Introduction to ISO9001:2008

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 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.

• There are 25 documents in the collection

altogether

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 What are the main ISO 9000
standards?
 ISO 9000:2005 Quality management systems – Fundamentals and vocabulary.
Covers the basics of what quality management systems are and also contains the core
language of the ISO 9000 series of standards. A guidance document used for reference
to understand terms and vocabulary related to quality management systems.
 ISO 9001:2008 Quality management systems – Requirements
This is the only ISO9000 standard for which certification can be gained.
Intended for use in any organization regardless of size, type or product including
service. It provides a number of Quality Management System requirements which an
organization needs to fulfil to achieve customer satisfaction. It includes a
requirement for the continual improvement.

 ISO 9004:2000 Quality management systems - Guidelines for performance

improvements. Covers continual improvement. This gives you advice on what you
could do to enhance a mature system. This standard very specifically states that it is
not intended as a guide to implementation.

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What are the ISO 9001 requirements for
a Quality Management System?
• The organisation needs to demonstrate its ability to
consistently provide product that meets customer and
regulatory requirements .

• The organisation must aim to enhance customer

satisfaction through the
effective application of the quality
management system. This includes
processes for continual improvement of
the system.

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What are the requirements of ISO 9001?

The requirements in ISO 9001 include:

a set of procedures that cover all key
processes in a business
monitoring processes to ensure they are effective
keeping adequate records
checking output for defects, with appropriate and
corrective action where necessary
regularly reviewing individual processes and the quality
system itself for effectiveness
Focus on continual improvement

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 What are the ISO 9001:2008 Quality
Management System requirements?

The ISO9001:2008 Standard consists of the following sections:

Section 1: Scope
Section 2: Normative Reference
Section 3: Terms and definitions
Section 4: Quality Management System
Section 5: Management Responsibility
Section 6: Resource Management
Section 7: Product Realization
Section 8: Measurement, analysis and improvement

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ISO 9001:2008 Quality Management System
requirements:
Section 4: Quality Management System from
our Manual

Quality Management System Section 4 ISO9001:2008

ISO 9001:2008 Clause Our Procedure

Introduction to the Quality Management

System
Section 4.1
Document Hierarchy

Documentation Requirements
Customer, Statutory and Regulatory
Requirements
Section 4.2
Document Control Procedure

Record Control Procedure

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 ISO 9001:2008 Quality Management System
requirements:
Section 5: Management Responsibility from our Manual
Management Responsibility Section 5 ISO9001:2008
ISO 9001:2008 Clause Our Procedure

Section 5.1 Senior Management Commitment

Section 5.2 Customer Focus

Section 5.3 Quality Policy

Quality Management System Planning

Section 5.4
Quality Objectives

Responsibility, Authority and Communication

Responsibility & Authority

Section 5.5
Management Representative

Internal Communication

Section 5.6 Management Review

8
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 ISO 9001:2008 Quality Management
System requirements:
Section 6: Resource Management from
our Manual

Resource Management Section 6 ISO9001:2008

ISO 9001:2008 Clause Our Procedure

Section 6.1 Provision of Resources

Section 6.2 Human Resources

Section 6.3 Infrastructure

Section 6.4 Work Environment

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ISO 9001:2008 Quality Management System
requirements:
Section 7: Product Realisation from our
Manual
Product Realisation Section 7 ISO9001:2008
ISO 9001:2008 Clause Our Procedure

Section 7.1 Planning of Product Realisation

Customer Related Processes
Contract Review
Production Planning
Section 7.2
Communication
Customer Communication
Authority Communication
Section 7.3 Design and Development
Purchasing
Purchasing Documents
Supplier Assurance and Approval
Section 7.4
Verification of Purchased Materials
Supplier Performance Review
Suppliers and Contractor Communication
10
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ISO 9001:2008 Quality Management System
requirements:
Section 7: Product Realisation from our
Manual
Product Realisation Section 7 ISO9001:2008
ISO 9001:2008 Clause Our Procedure

Control of Production and Service Provision

Identification and Traceability
Customer Property
Systems of Preservation of Product
Housekeeping Policy
Cleaning Policy
Section 7.5
Pest Control Policy
Control of Visitors and Contractors
Despatch and Distribution
Maintenance
Waste Management
Crisis Management
Control of Monitoring and Measurement
Section 7.6
Equipment

11
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ISO 9001:2008 Quality Management System
requirements: Section 8: Measurement,
Analysis and Improvement from our Manual

Measurement, Analysis and Improvement Section 8 ISO9001:2008

ISO 9001:2008 Clause Our Procedure

Measurement, Analysis and Improvement of the

Section 8.1
Quality Management System
Monitoring and Measurement
Customer Satisfaction
Section 8.2 Internal Audits
Monitoring and Measurement of Processes
Monitoring and Measurement of Product
Control of Non-Conforming Product
Section 8.3
Product Recall
Section 8.4 Analysis of Data
Corrective Action
Section 8.5 Preventative Action
Improvement

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 What are the ISO 9001:2008 Quality
Management System document
requirements?
ISO 9001:2008 refers specifically to only 6 documented
procedures (See next Slide).
Other documentation may be required by an organization in
order to manage the processes that are necessary for the
effective operation of the quality management system.
This will vary depending on the size of the organization, the
kind of activities in which it is involved and their complexity.
Our small business manual covers all the basic clauses of ISO
9001:2008 with 9 procedures/documents our ISO9001:2008 is
much more detailed and has 30 documents. Both include 14
records.

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 What are the ISO 9001:2008 Quality
Management System requirements?

The standard specifies six compulsory documents:

• Control of Documents (4.2.3)
• Control of Records (4.2.4)
• Internal Audits (8.2.2)
• Control of Nonconforming Product / Service (8.3)
• Corrective Action (8.5.2)
• Preventive Action (8.5.3)
• In addition to these ISO 9001:2008 requires a Quality
Policy and Quality Manual

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 What are the ISO 9001:2008 Quality
Management System requirements?

The standard specifies six compulsory documents:

Control of Documents (4.2.3)

•The ISO9001:2008 standard requires that

an organization needs a documented
procedure to control quality documents.
All employees must have access to
up-to-date documents and be aware of
how to use them.

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 What are the ISO 9001:2008 Quality
Management System requirements?
The standard specifies six compulsory documents:
Corrective Action (8.5.2)
• The ISO9001:2008 standard requires that you take Corrective
Action to rectify non-conformances. It is a
requirement to keep records of these activities
and monitor their effectiveness.
Preventive Action (8.5.3)
• The ISO9001:2008 standard requires that you
need to take Preventative Action to eliminate
potential causes of problems. It is a requirement to keep records
of these activities and monitor their effectiveness.

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 What are the ISO 9001:2008 Quality
Management System requirements?

ISO 9001:2008 requires a Quality Policy and Quality Manual:

•The quality policy is a formal statement from

management, closely linked to the business
and marketing plan and to customer needs.
The quality policy is understood and
followed at all levels and by all employees.
Each employee needs measurable objectives
to work towards.
•Your procedures will be maintained in your Quality Manual.

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 What are the ISO 9001:2008 Quality
management systems requirements?
The ISO9001:2008 standard has an absolute requirement to maintain the following records:
•Management Review Minutes
•Training Record
•Product Release Record
•Design and Development Records
- Results of the review of customer requirements
- Design and development inputs relating to product requirements
- Results of design and development reviews and actions
- Results of design and development verification and actions
- Results of design and development validation and actions
- Results of the review of design and development changes
•Supplier Assessment Record
* All of these records are provided in our manual packs

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 What are the ISO 9001:2008 Quality
Management System requirements?
The ISO9001:2008 standard has an absolute requirement to maintain the following records:
•Validation Record
•Identification and Traceability Record
•Register of Customer Property
•Calibration Record
- Basis used for calibration or verification of measuring equipment where no
international or national measurement standards exist
- Validity of the previous measuring results when the measuring equipment is
found not to conform to requirements
- Results of calibration and verification of measuring equipment
•Internal Audit Record
•Records of Non-conforming Product
•Corrective Action Request Form
•Preventative Action Request Form
* All of these records are provided in our manual packs

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 What are the 8 Quality Management
Principles?

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Why is customer satisfaction included in ISO
9001?

"Customer satisfaction" is one of the

main driving criteria for any organization.
In order to evaluate if a product meets
customer needs and expectations, it is
necessary to monitor and measure
customer satisfaction. Improvements
can be made by taking action to address any identified
issues and concerns. Your customers will gain confidence
that your products will meet their needs and increase their
satisfaction.

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 ISO 9001:2008 Process Approach to
Management

What is a “process approach”?

• The systematic identification and management

of the processes within an organization and the
interactions between the processes is known as
a process approach to management.
• The process approach is a key element of the
ISO 9000 standards.

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 ISO 9001:2008 Process Approach to
Management

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 What is the PDCA cycle?

The PDCA cycle is an established, logical, method that can be

used to improve a process. This requires:

(P) planning (what to do and how to do it),

(D) executing the plan (do what was planned),
(C) checking the results (did things happened according to
plan) and
(A) act to improve the process (how to improve next time).
The PDCA cycle can be applied within an individual process,
or across a group of processes.

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 PDCA Cycle

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 What do you need to do to comply with ISO
9001:2008?
When initially starting to use ISO 9001, you should familiarize
yourself with the Quality Management System standards,
especially ISO 9000, ISO 9001 and ISO 9004, and consider
their requirements.

If you wish to proceed to certification, you

should follow our guides and checklists and
implement the procedures and records in our
manual pack then use Gap Analysis Checklist
to determine if your system meets the requirements of ISO
9001. Developing and implement additional procedures or
processes to address any shortfalls.

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 What are the requirements for auditors?

The standards require that auditors are able to understand the

organization's activities and processes and appropriately audit against the
requirements of the ISO 9001 in relation to the organization's objectives.

Auditors should be able to demonstrate

competency in:
Quality Management Systems.
The requirements of the ISO 9001:2008.
A general understanding of ISO 9000:2005 and ISO 9004.
Auditing techniques.

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 How will the implementation of the
ISO9001:2008 standard help us?

Improves Efficiency and Streamlines operations:

• Your quality management system focuses on

your objectives and operating processes. This
encourages you to improve the efficiency of
your business, the quality of your products, the
service you provide and helps to reduce your
waste and customer complaints levels.

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 How will the implementation of the
ISO9001:2008 standard help us?

It increases customer satisfaction:

• The structure of ISO 9001 ensures that the needs of the

customer are being considered and met and your company
focus is on constantly increasing customer satisfaction.
• "Customer satisfaction" is one of the main driving criteria for any
organization. In order to evaluate if a product meets customer
needs and expectations, it is necessary to monitor and measure
customer satisfaction. Improvements can be made by taking
action to address any identified issues and concerns. Your
customers will gain confidence that your products will meet
their needs and increase their satisfaction.
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 What is the next stage for us?

View our Guide to the process of Implemen

ting an ISO9001:2008 compliant manual at
www.9001manual.com

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