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ISO 9000
The International Organisation for Standardisation (ISO) is an
international federation of
national standards involving more than 140 countries. ISO 9000 is a
well-known family of
guidelines and standards developed by the ISO. It has become popular
worldwide for its role in
setting up quality management systems within organisations.
Understanding > Introduction to ISO
What are Standards?
Today great emphasis is being laid on organisations following predefined levels of
standards in their processes
and
operation. But what are standards? How are they useful to an organisations business
performance?
Standards are documented technical specifications and other defined benchmarks. These
specifications are
applied as a set
of regulations and procedures to ensure that the materials, products, operations and
services conform to
predefined
requirements. Standards contribute to the enhancement of the product parameters such as
quality, safety,
reliability,
effectiveness and interchangeability at an optimum cost.
The ISO:
The International Organisation for Standardisation (ISO) is an international federation of
national standards
involving more
than 140 countries. A non-governmental organisation it was set up in 1947. The motto of
ISO is to endorse the
growth of
standardisation worldwide to promote international trade and services. ISO promotes
mutual collaboration
between various
organisations in the scientific, technology and economic related activities.
Advantages of ISO standards:
ISO sets up technical standards (that are voluntary) that help in enhancing various types
of organisational
processes. They
aid in the development, production and delivery of products and services in a more
effective, secure and cleaner
way. ISO
standards also seek to safeguard customer interests.
ISO Standards are acknowledged worldwide as the means for manufacturers and service
providers to bring about
utmost
ease and effectiveness in trading their products and services. These International
Standards provide a benchmark
to make
the transfer of technology between suppliers and their customers possible.
The evolution of ISO:
International standardisation was first initiated in the electro technical area. The
International Electro Technical
Commission (IEC) was established in 1906. The International Federation of the National
Standardising
Associations (ISA),
established in 1926, put in groundbreaking efforts in other areas. ISA focused mainly on
mechanical engineering.
Its
activities came to an end in 1942.
In 1946, representatives from 25 countries convened in London and decided to form a
new international
organisation, in
order to “make possible the international coordination and integration of organisational
standards". The new
organisation,
ISO, formally became operative on 23 February 1947.
ISO standards -The process:
ISO has a well-defined process for incorporating standards.
First phase:
In any country a business segment puts forward the need for a standard before its national
standards institute.
The latter
suggests this to the ISO. Once the necessity for an International standard has been
acknowledged and officially
approved,
the technological feasibility of the standard is defined. This stage is usually performed in
teams consisting of
professionals
from those countries that are interested in the particular standard.
Second phase:
Once the experts reach a conclusion on the technical parameters to be covered in the
standard, the participating
countries
discuss in detail the specifics pertaining to the standard. This is the consensus-building
phase.
Final phase:
The final phase comprises of the endorsement of the final draft of the
International Standard. This report is
subsequently
made available in print as an ISO International Standard.
Many of the standards need regular reviews. Various factors contribute to make a
standard obsolete: scientific
advancement, new techniques and equipment, changing trends in quality and safety
procedures. To consider
these issues,
ISO has stipulated that all ISO standards should be evaluated every five years.
Continue the tour:
The ISO 9000
Understanding > The ISO 9000
The ISO 9000:
The goal of any organisation is to constantly accrue benefits through product innovation
and efficiency in the use
of
resources. The critical aspect to achieve this is to attain all round quality performance.
Quality is a basic
consumer
requirement. A customer prefers organisations reliable as far as its quality performance is
concerned.
Consistently
manufacturing products and offering services of superior quality is the need of the hour
worldwide. This is a
critical aspect
in sustaining customer loyalty and retaining the market base.
In order to attain this, organisations have to comply with a set of procedures that are not
only acknowledged and
accepted
within a country but also internationally. ISO 9000 standards serve this purpose.
ISO 9000 is a well-known family of guidelines and standards developed by the ISO. ISO
9000 standards for a
Quality
Management System handles the processes concerned with the design, development and
delivery of a product or
service.
The standard stipulates specifications for the control and assessment of a process for
attaining quality
performance.
The 1987 version of ISO 9000 standard, (originally published as BS5750 by the British
Standards Institute)
emphasised on
quality control by means of effective checking and corrective actions. Quality control
(QC) is a management
function that
controls the quality of raw materials, products, components, and services concerned with
production and
inspection
activities. It aims to prevent defects in the products or services.
The 1994 version of the ISO 9000 standard focused on quality assurance via preventive
actions, and stipulated
the need
for documented procedures. Quality assurance (QA) comprises all measures taken to
ascertain that the standards
and
procedures are in conformity and that the products or services meet the performance
requirements.
An ISO 9000 certification indicates that the management is effectively controlling the
processes that are ‘critical
to quality’
with respect to the customer. ISO 9000 is not just about service or product quality; it's
about quality in
management.
These standards address aspects related to process management. This requires
organisations to identify,
document and
control processes ranging from executive management to the production of different
items.
An organisation could be successfully certified to ISO 9000 if it adhered to the
specifications of the standard. In
order to be
certified, an organisation must submit to an accredited assessor’s examination. The
assessor interviews staff
members to
ensure that they are aware of their roles and responsibilities in complying with the ISO
9000 standard. The
assessor also
examines the organisation's paperwork to check on ISO 9000 compliance. When all
issues are addressed, the
organisation
is deemed for certification.
Continue the tour:
The ISO 9000:94 Family
Understanding > The ISO 9000:94 family
ISO 9000:94 family is a set of international quality standards and guidelines that have
become popular worldwide
for their
role in setting up quality management systems within organisations.
In the past, organisations preferred to implement any of the three ISO 9000:94
requirement standards i.e. the
ISO 9001,
ISO 9002 and ISO 9003. Moreover, there was a notion that ISO standards are applicable
only in the
manufacturing sector.
ISO in a move to change this perception drafted some more guidelines that cater to the
requirements of the
service sector,
small and medium scale industries and software companies. Given below is a list of ISO
9000:94 guidelines and
standards.
ISO 8402, Quality management and quality assurance – Vocabulary. Defines the
essential terms used in the ISO
9000
family, which is necessary for avoiding misinterpretations.
ISO 9000-1, Quality management and quality assurance standards – Part 1: Sets the
guidelines for selection and
use of
specific standards. Provides the scope for understanding and selecting the appropriate
standards.
ISO 9000-2, Quality management and quality assurance standards –Part 2: Provides basic
guidelines for the
application
of ISO 9001, ISO 9002 and ISO 9003. Helps in interpreting ISO 9001, ISO 9002 and ISO
9003.
ISO 9000-3, Quality management and quality assurance standards –Part 3: Sets
guidelines for the application of
ISO
9001 1994 in the development, delivery, installation, and maintenance of computer
software. Also provides a
specific
interpretation of the requirements of ISO 9001 for computer software development
applications.
ISO 9000-4, Quality management and quality assurance standards –Part 4: Provides
guidance on how to plan,
organise
and control resources to produce reliable and sustainable products.
ISO 9001, Quality systems – Model for quality assurance in design, development,
production, installation and
servicing.
This is a requirement standard used to ascertain the process capabilities for the design and
development of the
product or
service, as well as for installation and servicing.
ISO 9002, Quality systems – Model for quality assurance in production, installation and
servicing.
This standard is used to ascertain process capabilities for production, installation and
servicing (identical to ISO
9001except for design control requirement).
ISO 9003, Quality systems – Model for quality assurance in final inspection and testing.
This is a requirement
standard
used to control product or service through final inspection and testing.
ISO 9004-1, Quality management and quality system elements –Part 1: Guidelines for
implementation. This
optional
standard provides guidelines to implement a quality system to satisfy the customers’ and
organisational
requirements.
ISO 9004-2, Quality management and quality system elements –Part 2: Sets guidelines
for services. This
standard is
analogous to ISO 9004-1, but the guidelines are designed specifically to suit the
requirements of the service
sector.
ISO 9004-3, Quality management and quality system elements –Part 3: Sets guidelines
for processed materials.
ISO 9004-4, Quality management and quality system elements –Part 4: Sets guidelines
for quality improvement.
Provides
guidelines for implementing continual quality improvement within the organisation using
tools and techniques
based on
information compilation and evaluation.
ISO 10005, Quality management –Sets guidelines for quality plans. This standard
provides guidance on how to
prepare
quality plans for the control of specific products, and projects.
ISO 10006, Sets guidelines to quality in project management
ISO 10007, Quality management –Sets guidelines for configuration management.
Provides guidelines to ensure
that a
complex product continues to work in the desired manner even when certain parts are
modified.
ISO 10011-1, Sets guidelines for auditing quality systems – Part 1: Provides guidelines
for auditing a quality
system, and
verifying the system’s capability to achieve set quality goals. It can be used within the
organisation or for
auditing the
suppliers.
ISO 10011-2, Sets guidelines for auditing quality systems – Part 2: Qualification criteria
for quality systems:
auditors.
Provides guidance on the education, training, know-how, personal traits and management
capabilities needed to
carry out
an audit.
ISO 10011-3, Sets guidelines for auditing quality systems – Part 3: Management of audit
programmes. Provides
basic
guidelines for managing quality system audit programmes.
ISO 10012-1, Quality assurance requirements for measuring equipment – Part 1: It is a
metrological
confirmation system
for measuring equipment. Provides guidelines on the key characteristics of a calibration
system to ensure that
measurements are done with the projected accuracy.
ISO 10012-2, Quality assurance for measuring equipment – Part 2:
Sets guidelines for control of measurement processes. Provides additional guidance on
the application of
statistical process
control whenever it is apt for achieving the objectives of Part 1.
ISO 10013, Sets guidelines for developing quality manuals. Provides guidelines for
the setting up, organising and
controlling quality manuals customised to specific needs.
Continue the tour:
The ISO 9000:94 Quality System Elements
Understanding > The ISO 9000:94 Quality System Elements
The ISO 9000 Quality system elements:
An ISO 9000 compliant quality assurance system includes 20 system elements. Of the
three system models (ISO
9001,
9002, and ISO 9003), ISO 9001 requires all 20-system elements whereas certain sub
clauses have been omitted
in ISO
9002 and 9003. The 20 system elements that ISO 9001 requires are listed below:
4.1 Management Responsibility.
4.2 Quality System.
4.3 Contract Review.
4.4 Design Control.
4.5 Document and Data Control.
4.6 Purchasing.
4.7 Control of Customer – Supplied Product.
4.8 Product Identification and Traceability.
4.9 Process Control.
4.10 Inspection and Testing
4.11 Control of Inspection, Measuring and Test Equipment.
4.12 Inspection and Test status.
4.13 Control of Non-Conforming Product.
4.14 Corrective and Preventive Action.
4.15 Handling Storage, Packaging, Preservation, and Delivery.
4.16 Control of Quality Records.
4.17 Internal Quality Audits.
4.18 Training.
4.19 Servicing.
4.20 Statistical Techniques.
The ISO 9002 standard comprises of all the twenty clauses except Design control (clause
4.4)
The ISO 9003 standard comprises all the twenty clauses as in ISO 9000 barring Design
control (4.4), Process
control (4.9),
Preventive action (4.14) and Servicing (4. 19)
The ISO 9000 Standard’s twenty system elements are explained in detail below.
4.1. Management Responsibility:
4.1.1. Quality policy:
•The organisation should establish a quality policy and properly document it.
• The goals set to achieve quality performance must be in line with the overall
organisational objectives.
•The quality policy should be communicated to all the departments of the organisation.
4.1.2. Organisation:
• An organisation should have a clear structure, in which individuals join together and
play clearly defined roles,
acting in co-ordination to further the aims of the organisation.
4.1.2.1. Responsibility and authority:
• An authorised official who is competent to examine and control the procedures that
have an influence on the
quality system should be selected.
• This person should be given the liberty to take necessary steps to ensure that the
organisation controls quality
related processes in an effective manner.
4.1.2.2. Resources:
• The organisation should identify resources required for achieving the specifications of
the quality policy.
•These resources should include trained employees.
4.1.2.3. Management representative:
•The organisation should appoint a management representative (on behalf of the
organisation’s management).
• This representative is responsible for the proper deployment of the quality system.
• He should convey the status of the quality system to the top management.
4.1.3. Management review:
• The management should regularly assess the quality system in order to ascertain its
consistency and efficiency.
4.2. Quality System:
4.2.1. General:
• Organisations should have a quality manual consisting of the functional aspects of this
standard.
• The quality manual should comprise of the information pertaining to the work to be
done in the quality system.
It
should also explain how it should be done, who should do it, and under what
circumstances.
4.2.2. Quality system procedures:
•The quality system procedures should be in line with the standard and quality policy.
• These procedures should be efficiently applied.
• The information pertaining to the procedures should be within the scope of the
organisational activities.
4.3. Contract Review:
4.3.1. General:
• The organisation must take steps to ensure that it identifies with the customer
requirements.
• If the essential technical requirements for the items, materials, or services vary from
that of the customer
needs,
a systematic procedure for resolving the matter should be put in place.
• The ISO 9000 standard also recommends that mutual interactions be kept up with the
customer during the
entire
transaction.
• Organisations should lay down procedures for the assessment of the customer invoice.
4.3.2. Review:
The organisations must conduct a thorough assessment of the customer orders before
taking them up.Therefore,
the
management should ensure that:
• The customers' order is well interpreted (if it is orally conveyed) before taking up the
order.
• The organisation has sufficient resources to fulfil the requirements of the customer.
4.3.3. Amendment to contract:
Sometimes, the consumer might go for a replacement of the order or the organisation
itself could fall short of the
specifications. The standard states that:
• Organisations must possess a documented system that specifies the modification
procedure and the
techniques
being implemented so that the relevant information is conveyed to the concerned people.
4.3.4. Records:
Upon the assessment of the customer order, the organisation should document the
information pertaining to the
order and
the subsequent assessment incorporated in it. This is to be preserved for a specific
duration.
4.4. Design Control:
4.4.1. General:
The organisation needs to lay down procedures to ensure that the design of the product
suits the customer
requirements.
4.4.2. Design and development planning:
The design plan must describe how the design process will be executed. It covers the
employees in various
hierarchies,
their interactions and design procedures. Experts must regularly evaluate the design
processes.
4.4.3. Organisational and technical interfaces:
All interfaces between the design of a product and other organisations that design it have
to be identified,
communicated,
and assessed periodically. The information required for carrying out a design process
within the organisation
must be
gathered and incorporated within the documents.
4.4.4. Design input:
The organisation must put in place procedures to ensure that the design team obtains the
crucial information
pertaining to
the design parameters. The design team must promptly explain, convey and solve
discrepancies in the product
specifications.
4.4.5. Design review:
The organisation must carry out design reviews at various phases of product evolution in
order to control the
design
process.
4.4.6. Design output:
The output of the design process consists of documented drawings, and tolerance
specifications, materials
requirements,
and assembly guidelines.
4.4.7. Design verification:
Design verification states that:
• As the designs develop, the design must be evaluated to ensure that the inputs are
conformed to.
• Designs are verified by means of tests, displays, and contrasting with previous designs.
4.4.8. Design validation:
The organisation must make sure that the final product conforms to the design
parameters, which in turn suit the
customer’s needs. To attain design validation, the product must be tested in the
environment it is going to be
used. This is
done to ensure that the product conforms to customer's requirements.
4.4.9. Design changes:
The course of action for making modifications in design should be documented.
4.5. Document and Data Control:
4.5.1. General:
All documents relevant to the ISO 9000 standard should be managed by a system with
relevant procedures laid
down for
document assessment, improvement, approval and disposition. This also includes
verifying documents used in
design and
testing. The documents must be easily accessible.
4.5.2. Documentation approval and issue:
To meet the terms of this clause:
• The concerned officials should assess, endorse review and approve all the documents
that are utilised.
• The organisation must maintain a record of all the documents in use.
• The organisation must ensure that employees can easily access documents pertaining to
them.
• Obsolete or incorrect documents must be removed from locations where there are
chances of their inadvertent
usage.
4.5.3. Document changes:
• Documented modifications must be assessed and authorised by those who conduct the
initial assessment, or
by
an official who has the freedom to use the relevant and crucial information to enable a
good evaluation.
• New modifications from the previous documents should be charted, when required.
4.6. Purchasing:
4.6.1. General:
• The organisation should have well laid down procedures to perform its purchasing
activities. Only then can the
materials being supplied to the organisation suit the specific needs of the product.
• The organisation must evolve an effective purchasing system with complete
documentation and records that
make sure that the purchased goods conform to the requirements.
4.6.2. Evaluation of subcontractors:
Assessment of a supplier must include an official documented assessment procedure.
Review of subcontractors
stipulates
that:
• The organisation must choose a contractor on the basis of his capacity to conform to
quality requirements.
• An assessment of the quality system set up in the supplier’s organisation must be
performed.
• The organisation must maintain accessible records of those vendors who conform to the
standards.
4.6.3. Purchasing data:
Goods being purchased should be clearly specified. This consists of pinpointing critical
components and high
lighting
process capabilities, guidelines for inspection and other relevant data. The purchase
record must contain details
of
conformity to a relevant standard.
4.6.4. Verification of purchased product:
It is the purchaser's choice to carry out a check of the product at the supplier’s place or
within the purchaser’s
organisation. Product verification proves that the information pertaining to the inspection
of the product is
incorporated in
the purchase record.
4.7. Control of Customer Supplied Product:
The organisation should lay down procedures to assess, stock up, utilise and maintain the
goods made available
by the
customer to be integrated into the final product. Materials that are not viable should be
identified, separated and
intimated
to the concerned customer.
4.8. Product Identification and Traceability:
To maintain product identification and traceability:
•The organisation should lay down procedures so that the materials are individually
traced from the time they
are
supplied to the organisation till the customer accepts them.
•Depending on the customer needs, organisations may even require to provide component
identification. The
organisation should have official documents and records in place to cater to the
customers’ requirements.
4.9. Process Control:
Process control can be defined as the means by which the process is designed to be in line
with the standards or
specifications.
• The organisation should execute operations under a controlled work environment that
ensure that the quality
of
the product is sufficient and in line with the documented specifications of ISO 9000
standard.
• The documents should stipulate the requirements for the machinery, location, reference
standards, and quality
plans. They must also include the procedure for routine inspection during the production
process.
• The equipment utilised by the employees must have proper operational guidelines. The
instructions should be
evaluated regularly to see that they are in line with the other procedures.
4.10. Inspection and Testing:
4.10.1. General:
• There should be a detailed inspection and testing system to check whether customer
needs are conformed to.
This should be promptly incorporated in the documents and records that are accessible
to the employees.
• Attribute acceptance sampling plans should have zero defects as the benchmark.
• Certified laboratories should be utilised on consumer request.
4.10.2. Receiving inspection and testing:
• The organisation should lay down procedures that ascertain use of material in the
processes till they suit the
predetermined quality aspects.
• During emergencies where the material is utilised before inspection, it should be
positively pinpointed and
documented in order to facilitate instant recall and replacement (if the set standards are
not met).
4.10.3. In-Process Inspection and Testing:
• The organisations should inspect and test the product as required by the documented
procedures.
•Utilisation of positive recall method in cases of emergency.
• Emphasis should be laid on defect minimisation techniques such as SPC, visual
management, mistake
proofing.
4.10.4 Final Inspection and Testing:
• The organisation should perform final inspection and testing in accordance with the
documented procedures.
This
will help to establish the conformance of the finished product to the specified
requirements.
• The Quality Plan for final inspection and testing stipulates that all specified inspection
and tests have been
accomplished. The results should satisfy the specifications.
• No product should be shipped until all the procedures specified in the documented
procedures have been
accomplished and the related information is approved officially.
4.10.4 Inspection and Test Records:
•The organisations should put in place records to ascertain whether a product has been
tested or not.
• These records will show clearly whether the product has passed or failed the inspections
conducted in
accordance
to the requirements.
• If a product fails any inspection or test, the procedure for control of nonconforming
product should be utilised.
•Records should clearly identify the officials who are in-charge of the despatching of the
product.
4.11. Control of Inspection, Measuring, and Test Equipment :
This clause defines the system established to ensure that the products meet the quality
requirements through
effective
inspection and testing.
4.11.1. General:
• The organisation should have a system in place to ensure that the devices used for
inspection and testing are
appropriately calibrated and managed.
• When using software to check the product’s conformance to the requirements, they
should be periodically
reexamined
for consistency.
•Records of calibration, authentication, and precision need to be easily accessible to the
customers.
4.11.2. Control procedure:
• Choose the pertinent device for testing.
• Pinpoint those devices that can positively influence product quality.
• Calibrate such devices at regular intervals.
• Designate the current state of calibration.
• Put in place records providing the information for calibration.
•Make sure that the devices used for testing and inspection are properly maintained and
regularly checked for
defects.
• Protect the equipment from modifications that could have a negative effect on
calibration.
4.12. Inspection and Test Status:
• The organisation should designate the current state of inspection and testing of the
products during the
various
stages of the production process.
• This can be done using stamps, labels, tags, records, or diskettes.
4.13. Control of Nonconforming Product:
This clause defines the system to manage nonconforming product.
4.13.1. General:
• Products that do not meet the requirements should be restricted from inadvertent usage
or installation.
• The organisation should lay down procedures to tackle product failures for e.g.
preventing the product from
being
delivered to the customer.
• These procedures should specify isolation of such products and the subsequent
corrective actions.
4.13.2 Nonconforming product review and disposition:
The defective product should be assessed in compliance with the procedures laid down.
This product may be:
• Modified to meet the specified requirements.

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Develop your knowledge of ISO 15189
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