INTEGRATED MANAGEMENT SYSTEMS LECTURE 1 General presentation of integrated systems. Reasons to develop an integrated system

1
INTEGRATED MANAGEMENT SYSTEMSLECTURE 1General
presentation of integrated systems. Reasons to
develop an integrated system

• by
• Prof. Liviu MOLDOVAN
• Department of Technological and Managerial
  Engineering, Petru Maior University of
  Targu-Mures, Romania

2

• Number of Credits 4
• Method of Delivery Face to face
• Lectures/Tutorials   20 (10 x 2) hours
• Laboratory sessions  12 (3 x4) hours 
• Competences Acquired This study unit should
  provide the student with sufficient knowledge and
  understanding of the integrated management
  systems quality, environment, health and safety,
  especially the practical aspects applied in HT
  and SE profile enterprises.

3
Syllabus 10 LECTURES

• 1. General presentation of integrated systems.
  Reasons to develop an integrated management
  system.
• 2. General presentation of the standards for
  quality (ISO9000), environment (ISO14000) and
  specifications for health and safety (OHSAS18001,
  18002).
• 3. Process approach parameters of processes,
  metrics for processes, process objectives,
  indicators, process procedures (flowchart).
• 4. Methods for analysis and evaluation of
  quality Ishikawa diagram, Pareto Diagram,
  Demerits methodology, Histograms, QFD (Quality
  Function Deployment), FMEA (Failure Mode and
  Effects Analysis).
• 5. Statistical methods (analysis of capability
  and stability), 6sigma.

4

• 6. Economical aspects of quality. The quality
  costs structure prevention costs, evaluating
  costs, defecting costs (external, internal),
  demonstrating costs.
• 7. Environmental management EU norms for
  Environmental management, processes with impact
  on environment, determination of processes with
  significant impact on environment, operational
  control of processes with significant impact on
  environment.
• 8. Health and safety the calculus of risks in
  workspace with HT and SE. Operational control of
  work places with high risk, processes/substances
  with high risk.
• 9. General procedures required by the integrated
  systems document control, registration control,
  treatment of unconformities, corrective actions,
  preventive actions.
• 10. Auditing of systems documentation,
  techniques, methodology, reporting. The
  management of corrective actions.

5
LECTURE 1 - General
presentation of integrated systems. - Reasons to
develop an integrated management system.

• OBJECTIVES for lecture 1
• To understand the scope of management systems
  why is important to develop a management systems
  
• Introduction in the ISO families 9000 and 14000
• Benefits of ISO 9001 and ISO 14001
• Quality system documentation the structure of
  documentation quality manual, operational
  procedures, working instructions, records
• Improvement and effectiveness in quality
  management systems
• Certification, registration, accreditation.

6
Management systems

• To be really efficient and effective, the
  organization can manage its way of doing things
  by systemizing it.
• Nothing important is left out.
• Everyone is clear about who is responsible for
  doing what, when, how, why and where.
• Management system standards provide the
  organization with an international,
  state-of-the-art model to follow.

7
Management systems (cont.)

• Large organizations, or ones with complicated
  processes, could not function well without
  management systems.
• Companies in such fields as aerospace,
  automobiles, defence, or health care devices have
  been operating management systems for years.
• The ISO 9001 and ISO 14001 management system
  standards now make these successful practices
  available for all organizations.

8
Why is this Important to (my) Organization?

• Better management
• Comprehensive and systematic approach to target
  setting and implementation of improvements
• Clear picture of responsibilities and roles of
  all actors in (and outside) of the organization
• User friendly only one system and not a handful

9
Success Factors (Pre-requisites)

• Know your organization, your processes, your
  products and your customers and other interested
  parties,
• Decide where you want to go and how (vision and
  mission),
• Specify by setting objectives and targets,
• Clarify roles and responsibilities for action
  using procedures, instructions and action plans,
• Measure progress (very) regularly and make
  revisions when needed,
• Communicate internally and externally.

10
ISO 9001 and ISO 14001 in brief

• ISO 9001 and ISO 14001 are among ISO's most well
  known standards ever.
• They are implemented by some 887 770
  organizations in 161 countries.
• ISO 9001 helps organizations to implement quality
  management.
• ISO 14001 helps organizations to implement
  environmental management.

11
Generic standards

• ISO 9001 and ISO 14001 are generic standards.
• Generic means that the same standards can be
  applied
• to any organization, large or small, whatever its
  product or service,
• in any sector of activity, and
• whether it is a business enterprise, a public
  administration, or a government department.

12
Generic standards (cont.)

• Generic also signifies that
• no matter what the organization's scope of
  activity,
• if it wants to establish a quality management
  system, ISO 9001 gives the essential features,
• or if it wants to establish an environmental
  management system, ISO 14001 gives the essential
  features.

13
Quality management

• ISO 9001 is for quality management.
• Quality refers to all those features of a product
  (or service) which are required by the customer.
• Quality management means what the organization
  does to
• ensure that its products or services satisfy the
  customer's quality requirements, and
• comply with any regulations applicable to those
  products or services.

14
Quality management (cont.)

• Quality management also means what the
  organization does to
• enhance customer satisfaction, and
• achieve continual improvement of its performance.

15
The ISO 9000 family

• ISO 9001 is the standard that gives the
  requirements for a quality management system.
• ISO 90012000 is the latest, improved version.
• It is the only standard in the ISO 9000 family
  that can be used for certification.
• There are 14 other standards in the family that
  can help an organization on specific aspects such
  as performance improvement, auditing, training

16
Environmental management

• ISO 14001 is for environmental management. This
  means what the organization does to
• minimize harmful effects on the environment
  caused by its activities,
• to conform to applicable regulatory requirements,
  and to
• achieve continual improvement of its
  environmental performance.

17
The ISO 14000 family

• ISO 14001 is the standard that gives the
  requirements for an environmental management
  system.
• ISO 140012004 is the latest, improved version.
• It is the only standard in the ISO 14000 family
  that can be used for certification.
• The ISO 14000 family includes 21 other standards
  that can help an organization specific aspects
  such as auditing, environmental labelling, life
  cycle analysis

18
Processes, not products

• Both ISO 9001 and ISO 14001 concern the way an
  organization goes about its work.
• They are not product standards.
• They are not service standards.
• They are process standards.
• They can be used by product manufacturers and
  service providers.

19
Processes, not products (cont.)

• Processes affect final products or services.
• ISO 9001 gives the requirements for what the
  organization must do to manage processes
  affecting quality of its products and services.
• ISO 14001 gives the requirements for what the
  organization must do to manage processes
  affecting the impact of its activities on the
  environment.

20
Benefits of ISO 9001 and ISO 14001

• International, expert consensus on
  state-of-the-art practices for quality and
  environmental management,
• Common language for dealing with customers and
  suppliers worldwide,
• Increase efficiency and effectiveness,
• Model for continual improvement,

21
Benefits of ISO 9001 and ISO 14001 (cont.)

• Model for satisfying customers and other
  stakeholders,
• Build quality into products and services from
  design onwards,
• Address environmental concerns of customers and
  public, and comply with government regulations,
• Integrate with global economy,

22
Benefits of ISO 9001 and ISO 14001 (cont.)

• Sustainable business,
• Unifying base for industry sectors,
• Qualify suppliers for global supply chains,
• Technical support for regulations,
• Transfer of good practice to developing
  countries,
• Tools for new economic players,

23
Benefits of ISO 9001 and ISO 14001 (cont.)

• Regional integration,
• Facilitate rise of services.
• For the customer
• Increase satisfaction and growth in confidence.

24
WHY QUALITY SYSTEM - ISO 9000

• to satisfy customers through a quality
  product,
• to gain self confidence we get what we
  planned,
• to achieve competitiveness in both the local
  and overseas markets,
• as a blueprint for efforts to improve the
  quality system of the organization.

25

• QUALITY SYSTEM VEHICLE
• QUALITY MANAGEMENT DRIVER
• QUALITY POLICY ROAD MAP

26
THE QUALITY CYCLE
27
WHAT IS IT INTENDED FOR?

• This International Standard specifies quality
  system requirements for use where organizations
  capability to design and supply conforming
  product needs to be demonstrated.
• The requirements specified are aimed primarily at
  achieving customer satisfaction by preventing
  nonconformity at all stages from design through
  to servicing.

28
ISO 90012000

• ISO 90012000 specifies requirements for a
  quality management system where an organization
• Needs to demonstrate its ability to consistently
  provide product that meets customer and
  applicable regulatory requirements, and
• Aims to enhance customer satisfaction through the
  effective application of the system, including
  processes for continual improvement of the system
  and the assurance of conformity to customer and
  applicable regulatory requirements.

29
ISO 9001 Revision 2000 been developed by TC 176,
after a great deal of research on Eight Quality
Management Principles

• 1- Customer - focused organization
• 2- Leadership
• 3- Involvement of people
• 4- Process approach
• 5- System approach to management
• 6- Continual improvement
• 7- Factual approach to decision making
• 8- Mutually beneficial supplier relationship

30
(No Transcript)
31
Principles of ISO 9000

• ISO 9000 is a standard for a quality system, not
  product.
• ISO 9000 is based on documentation and is
  premised on the following
• - Document what you do
• - Do what your document
• - Prove it and improve it.
• ISO 9000 emphasises prevention.
• ISO 9000 is a universal standard the focus is on
  what needs to be done and not on how it is to be
  carried out.

32
Quality Management System Documentation

• The organization shall establish, document,
  implement and maintain a quality management
  system and continually improve its effectiveness
  in accordance with the requirements of this
  International Standard.
• (Clause 4.1, ISO 90012000)
• Documentation is a set of documents, for example
  specifications and records.
• Document is information (meaningful data) and its
  supporting medium.
• Quality management system is a management system
  to direct and control an organization with regard
  to quality.
• Quality manual is the document specifying the
  quality management system of an organization.

33
(No Transcript)
34
LEVEL 1 QUALITY MANUAL

• The quality manual is the highest level
  document, at the peak of the pyramid, outlining
  the quality system and acting as a directory for
  the documents and procedures below.
• It outlines the companys policy and commitment
  to quality.

35
WHY NEED QUALITY MANUAL?

• Communicating the organizations quality policy,
  procedures and requirements
• Describing and implementing an effective quality
  system
• Providing improved control of practices and
  facilitating assurance activities
• Providing the documented bases for auditing the
  quality system
• Providing continuity of the quality system and
  its requirements during changing circumstances
• Training personnel
• Presenting quality system for external purposes
• Demonstrating compliance of the quality system
  with quality requirements.

36

• Quality Policy
• Clause 5.3
• The overall quality intentions and direction of
  an organization related to quality, as formally
  expressed by top management

37
LEVEL 2 OPERATION PROCEDURES

• Departmental procedures detail how the
  commitment is applied to the company operations
  and lay down procedures for the management to
  control the system.

38
PROCEDURES DEVELOPMENT

• Review current practice
• Analyse current practice
• Develop a draft procedure
• Release draft for comment
• Review comments
• Revise and issue procedure for acceptance
• Obtain approval
• Issue for use
• Implement
• Monitor and Review

39
SUGGESTED FORMAT

• PURPOSE
• APPLICATION/SCOPE
• REFERENCE DOCUMENT
• DEFINITION
• RESPONSIBILITY
• PROCEDURE
• RECORD
• ATTACHMENT

40
LEVEL 3 WORK INSTRUCTIONS

• This third tier of work instructions details the
  day-to-day operating instructions to provide
  control of quality and being applied in the
  manner laid down in operation procedures.

41
WORK INSTRUCTIONS

• The written and /or spoken direction given with
  regard to what is to be done, including the
  information given in training.
• What is to be done?
• How it should be done?
• Who should do it?
• When it should be done?
• Supplies, services equipment to be used
• Criteria to be satisfied
• Usually departmental, or specific to product
• Frequently changed
• In details

42
LEVEL 4 SUPPORTING DOCUMENTS

• Relates to all the forms, documents, records,
  labels, tickets, job cards, purchase orders,
  goods inwards notes, registers, etc. that are
  used to support the levels above.

43
Improvement and Effectiveness

• There are many examples and requirements in ISO
  90012000 that require the organization to
  address the effectiveness of its quality
  management system.
• Further requirements specify the need for
  continual improvements to the quality management
  system not just sporadic quality campaigns.

44
Effectiveness

• ISO 9001 specifies requirements for a quality
  management system that can be used for internal
  application by organizations, or for
  certification, or for contractual purposes. It
  focuses on the effectiveness of the quality
  management system in meeting customer
  requirements.
• ISO 9001 2000 0.3
• The effectiveness of the quality management
  system in meeting both quality and/or business
  objectives is likely to be the key attribute that
  ensures the on-going support and resource
  allocation to maintain the ISO 90012000 quality
  management system within the corporate
  environment.

45
Improvement and Effectiveness

• Top Management shall ensure that the quality
  policy includes a commitment to comply with
  requirements and continually improve the
  effectiveness of the quality management system.
• ISO 9001 2000 5.3
• The organization shall continually improve the
  effectiveness of the quality management system
  through the use of the quality policy, quality
  objectives, audit results, analysis of data,
  corrective and preventive actions and management
  review.
• ISO 9001 2000 8.5

46
Analysis of Data
Organizational Objectives
Customer requirements
Statutory regulatory requirements
Examples of objectives set by the Organization
Defect rate and customer returns
QMS controls
Purchasing
47
Analysis of Data
Organizational Results
Customer satisfaction
Statutory regulatory compliance
Quality system metrics
Examples of results recorded by the Organization
Inspection and test
Supplier performance
48
Effectiveness of the QMS
Organizational Objectives
Organizational Results
The gap measures the lack of effectiveness of the
quality management system. The narrower the gap,
the more effective the QMS.
Things are looking good!
49
Effectiveness of the QMS
Organizational Objectives
Organizational Results
The gap measures the lack of effectiveness of the
quality management system.
Management should get a wake up warning!
50
Effectiveness of the QMS
Organizational Objectives
Organizational Results
The gap measures the lack of effectiveness of the
quality management system.
The Organization is in trouble!
51
Improvement in the QMS
Organizational Objectives
Organizational Results
Improvement can also be measured
52
Improvement in the QMS
Organizational Results
Organizational Objectives
Improvement Initiatives
Customer Focus
Corrective Action
Procurement
53
Management Review
The improvement processes are also evaluated
during management review meetings and appropriate
action taken.
Which may cause the organization to again revise
its objectives.
54
Certification and registration

• Certification is known in some countries as
  registration.
• It means that an independent, external body has
  audited an organization's management system and
  verified that it conforms to the requirements
  specified in the standard (ISO 9001 or ISO
  14001).
• ISO does not carry out certification and does not
  issue or approve certificates.

55
Accreditation

• Accreditation is like certification of the
  certification body.
• It means the formal approval by a specialized
  body - an accreditation body - that a
  certification body is competent to carry out ISO
  90012000 or ISO 140012004 certification in
  specified business sectors.
• Certificates issued by accredited certification
  bodies - and known as accredited certificates -
  may be perceived on the market as having
  increased credibility.
• ISO does not carry out or approve accreditations.

56
Certification not a requirement

• Certification is not a requirement of ISO 90001
  or ISO 14001.
• The organization can implement and benefit from
  an ISO 9001 or ISO 14001 system without having it
  certified.
• The organization can implement them for the
  internal benefits without spending money on a
  certification programme.

57
Certification is a business decision

• Certification is a decision to be taken for
  business reasons
• if it is a contractual, regulatory, or market
  requirement,
• If it meets customer preferences,
• it is part of a risk management programme, or
• if it will motivate staff by setting a clear
  goal.

58
ISO does not certify

• ISO does not carry out ISO 9001 or ISO 14001
  certification.
• ISO does not issue certificates.
• ISO does not accredit, approve or control the
  certification bodies.
• ISO develops standards and guides to encourage
  good practice in accreditation and certification.

59
The ISO Survey
60
The ISO Survey (cont.)

• The worldwide total of certificates to ISO
  90012000 at the end of 2005 was 776 608.
• This was increase of 18  over 2004 when the
  total was 660 132 certificates.
• Certificates had been issued in 161 countries
  compared to 154 the previous year.

61
The ISO Survey (cont.)
62
The ISO Survey (cont.)

• The worldwide total of ISO 14001 certificates at
  the end of 2005 was 111 162.
• This was an increase of 24  over 2004 when the
  total was 89 937.
• Certificates had been issued in 138 countries
  compared to 127 the year before.