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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


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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
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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

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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?

Customer
focus
Mutually
beneficial
supplier Leadership
relationships

Factual Quality
approach to Involvement
decision Management of people
making
Principles

Continual Process
improvement approach
System
approach to
management

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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


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

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