by25%
Airsampling
StandardOnceper
month
Monitorsamples
Chagefilters
Macine cast parts R Zeropollution
Watersampling
Sixsamples
Onceper
month
Monitorsamples
Adjusttreatment
EMS Control PlanControl Plan Number: Key Contact/Phone: Date (original): Date (Revised):
Location/Department: Core Team: Other Approval/Date (IF Required):
Process Name/Activity
Characterics/AspectsRegulatory
CharacteristicsClass*
Methods
Objective/Target
EvaluationMeasurement
Technique
SampleSize Freq.
ControlMethod
ReactionPlan
*R - RegulatoryS - SignificantM - Medium
FumesMelting aluminum
Storm drain pollution
RReduce
emissions by25%
Airsampling
StandardOnceper
month
Monitorsamples
Chagefilters
Macine cast parts R Zeropollution
Watersampling
Sixsamples
Onceper
month
Monitorsamples
Adjusttreatment
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Example of a HSMS Control Plan
OH&SMS Control PlanControl Plan Number: Key Contact/Phone: Date (original): Date (Revised):
Location/Department: Core Team: Other Approval/Date (IF Required):
Process/Activity/Condition
Characterics/HazardRegulatoryCharacter-
istics Class*
Methods
Objective/Target Evaluation
Measure-ment
Technique
Sample
Size Freq.ControlMethod
ReactionPlan
*R - RegulatoryI - Intolerable RiskT - Tolerable
ArcWelding I Zero Eyeinjuries
Incidents AllOn-
goingCurtainGoggles
Treat-ment
OH&SMS Control PlanControl Plan Number: Key Contact/Phone: Date (original): Date (Revised):
Location/Department: Core Team: Other Approval/Date (IF Required):
Process/Activity/Condition
Characterics/HazardRegulatoryCharacter-
istics Class*
Methods
Objective/Target Evaluation
Measure-ment
Technique
Sample
Size Freq.ControlMethod
ReactionPlan
*R - RegulatoryI - Intolerable RiskT - Tolerable
ArcWelding I Zero Eyeinjuries
Incidents AllOn-
goingCurtainGoggles
Treat-ment
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Activities, Products or
Services
Legal and other requirements Environmental Policy Operation
and business requirements. Views of Interested Parties
Identify Environmental Aspects (4.3.1)
OP10
Associate Environmental Aspects with Activities, Products or Services (Inputs and Outputs)
EMS FMEA
Action Plan
Identify Significant Aspects and Inpacts
Implement and Define: Objectives &
Targets EMP's Operational
Controls EPR's
Control Plan
Implement Operational
Controls and EP&R
Work Instructions
EMSProcedures
Monitoring and Measuring
Nonconformance & Corrective Preventive
Action
QOS
OP20
OP30
Continual Improvement
(EMP's)
Environmental Performance Measuables
---------Systemic Causation
Process Control
Continual Improvement
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Review
1. Rationale for Integration
2. Brief Comparison of the Standards
3. Understanding the Requirements and their Relationships
4. The Process Approach - Strategies for Integration
5. Tools Used for Integration
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Thank You Thank You !!
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