Está en la página 1de 57

Introduction to ISO9001:2008

www.9001manual.com
What is ISO?

• The International Organization for


Standardization (ISO) was established in 1947
and is an association of 157 members, which
each represent their own country. ISO employs a
system of Technical Committees and Working
Groups to develop International Standards.
• British Standards Institute is the National
Standards Body that represents the United
Kingdom at ISO www.bsigroup.com

12/15/2009 www.9001manual.com 2
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

12/15/2009 www.9001manual.com 3
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.

12/15/2009 www.9001manual.com 4
What is the history of ISO 9001?
• ISO 9001:1987
Model for quality assurance in design, development, production, installation, and servicing
was for companies and organizations whose activities included the creation of new products.
Had the same structure as the UK Standard BS 5750 unfortunately the emphasis tended to be
placed on conformance with procedures rather than the overall process of management.

• ISO 9001:2000
Combination of the three standards 9001, 9002, and 9003 into one, called 9001. Design and
development procedures are required only if a company does engage in the creation of new
products. Introduced the concept of process management. Required the involvement of
Senior Management in order to integrate quality into the business system and avoid
delegation of quality functions to junior staff. Required measurement of the effectiveness of
tasks and activities. Expectations of continual process improvement and tracking customer
satisfaction were defined.

• ISO 9001:2008
Introduces clarifications to the existing requirements of ISO 9001:2000 and some changes
intended to improve consistency with Environmental Management Standard ISO 14001:2004.
The standard is now practical and business improvement focused. It is completely different to
the original standard which was discredited in some areas as a paper exercise.

12/15/2009 www.9001manual.com 5
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.
12/15/2009 www.9001manual.com 6
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
12/15/2009 www.9001manual.com 7
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
12/15/2009 www.9001manual.com 8
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 Document Number Our Procedure

4.1 Introduction
QM001 Quality Management System

4.2 Documentation
QM002 QMS Manual Summary

4.3 Internal Document Control


QM003 Document Control

4.4 External Document Control Customer, Statutory and


QM004
Regulatory Conformance
4.5 Quality System Records
QM005 Record Control

12/15/2009 www.9001manual.com 9
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 Document Number Our Procedure


5.1 Management Commitment QM006 Management Commitment

5.2 Customer Focus


QM007 Quality Policy
5.3 Quality Policy

5.4 Planning QM001 Quality Management System

5.5 Responsibility & Authority


QM008 Responsibility and Authority
5.6 Internal Communication

5.7 Management Review QM009 Management Review

12/15/2009 www.9001manual.com 10
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 Document Number Our Procedure


6.1 Resources
QM010 Resources and Training
6.2 Human Resources & Training

6.3 Infrastructure Infrastructure and Work


QM011
6.4 Work Environment Environment

12/15/2009 www.9001manual.com 11
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 Document Number Our Procedure

7.1 Planning
QM012 Contract Review
7.2 Customer Related Processes
7.3 Design and Development QM013 Design and Development
7.4 Purchasing, Orders and Purchasing, Orders and
Verification of Purchased QM014 Verification of Purchased
Materials Materials
7.5 Operational Control
7.5.1 Production
QM015 Production
7.5.2 Validation of Processes
7.5.3 Identification and
QM016 Identification and Traceability
Traceability
7.5.4 Customer Property QM017 Customer Property
QM018 Preservation of Product
7.5.5 Preservation of Product QM019 Despatch and Distribution
QM020 Maintenance
12/15/2009 www.9001manual.com 12
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 Document Number Our Procedure

8.1 General
QM023 Measurement and Monitoring
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction QM024 Customer Satisfaction
8.2.2 Internal Audit QM025 Internal Audit
8.2.3 Monitoring and Measuring Monitoring and Measuring QMS
QM026
QMS Processes Processes, Analysis of Data
8.3 Control of Non-Conforming Control of Non-Conforming
QM027
Product Product
8.4 Analysis of Data Monitoring and Measuring QMS
QM026
Processes, Analysis of Data
Corrective Action, Preventive
QM028
8.5 Corrective Action, Preventive Action and Improvement
QM029
Action and Improvement Crisis Management
QM030
Product Recall
12/15/2009 www.9001manual.com 13
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.

12/15/2009 www.9001manual.com 14
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

12/15/2009 www.9001manual.com 15
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.

12/15/2009 www.9001manual.com 16
What are the ISO 9001:2008 Quality
Management System requirements?

The standard specifies six compulsory documents:


Control of Records (4.2.4)

• The ISO9001:2008 standard requires


that Records are controlled in a similar
way to documents. They should be
retained to demonstrate conformity,
show how products were processed
and to allow products and problems to
be traced to the source.

12/15/2009 www.9001manual.com 17
What are the ISO 9001:2008 Quality
Management System requirements?
The standard specifies six compulsory documents:
Internal Audits (8.2.2)

• The ISO9001:2008 standard requires a


documented procedure for internal
audits. It is a requirement to regularly
review performance through internal
audits to determine whether the quality
system is working and what improvements
can be made. It is a requirement to keep
records of these activities and the resulting decisions.

12/15/2009 www.9001manual.com 18
What are the ISO 9001:2008 Quality
Management System requirements?
The standard specifies six compulsory documents:
Control of Nonconforming Product / Service (8.3)

• You need documented procedures for dealing


with actual and potential non-conformances
(problems involving suppliers or customers, or
internal problems). The procedure should
define how to isolate and quarantine product that
does not meet requirements, how you decide what
to do with this product and how you take action to
deal with the root cause of the problem. You must
also keep records of Non-Conforming Product to use
as a tool to improve the system.
12/15/2009 www.9001manual.com 19
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.
12/15/2009 www.9001manual.com 20
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.

12/15/2009 www.9001manual.com 21
What are the ISO 9001:2008 Quality
Management System requirements?

• The ISO 9001:2008 standard requires that


decisions about the quality system are made
based on recorded data and the system is
regularly audited and evaluated for conformance
and effectiveness.

12/15/2009 www.9001manual.com 22
What are the ISO 9001:2008 Quality
Management System requirements?

• The ISO9001:2008 standard requires that to


maintain the quality system and produce
conforming product, you need to provide
suitable infrastructure, resources,
information, equipment, measuring and
monitoring devices, and work environment.

12/15/2009 www.9001manual.com 23
What are the ISO 9001:2008 Quality
Management System requirements?

• The ISO9001:2008 standard requires that an


organisation needs to map out all key processes
in your company, control them by monitoring,
measurement and analysis, and ensure that
product quality objectives are met.
• If you can’t monitor a process by measurement,
then make sure the process is well enough
defined that you can make adjustments if the
product does not meet user needs.

12/15/2009 www.9001manual.com 24
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
12/15/2009 www.9001manual.com 25
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
12/15/2009 www.9001manual.com 26
What are the ISO 9001:2008 Quality
Management System requirements?

• The ISO9001:2008 standard requires that you


establish quality objectives, plan processes, and
document and measure results to use as a tool for
improvement.
• For each process it is important to determine
what kind of procedural documentation is
required

12/15/2009 www.9001manual.com 27
What are the ISO 9001:2008 Quality
Management System requirements?

• The ISO9001:2008 standard requires that you need to


determine key points where each process requires
monitoring and measurement, and ensure that all
monitoring and measuring devices are properly
maintained and calibrated.
• The ISO9001:2008 standard requires that you need to
have clear requirements for purchased product.
• The ISO9001:2008 standard requires that you need to
determine customer requirements and create systems
for communicating with customers about product
information, inquiries, contracts, orders, feedback and
complaints.

12/15/2009 www.9001manual.com 28
What are the ISO 9001:2008 Quality
Management System requirements?

The ISO9001:2008 standard requires


that when developing new products,
you need to plan the stages of
development, with appropriate
testing at each stage. You need to test and
document whether the product meets design
requirements, regulatory requirements and user
needs.

12/15/2009 www.9001manual.com 29
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

12/15/2009 www.9001manual.com 30
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.

12/15/2009 www.9001manual.com 31
What is Continual Improvement?

Continual improvement is the process


focused on continually increasing the
effectiveness and/or efficiency of the
organization to fulfil its policies and
objectives.

12/15/2009 www.9001manual.com 32
ISO 9001:2008 Process Approach to
Management

The ISO9001:2008 standard requires that an


organisation needs to map out all key processes
in your company, control them by monitoring,
measurement and analysis, and ensure that
product quality objectives are met.

12/15/2009 www.9001manual.com 33
ISO 9001:2008 Process Approach to
Management

What is a process?

• An activity which receives inputs and converts


them to outputs is a process.
• Almost all activities and operations involved in
generating a product or providing a service are
processes.

12/15/2009 www.9001manual.com 34
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.

12/15/2009 www.9001manual.com 35
ISO 9001:2008 Process Approach to
Management

12/15/2009 www.9001manual.com 36
ISO 9001:2008 Process Approach to
Management
What are the benefits “process approach”?

 The integration and alignment of its processes to enable the


achievement of its planned results.
 An ability to focus effort on process effectiveness and efficiency.
 Transparency of operations within the organization.
 Lower costs and shorter cycle times through effective and efficient
use of resources.
 The encouragement and involvement of people, and the clarification
of their responsibilities.
 The elimination of barriers between different functional units and
the unification of their focus to the objectives of the organization.
 Improved management of process interfaces.
12/15/2009 www.9001manual.com 37
ISO 9001:2008 Process Approach to
Management - How do you measure a process?
Typical factors that are useful to consider when identifying measures of
process control and process performance include:

• Product Conformity with requirements


• Customer satisfaction
• Supplier performance
• On time delivery
• Lead times
• Incident numbers and Failure rates
• Percentage Waste
• Process costs
• Order completion

12/15/2009 www.9001manual.com 38
ISO 9001:2008 Process Approach to
Management

What is the difference between a process and a procedure?

• A process may be explained as a set of interacting or


interrelated activities, which are employed to add value.
A procedure is a method of describing the way or in
which all or part of that process activities should be
performed.
• ISO 9000:2005 defines a procedure as a "specified way to
carry out an activity or a process", which does not
necessarily have to be documented.

12/15/2009 www.9001manual.com 39
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.

12/15/2009 www.9001manual.com 40
PDCA Cycle

12/15/2009 www.9001manual.com 41
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.
12/15/2009 www.9001manual.com 42
What are the requirements for consultants?

• As a minimum, quality management system


consultants should understand the
requirements of ISO 9001:2008, and also with
the content of ISO 9000:2005, ISO 9004 and
the Quality Management Principles.
• Consultants should understand their client’s
activities and processes.

12/15/2009 www.9001manual.com 43
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.
12/15/2009 www.9001manual.com 44
What is certification to ISO9001:2008?

Organizations have their quality management system certified to ISO


9001:2008:
 When an organization seeks to certify (sometimes referred to as
register) it’s quality management system to ISO 9001:2008, it is
required to agree a "scope of certification" with its certification
body (sometimes called registrar).
 This will define the products to which the organization's quality
management system is applicable, and against which it will be
assessed. An organization is not obliged to include within its "scope
of certification" all the products that it provides but may be selective
about those that are included. All applicable requirements of ISO
9001:2008 will need to be addressed by the organization's quality
management system that covers those products that are included in
the "scope of certification".
12/15/2009 www.9001manual.com 45
What is ISO 9001 certification?

A company or organization that has been


independently audited and certified to be in
conformance with ISO 9001 may publicly state that
it is "ISO 9001 certified" or "ISO 9001 registered".
Certification to an ISO 9001 standard does not
guarantee any quality of end products, it certifies
that approved business processes are being applied.
Although the standards originated in manufacturing,
they are now employed across several types of
organizations. A "product" in ISO vocabulary can
mean a physical object or services.

12/15/2009 www.9001manual.com 46
What are the main benefits to be derived
from implementing an ISO 9000 quality
management system?

• The ISO 9000 standards give organizations the


discipline to focus their activities and to
continually improve their performance.

• The standards require implementation of a


quality management system which manages the
processes within an organisation.

12/15/2009 www.9001manual.com 47
What are the benefits of using the ISO 9001
standard?
The management of an organization should be able to view the adoption of the ISO9001
Quality Management System standards as a profitable business investment, not just as a
required certification issue:

 The discipline of the standard drives the connection of quality management systems
to organizational processes
 The disciplines involved give improved organizational
performance, via:
- Using the 8 Quality Management Principles
- Using a "process approach"
- Commitment from senior management
- Using measurable objectives
- Focus "continual improvement" and "customer satisfaction"
- Measurement of the quality management system effectiveness
- Assessing resource requirements

12/15/2009 www.9001manual.com 48
How will the implementation of the
ISO9001:2008 standard help us?

• ISO 9001:2008 aims at guaranteeing the


effectiveness of the organization
• Further progress can be made by using ISO
9004 in addition to ISO 9001:2008. The ISO
9004 guiding quality management principles
are intended to assist an organization in
continual improvement

12/15/2009 www.9001manual.com 49
How will the implementation of the
ISO9001:2008 standard help us?

It gives you a Competitive advantage:

• ISO 9001 is senior management led so ensuring a


strategic approach to your management systems.
• The certification process ensures that your
business policies and objectives drive your
processes and working practices to ensure you
maximise the return from your resources.

12/15/2009 www.9001manual.com 50
How will the implementation of the
ISO9001:2008 standard help us?

It Improves performance :

• ISO 9001 helps your employees to raise the


organization’s performance above and beyond
competitors who aren’t using structured
management systems. Certification also makes it
easier to measure performance and improve the
way you manage your business.

12/15/2009 www.9001manual.com 51
How will the implementation of the
ISO9001:2008 standard help us?

It enhances Company reputation:

• Certification to ISO 9001 will boost your


company’s reputation and can be a useful
promotional and marketing tool. It sends a clear
message to all interested parties that this is a
company committed to high standards and
continual improvement.

12/15/2009 www.9001manual.com 52
How will the implementation of the
ISO9001:2008 standard help us?
It saves you money:

• Evidence shows that the financial benefits for


companies that have invested in and certified
their quality management systems to ISO 9001
include operational efficiencies, increased sales,
higher return on assets and greater profitability.

12/15/2009 www.9001manual.com 53
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.

12/15/2009 www.9001manual.com 54
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.
12/15/2009 www.9001manual.com 55
How will the implementation of the
ISO9001:2008 standard help us?

It encourages internal communication, raises


morale and employee ownership:

• ISO 9001 ensures that employees feel more


involved through improved communication and
training they will understand and take
ownership of the company policies and
objectives.

12/15/2009 www.9001manual.com 56
What is the next stage for us?

View our Guide to the process of


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

12/15/2009 www.9001manual.com 57