Quality Management System ISO 9001v2015 Awareness

TÜV AUSTRIA GROUP
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Group Presentation 2016 21/11/23
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ISO 9001:2015
Awareness course

course contents x
Introduction
ISO organization
Management System standards and certification.
Quality Management System Principles.
ISO 9001:2015 Structure.
ISO 9001:205 requirements.

What is TÜV
TÜVs (German pronunciation: [ˈtʏf]; short for German: Technischer Überwachungs verein, English:
Technical Inspection Association) are German businesses that provide inspection and product
certification services.
The TÜVs originated in Germany in the late 1800s during the Industrial Revolution, following the
explosion of a steam boiler at a brewery in Mannheim in 1865. This led a group of engineers to found
the first Dampfkessel Überwachungsverein (DÜV, Steam Boiler Inspection Association) and soon
similar associations were created in other German cities and these came together in an association
in 1873.
In 1906 the Grand Duchy of Baden issued regulations for vehicle inspection as well as drivers, and
the local DÜV was given that responsibility. By 1938 there were 37 DÜVs, and they were reorganized
and renamed into 17 TÜVs. In 1951 national regulation obligated people to have their cars inspected
by TÜV every two years.

TÜV Austria
European Name TUV widely accepted

What is TÜV Name : (German brand)
Technischer Überwachungs-Verein
Association for Technical Inspection binds all TUVs
VdTÜV (Association of Technical Inspection Agencies)

VISION & MISSION
TÜV AUSTRIA is a leading, impartial and independent

service provider for integrated management of safety,
quality, environment and resources with international
orientation
Autonomy and impartiality are the principles of our actions
in the service of safety.
We are committed to performing our services in a socially

and environmentally responsible and ethical way.
Our mission is the sustainable improvement of safety and

quality.
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ISO Organization
In 1946, delegates from 25 countries met in London and decided to create a new international
organization, of which the objective would be "to facilitate the international coordination and
unification of industrial standards".

ISO Organization
ISO organiztion, officially began operations on 23 February

1947
ISO is a network of the national standards institutes of 164
countries, on the basis of one member per country, with a
Central Secretariat in Geneva, Switzerland, that coordinates
the system. (http://www.iso.org)

ISO standards Certification
Accreditation
body ISO
Audit Issue
Audit
Implement
Certification Body Organization
ISO standard
Certificate e.g. 9001:2015

System Certification
Customer Satisfaction Energy
ISO 10002 Customer Satisfaction EN ISO 50001 Energy Management System
Cosmetics Social responsibility
ISO 22716 Cosmetics - Good Manufacturing SA 8000 Social responsibility
Practices (GMP) EN ISO 22301 Societal security. Business
Halal Continuity
Halal Food SEDEX Supplier Ethical Data Exchange
Medical Devices
EN ISO 13485 Quality Management System for
Medical Devices,
EN 15224 Health Services

x
What is Quality ?
‫ما هو مفهوم الجودة ؟‬

The Definition of Quality

Quality definition
x
 degree to which a set of inherent

characteristics of an object fulfils
requirements- ISO 9000:2015
 “Fitness for intended purpose”-Juran’s
 Meeting or exceeding customer expectations.

Quality Assurance Vs Quality
x Control
Quality Control (Q.C)
Part Of The Quality Management Focused On Fulfilling Quality Requirements

ISO 9000:2015
Quality Assurance (Q.A)
Part Of The Quality Management Focused On Providing Confidence That Quality Requirements
Will Be Fulfilled
ISO 9000:2015

Good &
Bad Defect products
Products
Loss
Acceptance
Only Criteria
good Filter
Products
x
ISO 9000 family development

2000
1994 2005
2008
1987 2015
ISO 9000 ISO 9001 ISO 9004

Terms & Requirements Guidelines
Definition

Quality Management Principles
• Customer Focus
• Leader ship
• Engagement of people
• Process Approach
• Improvement
• Evidence-based decision making.
• Relationship management

ISO 9001:2015 Structure
Composed of 10 clauses
1. Scope
2. References
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement
x
List of Clauses and Sub-clauses
4.0 Context of the Organization 5.0 Leadership
4.1 Understanding the organization and 5.1 Leadership and Commitment

its context 5.1.1 General
4.2 Understanding the needs and 5.1.2 Customer Focus
expectations of interesting parties 5.2 Quality Policy
5.3 Organization Roles ,
4.3 Determining the scope of the quality Responsibilities and Authorities
Management system
4.4. Quality management system and its

processes

x Sub-clauses
List of Clauses and
6. Planning 7. Support
6.1 Actions to address risks and 7.1 Resources

opportunities .
6.2 Quality objectives and planning to 7.1.1 General
achieve them . 7.1.2 People
6.3 Planning of changes. 7.1.3 Infrastructure
7.1.4 Environment for the operation of
processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational Knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented Information

7.5.1 General
7.5.2 Creating and Updating
7.5.3 Control of documented information

List of Clauses andx Sub-clauses
8. Operation
8.1 Operational planning and control 8.4 Control of externally provided processes,
products, and services
8.2 Determining the requirements for 8.4.1 General
products and services. 8.4.2 Type and extent of control
8.2.1 Customer Communication . 8.4.3 Information for external providers
8.2.2 Review of the requirements for products 8.5 Production and Service Provision
and services . 8.5.1 Control of production and Service
8.2.3 Changes to requirements for products Provision
and services. 8.5.2 Identification and Traceability
8.3 Design and development for products 8.5.3 Property belonging to customers or
and services external providers
8.3.1 General
8.3.2 Design and development planning 8.5.4 Preservation
8.3.3 Design and development Inputs
8.3.4 Design and development controls 8.5.5. Post delivery activities
8.3.5 Design and development outputs
8.3.6 Design and development changes 8.6 Release of products and services
8.7 Control of nonconforming outputs.

List of Clauses and
x Sub-clauses
9.0 Performance Evaluation 10. Improvement
10.1 General
9.1 Monitoring ,Measurement , analysis and
Evaluation 10.2 Nonconformity and corrective action
9.1.1 General 10.3 Continual Improvement

9.1.2 Customer Satisfaction
9.1.3 Analysis and Evaluation
9.2 Internal Audit
9.3 Management Review

9.3.1 General.
9.3.2 Management review Inputs.
9.3.3 Management review Outputs.

1- Scope
The Quality Management System
requires the organization to:
 needs to demonstrate its ability to consistently provide

products and services that meet customer and
applicable statutory and regulatory requirements
 aims to enhance customer satisfaction through the
effective application of the system, including processes
for improvement of the system and the assurance of
conformity to customer and applicable statutory and
regulatory requirements.

Samples of ISO Management Systems not in the
scope of ISO 9001:2015
• Environmental Management System

• Occupational Health and Safety
• Food safety management system
Compatibility with other management systems

2 Normative references
Latest edition of the referenced document
( including any amendment ) applies
ISO 9000: 2015 , Quality Management Systems

- Fundamental and Vocabulary

3.0 Terms and definitions
Documented Information :
Information required to be controlled and

maintained by the organization and the medium on which it is contained.
• — the management system, including related processes;
• — information created in order for the organization to operate
(documentation);
• — evidence of results achieved.

Product:
Output that is a result of activities where none
of them necessarily is performed at the interface
between the “ provider” and the “customer”.

Context of the Organization:

Combination of internal and external factors and combination that can have
an effect on an organization’s approach to its product ,service and
investments and interested parties

4. CONTEXT OF THE ORGANIZATION

4. Context of the organization

• Inputs required and the outputs expected from QMS processes;
• The sequence and interaction of these processes;
• Criteria and methods (including monitoring, measurements and related
• Performance indicators) needed to ensure the effective operation and
control of these processes;
• Determine the resources needed for these processes and ensure their
availability;
• Assign the responsibilities and authorities for these processes;
• Address the risks and opportunities as determined in accordance with the
requirements of 6.1;
• Evaluate these processes and implement any changes needed to ensure
that these processes achieve their intended results;

5 Leadership

5.1 Leadership and commitment
5.1.1
Top management need to demonstrate leadership and commitment.
➔Taking accountability for the effectiveness of QMS
➔Establishment of Quality Policy and Objectives
➔Integration of the QMS requirements
➔Promoting use of process approach and risk-based thinking
➔Provision of adequate resources.
(continued)

5.1 Leadership and commitment
5.1.1 (Continued)
➔ Communicating importance of effective QMS and conformity its requirements.
➔ Make sure that the QMS is achieving the results intended and must lead people to contribute to the
effective operation of the system.
➔ Drive continual improvement and develop leadership in their employees.

5.1.2 Customer Focus
Ensure customer and applicable statutory and regulatory requirements are identified, understood
and consistently met.
Consider and address any risks that threaten the ability of the organization to provide conforming
products and/or services, or which may negatively impact customer satisfaction.
Focus on enhancing its customers’ satisfaction.

5.2 Quality policy
5.2.1 Developing the quality policy.
Top management shall establish, implement

and maintain a quality policy that:
a) is appropriate to the purpose and context of the organization.

b) provides a framework for setting quality objectives.
c) includes a commitment to satisfy applicable requirements.
d) includes a commitment to continual improvement of QMS.

5.2.2 Communicating quality policy
a) To be available and maintained as documented information
b) To be communicated, understood and applied within the

organization
c) To be available to relevant interested parties, as appropriate.

5.3 Organizational roles, responsibilities and authorities
The top management of the organization need to ensure assignment of

the necessary responsibilities and authorities to the organizational
roles within the organization to carry out quality-related activities

Top management shall assign the responsibility and authority for ensuring:
a) QMS conforms to the requirements ISO 9001:2015.
b) Processes are delivering their intended outputs
c) Reporting on the performance of the QMS and on opportunities for improvement.
d) Promotion of customer focus throughout the organization
e) Integrity of the QMS is maintained when changes to the quality management system are planned and
implemented.

6 Planning for the quality management system

6.1 Actions to address risks and opportunities
6.1.1
The organization is required to consider their context when planning for their quality management
system.
Determine the risks and opportunities that need to be addressed for its given context to provide
assurance that the quality management system can achieve its planned results.
a) Assure the QMS can achieve its intended outcome.

b) Enhance desirable effects.
c) Prevent, or reduce, undesired effects, and
d) Achieve improvement.

6.1.2
Organization need to determine and plan how it will address the identified
risks and opportunities.
➔Actions to address these risks and opportunities.

➔Integrate and implement the actions into its quality management system
processes
➔Evaluate the effectiveness of these actions.

6.2 Quality objectives & planning to achieve them
6.2.1 Establish quality objectives for relevant functions, levels and processes
within its quality management system.
➢ Consistent with the quality policy.
➢ Measurable
➢ Take into account applicable requirements
➢ Relevant to conformity of products/services to enhance customer satisfaction
➢ Monitored, communicated and updated as appropriate and documented.

6.2.2
The organization must undertake planning in order to determine how its quality
objectives will be achieved.
➢ What will be done ?.
➢ What resources will be required ?.
➢ Who will be responsible ?.
➢ When it will be completed ?
➢ How the results will be evaluated ?.

6.3 Planning of changes
Any changes to QMS to be carried out in a planned and systematic manner.
Consider:-
➔ Purpose of the change and any of its potential consequences
➔ Integrity of the quality management system
➔ Availability of resources
➔Allocation or reallocation of responsibilities and authorities.

7 Support

7.1 Resources
7.1.1General
The organization need to determine and then provide all the resources
necessary to establish, implement, maintain and continually improve its
quality management system.
Shall Consider:-
➔ Capabilities of and constraints on existing internal resources.
➔ What needs to be sourced from external providers.

7.1.2 People
Provide people necessary for the effective implementation and operation

quality management system and its processes in order to meet the
customer and applicable statutory and regulatory requirements.
7.1.3 Infrastructure
Determine and maintain the infrastructure necessary for operation of the

process to achieve product/ service conformity
➔ Buildings and associated utilities.
➔ Equipment, Including hardware and software.
➔ Transportation resources.
➔ Information and communication technology.

7.1.4 Environment for operation of process
“Determine, provide and maintain” a suitable environment for the

operation of processes.
A suitable environment can be a combination of human and physical factors,

such as:
➔ Social
➔ Psychological
➔ Physical

7.1.5 Monitoring and measuring resources.
7.1.5.1 General
7.1.5.2 Measurement Traceability

➔ Measurement equipment shall be calibrated at specified intervals
➔ Traceable to Inter(national) standard.
➔ Documented information shall be maintained.
➔ Equipments shall be identified to determine status.
➔ Safeguard from adjustments, damage/ deterioration.

7.1.6 Organizational Knowledge
➔ Determine the knowledge necessary for the operation of organization’s

processes and to achieve conformity of products and services.
➔This knowledge need to be maintained and made available to the extent

necessary.
Organizational knowledge
Internal sources External Sources

7.2 Competence
➔ Determine the necessary competence of person , whose work can

affect the performance and effectiveness of QMS.
➔ Competent on the basis of appropriate education, training, or

experience
➔ Where applicable, take actions to acquire the necessary competence,

and evaluate the effectiveness of the actions taken
➔Retain appropriate documented information as evidence of

competence.

7.2 Awareness
Ensure that persons doing work under the organization’s control are aware of :-
a) The quality policy.
b) Relevant quality objectives.
c) Their contribution to the effectiveness of the QMS including the benefits of improved
performance.
d) The implications of not conforming with the QMS requirements.

7.4 Communication
The organization shall determine the internal and external communications relevant
to the QMS , including:
a) What it will communicate.

b) When to communicate.
c) With whom to communicate.
d) How to communicate.
e) Who communicates.

7.5 Documented information
7.5.1 General
An organization’s quality management system includes both documented information identified as

required in ISO 9001:2015 and documented information identified by the organization as
necessary for the effective operation of its quality management system
Extended of documented information for QMS can vary with organizations based on size of
organization and its activities, complexity of its processes and competence of personals.

7.5.2 Creating and updating.
When creating and updating documented information,
the organization need to ensure appropriate :-
➔ Identification and description,

➔ Format & Media
➔ Review and approval for suitability and adequacy.
7.5.3 Control of documented information.
7.5.3.1 The organization is required to control documented information in order to

ensure that it is available where and when needed and that it is suitable for use. It
must also be adequately protected against improper use, loss of integrity and loss of
confidentiality.

7.5.3.2 For the control of documented information, the organization shall address the following
activities, as applicable:
➔Distribution , access, retrieval and using documented information.

➔ Storage and preservation
➔Controlling changes.
➔Retention and disposal arrangements.
Documented information of external origin shall be identified as appropriate

and to be controlled.

8 Operation

8.1 Operational planning and control
Plan, implement and control the process for product

or service realization and for the achievement of
quality objectives by:
1. Determining the requirements for the products and services.

2. Establishing criteria for the processes, and acceptance of product and service.
3. Determine the resources needed to achieve conformity.
4. Implementing the control of processes.
5. Determine and keeping documented information to the extent necessary.
The organization shall ensure that outsourced processes are controlled.

8.2 Requirements for products and services
8.2.1 Customer Communication
a) Information relating to products and services.

b) Handling enquiries, contracts or orders, including changes.
c) Customer feedback including customer complaints.
d) Handling or controlling customer property.
e) Establishing specific requirements for contingency actions, when relevant.

8.2.2 Determining requirements for the products and services
The organization is required to ensure that:-
1. The requirements for the products and services are defined, including any applicable
statutory and regulatory requirements and those considered necessary by the organization.
2. The organization can meet the claims for the products and services it offers.

8.2.3 Review of requirements related to products and services
8.2.3.1 The organization shall conduct a review before committing to supply products and services to a customer, to
include:
a)Requirements specified by the customer including

the requirements for delivery and post-delivery activities.
b) Requirements not stated by the customer, but necessary

for the specified or intended use, when known.
c) Requirements specified by the organization.
d) Statutory and regulatory requirements applicable

to the products and services.
e) Contract or order requirements differing from

those previously expressed.

8.2.3.2 The organization shall retain documented information, as applicable:
a) On the results of the review.

b) On any new requirements for the products and services.
8.2.4 Changes to requirements for products and services
➔ Related documented information need to be amended.
➔ Ensure communication about the changes to all relevant persons.

8.3 Design and development of product and services.
8.3.1 General. The organization shall establish, implement and

maintain a design and development process that is appropriate
to ensure the subsequent provision of products and services.

8.3.2 Design and Development Planning.
Consider the following while determining stages and controls for design and
development process.:-
a) The nature, duration and complexity.

b) The required process stages, including reviews.
c) Verification and validation activities.
d) Responsibilities and authorities .
e) Internal and external resource needs

8.3.2 Design and Development Planning. (Cont.)
f) Control of interfaces between persons
g) Involvement of customers and users.
h) The requirements for subsequent provision of products and services.
i) The level of control expected for the design and development process
by customers and other relevant interested parties.
j) Documented information.

8.3.3 Design and Development inputs.
a. Functional and performance requirements.

b. Information derived from previous similar design and development activities.
c. Statutory and regulatory requirements.
d. Standards or codes of practice that the organization has committed to implement.
e. Potential consequences of failure due to the nature of the products and services
The organization shall retain documented information on design and development

inputs.

8.3.4 Design and Development Controls
a) The results to be achieved need to be defined.

b) Review to evaluate ability of result to meet requirements.
c) Verification activities.
d) Validation activities.
e) Necessary actions are to be taken on problems determined during the
reviews, or verification and validation activities.
f) Documented information of these activities need to be retained.

8.3.5 Design and development outputs.
➔Outputs from design and development should meet the input

requirements for design and development and shall be suitable for
provision of products and services.
➔Include or reference monitoring and measuring requirements, as

appropriate, and acceptance criteria.
➔Specify the characteristics of the products and services that are

essential for their intended purpose and their safe and proper provision.
The organization shall retain documented information on design and

development outputs.

8.3.6 Design and development Changes.
If changes are made either during or after design and development that may have an adverse
impact on conformity to requirements then the organization must identify, review and control those
changes.
The organization shall retain documented information on:

a) Design and development changes.
b) The results of reviews.
c) The authorization of the changes.
d) The actions taken to prevent adverse impacts.

8.4 Control of externally provided processes,
products and services
8.4.1 General
The organization must employ controls to verify that externally

provided processes, products or services meet the requirements.
When:-
➔ While using product and (or) service from external providers.
➔Products and (or) services to be provided directly to the customer by the
external provider.
➔Outsourcing processes or parts of processes to an external provider.

8.4 Control of externally provided processes, products
and services (Cont.)
The organization shall determine and apply:
➔ Criteria to evaluate and select external providers.
➔ Monitoring performance of external providers.
➔ Re-evaluate them based on their ability to provide processes, products and

services that conform to requirements.
➔ Related documented information need to be maintained.

8.4.2 Type and extent of control
➔Determine the type and extent of controls that organization wishes to apply to
external providers
➔Ensure that all outsourced processes stay within the control of organization’s
QMS.
➔Define the controls for both the external provider and resulting outputs.
➔Impact on its ability to consistently meet requirements
➔Effectiveness of the controls it applies to the external provider.
➔Determine verification (or other) activities necessary to ensure conformance to

requirements.

8.4.3 Information for external providers
Information need to be reviewed for adequacy

prior to being communicated.
➔The processes, products and services to be provided.

➔The approval of the product and service.
➔The approval of methods, processes and equipment.
➔ The approval of the release of products and services.
(Continued)

8.4.3 Information for external providers (Cont.)
➔The competence of personnel, including any necessary qualifications .
➔The interactions between the organization and the external provider.
➔How the external provider’s performance will be monitored and controlled by the organization.
➔ Verification or validation activities that the organization (or its customer) intends to perform at the
external provider’s premises.

8.5 Production and service provision
8.5.1 Control of production and service provision.

Organization shall have a control over the way in which they produce their products and
provide their services.
Documented information :-
➔ Characteristics / Specification of product or service.

➔ That defines the activities that need to be performed
to produce the product or deliver the service.
➔ That defines the results that are to be achieved.
(continued)

8.5.1 Control of production and service provision(Cont.):
➔ Suitable monitoring and measurement resources.
➔Suitable process environment, infrastructure and competent personnel.
➔Validation of process.
➔ Actions to prevent human error, product and

service release, delivery and post-delivery activities
are to be implemented as applicable.

8.5.2 Identification and traceability
Identification and traceability need to maintained :-
➔ To demonstrate outputs conform to requirements.
➔ To identify status of outputs, through-out product/service realization

stages with respect to monitoring and measurement requirements.
In cases where traceability is a requirement :-
➔ Outputs need to be uniquely identified and retain related documented information.

8.5.3 Property belonging to customers or external providers
➔Organization shall take care of property owned

by customers or by external providers while it is
being used by the organization or under its control.
➔Such property shall be identified, verified, protected

and safeguarded.
If any mishandling happened with such property, organization must make sure that this is reported back
to the customer or external provider and documented information related to it need to be
maintained.

8.5.4 Preservation
Appropriate measures shall be taken during production and service provision to safeguard
outputs/products to maintain conformity with requirements.
These include identification, handling, contamination control, packaging, storage, transmission or

transportation and protection.

8.5.5 Post-delivery activities
Organization shall determine the nature and extent
of any post-delivery activities it needs to undertake.
Consider :-
Statutory or legal requirements, unwanted consequences, nature of the product or service, how the
product or service will be used and the product’s or service’s intended lifetime.
Post-delivery activities also needs to take into account customer requirements and customer
feedback.

8.5.6 Control of changes
➔ The organization is required to control any changes that are necessary in order to ensure that
products or services continue to meet their specified requirements.
➔The organization must retain documented information describing the results of the review of the
changes, the person authorizing the changes and any necessary actions arising from the review.

8.6 Release of products and services
➔Organization shall carry out pre determined

checks/inspection to make sure product/service
conform to the acceptance criteria.
➔Product or service shall not be released without completing all planned tests/inspections has
been completed unless its release is approved by relevant authority. (Where applicable, approval for
early release must also be obtained from the customer)
Documented information must evidence acceptance criteria conformity. It must also provide traceability to the
individual who authorized the release.

8.7 Control of nonconforming outputs
8.7.1 Non conforming outputs needs to identified.

Controls shall be established and implemented to
ensure those outputs does not reach customer or its
unintended use is prevented.
Also applies to nonconforming products or services that are detected after delivery
of products, during or after the provision of services.

8.7 Control of nonconforming outputs (Cont.)
The organization is required to deal with nonconforming outputs in one or

more of the following ways by: -
➔Correcting the fault.

➔Segregation or containment.
➔Securing the return of the output, product or service.
➔Suspension of the provision of products and services.
➔Informing the customer.
➔Obtaining authorization for acceptance under a concession.
Corrective action taken against nonconformity need to be verified.
8.7.2 Supporting documented information shall be maintained specifying

any concessions obtained and deciding authority for taking action against
non conformity.

9. Performance Evaluation

9.1 Monitoring Measurement and Analysis.
9.1.1 General
Organization shall initially determine what it needs to monitor and measure and how it is going to
carry out these activities in order to ensure that the results obtained are valid.
It shall include the decision on when (stage) the monitoring and measurement will be performed
and when the result obtained from it will be analyzed and evaluated.
➔ Performance and effectiveness of QMS need to be analyzed.
➔Documented information need to maintained as evidence.

9.1.2 Customer satisfaction
Organization to put in place arrangements to monitor the degree to which customers believe their
requirements for products and services have been met.
Methods shall be put in place for obtaining, analyzing and reviewing this information.
Eg: Customer surveys, Customer feedback on delivered products and services, Meetings with customers,
Market-share analysis, Compliments, Warranty claims and Dealer reports.

9.1.3 Analysis and evaluation
Organization shall analyze and evaluate appropriate data and information that it has
obtained from monitoring and measurement.
➔ To demonstrate that the organization’s products and services conform to requirements.
➔To assess customer satisfaction
➔To ensure the conformity and effectiveness of the quality management system.
➔To demonstrate that planning has been successfully implemented and to assess
effectiveness of action taken to address risks and opportunities.
Additionally, it is to be used to evaluate the performance of external providers,

and to determine the need for improvements within the quality management system.

9.2 Internal audit
9.2.1Organization need to carry out internal audits at planned intervals in order to provide
information as to whether the quality management system conforms to both the organization’s own
requirements and the requirements of ISO 9001:2015.
Internal audits must also identify whether the quality management system is being effectively
implemented and maintained.

9.2.2
➔When designing an audit programme, the organization needs to

consider their quality objectives, the importance of the processes
concerned, customer feedback, changes within the organization, risks and
opportunities, and the results of previous audits.
➔Audits and auditors need to be impartial and objective.
➔The findings from audits need to be fed back to the relevant

management with any required corrections or corrective actions being
taken in a timely manner.
➔Documented information need to be maintained.

9.3 Management review
9.3.1 General
To ensure adequacy, effectiveness and continuing suitability, the QMS need to

be reviewed at defined intervals.

9.3.2 Management Review Inputs
➔ Follow-up actions from previous review
➔ Changes to QMS (External & Internal)
➔ Performance & Effectiveness of QMS including trends in:-

- Customer feedback /Satisfaction.
- Performance of Quality Objectives.
- Process performance & conformity.
- Non conformities and corrective actions.
- Audit results and monitoring and measurement results.
- Performance of external providers. (continued)

➔ Adequacy of resources.
➔ Effectiveness of actions taken against identified risks and opportunities.
➔ Opportunities for improvement.
9.3.3 Management review output
➔Improvement opportunities
➔Changes to QMS
➔Resource needs

10. Improvement

10 Improvement
10.1 General
Organization actively to seek out and realize improvement opportunities

that will better enable the organization to meet customer requirements
and enhance their customers’ satisfaction.
➔ Improving products and services.

➔Correcting, preventing or reducing undesired effects.
➔Improving performance and effectiveness of QMS.

10.2 Nonconformity and corrective action
10.2.1
The organization is required to take whatever action is necessary to control and correct the
nonconformity, and to deal with any resultant consequences.
Review and analyze the nonconformity, to determine what caused it and then to consider if the
problem exists elsewhere or the potential for a similar problem to occur in the future exists.

➔ Update the risk and opportunities determined during planning (if necessary)
➔The organization is then required to implement any actions identified as needed, to

subsequently review the result for effectiveness and to make changes to the QMS if
necessary.
10.2.2
Documented information to be maintained describing nature of NC,
action taken and result of action taken.

10.3 Continual Improvement
The organization need to continually to improve its quality management system in terms of its
suitability, adequacy and effectiveness.
Use the outputs from analysis and evaluation and from management review to determine areas of
underperformance and to identify any opportunities for improvement.

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Fire Protection Engineering Cranes, Lifting
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Technical & Legal Gates
Quality Calibration
Game, Sport, Management Mechanical
and Leisure Engineering
Equipment
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& Welding
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Technology Personnel
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Quality Management System ISO 9001v2015 Awareness

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Quality Management System ISO 9001v2015 Awareness

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TÜV AUSTRIA GROUP

Group Presentation 2016 21/11/23

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Legal Compliance Loss Adjustment

270 x Safety. Worldwide. Simply safe.

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European Name TUV widely accepted

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VISION & MISSION

TÜV AUSTRIA is a leading, impartial and independent

We are committed to performing our services in a socially

Our mission is the sustainable improvement of safety and

BACK MENU MAP

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ISO organiztion, officially began operations on 23 February

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 degree to which a set of inherent

 Meeting or exceeding customer expectations.

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Quality Control (Q.C)

Part Of The Quality Management Focused On Fulfilling Quality Requirements

Quality Assurance (Q.A)

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ISO 9000 family development

ISO 9000 ISO 9001 ISO 9004

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4.0 Context of the Organization 5.0 Leadership

4.1 Understanding the organization and 5.1 Leadership and Commitment

4.4. Quality management system and its

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6.1 Actions to address risks and 7.1 Resources

7.5 Documented Information

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8.7 Control of nonconforming outputs.

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9.0 Performance Evaluation 10. Improvement

9.1.1 General 10.3 Continual Improvement

9.2 Internal Audit

9.3 Management Review

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 needs to demonstrate its ability to consistently provide

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• Environmental Management System

Compatibility with other management systems

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ISO 9000: 2015 , Quality Management Systems

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Information required to be controlled and

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Context of the Organization:

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