QM4900

Chapter 6
Quality Management Systems
ISO9001
What is ISO ?

What is ISO? Simply stated…

1) Say what you do. (Document your processes.)

2) Do what you say. (Follow your documents.)

3) Do it well. (Be consistent.)

4) Provide evidence that (Audit your results and

you did it well. improve your processes.)
https://www.youtube.com/watch?v=fkK6LurTR8A (ISO-5min)
What is ISO ?
• The term ISO stands for the International Organization for
Standardization.
ISO created in 1946, when delegates from 25 countries met in
London after the WWII, and decided to create a new International
Organization for the purpose to facilitate the international
coordination and unification of industrial standards.
• What are the ISO 9000 standards ?
• The ISO 9000 standards are a collection of formal International
Standards, Technical Specifications, Technical Reports,
Handbooks and web based documents on Quality Management.
https://www.youtube.com/watch?v=FDyIcM-AFzU
ISO 9001 Approach
• ISO 9001 takes a process-oriented approach.
• ISO 9001 requirements describe ‘what’ a company must accomplish in order to
meet customer expectations.
• ‘How’ these things are accomplished is left up to the particular company.

• ISO 9001 is NOT a product Standard - it contains no product

requirements. It is a series of generic requirements for quality
management systems.
ISO 9001: Redefining the Process Approach

The clauses of ISO 9001

First what is QMS?

• What is a Quality Management System?

• A Quality Management System (QMS) is a set of policies, processes

and procedures required for planning and execution the
production/development/service in the core business area of an
organization.

• (Example: Areas that can impact the organization's ability to meet

customer requirements.)
• https://www.youtube.com/watch?v=WgtBHMxxEaI (QMS- 5min)
• ISO 9001 is an example of a Quality Management System.
• AS9100 is another example of QMS.
• TS 16949 defines automotive industry standards world-wide.
• https://www.iso.org/obp/ui/#iso:std:iso:ts:16949:ed-3:v1:en
Processes and Procedures?

• Process?
• Sequence of interdependent and linked procedures which, at
every stage, consume one or more resources (employee time, energy,
machines, money) to convert inputs (data, material, parts, etc.)
into outputs.

• Procedure?
• A fixed, step-by-step sequence of activities or course of
action (with definite start and end points) that must be followed in
the same order to correctly perform a task.
Why and how to obtain ISO Certification?
• Obtaining an ISO certification requires an investment
of time, money and effort.
• ISO Certification will allow a company to benefit from
improved processes and controls while providing the
company with additional credibility with customers.

• https://www.youtube.com/watch?v=fkK6LurTR8A (ISO-5min)
How much does a ISO Certification cost?
• First—There are developmental costs, namely the time spent
documenting and implementing the system.
• Second—There are costs associated with training employees to
prepare the necessary documents and to plan and conduct
effective internal audits.
• Third—There is the cost of registration, which includes
conducting the audit and registering the management system.
The cost depends on the number of locations, the scope of
work, the number of shifts and so on.
• It will cost between $12,000 and $50,000 to implement a formal
management system, plus the costs of the registration audits, which
usually run between $2,000 and $30,000 per year.
How to get ISO Certified? (Step #1)
1. Develop your management system
• Identify your core or business processes.
• Document processes with the involvement of employees.
• Review, approve and distribute the documents to those who need access
to the information.
How to get ISO Certified? (Step #2)
2. Implement your system
• Ensure procedures are being performed as they are described in
your documentation.
• Ensure employees are trained properly for the tasks they are
performing.
• Create effective reporting systems to cover inspection, testing,
corrective actions, preventive actions, management review
meetings, monitoring of objectives, statistical techniques and so
on.
• Monitor the effectiveness of your processes through the use of
measurable data, where possible.
• Review and take action to improve in the areas required.
How to get ISO Certified? (Step #3)
3. Verify that your system is effective
• Conduct the audit and review the processes and
system for compliance and effectiveness. Observe,
interview people and look at sample records.
• Identify and report strengths and weaknesses of the
management system.
• Take corrective or preventive action as required.
How to get ISO Certified? (Step #4)
4. Register your system
• Select the appropriate auditing body for external
registration.
• Submit your management system documentation for
review to ensure it complies with the applicable
standard.
• Prepare for review by an external auditor to confirm
that the system’s requirements are being satisfied and
that the management system is implemented
effectively.
ISO 9001 Standard Explained:
• Quality management standards such as ISO 9001 cover
everything an organization does to manage its
processes and activities.
• Implementing a quality management standard offers
benefits for companies across industries, regardless of
their size.
• ISO international standards are the most widely used
quality management standards around the world.
Why ISO 9001 - Quality Management?
More than one million businesses around the world are certified
to ISO 9001. Obtaining this standard shows your commitment to
providing the highest quality products or services to your
customers.
Getting ISO 9001 certified can help you:
• Reduce quality problems
• Increase cost savings and productivity
• Enhance customer satisfaction
• Create greater demand for your products and services
• Make your business more competitive
• Make better decisions and improve employee morale
ISO 14000—Environmental management
ISO 14000 is an international standard for
environmental management systems.
ISO 14001 certification can help you:
• Enhance your environmental performance
• Fulfill compliance obligations
• Achieve environmental objectives
• Generate greater demand for your products and
services and increase their acceptance
• Reduce risk and liability while increasing efficiency and
customer confidence
ISO 22000—Food safety management
The ISO 22000 certification is an international food
safety management system.
ISO 22000 certification can help you:
• Develop a food safety management system
• Demonstrate your compliance with government food
safety requirements
• Gain customer confidence
• Develop new partnership and export opportunities
• Build employee awareness of hygiene and safety
ISO 50001—energy management
The ISO 50001 certification works with the ISO 9001
and ISO 14001 standards to integrate energy
management into your company’s overall quality
and environmental improvement efforts.
ISO 50001 certification can help you:
•Develop a policy for energy efficiency
•Establish energy use targets
•Collect and use data to make decisions about
energy use
7 Principles of ISO 9001
These 7 principles aim at continually improving performance over
the long term by focusing on customers while addressing the
needs of all other stakeholders:

1. Customer Focus
2. Leadership
3. Engagement of People
4. Process Approach
5. Improvement
6. Evidence Based Decision-Making
7. Relationship Management
Principle 1: Customer Focused Organization
"Organizations depend on their customers and therefore should
understand current and future customer needs, meet customer
requirements.”

Steps in application of this principle are:

1. Understand customer needs and expectations for products,
delivery, price.
2. Communicate these needs and expectations throughout the
organization.
3. Measure customer satisfaction & act on results.
4. Manage customer relationships.
Principle 2: Leadership
“Leaders should create and maintain the internal environment in
which people can become fully involved in achieving the
organization's objectives.”

Steps in application of this principle are:

1. Be proactive and lead by example.
2. Establish a clear vision of the organization's future.
3. Provide people with the required resources and freedom
to act with responsibility.
4. Build trust and eliminate fear.
5. Consider the needs of all stake holders including customers,
owners, people, suppliers and society .
6. Educate, train and coach people.
Principle 3: Involvement of People
"People at all levels are the essence of an organization and their
full involvement enables their abilities to be used for the
organization's benefit".

Steps in application of this principle are:

1. Accept ownership and responsibility to solve problems.
2. Freely share knowledge & experience in teams.
3. Improve the way of representing the organization to
customers, local communities.
4. Help people derive satisfaction from their work.
5. Make people to be part of the organization.
Principle 4: Process Approach
"A desired result is achieved more efficiently when related
resources and activities are managed as a process."

Steps in application of this principle are:

1. Identify and measure the inputs and outputs of the process.
2. Evaluate possible risks, and impacts of processes on customers,
suppliers and other stake holders of the process.
5. Establish clear responsibility, authority, and accountability for
managing the process.
6. Identify internal and external customers, suppliers and other
stake holders of the process.
Principle 5: Continuous Improvement
"Continuous improvement should be a permanent objective of
the organization.”

Steps in application of this principle are:

1. Apply the basic improvement concepts.
2. Continually improve the efficiency and effectiveness of all
processes.
3. Promote prevention based activities.
4. Provide every member of the organization with appropriate
education and training, on the methods and tools of continual
improvement .
5. Establish measures and goals to guide and track improvements.
Principle 6: Factual Approach to Decision Making
"Effective decisions are based on the analysis of data and
information.”

Steps in application of this principle are:

1. Take measurements and collect data and information relevant
to the objective.
2. Ensure that the data and information are sufficiently accurate,
reliable and accessible.
3. Analyze the data and information using valid methods.
4. Understand the value of appropriate statistical techniques.
5. Make decisions and take action based on the results of logical
analysis balanced with experience and intuition.
Principle 7: Relationship Management
"An organization and its suppliers are interdependent, and a
mutually beneficial relationship enhances the ability of both to
create value.”

Steps in application of this principle are:

1. Identify and select key suppliers.
2. Create clear and open communications.
3. Initiate joint improvement of products and processes.
4. Jointly establish a clear understanding of customers' needs.
5. Share information and future plans.
6. Recognize supplier improvements and achievements.
Why is ISO 9001 Important?
People in the organization will benefit by:
• Better working conditions
• Increased job satisfaction
• Improved health and safety
• Improved stability of employment
Owners and investors will benefit by:
• Increased return on investment
• Improved operational results
• Increased market share
• Increased profits
Why is ISO 9001 Important?
Suppliers and partners will benefit by:
• Stability
• Growth
• Partnership and mutual understanding
Society will benefit by:
• Fulfillment of legal and regulatory requirements
• Improved health and safety
• Reduced environmental impact
• Increased security
ISO 9001 Requirements
• ISO 9001 requires:
• a greater focus on identifying customer requirements, needs and expectations.
• the establishment of procedures for customer communication.
• making employees aware of the importance of meeting customers’ requirements.
ISO 9001 Requirements
nISO 9001 requires:
na greater focus on continuous improvement
n establishing quality policies
n establishing quality objectives
n doing quality planning
n gathering quality performance data
n performing management reviews
ISO 9001 Requirements
• Anything else required?
• Quality Manual (signed by management): document
specifying the quality management system of an organization.
• information and its supporting medium, for examples:
Paper, Web based documents, electronic or optical computer disc, photograph.
• Primary uses of the quality manual
• To communicate management's expectations for quality to the organization
• To reveal the organization conformity with ISO 9001 requirements
• To serve as a measure for compliance to management's expectations for:
• Internal audits
• ISO Registrar audits
• Customer audits
ISO 9001 Requirements
Nature of the document in the Quality Manual?
• Process maps, process flow charts and/or process descriptions
• Organization charts
• Specifications
• Work and/or test instructions
• Documents containing internal communications
• Production schedules
• Approved supplier lists
• Test and inspection plans
• Quality plans
https://www.youtube.com/watch?v=GeULk8JefHY (3min)
ISO 9001 Requirements
Anything else absolutely required?

Quality Policy and Quality Objective Statements

Documented statements of a quality policy and quality objectives.

What about any measured data?

ISO 9001 Requirements
• Data Records as required by the standard;
• Management Reviews (5.6.1)
• Education & Training (6.2.2 e)
• Evidence of Requirements Fulfilled (7.1 d)
• Design & Development Input (7.3.2)
• Design Reviews (7.3.4)
• Design Verification (7.3.5)
• Design Change Review (7.3.7)
• Results of Supplier Evaluations (7.4.1)
ISO 9001 Requirements
• Data Records as required by the standard;con’t
• Process Validation (7.5.2 d)
• Unique Identification (7.5.3)
• Nonconforming Customer Property (7.5.4)
• Local Standards for Calibration (7.6)
• Validity of Previous Results (7.6)
• Results of calibration (7.6)
• Internal Audit Results (8.2.2)
• Record of Product Conformity (8.2.4)
• Product Nonconformity (8.3)
• Corrective & Preventive Actions (8.5.2 and 8.5.3)
Introduction to AS9100

• To assure customer satisfaction, aviation, space and defense

organizations must produce, and continually improve, safe, reliable
products that meet or exceed customer and applicable statutory
and regulatory requirements.
• The globalization of the industry and the resulting diversity of
regional and national requirements and expectations have
complicated this objective.
• Organizations have the challenge of purchasing products from
suppliers throughout the world and at all levels of the supply chain.
• Suppliers have the challenge of delivering products to multiple
customers having various quality requirements and expectations.
What is AS 9100, EN 9100, & JISQ 9100
Certification?
• AS 9100 is the internationally recognized quality system standard specific to
the aerospace industry.
• Known as AS 9100 in North America, EN 9100 in Europe and JISQ 9100 in
Japan, the standard is strongly supported and adhered to by major
aeronautics manufacturers including Airbus, Boeing, GEAE and Rolls-Royce.
• Indeed, AS 9100 certification has already become the basic requirement
demanded by all these companies to their suppliers.
• Based on ISO 9000 requirements, AS 9100 puts a particular focus on quality,
safety and technology in all disciplines throughout the aerospace industry,
and along the entire supply chain.

• It applies to every domain whether civil or military.

What are the benefits of AS9100 Aerospace Quality
Management?

• Reduce the risk product or service mistakes and fatal failures

• Demonstrate effective quality management to achieve a
license to trade
• Get a listing in the Online Supplier Information System
(OASIS) database
• Become a preferred supplier and gain customer and
stakeholder trust
• Continually improve and win international growth
opportunities.
Certification Is Only The Beginning?

• After certification/registration, the certification body/registrar will conduct

surveillance audits regularly to confirm the continued conformance of the
QMS with ISO 9000.

• The auditors will follow the same general steps as the

certification/registration audit to conduct the surveillance audits.

• They will also pay particular attention to the effectiveness of the QMS with
regard to achieving the organization’s objectives, changes and improvements
implemented to the QMS since the last visit, areas that have generated non-
conformities and results of the corrective actions taken by the AIS provider.
What about Audits?

• The minimum frequency of surveillance audits is once every 12 months, but

some certification bodies/registrars will audit once every 6 months.

• The certification expires after three years.

• A recertification audit is required at the end of the third year after initial
certification and the whole cycle begins again.

• As the certification itself is not a mandatory requirement of the ISO 9001

standard, the organization must decide whether the ISO 9001 QMS should be
implemented as an internal improvement instrument or as an external
business tool in most cases involving aviation services.