Integrating QMS and EMS

Linking ISO 9000:2000/TS 16949:2002 based QMS and ISO 14000 based EMS

North Shore Management Systems Inc. AQSR Windsor

Presenters: Jeff Greaves and Branko Dimitrijevic

Integrating QMS and EMS 1

Presentation Objectives
Quality and Environmental background for ISO 9000 and ISO 14000 Understanding needs for different management systems, Common requirements between ISO/TS 16949 and ISO 14000, Implementation tips for developing combined QMS and EMS, Performing combined QMS and EMS audits.

Integrating QMS and EMS 2

Quality Background - History

Management Responsibility TQM QA TQC QC 1900 SPC 30 50-70 80 90 Time Prevention

Integrating QMS and EMS 3

Quality Background of the ISO 9000 Standards - TQM

TQM is: the management approach of an organization centered on quality, based on the participation of all its members and aiming at long-term success through customer satisfaction, and benefits to all members of the organization and to society.

Integrating QMS and EMS 4

History of Environmental Awareness And Concern

Pre-1970
Industrial revolution led to exploitation of natural resources and technology to mass produce energy and manufactured commodities for human use Generated waste materials were often discarded with little or no thought of environmental consequences Millions of gallons and tonnes of gaseous, liquid and solid waste were deposited into the air, ground and water bodies over a 75 to 100 year period

Late 60s/Early 70s

The United States enacts comprehensive air and water laws and regulations to help prevent further deterioration of air and water quality The United States Environmental Protection Agency (USEPA) is created to administer and enforce environmental laws/regulations to safeguard the environment
Integrating QMS and EMS 5

History of Environmental Awareness And Concern

Early 70s
Love Canal incident occurs in Niagara falls, New York - local residents discover that their neighbourhoods (homes, schools, etc.) are built on top of a toxic waste site High incidents of cancer and other related illnesses are attributed to the toxic waste Both the public and government are shocked to discover the extent of toxic chemicals and wastes that were deposited into the ground The area is subsequently evacuated, all buildings are demolished, and the area is permanently quarantined The area continues to remain quarantined - environmental testing and monitoring will likely continue to occur over the next 100 years

Integrating QMS and EMS 6

History of Environmental Awareness And Concern

1980
The United States government recognizes that there are hundreds of abandoned toxic waste sites, similar to Love Canal, throughout the U.S. The USEPA identifies what are considered to be the most toxic abandoned hazardous waste sites across the country and lists them on a registry entitled the National Priorities List (NPL) The U.S. Congress enacts a strict new law for toxic waste sites (CERCLA) and sets aside $2.2 billion (referred to as the Superfund) for the investigation and cleanup of NPL sites

1986
The money in the Superfund is almost depleted due to the vast number of NPL sites (also referred to as Superfund sites) and the costs associated with investigations and cleanups The U.S. Congress enacts more strict environmental laws for polluters (SARA) and sets aside an additional $6.6 billion for the Superfund
Integrating QMS and EMS 7

History of Environmental Awareness And Concern

Late 80s
Directors and officers of large corporations recognize that they may be personally liable for environmental offences committed by their organization Environmental consultants are hired by directors to conduct compliance reviews/audits of organizations to identify where environmental laws are being violated, and to recommend measures to correct the situations and achieve compliance

Early to Mid 90s

Environmental compliance audits are completed for numerous organizations - unfortunately, many of the recommendations to achieve compliance are ignored There are no management systems in place to review, prioritize, implement and monitor the effectiveness of the recommendations and investigate the initial cause of noncompliance and implement measures to prevent its recurrence
Integrating QMS and EMS 8

History of Environmental Awareness And Concern

1996
The ISO 14000 Standards are published (final version) by the International Organization for Standardization The standards stipulate requirements for the implementation of environmental management systems designed to enable organizations to control the environmental impacts associated with their activities, products and/or services

Late 90s/Early 2000

OEMs obtain ISO 14001 registration and impose deadlines for all Tier 1 suppliers to achieve ISO 14001 registration OEMs threaten to remove non-registered suppliers (after the imposed deadlines) from their approved supplier lists

Integrating QMS and EMS 9

ISO Standards

What does the ISO stand for?

Integrating QMS and EMS 10

ISO Standards

International Organization for Standardization - Geneva, Switzerland

Integrating QMS and EMS 11

ISO 9000/QS-9000/TS 16949 History and Changes

1987 1994 1995 1998 1999 2000 2002 2003 2006 ISO 9000:1994 ISO 9000:2000 QS-9000:1998 TS 16949:2002
Integrating QMS and EMS 12

Business Stakeholders
Who has an interest in your business? Who are the stakeholders of any business?

Integrating QMS and EMS 13

Business Stakeholders
Customers/Clients Public/Surrounding Community Government/Regulatory Bodies Insurers Financial Institutions/Lenders Shareholders Management Employees Everyone!
Integrating QMS and EMS 14

QMS and EMS Definitions

Importance of definitions ISO 9000:2000 QMS - Fundamentals and vocabulary (replaces ISO 8402 ) ISO 14004 EMS General guidelines on principles, systems and supporting techniques

Integrating QMS and EMS 15

Importance of Definitions

Integrating QMS and EMS 16

Definitions
system management system quality management system quality control quality management quality assurance effectiveness
Integrating QMS and EMS 17

management

top management quality policy

quality objectives continual improvement quality improvement efficiency

quality planning

QMS Definition - ISO 9000

Quality management system:
the part of the organizations management system that focuses on the achievement of results, in relation to the quality objectives, to satisfy the needs, expectations and requirements of interested parties, as appropriate.

Integrating QMS and EMS 18

EMS Definition - ISO 14001

Environmental management system:
the part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.

Integrating QMS and EMS 19

Management System Integration

ISO 9001:2000
0.4 Compatibility with other management systems
This International Standard (ISO 9000:2000) has been aligned with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the user community. This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management or risk management. However, this International Standard enables an organization to align or integrate its own QMS with related management system requirements.
Integrating QMS and EMS 20

ISO/TS 16949 8 QMS Principles

Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships
Integrating QMS and EMS 21

ISO 14000 5 EMS Principles and Elements

Commitment and policy Planning Implementation Measurement and evaluation Review and Improvement

Integrating QMS and EMS 22

Continual Improvement Cycle

PDCA Cycle of Continual Improvement

A C

P D
Integrating QMS and EMS 23

ISO 9000/TS 16949

ISO 9000:2000 - Major difference is Business Process Model
4.0 QMS Continual Improvement 5.0 Management Responsibility 6.0 Resources Management input 8.0 Measurement, analysis and improvement Customers (and other interested parties) Satisfaction

Customers (and other interested parties) Reqnts

7.0 Product Product Realization out

Integrating QMS and EMS 24

ISO 9000/TS 16949

20 clauses have become five major Sections : Quality Management System Management Responsibility Resource Management Product Realization

(processes, documentation, control of documents & records ) (commitment, customer focus, policy, objectives, mgmt. review, internal communication ) (human resources, infrastructure, work environment) (planning, customer requirements, customer communication, design, purchasing, production, identification, calibration) (monitoring, customer satisfaction, audit, control of NC, analysis of data, continual improvement )
Integrating QMS and EMS 25

Measurement, Analysis and Improvement

ISO 14001 Elements

4.1 General requirements 4.2 Environmental policy 4.3 Planning 4.3.1 Environmental aspects 4.3.2 Legal and other requirements 4.3.3 Objectives and targets 4.3.4 Environmental management programme(s) 4.4 Implementation and operation 4.4.1 Structure and responsibility 4.4.2 Training, awareness and competence 4.4.3 Communication 4.4.4 EMS documentation 4.4.5 Document control 4.4.6 Operational control 4.4.7 Emergency preparedness and response 4.5 Checking and corrective action 4.5.1 Monitoring and measurement 4.5.2 Nonconformance and CA/PA 4.5.3 Records 4.5.4 EMS audit 4.6 Management review

Integrating QMS and EMS 26

ISO 14001 Elements

Act
Management Review

Plan

Check
Checking & Corrective Action Monitoring & Measuring Nonconformances Records Audit

A P C D
Do

Environmental Policy Aspects/Impacts Legal Requirements Objectives & Targets EMPs

Implementation & Operations Responsibility Training Communication Document Control Operational Control Emergency Response

Integrating QMS and EMS 27

Common requirements between ISO/TS 16949 and ISO 14000

ISO 9001 / TS 16949 4.1 General requirements Identifying QMS Processes ISO 14001 4.3 Planning 4.3.1 Environmental Aspects 4.3.2 Legal and other requirements 4.4.4 EMS Documentation

4.2 Documentation requirements 4.2.3 Control of documents 4.2.4 Control of records

4.4.5 Documentation Control 4.5.3 Records

Integrating QMS and EMS 28

Common requirements between ISO/TS 16949 and ISO 14000

ISO 9001 / TS 16949 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy Appropriate Commitment to comply with requirements and CI
Framework for objectives

Communicated and understood Reviewed for continuing suitability

ISO 14001 4.2 Environmental Policy Appropriate Commitment to CI and prevention of polution Commitment to comply with legal and other requirements Framework for objectives Documented, implemented, maintained, communicated Available to public

Integrating QMS and EMS 29

Common requirements between ISO/TS 16949 and ISO 14000

ISO 9001 / TS 16949
5.4 Planning 5.4.1 Quality objectives 5.4.2 Quality management system planning Quality objectives established at relevant functions and levels Business Plan ISO 14001 4.3.3 Objectives and Targets Objectives and targets shall be established, maintained and documented at each relevant function and level within the organization 4.3.4 EM Programme(s ) Responsibilities assigned Means and time-frame established

Integrating QMS and EMS 30

10

Common requirements between ISO/TS 16949 and ISO 14000

ISO 9001 / TS 16949 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority 5.5.1.1 Responsibility for quality 5.5.2 Management rep. 5.5.2.1 Customer rep. 5.5.3 Internal communication ISO 14001 4.4.1 Structure and responsibility Roles defined , documented and communicated Resources provided EMS Management Representative

4.4.3 Communication

Integrating QMS and EMS 31

Common requirements between ISO/TS 16949 and ISO 14000

ISO 9001 / TS 16949 5.6 Management review 5.6.1 General 5.6.1.1 Quality management system performance 5.6.2 Review input 5.6.2.1 Review input Supplemental 5.6.3 Review output ISO 14001 4.6 Management Review

Integrating QMS and EMS 32

Common requirements between ISO/TS 16949 and ISO 14000

ISO 9001 / TS 16949 6.1 Provision of resources 6.2 Human resources 6.2.1 General 6.2.2 Competence, awareness and training 6.2.2.1 Product design skills 6.2.2.2 Training 6.2.2.3 Training on the job 6.2.2.4 Employee motivation and empowerment ISO 14001 4.4.2 Training, Awareness and Competence Employees aware of importance of conforming with env. policy and procedures and requirements of the EMS significant environmental impacts, their roles and responsibilities in potential consequences

Integrating QMS and EMS 33

11

Common requirements between ISO/TS 16949 and ISO 14000

ISO 9001 / TS 16949
6.3 Infrastructure 6.3.1 Plant, facility and equipment planning 6.3.2 Contingency plans 6.4 Work environment 6.4.1 Personnel safety to achieve product quality 6.4.2 Cleanliness of premises ISO 14001 4.4.1 Structure and Responsibility Resources provided 4.4.7 Emergency preparedness and response

Integrating QMS and EMS 34

Common requirements between ISO/TS 16949 and ISO 14000

ISO 9001 / TS 16949
7 Product Realization 7.1 Planning / APQP 7.2 Determining and Reviewing Customer Reqs 7.3 Product and Process Design 7.4 Purchasing 7.5 Production and Service Provision 7.6 Control of Measuring and monitoring devices ISO 14001 4.4.6 Operational Control Identify operations that are associated with significant aspects Plan these activities including documenting procedures, stipulating operating criteria, communication to suppliers and subcontractors 4.5.1 Monitoring and Measurement

Integrating QMS and EMS 35

Common requirements between ISO/TS 16949 and ISO 14000

ISO 9001 / TS 16949 8.1 General 8.1.1 Identification of statistical tools 8.1.2 Knowledge of basic statistical concepts 8.2 Monitoring and measurement 8.2.1 Customer satisfaction ISO 14001 4.5.1 Monitoring and Measurement 4.6 Management Review

Integrating QMS and EMS 36

12

Common requirements between ISO/TS 16949 and ISO 14000

ISO 9001 / TS 16949 8.2.2 Internal audit 8.2.2.1 Quality management system audit 8.2.2.2 Manufacturing process audit 8.2.2.3 Product audit 8.2.2.4 Internal audit plans 8.2.2.5 Internal auditor qualification

ISO 14001 4.5.4 EMS Audit

Integrating QMS and EMS 37

Common requirements between ISO/TS 16949 and ISO 14000

ISO 9001 / TS 16949 8.2.3 Monitoring and measurement of processes 8.2.3.1 Monitoring and measurement of manufacturing processes 8.2.4 Monitoring and measurement of product 8.2.4.1 Layout inspection and functional testing 8.2.4.2 Appearance items
Integrating QMS and EMS 38

ISO 14001 4.5.1 Monitoring and Measurement 4.6 Management Review

Common requirements between ISO/TS 16949 and ISO 14000

ISO 9001 / TS 16949 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement 8.5.1 Continual improvement 8.5.2 Corrective action 8.5.2 Preventive action ISO 14001 4.5.1 Monitoring and Measurement 4.5.2 Nonconformance and corrective and preventive action 4.6 Management Review

Integrating QMS and EMS 39

13

Common activities/documentation between EMS and QMS

Policy Management Review CI Structure Internal Audit CA/PA Operational Control

Integrating QMS and EMS 40

ISO/TS 16949 Documentation

Level 1 Level 2 Level 3 Quality (Policy) Manual Procedures Job or Work instructions External Docs. Forms Drawings Regulations Sales Design Purchasing Manufacturing

Level 4

Business Processes
Integrating QMS and EMS 41

Integrating EMS and QMS Benefits

Facilitate Planning Allocation of resources Definition of complementary objectives Evaluation of the overall effectiveness

Integrating QMS and EMS 42

14

Integrating EMS and QMS Audit

ISO 19011:2002 Guidelines for quality and/or environmental management systems auditing ISO/TS 16949 Customer Oriented Processes Support Processes Use of Turtle diagrams

Integrating QMS and EMS 43

Integrating EMS and QMS Audit

Use of Turtle diagrams
Equipment People

input

Process
Methods Measurables

output

Integrating QMS and EMS 44

Integrating EMS and QMS Audit

Integrated external audits

Integrating QMS and EMS 45

15

Integrating EMS and QMS

Questions
Jeff Greaves jgreaves@aqsr.com , 519-726-9669 Branko Dimitrijevic brankod@aqsr.com , 519-726-9669 Harold Jean hjean@aqsr.com, 519-726-9669
Integrating QMS and EMS 46

16