This document provides an overview of the ISO 9001:2008 Quality Management System standard and the Lead Auditor training course. It discusses the background and origins of ISO, describes the key elements and requirements of the ISO 9001 standard such as documentation, management responsibility, resource management, and product realization. It also summarizes the concepts of continual improvement, customer focus, and exclusions in the standard.

1. Course title : Lead Auditor,
ISO 9001:2008
Quality Management System
And
HopLun

2. Background
The International Organization for Standardization (ISO) was
founded in Geneva in 1947. The original Purpose of the
organization was to provide standardization of technical
specifications for products traded in the International market place.
The term “ISO” is a word derived from the Greek “isos,” meaning
“equal.” Over 150 countries are members of ISO, and there are
more than 10,000 ISO standards used worldwide. These Standards
determine how various products and services are produced, and
include standards for instance :
Film speed.
Thickness of credit cards.
Compact disc format.
Screw thread number.
Standardization has served an important role in promoting quality
and compatibility of products on a global basis

3. Background
ISO 9001 is the world’s most popular Quality Management System(QMS) standard and
its is all about keeping customers satisfied. Whatever sector the company operates in,
from manufacturing to services, Whoever followed the principles of quality
management system against this ISO standard has been benefited from more efficient
ways of working, better cost control and fast and more effective implementation of
new working practices.
What it means
Lay out the processes needed by the company, and have them in sequence , making
sure that they are effective.
The management of the company have to be committed to putting in ISO and have to
set quality objectives that can be measured. It should be focused on customer
satisfaction, and communicate this to all employees.
Defining responsibilities and plan a management meeting to assess how you are doing
and where you need to improve.
Providing resources and support.

4. Model of a process-based Quality Management System

5. “PDCA”
The methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to
all processes. PDCA can be briefly described as follows
Plan: Establish the objectives and processes necessary to deliver results in
accordance with customer requirements and the organization's policies.
Do: Implement the processes.
Check: Monitor and measure processes and product against policies,
objectives and requirements for the product and report the results.
Act: Take actions to continually improve process performance.

6. 8 Principles of ISO 9001 Standard
Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationship

7. The concept of exclusions
All requirements of this International Standard are generic and are intended to be
applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to
the nature of an organization and its product, this can be considered for exclusion.
Therefore, an organization should consider whether all the requirements of the
standard are relevant to its activities, based on the nature of the organization
itself, its products, and the processes it uses to meet customer, statutory and
regulatory requirements. In addition, the organization should take into account
any commitments it has made in its Quality Policy and Objectives and how these
could affect the need to undertake particular realization processes. All of these can
affect the scope of the organization’s QMS.
The exclusions could be :
 Clause 7.3 Design and Development.
 Clause 7.5.4 Customer Property.
 Clause 7.6 Control of Monitoring And Measuring Equipments .

8. 4. Quality Management System.
4.1. General Requirements.
Preparing documents is all about standardizing the way you do things through
policies, procedures , instructions, flow diagrams, forms etc. Does the company
have a repeatable controlled system where records are maintained to prove
compliance. In short “say what you do and do what you say” – and prove it!
Documentation provides proof of requirements, thus providing a common source
for reference. It also makes communication more reliable and removes the need
for repeating and remembering verbal instructions.
Its all about how does the job get done when you are not around!

9. 4.2 Documentation Requirements.
4.2.1 General
Quality Management System documentation shall include:
Documented statements of a Quality Policy and Quality Objectives.
A Quality Manual.
Documented procedures required by this International Standard :
a) Control of document.
b) Control of quality record.
c) Internal quality record .
d) Control on non conforming product.
e) Corrective and preventive action.
Documents needed by the organization to ensure the effective planning, operation and control of
its processes.
Records required by this International Standard :
a) Minutes of meeting review.
b) Training report.
c) Record of design input.
d) Calibration report.
e) Internal Audit result.

10. 4.2.2 Quality Manual
Quality Manual format and structure is a decision for each organization, and will
depend on the organization’s size, culture and complexity. Some organizations
may choose to use the quality manual for other purposes besides that of simply
documenting the QMS
A small organization may find it appropriate to include the description of its entire
QMS within a single manual, including all the documented procedures required by
the standard.
Large, multi-national organizations may need several manuals at the global,
national or regional level, and a more complex hierarchy of documentation.
The quality manual is a document that has to be controlled in accordance with the
requirements of clause 4.2.3 :
a) Scope of the quality management system
b) Details and justification for any exclusions
c) Procedures or references to the procedures
d) Description of interaction between processes

11. 4.2.3 Control of Documents
Control the documents required by the Quality Management System.
Records are a special type of document and must be controlled as
required by clause 4.2.4.
Establish a documented procedure to:
1) Approve documents for adequacy prior to issue.
2) Review, update as necessary, and re‐approve documents.
3) Identify the changes and current document revision status.
4) Make relevant documents available at points of use.
5) Ensure the documents remain legible and readily identifiable.
6) Identify external documents and control their distribution.
7) Prevent obsolete documents from unintended use.
8) Apply suitable identification if obsolete documents are retained.

12. 4.2.4 Control of Record
Establish and control records as evidence of conformity to requirements
and to demonstrate the effective operation of the quality management
system.
Establish a documented procedure to define the controls needed for
record:
1) Identification
2) Storage
3) Protection
4) Retrieval
5) Retention
6) Disposition
Keep records legible, readily identifiable, and retrievable

13. 5. Management Responsibility
The management of the company have to be committed to putting it in
ISO. They have to set Quality Objectives that can be measured, focused
on customer satisfaction, and communicate this to all employees. Define
responsibilities and plan a management meeting to assess how they are
doing and where they need to improve. It shows that implementing ISO is
a management initiative and will be supported right through the company.

14. 5.1 Management Commitment
Providing evidence of management commitment to develop and
implement the Quality Management System, as well as, continually
improve its effectiveness by:
1) Expressing the importance of meeting requirements.
2) Establishing the Quality Policy and Quality Objectives.
3) Conducting management reviews.
4) Ensuring the availability of necessary resources.

15. 5.2 Customer Focus
Its all about ensuring customer requirements are determined and met in order to
improve customer satisfaction. And the top management need to understand
customer’s current and future needs to meet customer requirements and strive to
exceed customer expectations. This really involves the monitoring of customer
perception. It does not mean that you have to send questionnaires to your
customers. There are many different ways of monitoring perception. The
organization can use methods relevant to its business.
5.3 Quality Policy
The top management must have to ensure the Quality Policy is:
1) Appropriate to the purpose of the organization.
2) Focused on meeting requirements and continual improvement.
3) Used as a framework for Quality Objectives.
4) Communicated and understood at appropriate levels.
5) Reviewed for continuing suitability.

16. 5.4 Planning
5.4.1 Quality Objectives
The top management shall establish Quality Objectives to meet product
requirements at the relevant functions and levels within the organization.
The Quality Objectives must have to be measurable and consistent with
the Quality Policy.
5.4.2 Quality Management System Planning
The top management shall ensure that planning for the quality
management system:
a) Meets the general requirements (4.1), as well as, Quality
Objectives (5.4.1)
b) Maintains the system integrity when changes are planned and
implemented.

17. 5.5 Responsibility, Authority, and Communication
5.5.1 Responsibility and Authority
Responsibilities and authorities Must have to be defined and communicated
within the organization.
5.5.2 Management Representative
A member of the management must have to be appointed who has the
responsibility and authority to:
a) Ensure the needed processes are established, implemented, and
maintained.
b) Report to top management on Quality Management System
performance.
c) Report to top management on any need for improvement.
d) Ensuring the promotion of awareness of customer requirements .
The responsibility of a management representative can include being the
liaison with external parties on matters relating to the Quality Management
System.

18. 5.5.3 Internal Communication
Appropriate communication processes must has to be established and carried out within
the organization regarding the effectiveness of the system.
5.6 Management Review
5.6.1 General
The Quality Management System must have to be reviewed at planned intervals to:
a) Ensure a suitable, adequate, and effective system
b) Assess possible opportunities for improvement
c) Evaluate the need for any changes to the system
d) Consider the need for changes to the quality policy and objectives
Records of the management reviews must have to be maintained as well .

19. 5.6.2 Review Input
Inputs for management review must include information on:
a) Results of audits.
b) Customer feedback.
c) Process performance and product conformity.
d) Status of preventive and corrective actions.
e) Follow‐up actions from earlier reviews.
f) Changes that could affect the quality system.
g) Recommendations for improvement.

20. 5.6.3 Review Output
Outputs from the management review must include any decisions and
actions related to:
a) Improvement of the effectiveness of the Quality Management
System and its processes.
b) Improvement of product related to customer requirements.
c) Resource needs.

21. 6. Resource Management
6.1 Provision of Resources
All necessary resources must have to be determined and provided to:
a) Implement and maintain the Quality Management System.
b) Continually improve the effectiveness of the system.
c) Enhance customer satisfaction by meeting customer requirements.
Resources are looked at in three ways: people, infrastructure and work environment.
6.2.1 General
This part deals with the people who work for the company every day and have a
quality impact on the product or service. All employees need to have appropriate
education, training and skills, and be competent to do their job. A method is also
needed to show that these trainings are effective.
Failure to train personnel may result in mistakes, & poor decisions. We cannot
expect staff to do their job properly if they are not trained to do so.

22. 6.2.2 Competence, Training, and Awareness
The organization must:
Determine the competency needs for personnel.
Provide training (or take other actions) to achieve the necessary
competence.
Evaluate the effectiveness of the actions taken.
Inform employees of the relevance and importance of their activities.
Ensure they know their contribution to achieving quality objectives.
Maintain education, training, skill, and experience records.

23. 6.3 Infrastructure
We must need to identify and maintain those processes and equipment
that make the product or provide the service. When we take on a contract
we need to provide and maintain all the necessary equipment to deliver
the end result or to achieve product conformity. Infrastructure includes:
Buildings, workspace, and associated utilities.
Process equipment (both hardware and software).
Supporting services (such as transport, communication, or information
systems).

24. 6.4 Work Environment
Here we must have to look at the conditions under which work is being
performed including :
Physical.
Environmental .
Noise .
Temperature.
Humidity.
Lighting.
Weather .
We must have to ensure that those are appropriate for meeting customers’
requirements. Again, we must need to ensure that this is reviewed regularly.
It’s important that the environment in which we make the product or provide
the service is controlled. Improvements in work environmental conditions
create a positive quality culture, more satisfied workers, and thus a more
satisfied customer.

25. 7. Product Realization
7.1 Planning of Product Realization
We need to create processes that turn the idea into a finished product or service. This
needs to be planned so we ensure we can achieve our objective. We need to
understand just what are the quality requirements of the product or service, and
provide a method to make, measure, and prove that the finished product or service
does in fact meet what we set out to do. In planning product realization, the
organization shall determine the following :
1) Quality objectives and product requirements.
2) Need for processes, documents, and resources.
3) Verification, validation, monitoring, measurement, inspection, and test
activities.
4) Criteria for product acceptance.
5) Records as evidence the processes and resulting product meet requirements.
A document specifying the processes of the Quality Management System (including the
product realization processes), and the resources to be applied to a specific product,
project or contract, can be referred to as a Quality Plan.

26. 7.2 Customer-related processes
This is much more focused on the detailed requirements that the customer
actually requested.
7.2.1 Determination of Requirements Related to the Product
Determine customer requirements:
1) Specified for the product (including delivery and post‐delivery activities- like
warranty provision, contractual obligations such as maintenance services, and
supplementary services such as recycling or final disposal).
2) Not specified for the product (but needed for specified or intended use,
where known).
3) Statutory and regulatory requirements applicable to the product.
4) Any additional requirements considered necessary by the organization.

27. 7.2.2 Review of Requirements Related to the Product
We must have to review the product requirements before committing to supply
the product to the customer in order to:
a) Ensure product requirements are defined.
b) Resolve any requirements differing from those previously expressed.
c) Ensure its ability to meet the requirements.
Records of the results of the review and actions arising from the review(any
subsequent follow‐up actions) must have to be maintained. When the
requirements are not documented, they must be confirmed before acceptance. If
product requirements are changed, ensure relevant documents are amended and
relevant.

28. 7.2.3 Customer Communication
Determine and implement effective arrangements for communicating with
customers on:
1) Product information.
2) Inquiries, contracts, or order handling (including amendments).
3) Customer feedback (including customer complaints)

29. # 7.3 Design and development #
Firstly the organization must have to confirm that they actually design the
products they make. If they do, then there is a step by step design process they
must have to follow. In simple terms they are defining a method where, by the
customer requirements are put into suitable designs so that it is made correctly.
Careful documentation is required here and maintaining all records especially
change control, authorization and .ommunication. The organization must have to
Plan and control the product design and development. This planning must
determine the:
1) Stages of design and development.
2) Appropriate review, verification, and validation activities for each stage.
3) Responsibility and authority for design and development.

30. 7.3.2 Design and Development Inputs
Determine product requirement inputs and maintain records. The inputs
must include:
1) Functional and performance requirements.
2) Applicable statutory and regulatory requirements.
3) Applicable information derived from similar designs.
4) Requirements essential for design and development.
5) Reviewing these inputs for adequacy.
6) Resolving any incomplete, ambiguous, or conflicting
requirements.

31. 7.3.3 Design and Development Outputs
Document the outputs of the design and development process in a form suitable for
verification against the inputs to the process. The outputs must:
1) Meet design and development input requirements.
2) Provide information for purchasing, production, and service.
3) Contain or reference product acceptance criteria.
4) Define essential characteristics for safe and proper use.
6) Be approved before their release
Information for production and service can include details for product preservation.
7.3.4 Design and Development Review
It is all about Performing systematic reviews of design and development at suitable stages in
accordance with the planned arrangements (7.3.1) to:
1) Evaluate the ability of the results to meet requirements
2) Identify problems and propose any necessary action.
The reviews must include representatives of the functions concerned with the stage being
reviewed. Maintain the results of reviews and subsequent follow‐up actions.

32. 7.3.5 Design and Development Verification
Performing design and development verification in accordance with planned
arrangements (7.3.1) to ensure the output meets the design and development
input requirements. Maintain the results of the verification and subsequent
follow‐up actions.
7.3.6 Design and Development Validation
Performing validation in accordance with planned arrangements (7.3.1) to
confirm the resulting product is capable of meeting the requirements for its
specified application or intended use, where known. When practical, complete the
validation before delivery or implementation of the product. Maintain the results
of the
7.3.7 Control of Design and Development Changes
Identifying design and development changes and maintain records. Review, verify,
and validate (as appropriate) the changes and approve them before
implementation. Evaluate the changes in terms of their effect on constituent parts
and products already delivered. Maintain the results of the change review and
subsequent follow‐up actions .

33. 7.4 Purchasing
7.4.1 Purchasing Process
We must have to ensure that the material we purchase, is in fact suitable for it’s
intended purpose. This includes assessing the suppliers. We need to make sure
that our purchase orders clearly specify what we need, and also we have a
method to confirm it meets this requirement when received. Remember we are a
customer too, and in order for us to meet our customer requirements we must
have to ensure that the material purchased is what was intended, and have a
method to monitor and control this. The quality of what we receive will directly
affect our customers.
We must have to evaluate and select suppliers based on their ability to supply
product in accordance with the our requirements. Criteria for selection,
evaluation and re-evaluation shall be established. Records of the results of
evaluations and any necessary actions arising from the evaluation must have to be
maintained.

34. 7.4.2 Purchasing Information
We must have to ensure the purchasing information, contains information
describing the product to be purchased, including the requirements for:
1) Approval of product, procedures, processes, and equipment.
2) Qualification of personnel.
We must have to ensure the adequacy of the specified requirements before
communicating the information to the supplier.
Also include Quality Management System requirements in the purchasing information.
7.4.3 Verification of Purchased Product
We must have to establish and implement the inspection or other necessary
activities for ensuring the purchased products meets the specified purchase
requirements. If we or our customer proposes to verify the product at the
supplier location, we must have to state the intended verification arrangements
and method of product release in the purchasing information.

35. 7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
We must have to plan and carry out production and service provision under
controlled conditions to include, as applicable:
1) Availability of product characteristics information.
2) Availability of work instructions, as necessary.
3) Use of suitable equipment.
4) Availability and use of monitoring and measuring equipment.
5) Implementation of monitoring and measurement activities
6) Implementation of product release, delivery, and post‐delivery
activities.

36. 7.5.2 Validation of Processes for Production and Service Provision
We must have to validate any production or service provision where subsequent
monitoring or measurement cannot verify the output. This validation includes
processes where deficiencies may become apparent only after product use or
service delivery. Demonstrate through the validation the ability of processes to
achieve the planned results. Establish validation arrangements including, as
applicable:
1) Criteria for process review and approval.
2) Approval of equipment.
3) Qualification of personnel.
4) Use of defined methods and procedures.
5) Requirements for records.
6) Re‐validation.

37. 7.5.3 Identification and Traceability
Identify, where appropriate, the product by suitable means during product
realization. Identify the product status with respect to monitoring and
measurement requirements throughout product realization. Where traceability is
a requirement, control the unique identification of the product and maintain
records.

38. 7.5.4 Customer Property
This could be material, equipment or intellectual property supplied by the customer to
be used in your process. We must have to put extra care and ensure it is identified and
protected throughout the process. If we loose, damage or find it is unsuitable then we
must have to inform the customer and keep records of this.
This clause just ensures that we look after customer property, and have a method to
report any damage etc to the customer. It helps in keeping the confidentiality and a
very positive customer relationship.
7.5.5 Preservation of Product
Preserving the product during internal processing and delivery to the intended
destination in order to maintain conformity to requirements. As applicable,
preservation includes:
1) Identification.
2) Handling.
3) Packaging.
4) Storage.
5) Protection.

39. 7.6 Control of Measuring and Monitoring Equipment
Sometimes better known as “calibration” . this clause ensures that the measuring
equipment we use to measure the product or service is adequate to meet the
customer requirements and is safeguarded from unintended use. Also the equipment is
checked at frequent intervals to confirm it is in specification. If a problem is found then
there must be a way to review product already measured using the device. To maintain
the consistent measurement capability against the requirements we must have to
ensure to :
1) Calibrate and/or verify the measuring equipment at specified intervals or
prior to use.
2) Calibrate the equipment to national or international standards (or record
other basis).
3) Adjust or re‐adjust as necessary.
4) Identify the measuring equipment in order to determine its calibration
status.
5) Safeguard them from improper adjustments.
6) Protect them from damage and deterioration.
We must have to assess and record the validity of prior results if the device is found to
not conform to requirements. Maintain records of the calibration and verification
results .
We must have to confirm the ability of software used for monitoring and measuring for
the intended application before its initial use (and reconfirmed as necessary).

40. 8. Measurement, Analysis, and Improvement
8.1 General
Plan and implement the monitoring, measurement, analysis, and improvement
processes needed to:
1) Demonstrate conformity to product requirements.
2) Ensure conformity of the system.
3) Continually improve effectiveness.
Determine through planning the need for, and use of, applicable methods,
including statistical techniques, as well as, the extent of their use.
8.2.1 Customer Satisfaction
This is all about how the customer perceives our product and service. Just because
a customer has not complained about the product or service does not mean they
are satisfied. We must have to come up with a way to monitor the customer and
use this data to improve the relationship. Monitoring customer perception can
include obtaining input from sources such as customer satisfaction surveys,
customer data on delivered product quality, user opinion surveys, lost business
analysis, compliments, warranty claims, and dealer reports.

41. 8.2.2 Internal Audit
Conducting internal audits at planned intervals to determine if the Quality
Management System:
a) Conforms to planned arrangements (see 7.1).
b) Conforms to requirements of ISO 9001.
c) Is effectively implemented and maintained.
The organization must:
1) Plan the audit program.
2) Consider the status and importance of the audited areas.
3) Consider the results of prior audits.
4) Define the audit criteria, scope, frequency, and methods.
5) Select and use impartial and objective auditors (not audit their own work).
Establishing a documented procedure to address responsibilities and requirements to:
1) Plan audits and conduct audits.
2) Establish records and report results.
3) Maintain records of the audits and their results.
Ensuring management of the audited areas takes actions without undue delay to
eliminate detected non conformities and their causes. Verify through follow‐up actions
the implementation of the action and report the results.

42. 8.2.3 Monitoring and Measurement of Processes
We must have to apply suitable methods for monitoring and, where applicable,
measurement of the Quality Management System processes. These methods shall
demonstrate the ability of the processes to achieve planned results. When
planned results are not achieved, correction and corrective action must have to
be taken, as appropriate.
8.2.4 Monitoring and Measurement of Product
We must have to set criteria to measure the key characteristics of the product or
service. This ensures that the requirements have been met from the initial plan.
This should be done at appropriate stages. We need to provide evidence of these
checks, and record the final check and person who does final release. Before we
ship any product or complete a service, we have to be satisfied that it meets its
intended purpose and all the checks and balances have been done.

43. 8.3 Control of Nonconforming Product
We must have to ensure that any nonconforming product is being identified and
controlled to prevent its unintended use or delivery. A documented procedure
must have to be established to define the controls and related responsibilities and
authorities for dealing with nonconforming product. Where applicable, the
nonconforming product has to be dealt by one or more of the following ways:
1) Take action to eliminate the detected nonconformity.
2) Authorize its use, release, or acceptance by concession.
3) Take action to preclude its original intended use or application.
4) Take action appropriate to the effects, or potential effects, of the
nonconformity when nonconforming product is detected after delivery or use has
started.
Maintain records of the nature of the nonconformity, and any subsequent actions,
(including any concessions). When the nonconformity is corrected, re‐verify it to
show conformity.

44. 8.4 Analysis of Data
Determine, collect, and analyze appropriate data to demonstrate the suitability
and effectiveness of the quality management system, as well as, evaluate where
continual improvement of the effectiveness of the quality management system can
be made. Include in the analysis the data generated by monitoring and measuring
activities and from other relevant sources. Analyze this data to provide information
on:
1) Customer satisfaction (see 8.2.1).
2) Conformity to product requirements (see 8.2.4).
3) Characteristics and trends of processes and products, including
opportunities for preventive action (see 8.2.3, 8.2.4, and 8.5.3)
4) Suppliers (see 7.4)

45. 8.5 Continual Improvement
8.5.1 Continual Improvement
One of the most important elements of this Quality Management System is the
area of continuous improvement, and the use of corrective and preventative
action reports. These are used both to correct a known problem, but also to
prevent their occurrence. Continual improvement effects of Quality Management
System through:
1) Quality policy.
2) Quality objectives.
3) Audit results.
4) Analysis of data.
5) Corrective and preventive action.
6) Management review.

46. 8.5.2 Corrective Action
We must have to take corrective action to eliminate the causes of nonconformities
and prevent recurrence. Corrective action must have to be appropriate to the
effects of the problem. A documented procedure has to be established a for
corrective action that defines requirements to:
1) Review nonconformities (including customer complaints).
2) Determine the causes of nonconformities.
3) Evaluate the need for actions to prevent recurrence.
4) Determine and implementing the needed action.
5) Maintain records of the results of the action taken.
6) Review the effectiveness of corrective action taken.

47. 8.5.3 Preventive Action
We must have to determine the action to eliminate the causes of potential
nonconformities in order to prevent their occurrence. We must have to ensure
that preventive actions are appropriate to the anticipated effects of the potential
problem. Again a documented procedure has to be established for preventive
action to define requirements to:
1) Determine potential nonconformities and their causes.
2) Evaluate the need for actions to prevent occurrence.
3) Determine and implementing the needed action.
4) Maintain records of the results of the action taken.
5) Review the effectiveness of preventive action taken.

48. PREPARED BY : MOHAMMED ENAMUL KABIR.
Thank You
For Your Patience