Internal Auditor Training Program

Quality Management System based on ISO 9001 : 2008

 Program Objective

 Understanding the requirements of ISO 9001: 2008

Relating the requirements to the individual’s activity

 Understanding the roles and responsibilities

 Implementing the requirements of the standard

 Contributing for continual improvement

 Agenda

Time Program Detail

Day -1 29th January , 2011
08.30 – 09.00 Attendance /Registration
09.00 – 10.30 QMS Requirements
10.30 – 10.45 Break
10.45 – 12.00 QMS Requirements Contd….
12.00 – 13.00 Prayer & Lunch Break
13.00 – 14.30 QMS Requirements Contd….
14.30 – 14.45 Break
14.45 – 16.00 QMS Requirements Contd….
16.00 Close of day 1
 About ISO..

 ISO stands for “ International Organization for Standardization”

 ISO Central Secretariat is based in Geneva (Switzerland)

 163 Countries are its members

 ISO is a non government organization

 ISO has developed around 17500 standards

ISO develops international standards for all sectors except electro

technology ( IEC) and Telecommunication by ITU

Management System standards developed by ISO are generic standards

 What is Quality ?

The degree to which a set of inherent characteristics fulfills a need or

expectation that is stated, generally implied or obligatory

Or Simply “ Quality is the difference between the standard required and

the standard reached”.

We can define quality in following ways too !

 A degree of excellence
 Conformance with requirements
 Fitness for use Quality
 Fitness for purpose
 Freedom from defect imperfections or contaminations
 Delighting customers

Quality Control : Part of quality management focused on fulfilling quality

requirements.
Quality Assurance : Part of quality management focused on providing
confidence that quality requirements will be fulfilled.
 Quality Characteristics

Product

 Accessibility  Disposability Security Transportability

Availability  Functionality Size Weight
Appearance  Maintainability Storability
Adaptability  Operability Strength
Consumption Reliability Taste
 Durability  Safety Traceability

 Accessibility  Dependability  Promptness

 Accuracy  Efficiency  Responsiveness
Service

 Courtesy  Effectiveness
 Comfort  Flexibility  Reliability
 Credibility  Honesty  Security
 Terms and Definitions

Audit
A Systematic independent and documented process for obtaining “audit
evidence” and evaluating it objectively the extent to which “audit
criteria” are fulfilled.

Corrective Action
Action to eliminate the detected non conformity or other undesirable
situation
There can be more than one cause for a nonconformity
Corrective action is taken to prevent recurrence

Customer
As per the standard customer is an organization or person that receives
a product and includes consumer, client, end user, retailer, beneficiary
and purchaser.

7
 Terms and Definitions

Document
Information and supporting medium ( Medium can be paper, magnetic,
electronic or optical Computer disk, photograph or master sample, or a
combination thereof )
Documents can be changed.

Nonconformity
Non Fulfillment of a requirement.

Organization
Company, operation, firm, enterprise, institution, or association, or part
thereof, whether incorporated or not public or private that has its own
function and administration.

8
 Terms and Definitions

Preventive Action
Action to eliminate the cause of a potential nonconformity or other
undesirable potential situations.
Preventive action is taken to prevent occurrence of nonconformity

Procedure
Specified way to carryout an activity or a process

Product
A result of a process. Product means service also.

Records
Documents stating results achieved or providing evidence of activities
performed.
Records cannot be changed .

9
 Eight Quality Management Principles

Customer Focus
Leadership
Continual
Improvement

Process Mutually Beneficial

Approach Supplier
Relationships

Involvement of People
System Approach
Factual Approach

All the requirements of ISO 9001: 2008 are related to one or more of these
principles.

10
 Continual Improvement

Difference between continuous and continual

 Continuous means without break or interruption.
 Continual means repeated regularly and frequently.
Continual Improvement means:
 Continually questioning their performance, methods and targets and
seeking new performance, innovate and implement better methods and
seeking new targets.
 Improvement may be related to a specific activity, specific process,
specific product or services etc.

Error correction to course correction…

11
 Improvement through PDCA Cycle

The QMS must be used for continual

improvement ...
Plan Do Results
Measure/Monitor Results
Act Check Against Objectives - Improve
Process and Change QMS as
Needed to Achieve and Sustain
QMS Desired Results
Improvement
Objective Baseline Performance

12
 Continual Improvement of the Quality
Management System
The ISO Model

Management
Responsibilit
y

Measurement
Resource
, Analysis,
Management
Improvement

Inputs Product Outputs

Realization Product

13
 QMS General Requirements

General Requirement.
 Establishing, documenting, implementing and maintaining a QMS and
continually improving its effectiveness.
While developing QMS following is considered.
 Determining the processes needed.
 Determining the sequence and interaction.
 Determining the criteria and methods for ensuring effective processes
and operations.
 Ensuring availability of resources and information's.
 Monitoring, measuring and analyzing the processes.
 Implementing actions necessary to achieve planned results and
continual improvement.
 Identifying outsourced processes and controlling them.

Clause 4.1 , ISO 9001: 2008

14
 Documentation Requirements- General

Documentation of QMS include

 Documented quality policy
 Documented objectives.
 Quality manual.
 Mandatory documented procedures and records.
 Other procedures, records, work instructions, process flow etc.
Example :
Operational procedures
Forms
Checklist etc.

Clause 4.2.1 , ISO 9001: 2008

15
 Quality Manual

Establishing and maintaining a quality manual including

 Scope of the QMS
 Exclusions and justifications
 Documented procedures or a reference to them.
 Description of the interaction between the processes of QMS.
Note : Exclusions are permitted only under section 7.0.

AKS will have a Quality and EHSMS Manual.

Clause 4.2.2 , ISO 9001: 2008

16
 Control of Documents

Establishing documented procedure for controlling QMS documents.

 Documented procedure is mandatory .
Document control procedure shall define the controls for the following.
 Approving documents prior to issue.
 Reviewing, updating and re-issuing of documents.
 Ensuring that changes and current revision status is identified.
 Ensuring relevant versions of applicable documents are available at
the point of use.
 Ensuring that documents remain legible and identifiable.
 Ensuring that documents of external origins are identified and
controlled.
 Preventing unintended use of obsolete documents and applying
suitable identity in case they are retained for some purpose.

Clause 4.2.3 , ISO 9001: 2008

17
 Control of Records

Establishing records for demonstrating the evidence of conformity of

operations and the QMS.
QMS records shall be controlled.
 Documented record control procedure is mandatory .
Record control procedure shall define the controls for the following.
 Identifying records.
 Storing records.
 Protecting records.
 Retrieving records.
 Retaining records.
 Disposing off records.
Records shall remain legible, readily identifiable and retrievable.

Clause 4.2.4 , ISO 9001: 2008

18
 Management Commitment

 Committing to the development and improvement of the quality

management system.
 Communicating the importance of meeting customer requirements
and applicable regulatory and legal requirements.
 Establishing Quality Policy and ensuring that it meets the prescribed
criteria.
 Ensuring that customers needs and expectations are determined,
converted into requirements and fulfilled to achieve customer
satisfaction.
 Establishing quality objectives at relevant functions and levels.
 Ensuring that resources needed to achieve the objectives are identified,
planned and are available.
 Appointing Management Representative.
 Periodically reviewing the management system to ensure that it
remains relevant and effective.
Clause 5.1 , ISO 9001: 2008
19
 Customer Focus

1. Determining Customer Requirements

 An effective process is in place for determining customer requirements.

 Requirements include a need or expectation that is stated,

customarily implied or obligatory.
2. Meeting determined requirements
 Customer requirements to be met with the aim of enhancing customer
satisfaction.
 If Customer’s requirements is incorrect in some way, an organization has
an obligation to go beyond the requirements and aim for customer
satisfaction.

Clause 5.2 , ISO 9001: 2008

20
 Quality Policy

Quality policy
 Is appropriate to the needs of the AKS and its customers.
 Is signed by the MD .
 Contains AKS’s commitment to comply with the requirements.
Note: Requirements include customer requirements, statutory and
regulatory requirements, requirements etc.
 Contains a commitment to continually improve the effectiveness of the
management system.
Must have a system in place for improving overall performance of AKS.
 Provide a framework for establishing and reviewing quality objectives.
Example: Enhancing customer satisfaction

Clause 5.3 , ISO 9001: 2008

21
 Quality Policy

 Is communicated and understood by all within the AKS .

Note : Understood means every one understands the importance of their
roles, responsibilities and contribution needed for achieving objectives.
 Is reviewed for continued suitability
Note: Reviewed by AKS CEO together with Directors, Mangers and
Department Heads for its relevance in the changing business and
economic environment and in the light of AKS ‘s needs.

Understanding Quality Policy

Clause 5.3 , ISO 9001: 2008

22
 Quality Objective

1. Ensuring that quality objectives are established

 For products and services
 At relevant functions and levels within the organization.
Responsibility lies with the AKS management

2. Ensuring that established quality objectives are measureable and

consistent with the policy.
 Objective means a result that is being aimed for and to be achieved.
 The results must be expressed in measurable form and within a definite
time period.
In simple terms : Objective means “ What is to be achieved and when”

Clause 5.4.1, ISO 9001: 2008

23
 Quality Objective

Objectives must be SMART

S Specific Specific actions

M Measurable Measurable actions having specific end conditions.
A Achievable Achievable with the available resources
R Realistic Realistic in the context of current business
environment and projected workload
T Timely Time bound actions. ( Specific start and end time)

Examples:
 Lead time for procurement
 Lead time for recruitment

Claus 5.4.1 , ISO 9001: 2008

24
 Quality Management System Planning

1. Ensuring that while planning the quality management system

following requirements are considered.
 Identifying required processes and their interactions.
 Establishing criteria and methods for controlling processes.
 Establishing performance measures for processes.
 Ensuring availability of necessary resources and information for
supporting operations and controlling processes.
 Implementing actions that are necessary for achieving the planned
results and continually improving them.
 Establishing objectives.

Clause 5.4.2 , ISO 9001: 2008

25
 Quality Management System Planning

2. Ensuring that integrity of the quality management system is

maintained while planning and implementing the changes.
For example:
 Changes in the organization structure.
 Changes in the hardware and software.
 Changes in the technology .
 Changes in the competency level of the staff.
 Any other changes.

Clause 5.4.2 , ISO 9001: 2008

26
 Responsibility and Authority

1. Defining responsibilities and authorities

In simple terms responsibility means “ One is entitled to act on his/her
accord”. We can also say “ It is an obligation of an individual to achieve the
desired condition for which he/she is responsible”.
Authority means “Right to take actions and make decisions”. In the
management context : “Use of position to give instructions for taking
actions”
Authority Matrix is an instrument “ Through which decision making
power is delegated to different level of persons who are in direct contact
with the subject that need to be resolved”. Authority matrix speeds up the
decision making process.
Through the process of delegation authority passes downwards and
whereas responsibility moves upwards.

Clause 5.5.1 , ISO 9001: 2008

27
 Responsibility and Authority

2. Communicating responsibilities and authorities

 Ensuring that employees understand their obligations and
accountability.
By communicating:
 Conflicts and confusions can be avoided.
 Easy to motivate employees.
 Smoothens the communication channel and unplanned
interruptions are minimized.
 Easy to indicate who will receive instructions from whom, for
whom they are accountable and to whom to approach to resolve
conflicts and difficulties.
Responsibilities and authorities can be demonstrated through
organization chart, job description, procedures, process flow etc.

Clause 5.5.1 , ISO 9001: 2008

28
 Management Representative

Appointing Management Representative

 One Manager need to be delegated with the responsibility and authority
for planning , organizing and controlling the management system.
 Commonly he is termed as MR.
 Everyone in the organization need to know the identity of MR.
It is not a one man job and cannot be done in isolation.
Hence, MR acts as a
Coordinator.
Facilitator.
Change agent
and induce changes in the system through others.
Consultant or a subcontractor employee cannot be appointed as a MR

Clause 5.5.2 , ISO 9001: 2008

29
 Internal Communication

1. Ensuring that communication process is established .

2. Communicating regarding effectiveness of quality management
system.
Communication process is a process that convey information and impart
understanding upwards, downwards and laterally within the organization.
Examples :
Communication of policies, procedures, customer requirements, customer
complaints, Statutory and regulatory requirements etc.
Appropriate medium may be selected for communication such as
telephone/e-mail/fax/notice/memo/briefing/conference/meeting/
presentation/ publication etc.
All staffs must be encouraged to report system effectiveness or
ineffectiveness whenever encountered.

Clause 5.5.3 , ISO 9001: 2008

30
 Management Review

1. Reviewing management system for ensuring continued suitability,

adequacy and effectiveness.
 Suitability means ability of QMS to enable AKS to sustain its current
performance level.
 Adequacy means capability of QMS to deliver the products or service
that satisfies requirements, standards and regulations.
 Effectiveness means how well it enables the AKS to fulfill the needs of
the stakeholders.

2. Planning the review at planned intervals

It can be defined by the AKS. Could be quarterly, annual etc.
Plan may be adjusted to reflect the circumstances.

Clause 5.6, ISO 9001: 2008

31
 Management Review

3. Scope of review
 Reviewing performance of the management system.
 Assessing opportunity for improvement.
 Assessing required changes in the management system.

4. Maintaining the review records

 Maintaining meeting minutes. Minutes should contain the decision,
responsibility and time frame.

Clause 5.6, ISO 9001: 2008

32
 Management Review

Review Inputs
 Results of audits ( Internal and external).
 Feedback from the customers.
Process and product/service performance.
Status of corrective and preventive actions.
 Follow-up from the previous MRM.
Changes that could affect the QMS
 Recommendations for improvement.
Review Output
Decisions and actions related to
 Improving the effectiveness of the QMS an the processes.
 Improvement on products /services.
 Resource needs.

Clause 5.6.1 & 5.6.2 , ISO 9001: 2008

33
 Provision of Resources

Determining and providing required resources

 For implementing the quality management system.
Note: Includes human, physical and financial resources.
 For maintaining the quality management system.
Note : Maintaining current level of performance as a minimum.
 For continually improving the effectiveness of the management system.
Note: For improving the performance and implementing changes for
improvement.
 For enhancing customer satisfaction by meeting their requirements
Note : Realizing quality objectives
Important: Determining and providing resources is not about the
quantities. It is all about determining and providing capable resources
that can deliver the results.

Clause 6.1 , ISO 9001: 2008

34
 Human Resources – General Requirement

Personnel performing work that is affecting the product or service

conformity
 Must be competent on the basis of appropriate education, training,
experience and skills.
Note: Qualified and competent are not same.
 A person with qualification, experience and skill to perform a job is
considered as qualified for the job.
 If a person demonstrates the ability to achieve the desired result is
considered as competent.
 The difference between qualified and competent is “ ability to achieve
the desired result.
Important: Competence is more than a list of attributes. It is concerned
with outcomes.

Clause 6.2.1 , ISO 9001: 2008

35
 Competence, Training and Awareness

 Determining necessary competence .

Note : Ensuring competent persons are recruited for the work.
 Identifying training or any actions to enhance competence level.

Example : On the job training, external training etc.

 Evaluating effectiveness of the actions.
Note : To ensure that person has achieved the required level of
competence ( Able to deliver the expected results). Should be performed
over a period of time.
 Ensuring personnel’s are aware of the relevance and importance of
their activity and their contribution for the achievement of objectives.
Note: Everyone is applying individual knowledge, skills, experience and
instinct in the clear direction for realizing objectives and must know
their proportion.
 Maintaining records of education, training , skills and experience
Clause 6.2.2 , ISO 9001: 2008

36
 Infrastructure

1. Determining and providing necessary infrastructures to achieve

product/service conformity.
Means identifying and providing permanent facilities and equipment.
Note: Infrastructure includes basic facilities, services, equipment etc. which
are required for the growth of the AKS. This includes building, utility services,
telecommunication facilities, hardware, software, IT equipment etc.
Important: Infrastructure does not include financial, human and
consumable items.
2. Maintaining infrastructures to achieve product/service conformity.
Note: Maintenance means maintaining the capability of the facilities and
equipment.
Examples :
 Planned Maintenance
 Preventive Maintenance
Clause 6.3 , ISO 9001: 2008
37
 Work Environment

Identifying and managing the work environment needed to achieve

the product conformity
Note : Work environment consists of three kinds of environment – Physical,
Social and Psychological.
Physical: Related to ergonomics such as space, temperature, light, humidity,
noise, cleanliness etc.
Social : Interaction between the people, organization ethics, culture etc.
Psychological : Recognition, responsibility, reward, job security etc.

Important: While developing and implementing QMS all of the above need
to be considered.

Clause 6.4 , ISO 9001: 2008

38
 Planning for Product Realization

Planning and developing product realization process

Realization processes are those processes which are needed to specify ,
develop , implement and deliver the projects /products/services.
While Planning and developing product realization process, following
need to be considered.
 Planning for project /product/service requirements.
Note: Requirements include customer specified requirements, requirements
for intended use, statutory and legal requirements etc.
 Planning for quality objectives.
Note : Planning for required results to be achieved for related projects/
services /products.
 Establishing processes and required documentation.
Note : Designing the processes required for the products/services / projects
and related documentations.

Clause 7.1 , ISO 9001: 2008

39
 Planning for Product Realization

 Planning for resources and infrastructure requirements

Note : Planning for human resources, financial resources, facilities,
equipment, IT infrastructures etc.
 Planning for verification, validation, monitoring, measurement,
inspection, testing and acceptance criteria.
 Planning for records to demonstrate the product/project conformities.
Note: Records related to the results achieved at various stages of the
projects to demonstrate the conformity of the project /products etc.
Records may be in the electronic form or in paper from.

Clause 7.1 , ISO 9001: 2008

40
 Customer Related Process

1.0 Determining product or service related requirements.

 Requirements specified by the customer including
requirements for delivery and post delivery.
Means capturing stated expectations, implied and obligatory
requirements stated verbally or in writing, implied or obligatory , have
to be resolved, pinned down to the extent that neither party is doubt so
as to what is required.
Post delivery support means the support customer requires to
maintain , product/service or any other kind of support to retain the
product or service in workable condition.
 Determining requirements not specified by the customer but
necessary for known intended use.

Clause 7.2.1 , ISO 9001: 2008

41
 Customer Related Process

Means determining requirements for a product or service to meet the

requirements of intended use. This may be related to safety, user
friendliness, environmentally compatible and so on.

 Determining statutory and regulatory requirements related to the

product
Note: If the product or service is not meeting the requirements of the
law of land, the product or service cannot be used. Alternatively, failure
to observe the law of land may force the organization to suspend the
operations. Hence , ability to serve customer is lost .

 Determining any other requirements related to the product

Clause 7.2.1 , ISO 9001: 2008

42
 Customer Related Process

2.0 Conducting the review of requirements related to the product

 Product /service requirements are defined.
Note: All requirements that have been identified through the requirement
determination process should be examined for the said product or service
in question.
Examples : Inherent characteristics of the product/service, delivery
requirements, procurement requirements, security requirements related
to the protection of information’s, commercial requirements such as copy
right, intellectual property right, licensing requirements etc.
 Contract or order requirements are resolved.
Note : Before getting into an agreement with the customer all open points
of doubt must be resolved. Any changes to the product requirements
must be reviewed to make sure that no ambiguity exists.

Clause 7.2.2 , ISO 9001: 2008

43
 Customer Related Process

 Review should be conducted prior to the decision or making a

commitment for delivering a product/service.
Note: Making sure that AKS has all capacity to honour the obligations and
commitments made to the customer. Hence, AKS must make a double
check to ensure that required resources including technology, expertise,
equipment, competent personnel, suppliers and time are available or will
be available when required.

 Maintaining the results of review and actions arising out of review.

Note: Decision of review including action plans, meeting minutes etc.
should be maintained should a need arises in future for what so ever
reason.

Clause 7.2.2 , ISO 9001: 2008

44
 Customer Related Process

3.0 Determining and implementing effective arrangements for

communicating with customers.
 Providing product related information
Note: Product information may be in the form of publications,
specifications, demonstrations, trial run of product etc. Idea here is to
make sure that correct and precise information's related to products are
provided to the customers.
 Determining and implementing effective communication method
to handle enquiries related to the product or service, contracts ,
agreements , orders etc.
Note : The idea here is to establishing and implementing a system for
recording enquiries, providing clarifications on specifications,
standards, projects , programs initiatives etc. and developing a AKS and
an effective relationship.

Clause 7.2.3 , ISO 9001: 2008

45
 Customer Related Process

 Determining and implementing effective communication

arrangements to handle customer feedbacks including customer
complaints.
Note : An arrangement should be made to receive customer feedback
and complaints.
Example : Establishing call centers, making a provision in the website
for giving feedback and lodging complaints, dedicated toll free numbers,
help desks etc.

Clause 7.2.3 , ISO 9001: 2008

46
 Design and Development

1.0 Planning and controlling the design and development of product

Note : Design is a creative process . The controls specified in the standard
applies to product/service design and process design.
 Design control keeps the designing process on track.
 Design control process controls the components of designing process
such as inputs, outputs, selection of technologies, techniques, processes ,
materials etc. and NOT the designers or creativity of the designers.
Important : 10 Primary steps in designing process.
1. Establishing customer needs.
2. Converting customer needs to specification.
3. Planning for meeting requirements.
4. Organizing resources, technologies, infrastructure etc.
5. Conducting a feasibility study to know whether the intended
product/service is feasible.
Clause 7.3.1 , ISO 9001: 2008
47
 Design and Development

6. Conducting project definition study to know the possible solutions.

7. Developing a specification that meets the requirements of customer.
8. Producing a prototype
9. Conducting extensive trials and collect data.
10. Feeding back the data to the process and repeat trials until the desired
outcome is achieved.
Planning for the design & development of product includes determining
design objectives, design strategy, design stages, time scales, costs, resources,
finance etc.

Clause 7.3.1 , ISO 9001: 2008

48
 Design and Development

 Determining design and development stages

At each stage of designing process, design reaches cretin level of
maturity.
Various stages in the designing process are:
 Feasibility stage – Studies are made for the feasibility
 Conceptual design stage- Ideas are conceived and theories are
tested.
 Design definition stage-Architecture or layout takes form.
 Detail design stage- Detailed characteristics are established.
 Development stage – Prototype is proven.
 Determining review, verification and validation stages.
 Verification : Design output is checked against the design input.

Clause 7.3.1 , ISO 9001: 2008

49
 Design and Development

 Validation : Design output is compared with design brief or

requirements for ensuring accuracy and correctness.
 Review : Result of verification and validation is reviewed are reviewed
to confirm design solutions, recommend change, stop or allow for
further development.
 Determining responsibilities and authorities for design and
development .
 Managing interfaces between different groups involved in the
design and development.
 Ensuring the updating of design plan as the design and
development progresses.

Clause 7.3.1 , ISO 9001: 2008

50
 Design and Development

2.0 Determining design and development inputs

Note : Requirements governing the design of intended products. It
includes:
 Functional and performance requirements: Actions that a product is
required to perform with or without external stimulus.
 Applicable statutory and regulatory requirements.
 Information's derived from previous similar designs.
 Other requirements essential for design and development .

Clause 7.3.2 , ISO 9001: 2008

51
 Design and Development

3.0 Determining design and development outputs

 Providing design and development outputs in a form that enables
verification against the design and development inputs.
It comprises of :
 Information’s, specimens or models.
 Drawings
 Calculations
 Assumptions
 Data’s etc.
 Outputs meeting the design and development inputs.
 Design output must be traceable to design inputs directly or indirectly.
 It may be compared with the input specifications, required performance
requirements etc.

Clause 7.3.3 , ISO 9001: 2008

52
 Design and Development

 Providing information for purchasing, production or service

provisions.
Means providing inherent characteristics of products that facilitates
procurements, development and service provision activities.
 Defining acceptance criteria
 if criteria is met, the product would be considered as acceptable.
 Specified in measurable terms.
 Contains tolerances and limits.
 Leaves no doubt whether the product is acceptable or unacceptable.
Specifying characteristics that are essential for safe and proper use.
 Those characteristics that a product need to exhibit for functioning
correctly.
 Those characteristics that are exhibited when a product is put into use
or maintained incorrectly.

Clause 7.3.3 , ISO 9001: 2008

53
 Design and Development

 Approving design output prior to release.

 Design approval means approving design description in whatever form it
is .
Design approval proceeds through three stages.
 Design information should be approved prior to design review.
 Design should be approved before verification.
 Design should be approved before validation.

Clause 7.3.3 , ISO 9001: 2008

54
 Design and Development

Reviewing systematically design and development at suitable stages

as
per planned arrangements:
 For evaluating the ability of the results of design and development
to meet requirements.
 Identifying any problems and proposing necessary actions.
All related people must participate in the design review and records
of the review need to be maintained.
Systematic review means
 Reviewing design and development from highest levels to associated
lowest level in a logical manner performed stage by stage, methodical
and with a purpose.
 Probing the design solutions and interface between all the stages.
Suitable stages means transition between various phases of design maturity.

Clause 7.3.4 , ISO 9001: 2008

55
 Design and Development

Planned arrangements means reviews have been planned for inputs, outputs
and acceptance criteria before going ahead with further actions.
Related people must participate in the design means not only designers. It
may include customer etc.
Records of design review includes meeting minutes and all the evidence that
has been accumulated in evaluating a particular design, identifying problems
and determining actions required to resolve them.

Clause 7.3.4 , ISO 9001: 2008

56
 Design and Development

1.0 Performing design and development verification as per planned

arrangements for
 Ensuring that output meets the design and development input.
2.0 Records of results pertaining to verification shall be maintained.
Verification may take the form of document review, verifying alternative
calculations, similarity analysis or tests, demonstration on representative
samples, prototypes etc.
Purpose of verification is to prove that the design is right, means meets the
requirements.
Results pertaining to verification includes data testifying the condition,
acceptance criteria, the measurements tec.

Clause 7.3.5 , ISO 9001: 2008

57
 Design and Development

1.0 Performing design and development validation as per planned

arrangements for
 Confirming that that resulting product is capable of fulfilling the
requirements for the specified application or intended use where
known.
2.0 Completing validation prior to implementing product or
delivering product where practicable.
3.0 Records of results pertaining to Validation shall be maintained.
Validation means provision of confirmation through the objective evidence
that requirements for a specific intended application or use have been
fulfilled.
Example : Where software designed for one application can be proven fit for
use in different applications. To achieve this multiple validations need to be
performed to qualify a design for different applications.
Safety , reliability etc. may need to be tested before launching a product.
Clause 7.3.6 , ISO 9001: 2008
58
 Design and Development

Controlling design and development changes.

 Identifying the changes and maintaining records.
 Identifying and recording product design changes.
 Identifying and recording product modifications.
 Reviewing and approving changes before implementing
 Verifying and validating changes as appropriate before
implementation.

Clause 7.3.7 , ISO 9001: 2008

59
 Purchasing

1.0 Ensuring that purchased products conform to the specified

purchase requirements.
 Those requirements which are specified by the AKS.
 Requirements specified by the customer.
 Requirements specified by statue or regulations that apply to the
purchased product.
This includes ant requirements limiting the condition or source of supply.
2.0 Applying the type and extent of controls on supplier and purchased
product proportionate to the affects on the subsequent product or
service realization process.
 Type and extent of controls applied on the supplier
 Type and extent of controls applied on the product.

Clause 7.4.1 , ISO 9001: 2008

60
 Purchasing

Controls applied on the product :

 Type of control means control should act before , during or after receipt
of a product or service.
 Extent of control refers whether it is remote ( on the supplier premises),
on the basis of product data or to be evaluated before authorizing delivery.
Controls applied on the Supplier:
 Type of control means whether or not to qualify the supplier.
 The degree to which AKS is involved with the supplier in managing the
purchase.
3.0 Evaluating and selecting supplier based on their ability to supply
product in accordance with the AKS’s requirements and
establishing criteria for evaluation, selection and re-evaluation.

Clause 7.4.1 , ISO 9001: 2008

61
 Purchasing

 Selecting a supplier on the basis of capability to supply the product or

service.
 Selecting or ignoring a supplier should be based on the criteria defined
by AKS.
Following are some of the steps that are involved.
 Selection process.
 Preliminary supplier assessment.
 Prequalification of suppliers.
 Qualification of suppliers.
 Invitation to tender.
 Tender/quote evaluation.
 Contract negotiation.

Clause 7.4.1 , ISO 9001: 2008

62
 Purchasing

 Satisfying regulatory requirements.

 Criteria for periodic evaluation.
3.0 Maintaining records of evaluation and sequent follow-ups.
Note : This is not approved supplier list or approved vendor list but the
objective evidence based on which decision was made to include the supplier
on the approved suppliers list or approved vendor list.

Clause 7.4.1 , ISO 9001: 2008

63
 Purchasing

1.0 Describing the product to be purchased, including

 Requirements for approval of product, procedures, processes and
equipment .
 Requirements for qualification of personnel.
 QMS requirements.
Essential information's must be submitted to the supplier to let them know
what you require. This may include :
 Product identification
 Personnel with specific qualification
 Purchase specification etc.
Above information's must be included in the LPO or contracts.
2.0 Ensuring the adequacy of specified purchase requirements prior
to their communication to the suppliers.
Means accuracy of information's related to the product in requirement.

Clause 7.4.2 , ISO 9001: 2008

64
 Purchasing

1.0 Ensuring purchased product meets the specified purchase

requirements by establishing relevant inspection or other activities.
 Includes testing or inspection activity.
 May be performed before , during or after receipt of delivery.
 Timing of inspection may be decided by AKS.
 Inspection and testing activities may be performed by the AKS personnel
or by an appointed agency.
2.0 Performing verification at the suppliers premises and agreeing on
the arrangements for the product release in the purchasing
information.
AKS to indicate if the product should be tested/inspected at the supplier’s
premises before authorizing for delivery. This requirement must be included
in the LPO or contract.

Clause 7.4.3 , ISO 9001: 2008

65
 Control of Production and Service Provision

1.0 Planning of production and service provision under controlled

conditions . Controlled conditions include:
 Ensuring availability of information describing the product
characteristics.
Means identifying product /service specification, defining the process stages
and objectives, defining inputs and outputs, defining resources required,
defining the methods etc.
 Ensuring availability of work instructions as necessary.
 Ensuring use of suitable equipment ( Appropriate hardware and software)
 Ensuring availability of appropriate monitoring and measuring equipment.
 Implementing monitoring and measurement.
Implementing product release, delivery and post delivery activities.

Clause 7.5.1 , ISO 9001: 2008

66
 Validation of Processes for Production and Service Provision

1.0 Validating production and service provision process where

resulting output cannot be verified by subsequent measurement and
monitoring. ( Also called special process).
Means : There are some processes where the output is totally dependent on
the personnel, equipment and the facilities. Moreover, cannot be fully verified
by the examination of end product at any stage of production.
Examples : Software development, professional advisor services etc.
2.0 Establishing necessary arrangements for validating processes
which includes:
 Defining criteria for review and approval of processes.
 Approving equipment and qualification of personnel.
 Approving use of specific method and procedures
 Maintaining records of validation and revalidating process.

Clause 7.5.2 , ISO 9001: 2008

67
 Identification and Traceability

1.0 Identifying the product throughout the product by suitable means

throughout the product realization process.
Projects must be identified by suitable means during different phase of
projects.
2.0 Identifying the status of product with respect to measurement
and monitoring requirements
Required for differentiating between conforming products and non
conforming products. Example : For software's, verification status can be
denoted on the software as a comment or on records testifying its
conformance. For website , Notifying on website, under Maintenance etc. !
( when not performing)
3.0 Controlling and recording the unique identification, where
traceability is a requirement.

Clause 7.5.3 , ISO 9001: 2008

68
 Customer Property

Organization shall handle the customer property with utmost care

when it is under the control or being used by the organization.
 Identifying, verifying, protecting and safeguarding of the customer
property is responsibility of the organization.
 Reporting the customer if a property is lost, damages or becomes unfit
for use and maintaining records.
 Customer property may be a software, hardware, standards, etc.
 Documentation is not considered as a customer property unless it is
specifically agreed on contract to return the document.

Clause 7.5.4 , ISO 9001: 2008

69
 Preservation of Product

Preserving the product during internal processing and during

delivery to the intended location including identification, handling
packaging, storage and protection.
Means making sure that product conformity does not get affected.

Clause 7.5.5 , ISO 9001: 2008

70
 Control of Monitoring and Measuring Equipment

 Identifying equipment requiring calibration.

 Establishing a process to ensure that calibration is carried out at the
required intervals.
 Identifying calibration status on the equipment.
 Protecting equipment while handling and storing etc.
 Maintaining records of calibration.
Calibration of software's are performed by configuration Management.
Integrity of the software need to be verified before use. Software’s may
become corrupted.

Clause 7.6, ISO 9001: 2008

71
 Measurement , Analysis and Improvement

Planning and implementing the monitoring, measurement, analysis

and improvement process for
 Demonstrating conformity to the product requirements.
 Ensuring conformity of the QMS
 Continually improving the effectiveness of the QMS.
And
Determining applicable methods including statistical techniques and
extent of their use.
KPI’s need to be established, implemented and monitored.
No process, system etc should be left to the chance.
Example : If training process is monitored, untrained staff could produce
unacceptable product/service.

Clause 8.1, ISO 9001: 2008

72
 Customer Satisfaction

 Monitoring information relating to customer perception as to

whether the organization has met customer requirements.
 Determining the methods for obtaining and using this information
The term perception is used because satisfaction is subjective and depends
on human condition unlike acceptance that is based on objective evidence.
As per the standard customer is an organization or person that receives a
product and includes consumer, client, end user, retailer, beneficiary and
purchaser.
Information relating to customer perception is any meaningful data from
which a judgment can be made about customer satisfaction and would
include compliments, complaints, survey results etc.
Requirement of the standard is monitoring of perception rather than
measurement of satisfaction.
Monitoring involves systematic checks on a periodic or continuous basis.

Clause 8.2.1, ISO 9001: 2008

73
 Internal Audit

Determining
 Whether the QMS conforming to the requirements of this
standard.
 Is effectively implemented and maintained.
Planning of internal audit
 Preparing audit programme considering the following.
 Status and importance of the processes and areas.
 Results of previous audit
 Determining criteria, scope, frequency and method.
 Ensuring auditors do not audit their own work .
 Conducting audit as per the documented procedure.
 Taking appropriate corrective and preventive actions where the
nonconformities are reported.
 Conducting follow-up audit.
 Documented procedure is mandatory.
Clause 8.2.2, ISO 9001: 2008
74
 Monitoring and Measurement of Processes

Applying suitable methods for monitoring and where applicable

measuring QMS processes.
Measurement of processes means determining and implementing a range of
parameters that are critical for the process to consistently deliver the correct
results.
Implementing monitoring and measurements methods for
demonstrating the ability of processes to achieve planed results.
To demonstrate ability means either by observation or through validated
records , evidence must be available which shows that process is capable of
achieving desired results.

Clause 8.2.3, ISO 9001: 2008

75
 Monitoring and Measurement of Product

 Monitoring and measuring the characteristics of the product to

verify the product requirements have been met.
 Monitoring and measuring activities are conducted at the
appropriate stages in accordance to the planned arrangements.
 Achieved characteristics are accessible for measurement.
 An economic means of measurement can be adopted.
 Correction of error is less costly than if it is detected at a later stage.
Planned arrangement means plans made for verifying product in terms of
What is to be verified, Who will verify, when it is to be verified, how it is to be
verified and where it is to be verified and What criteria to be used to judge
nonconformity.
Stages may be in process and final verification.
 Maintaining evidence of conformity is required. Also, records must
who has authorized the product release.
 Products shall not be released to the customer unless it is
authorized by a relevant authority.
Clause 8.2.4, ISO 9001: 2008
76
 Control of Nonconforming Product

 Identifying and controlling the nonconforming product and

preventing its delivery.
 Defining responsibilities and authorities for dealing with
nonconforming product.
Nonconforming product means “ Product which does not conform to the
agreed product requirements when either subjected to planned or
unplanned verification. A nonconforming product is one that fails to meet
the:
 Customer specified requirements.
 Intended usage requirements.
 Stated or implied needs.
 Organizations own requirement.

Clause 8.3, ISO 9001: 2008

77
 Control of Nonconforming Product

When detected, nonconforming product shall be handled in the following

manner.
 By correcting the nonconformity : In such case a re-inspection would be
required.
 Taking actions to eliminate the non conformity.
 Authorizing its use, release or acceptance by relevant authority and
preferable by customer.
 Taking other appropriate actions .
Where the nonconformity is detected is after deliver, a process should be
there for subsequent actions.
Maintaining records of nonconformity including actions taken.
 Documented procedure is mandatory for handling nonconformance.

Clause 8.3, ISO 9001: 2008

78
 Analysis of Data

Determining, collecting and analyzing appropriate data to demonstrate the

suitability and effectiveness of the QMS.
 The standard does not indicate what data needs to be collected.
 Organizations should collect the data on the basis of importance and
priority, analyze it and based on the results initiate actions for
improvement.
Some examples are :
 Customer satisfaction survey results.
 Customer complaints .
 Average recruitment time .

Clause 8.4, ISO 9001: 2008

79
 Continual Improvement

Continually improving the effectiveness of the quality management

system through use of the quality policy, quality objectives, audit
results, analysis of data, corrective and preventive actions and
management review.
Improvement can be achieved by :
 Improvement by better controls on processes .
 Improvement by better utilizing the resources.
 Improvement by better understanding of stakeholders needs.

Clause 8.5.1, ISO 9001: 2008

80
 Corrective Action

 Taking actions to eliminate the cause of nonconformities in order to

prevent recurrence.
 Actions taken must be appropriate to the effect on nonconformities
encountered.
Important Note :
Inspections detect nonconformity.
Nonconformity control identifies, segregates and rectifies nonconforming
item.
Corrective action serves to prevent the nonconformity from reoccurring.
Preventive action serves to prevent nonconformity from occurring.
A documented procedure is mandatory for corrective action.
Customer compliant is a nonconformity. It may be related to product, it may
be related to delivery, it may be related to staff attitude etc or may be related
to a false claim in the website.

Clause 8.5.2, ISO 9001: 2008

81
 Corrective Action

Steps in the corrective action process

1. Review the nonconformity
2. Determine the root cause of nonconformity.
3. Determine the action needed to prevent the nonconformity from
reoccurring.
4. Implement the actions agreed.
5. Record the results of action taken/implemented.
6. Assess the effectiveness of the action taken.

Clause 8.5.2, ISO 9001: 2008

82
 Preventive Action

Preventive Actions
 Taking actions to eliminate the potential cause of nonconformities
in order to prevent their occurrence.
 Actions taken must be appropriate to the effect of potential
problems.

A documented procedure is mandatory for preventive action.

Clause 8.5.3, ISO 9001: 2008

83
QA Session