Here are the key steps to identify applicable legal and other requirements: 1. Identify the relevant environmental legislation and regulations. 2. Identify applicable industry standards and codes of practice. 3. Establish procedures to regularly monitor for new or amended legal requirements. 4. Maintain a register of all applicable legal and other requirements. 5. Communicate relevant requirements to those within the organization. 6. Establish procedures to evaluate compliance and take action when needed. This helps ensure an organization is aware of and meets its compliance obligations.

1. Lead Auditor Course for
Quality and Environmental
Management Systems
Eng. Ahmed Sabry
1

2. Course assessment
• Continual assessment
• You will be informed of progress as we go
• The daily Workshop
• Present 80%
• Negotiations
• Exam Pass Criteria
• 70% pass mark
2

3. 1. Introduction
Contents
23. 8. Mutually Beneficial Supplier 44. EMS Auditing
2. What Does “Quality” mean? Relationship 45. Objectives and Targets
3. Quality 24. System Documentation 46. How to set the objectives and
4. Quality Assurance (QA) 25. 4: Quality Management System targets
5. System assessment 26. 5: Management Responsibility 47. Objectives and Targets should be
6. Quality development 27. 6: Resources achievable goal .
7. Quality Management System 28. 7: Product Realisation 48. Environmental Management
29. 8: Measurement, Analysis & Program
8. What is ISO 9000:2008 QMS?
Improvement 49. 4.4 Operational requirements
9. Continual improvement of the
Quality Management System 30. Quality Manual 50. 4.4.3 Establish communication
31. Quality policy procedures.
10. The triple mutual relation
32. Quality objectives 51. 4.4.5 Control the environmental
11. TQM means: management documents.
12. Basic principles of TQM 33. Environmental Management
System (EMS) 52. 4.5 Checking requirements
13. Customer Focus 53. 4.6 Management review
14. Leadership 34. Environment
35. “Treat the Earth well. It was not 54. Quality Audits
15. Involvement of People 55. Objective Evidence
given to you by your pa...
16. 4.Process Approach 56. Specified Requirements
36. What is ISO 14001?
17. Example: Management, 57. Quality Audits’ Objectives
Responsibility 37. Environmental Aspects
38. Input-Out put Model 58. Types of quality audits
18. 5. System Approach to
Management 39. Environmental Aspects 59. Auditor’s characteristics
19. 6. Continual Improvement: PDCA 40. Some examples for aspect and 60. Non conformity
Cycle impact 61. Planning the audit
20. Continual improvement 41. Identification and evaluation of 62. Information sources to the auditor 3
21. Planned continual improvement Environmental aspects St... 63. Checklist preparation
22. 7. Factual Approach to Decision- 42. Legal and other Requirement 64. Executing the audit
Making 43. ENVIRONMENTAL POLICY 65. Audit report

4. What Does “Quality” mean?
The dictionary defines Quality as :
“Degree of excellence” but
- What is excellence?
- How do we measure it?
4

5. Quality
Fitness for use
Fitness for purpose
Meet requirements
User trust
Customer satisfaction
Totality of characteristics of an entity which bear in its ability to satisfy the
implied and stated requirements ISO 9000.
5

6. Quality Assurance (QA)
All the planned and systematic activities
implemented within the quality system to
provide adequate confidence that an entity
will fulfill requirements for quality
6

7. System assessment
Write
what you
do
Assess
Do what
you Kiss
write Keep it short & simple
7

8. Quality development
T.Q.M. : EFQM – MBQA – Deming &
ISO 9004 / 2000-2008
Q.M.: ISO 9001 / 2000 *people.
*Env.
^ Customer. *Finance
^ Process.
^ Analysis.
^ Performance.
^ Continual improvement.
Q.ASS.: ISO 9000/87-94
1&2&3
Q.C. 8
Inspection

9. Quality Management System
ISO 9000 Fundamentals & Vocabulary
ISO 9001 Requirements
ISO 9004 Guidelines for performance improvements
9

10. What is ISO 9000:2008 QMS?
• ISO = International Organization for Standards
• 9000 = code to denote QMS Family
• 2008 = year of last revision
• Is a family of standards for implementing a Quality Management
System (QMS)
10

11. Continual improvement of the Quality Management System
Customer Management responsibility Customer
Measurement,
Resource
Analysis&
management
improvement
Requirements Satisfaction
Product/or service realization Prod.
Input Output
11
Model of a process-based quality management system

12. The triple mutual relation
Supplier
Processing
Customer
12

13. TQM means:
TQM means:
Every body
Every thing
Every time
Every where
13

14. Basic principles of TQM
1-Customer – focused organization
2- Leadership
3- Involvement of people.
4- Process approach.
5- System approach to management
6- Continuous improvement
7- Factual approach to decision making
8- Mutually beneficial supplier relationship.
14

15. 1. Customer Focus
• Organizations depend on their customers; therefore they
should
CUSTOMER REQUIREMENTS
CUSTOMER SATISFACTION
• Know their current and future needs
• Meet their requirements
• Exceed their expectations
• Get their feedback
15

16. 2. Leadership
• Leaders create common purpose and direction; therefore management
responsibility
they should
• Maintain a healthy internal environment
• Inspire workforce to excel
16

17. 3. Involvement of People
resource
• People are the essence of an organization; therefore management
• They should be fully involved
• Their abilities should be used for organization benefits
17

18. 4.Process Approach
 Manage activities and related
resources as a PROCESS
Review Purchase Design Make Deliver
Order Product
18

19. Example: Management, Responsibility
with what with who
Management Review Management team
forum Quality manager
Previous year’s results Team leaders
inputs Management
outputs
Internal audits responsibility &
Customer satisfaction trends objective Annual plan
Process/Product measures setting Improvement objectives
Faults/Complaints data
measures support how
Implementation plan
Results vs plan
Customer surveys
processes Resource allocation
Roles & responsibilities
Milestones IT systems Communications
Purchasing
HR, Training
19

20. 5. System Approach to Management
• Managing interrelated processes as a system helps the organization
in achieving its objectives in an effective and efficient manner
20

21. 6. Continual Improvement: PDCA Cycle
Continual Improvement of the QMS
management
responsibility
Plan Act
resource meas., analysis
management improvement
Do Check
product
realization 21

22. Planned continual improvement
Management review (5.6)
• Inputs
Policy (5.3)
• Outputs
• Monitor progress
Objectives (5.4.1)
Planning (5.4.2 Corrective action (8.5.2)
, 8.5.1) Preventive action (8.5.3)
Measures (8.2)
Product , process,
Internal audit & customer
satisfaction Identify opportunities (8.4)
23
Data collection (8.4) Analysis of data (8.4)

23. 7. Factual Approach to Decision-Making
• Effective decisions are based on the analysis of data
and information
CUSTOMER REQUIREMENTS
CUSTOMER SATISFACTION
info. flow
management
responsibility
meas., analysis info. flow
improvement
product
realization
24

24. 8. Mutually Beneficial Supplier Relationship
• Interrelated
• Win-Win
product
Supplier realization
25

25. System Documentation
Quality Manual
(Policy & Objectives)
Processes
(Procedures & W.I’s)
Specifications & Standards
Quality Records 26

26. 4: Quality Management System
• General requirements (4.1)
– General requirements for approach & content of the QMS (e.g. for the
adoption of the process approach)
– Outsourcing
• Documentation requirements (4.2)
– General sufficiency of documentation and records
– Mandatory procedures
– Manual, Policy & Objectives
– System for Document Control
– System for Control of Records
27

27. 5: Management Responsibility
• The areas where direct Top Management involvement is mandatory
– Demonstrating commitment
– Demonstrating customer focus
– Input into policy development & review
– Identification of objectives and input into the planning process
– Defining responsibilities, providing resources
– Ensuring internal communications are effective
– Involvement in management review
28

28. 6: Resources
• Human Resources
• Ensuring adequacy particularly in respect of training
• Infrastructure
• Buildings, work space, equipment, vehicles, information systems etc
• Environmental controls (Aligned with ISO14000)
• Heat, light, humidity, temperature, clean rooms
• In fact any controls that are applicable
29

29. 7: Product Realisation
• Think of this as “Production” or “Service Delivery”
• Control of the core day to day operations
• Operational planning (7.1)
• Handling contracts, enquiries & customer communication systems (7.2)
• Design (7.3)
• Management of supplies and suppliers (7.4)
• Operational controls (7.5)
• Calibration (7.6)
• Exclusions may apply
30

30. 8: Measurement, Analysis &
Improvement
• The collection and constructive use of data
– Measuring product (conformity checks and inspection)
– Measuring process (efficiency measures)
– Customer satisfaction (Survey, Feedback, Complaint)
– Internal audit
– Control of quarantine/isolation activities
– Analysis of data (you must do something with data)
– Continual improvement (the standard encourages the
application of the process approach to improvement)
– Corrective action (Correction + Corrective Action)
– Preventive action
31

31. Quality Manual
A document specifies the quality management
system of an organization.
Quality Manuals can vary in detail and format to
suit the size and complexity of an individual
organization.
32

32. Quality policy
• Overall intentions and direction of an Organization with regard
to quality, as formally expressed by top management. It must be :
1- Adequate to organization’s activities.
2- Committed to international standard requirements.
3- Committed to continual improvement.
4- Providing a framework for establishing and reviewing quality
objectives.
5- Deployed to all organization’s personnel levels and be
understood.
6- Always reviewed to assure its suitability.
33

33. Quality objectives
• Are established to provide a focus to direct
the organization, determine the desired
results and assist the organization to apply its
resources to achieve these results.
It must be:
• suitable for all jobs & levels.
• measurable
• consistent with quality policy.
• S M A R T 34
Specified Measurable Achievable Realistic Time table

34. Environmental Management System (EMS)
• “the part of the overall management system that includes
organizational structure, planning activities, responsibilities,
practice, processes and resources for developing,
implementing, achieving, and maintaining the environmental
policy”
• 3.5, ISO 14001:1996
35

35. Environment
• surroundings in which an organization
operates, including air, water, land,
natural resources, flora, fauna,
humans, and their interrelation
36

36. “Treat the Earth well. It was not
given to you by your parents. It was
lent to You by your children”
• Kenyan Proverb
37

37. What is ISO 14001?
• 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.
38

38. Environmental Aspects
Emissions to atmosphere
Raw site Product
Materials activities use and
& energy disposal
Waste disposal Landfill
Incineration
Spillage contaminating the land Discharges to water or sewers
39

39. Input-Out put Model
INPUT PROCESS OUTPUT
LOSSES
Waste
Regulations Energy
Air Emissions
Water Effluents 40

40. Environmental Aspects
41

41. Environmental Aspects
42

42. Environmental Aspects
43

43. Environmental Aspects
44

44. Environmental Aspects
Element of an organization's activities or
products or services that can interact with the
environment
Transporta Generation
tion
Raw Material
Acquisition
Use 45
Disposal

45. Environmental impacts
Any change to the environment, whether
adverse or beneficial, wholly or partially
resulting from an organization's
environmental aspects
46

46. Some examples for aspect and impact
Environmental Aspect Environmental Impact
Production of infectious waste Contamination of people
Generation of radioactive waste Contamination of soil, water and
people
Use of water and energy Depletion of natural resources
Production of chemical waste Pollution of soil and water
Spillage of chemicals Water and soil pollution
Use of CFC in freezers and air- Ozone Depletion
conditioning machines
47
Use and disposal of fluorescent Contamination of the environment
lamps with mercury

47. Identification and evaluation of Environmental aspects Step 1
• Step 1: Evaluate the frequency
• When evaluating the "frequency", the number shall be
determined from the following scale, based on documented
evidence, by asking the following question :
• How often has a problem occurred?
Frequency Scale
Continuously 10
once per shift 9
once per day 8
Weekly 7
Monthly 6
Quarterly 5
semi-annually 4
Annually 3
once every 1 to 5 years 2 48
over 5 years 1
Never 0

48. Identification and evaluation of Environmental aspects Step 2
Step 2 : Evaluate the severity
•When evaluating the "severity" use the scale below, based on documented evidence.
•When considering human impact, it is important to include contractors, neighbors,
customers, etc., as well as team members.
Severity Animal / Plant
Human Impact Public Relations
Scale Effect
widespread
10 multiple deaths permanent plant closure
destruction
on-site permanent permanent public
9 single death
destruction disfavor
interrupted
8 disabling injury Widespread genetic impact
operations
long term health loss of historical
7 on site genetic impact
effects assets
lost time wide spread national
6
Injury/Illness disfigurement protest
5 restricted duty on-site disfigurement city protest
wide spread
4 medical only employee protest
appearance
reduction of natural
3 first aid treatment
beauty
public inconvenience 49
2 Discomfort on-site appearance public disfavor
1 None none none

49. Identification and evaluation of Environmental aspects Step 3
• Step 3:
• Impact ratings shall be determined by multiplying the
frequency and severity numbers.
• The environmental team shall determine an appropriate cutoff
level for significant impacts.
50

50. Legal and other Requirement
EMS should include a procedure for identifying and
analyzing the applicable legal and other
requirements.
• “Other requirements” include many things e.g.
the industry code of practice
51

51. Legal and other Requirement
• There are many methods for obtaining information about
applicable laws or regulations:
• regulatory agencies ;
• trade groups / associations;
• the Internet ;
• public libraries;
• seminars and courses;
• newsletters / magazines;
• consultants
52

52. ENVIRONMENTAL POLICY
• Include an opening paragraph that describes the:
1. activities,
2. products and/or
3. services of the facility.
• Include a statement that shows the facilities commitment to:
1. minimize the creation of waste and pollution.
2. complying with acceptable environmental practices,
3. struggle for continual improvements and
4. meet or exceed legal, regulatory and other requirements,
• Include a list, in general terms, of objective or programs relevant to
significant environmental aspects, thus making the policy "facility
specific".
• The policy should be signed by the facility manager.
• The policy should be made available to the public, by:
53
1. Posting at the facility entrance
2. Providing copies to the public upon request

53. EMS Auditing
Objective evidence of conformance with EMS requirements
• The company should:
• develop audit procedures;
• determine an appropriate audit frequency;
• select and train the auditors; and,
• maintain audit records.
• The outputs from the audit go into two separate processes:
• Management Review and
• Corrective and Preventive Actions.
• All parts of the EMS should be audited at least annually
• The Management Representative is responsible for notifying :
• EMS auditors
• Plant managers
• of any upcoming audits a reasonable time prior to the scheduled audit date.
• The Lead of Auditors is responsible for ensuring that :
• the audit,
• audit report and
54
• any feedback
• of the activities covered by the audit is completed according to the audit schedule.

54. Objectives and Targets
Objectives Targets
Reduce energy usage • Reduce electricity use by 10% in
2011
• Reduce natural gas use by 15% in
2011
Reduce usage of hazardous • Eliminate use of CFCs
chemicals • Reduce use of high-VOC paints by
25%
Improve employee awareness of • Hold monthly awareness training
environmental issues courses
• Train 100% of employees by end of
year
55
Improve compliance with • Zero permit limit violations by the
wastewater discharge permit end of 2011
limits

55. How to set the objectives and targets
• Evaluate each Significant Aspect to assess whether an Objective and
Target should be established.
• For each Significant Aspect answer three questions :
• Is the aspect under your control or influence?
• Do technical options exist to control the aspect?
• Are the technical options financially feasible?
• Determine whether an Objective and Target should be established
using the decision logic .
• Record the results of your evaluation
56

56. Objectives and Targets should be
achievable goal .
For example:
• 100% compliance with regulations
• Zero hazardous chemical releases or spills
• 10% reduction in electricity use
• 28 % reduction in solid waste disposal
57

57. Environmental Management Program
• Environmental Management Programs shall include:
- Designation of responsibility
- Resources required (budget, staff and technology)
- Time frame for execution
• The program should be a dynamic one.
modify your program when:
- objectives and targets are modified;
- legal requirements are introduced or changed;
- progress in achieving your objectives and targets has been
made (or has not been made);
• your products, services, processes changed
• any other issues arise. 58
• Register of Environmental Management Programs

58. 4.4 Operational requirements
4.4.1 Provide resources and establish the structure and jobs description
• Establish environmental management roles, responsibilities, and
authorities.
• Appoint someone to represent the top management
4.4.2 Deliver training and awareness programs
• Identify your organization’s environmental training needs.
• Deliver training programs that meet these needs
59

59. 4.4.3 Establish communication procedures.
• to control your internal environmental
communications.
• to control your external environmental
communications.
4.4.4 Document your EMS:
• policy
• objectives
• targets
• the main parts of your EMS 60

60. • 4.4.5 Control the environmental
management documents.
• 4.4.6 Control environmentally significant operations
• 4.4.7 Establish an emergency plan
Prepare for emergency situations and accidents
that could have a significant impact on the
environment.
• Test your plan
• Review it
61

61. 4.5 Checking requirements
4.5.1 Establish monitoring and measurement activities.
• Use calibrated equipments.
4.5.2 Evaluate legal and other compliance.
4.5.3 Deal with nonconformities
• Establish nonconformance procedures.
4.5.4 Control your environmental records.
• Establish procedures to control the records.
4.5.5 Perform internal environmental audits
• Plan an internal audit program
• Conduct the internal audit
• Report results to the organization’s management.
62

62. 4.6 Management review
• Review the suitability and effectiveness of the EMS
• Assess opportunities for improvement of:
• EMS
• environmental policy
• environmental objectives
• targets
63

63. Quality Audits
• Systematic and independent examination
to determine whether quality activities
and related results comply with planned
arrangement and whether these
arrangements are implemented effectively
and are suitable to achieve objectives.
64

64. Objective Evidence
• Data supporting the existence or verify of
something.
• It may be obtained through observation,
measurement, test, or other means.
65

65. Specified Requirements
•Customer requirements.
•Quality System requirements.
• Manuals.
• Procedures/Working instructions.
•Quality international standards(ISO 9001/2008)
•Legal requirements.
•Regulatory requirements.
66
•Accreditation body requirements.

66. Quality Audits’ Objectives
1- Intent:
To verify that the documented Q.S.is competent to achieve the
requirements of the international standard ISO 9001/2008
2- Implementation:
To verify by the objective evidence, that the documented Q.S. is
the already implemented Q.S. by using manuals and procedures.
3- Effectiveness:
To verify by the objective evidence, that the implemented Q.S.is
effective and comply with the quality objectives. 67

67. Types of quality audits
Quality audit
Internal External
1st party 2nd party 3rd party
- ISO 9001/2008 requirements
- Management control tool
- Good tool for continual
improvement through: Client Certification
A-people involvement
B-personnel communication
C-people awareness
68

68. Auditor’s characteristics
Is able to carry out the audit of high management.
Is distinguished in his job.
Understands the process.
Has a teamwork capability.
Has an enough background of the legal requirements.
Knows the interference between the processes.
69

69. Auditor’s characteristics
The auditor must be flexible with:
•Various situation
•Different type of management
•Different level of employees and employers
-The auditor must be able to:
• Find & assign the nonconformities. 70
• Assess the effectiveness of the corrective actions.

70. Auditor’s characteristics
Objective Communicative
Industrious Prepared
Polite Principled
Positive Unbiased
Punctual Persevering
Practical Helpful
71

71. Non conformity
Nonfulfilment of specified requirements.
The definition covers the departure or absence of one or more quality
characteristics or quality system elements from specified requirements.
N.C.R
What should be? What did you see? Where is your objective?
72

72. Non conformity
N.C.R
Major Minor Observation
1- System 4- Delivery of
2- No 3- Many minors Without
doesn’t reflect suspected Objective
implementation in the same Objective
standard product to evidence
for ISO clause. area. evidence
requirements customer.
73

73. Planning the audit
•Understand the audited activity.
•Put the objective.
•Audit scope.
•Processes and interferences.
•Estimate the audit period.
•Select the team.
•Inform the auditee by the audit time.
•Audit program preparation.
•Checklist preparation.
74

74. Information sources to the auditor
• Quality manual/processes/procedures/w. instructions.
• ISO 9001/2008
• Management priorities.
• Quality problems.
• The previous audits.
• Product/or service information
• Auditor’s experience.
75
• Pre-visit.

75. Checklist preparation
• Questions …?
• Processes and interferences.
• Who.?,What.?,When.?,Where.?,Why.?,How.?
Show me …..
• Prepare checklist:
Look at Look for
*The documents validation
*The material definition/inspection
*Measuring & test equipment calibration status
76
*Processes capability to control the system

76. Executing the audit
I-Start:
• introduce the audit team to the auditee.
• review the scope and the objectives of the audit
• provide a short summary of the methods and
• procedures to be used to conduct the audit.
• establish the official communication links
• between the audit team and the auditee.
• confirm that the resources and facilities needed
• by the audit team are available.
• confirm the estimation time of the audit end.
50

77. Executing the audit
II-Examination:
• Evidence should be collected through interviews,
examination of documents, and observation of
activities and conditions in the areas of concern.
• All audit observations should be documented.
• After all activities have been audited, the audit team
should review all of their observations to determine
which are to reported as nonconformities.
• The audit team should then ensure that these are
documented in a clear, concise manner and are
supported by evidence.
• All observations of nonconformities should be 51
acknowledged by the auditee management.

78. Executing the audit
• III-End:
• At the end of the audit, prior to preparing the audit
report, the audit team should hold a meeting with the
auditee's senior management and those responsible for
the functions concerned.
• The main purpose of this meeting is to present audit
observations to the senior management in such a
manner so as to ensure that they clearly understand the
results of the audit.
• The auditor should present the audit team’s conclusions
regarding the quality system’s effectiveness in ensuring
that quality objectives will be met. 52

79. Audit report
Should faithfully reflect both the tone and content of
the audit. It should be dated and signed by the lead
auditor.
Is prepared under Should has team’s judgmen
the direction of the of the extent of the audite
lead auditor, who is compliance with the
responsible for its Audit report applicable quality syste
accuracy & standard and related
completeness documentation.
Content
*Scope&objectives. *Audit plan. *Id’s of auditors.
*Id’s of auditees. *Audit date. *Id’s of Org. audited.
*Id’s of ref. documents against which the audit was conducted.
*Nonconformities. *CA/PA’s *Due date of CA/PA’s
*The effectiveness of CA/PA’s.

80. 90% or more of processes can be
improved
by modifying organizational systems
(a management responsibility) rather
than attempting to modify an
individual employee’s performance.
W. Edwards Deming 81