ISO 13485: 2016: A Complete Guide to

Quality Management in the Medical

Device Industry, Second Edition Itay
Abuhav
Visit to download the full and correct content document:
https://textbookfull.com/product/iso-13485-2016-a-complete-guide-to-quality-manage
ment-in-the-medical-device-industry-second-edition-itay-abuhav/
More products digital (pdf, epub, mobi) instant
download maybe you interests ...

ISO 9001: 2015 A Complete Guide to Quality Management

Systems 1st Edition Itay Abuhav

https://textbookfull.com/product/iso-9001-2015-a-complete-guide-
to-quality-management-systems-1st-edition-itay-abuhav/

Design Controls for the Medical Device Industry, Third

Edition Marie B. Teixeira

https://textbookfull.com/product/design-controls-for-the-medical-
device-industry-third-edition-marie-b-teixeira/

Coulson and Richardson’s Chemical Engineering, Fourth

Edition: Volume 3A: Chemical and Biochemical Reactors
and Reaction Engineering R. Ravi

https://textbookfull.com/product/coulson-and-richardsons-
chemical-engineering-fourth-edition-volume-3a-chemical-and-
biochemical-reactors-and-reaction-engineering-r-ravi/

The Complete Guide To Medical Skills Tactics and

Techniques Mccullough

https://textbookfull.com/product/the-complete-guide-to-medical-
skills-tactics-and-techniques-mccullough/
Biota Grow 2C gather 2C cook Loucas

https://textbookfull.com/product/biota-grow-2c-gather-2c-cook-
loucas/

Quality Management in Construction Projects, Second

Edition Abdul Razzak Rumane

https://textbookfull.com/product/quality-management-in-
construction-projects-second-edition-abdul-razzak-rumane/

The Complete Business Guide for a Successful Medical

Practice 1st Edition Neil Baum

https://textbookfull.com/product/the-complete-business-guide-for-
a-successful-medical-practice-1st-edition-neil-baum/

Warehouse Management A Complete Guide to Improving

Efficiency and Minimizing Costs in the Modern Warehouse
Gwynne Richards

https://textbookfull.com/product/warehouse-management-a-complete-
guide-to-improving-efficiency-and-minimizing-costs-in-the-modern-
warehouse-gwynne-richards/

Electronically Stored Information The Complete Guide to

Management Understanding Acquisition Storage Search and
Retrieval Second Edition David R Matthews

https://textbookfull.com/product/electronically-stored-
information-the-complete-guide-to-management-understanding-
acquisition-storage-search-and-retrieval-second-edition-david-r-
 ISO 13485:2016
A Complete Guide to
Quality Management in the
Medical Device Industry
Second Edition
 ISO 13485:2016
A Complete Guide to
Quality Management in the
Medical Device Industry
Second Edition

Itay Abuhav
CRC Press
Taylor & Francis Group
6000 Broken Sound Parkway NW, Suite 300
Boca Raton, FL 33487-2742

© 2018 by Taylor & Francis Group, LLC

CRC Press is an imprint of Taylor & Francis Group, an Informa business

No claim to original U.S. Government works

Printed on acid-free paper

International Standard Book Number-13: 978-1-138-03917-9 (Hardback)

This book contains information obtained from authentic and highly regarded sources. Reasonable
efforts have been made to publish reliable data and information, but the author and publisher ­cannot
assume responsibility for the validity of all materials or the consequences of their use. The authors
and publishers have attempted to trace the copyright holders of all material reproduced in this publi-
cation and apologize to copyright holders if permission to publish in this form has not been obtained.
If any copyright material has not been acknowledged please write and let us know so we may rectify
in any future reprint.
Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, repro-
duced, transmitted, or utilized in any form by any electronic, mechanical, or other means, now
known or hereafter invented, including photocopying, microfilming, and recording, or in any
information storage or retrieval system, without written permission from the publishers.
For permission to photocopy or use material electronically from this work, please access www.
copyright.com (http://www.copyright.com/) or contact the Copyright Clearance Center, Inc.
(CCC), 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. CCC is a not-for-profit organi-
zation that provides licenses and registration for a variety of users. For organizations that have
been granted a photocopy license by the CCC, a separate system of payment has been arranged.

Trademark Notice: Product or corporate names may be trademarks or registered trademarks,

and are used only for identification and explanation without intent to infringe.
Visit the Taylor & Francis Web site at
http://www.taylorandfrancis.com
and the CRC Press Web site at
http://www.crcpress.com
Contents

Preface..................................................................................................................ix
Acknowledgments.............................................................................................xi
Author............................................................................................................... xiii

1. Scope.............................................................................................................. 1

2. Normative references.................................................................................. 9

3. Terms and definitions............................................................................... 11

4. Quality management system.................................................................. 13

4.1 General requirements...................................................................... 13
4.2 Documentation requirements........................................................ 94
4.2.1 General������������������������������������������������������������������������������� 94
4.2.2 Quality manual................................................................ 106
4.2.3 Medical device file........................................................... 120
4.2.4 Control of documents...................................................... 124
4.2.5 Control of records............................................................ 143

5. Management responsibility.................................................................. 161

5.1 Management commitment............................................................161
5.2 Customer focus...............................................................................167
5.3 Quality policy................................................................................. 170
5.4 Planning...........................................................................................176
5.4.1 Quality objectives.............................................................176
5.4.2 Quality management system planning........................ 182
5.5 Responsibility, authority, and communication.......................... 185
5.5.1 Responsibility and authority.......................................... 185
5.5.2 Management representative........................................... 191
5.5.3 Internal communication................................................. 196

v
vi Contents

5.6 Management review...................................................................... 203

5.6.1 General����������������������������������������������������������������������������� 203
5.6.2 Review inputs................................................................... 208
5.6.3 Review outputs................................................................ 215

6. Resource management............................................................................ 221

6.1 Provision of resources................................................................... 221
6.2 Human resources........................................................................... 225
6.3 Infrastructure................................................................................. 241
6.4 Work environment and contamination control......................... 266
6.4.1 Work environment........................................................... 266
6.4.2 Contamination control.................................................... 282

7. Product realization.................................................................................. 295

7.1 Planning of product realization................................................... 295
7.2 Suitable planning for the organization’s operations:
A practical quality plan................................................................ 334
7.2.1 Determination of requirements related to product.... 336
7.2.2 Review of requirements related to the product........... 343
7.2.3 Communication................................................................ 354
7.3 Design and development.............................................................. 366
7.3.1 General����������������������������������������������������������������������������� 366
7.3.2 Design and development planning............................... 369
7.3.3 Design and development inputs.................................... 381
7.3.4 Design and development outputs................................. 391
7.3.5 Design and development review................................... 400
7.3.6 Design and development verification........................... 409
7.3.7 Design and development validation............................. 425
7.3.8 Design and development transfer................................. 452
7.3.9 Control of design and development changes.............. 460
7.3.10 Design and development files........................................ 470
7.4 Purchasing...................................................................................... 473
7.4.1 Purchasing process...........................................................474
7.4.2 Purchasing information.................................................. 495
7.4.3 Verification of purchased product................................. 509
7.5 Production and service provision............................................... 520
7.5.1 Control of production and service provision............... 520
7.5.2 Cleanliness of product.................................................... 548
7.5.3 Installation activities....................................................... 557
7.5.4 Servicing activities........................................................... 563
7.5.5 Particular requirements for sterile medical devices..... 576
7.5.6 Validation of processes for production and service
provision........................................................................... 584
Contents vii

7.5.7 Particular requirements for validation

of processes for sterilization and sterile
barrier systems................................................................. 625
7.5.8 Identification..................................................................... 635
7.5.9 Traceability����������������������������������������������������������������������� 652
7.5.10 Customer property.......................................................... 666
7.5.11 Preservation of product.................................................. 671
7.6 Control of monitoring and measuring equipment................... 681

8. Measurement, analysis, and improvement........................................ 701

8.1 General............................................................................................ 701
8.2 Goal of monitoring, measurement, analysis for
improvement.................................................................................. 702
8.2.1 Planning and implementing processes for
monitoring, measurement, analysis, and
improvement.................................................................... 704
8.2.2 Feedback��������������������������������������������������������������������������� 707
8.2.3 Complaint handling........................................................ 717
8.2.4 Reporting to regulatory authorities.............................. 736
8.2.5 Internal audit.................................................................... 740
8.2.6 Monitoring and measurement of processes................. 757
8.2.7 Monitoring and measurement of product.....................767
8.3 Control of nonconforming product............................................. 778
8.3.1 General����������������������������������������������������������������������������� 779
8.3.2 Actions in response to nonconforming products
detected before delivery.................................................. 795
8.3.3 Actions in response to nonconforming products
detected after delivery.................................................... 805
8.3.4 Rework�������������������������������������������������������������������������������816
8.4 Analysis of data.............................................................................. 820
8.5 Improvement.................................................................................. 834
8.5.1 General����������������������������������������������������������������������������� 834
8.5.2 Corrective action.............................................................. 843
8.5.3 Preventive action.............................................................. 854

Index................................................................................................................. 863
Preface

The quality management world of the medical device industry has gone
through a significant change represented by the publication of the new
revision of the ISO 13485 Standard, the 2016 revision. This revision brings
new challenges to organizations as well as changes to old challenges. This
book is a complete guide to implementing all of the requirements of the
standard. In order to present the reader with a practical and useful guide,
I have provided a definition of my quality policy and objectives.

My quality policy
Presenting and reviewing the ISO 13485:2016 standard requirements
through analysis, interpretation, and demonstration, with explanations,
insightful examples, and events from various industries and sectors.

My quality objectives
• Commitment to the highest level of consulting regarding the ISO
13485:2016 standard.
• Reviewing all the topics and issues related to the realization of a
product or service with reference to various types of processes and
products.
• Providing support in the implementation of an effective quality
management system.
• Facilitating the documentation of processes.
• Providing a reference to the new challenges presented in the ISO
13485:2016 standard.

However, a policy and related objectives are ineffective without also

having in place designed and structured tactics and methods to achieve
them:

ix
x Preface

• This guide is designed and structured to mirror the standard’s table

of contents in order to simplify navigation and use.
• Each clause and subclause of the standard is discussed and analyzed
through quality and regulatory perspectives, such as the implications
for an organization—its processes, risk management, resources,
infrastructures, work environment, control and effectiveness, and
documents and records.
• The ISO 13485:2016 standard acts like a complicated web of
prerequisites with relations between them. A full and comprehensive
reference to the interrelations between the different clauses and
subclauses has been included.
• Putting words into actions—the book will assist in translating the
requirements and objectives into feasible activities and tasks. It
visualizes situations with everyday events from the different sectors,
branches, and products or services.

List of exclusions
I decided to exclude Chapter 0 of the standard from this book since it
mainly provides explanations regarding ISO 13485:2016 that are already
covered elsewhere in this book. I also reduced Chapter 3 to the minimum
because the terms and definitions are already thoroughly discussed in the
standard.
My biggest wish is that you, as a reader, will refer to this guide as a
consulting session, read and explore it, draw information and knowledge
that suits you and your organization, and introduce this information to
your quality management system and processes.
Acknowledgments

I wish to thank all the people—consultants, co-workers, auditors, mentors,

bosses, and friends—who introduced me to the quality world, and who
have aided, supported, taught, lectured, consulted, and provided valuable
knowledge and information during the undertaking of this book and also
in my professional career. You have helped give an edge to this book. The
list of names is too extensive to include here, but you know who you are.
I wish to thank my dear family for their warm support throughout
the years.
I also wish to thank my wife Angela, daughter No’omi and son Gabriel
for understanding, pushing, believing, and supporting me throughout this
project.
Thank you.

xi
Author

Itay Abuhav is a highly experienced medical device quality control

expert and consultant based in Geneva, Switzerland. He has over 25 years
of experience in dealing directly with a number of large medical device
enterprises in their quality control manufacturing processes of state-of-
the art medical devices. He has also been awarded 15 patents in medical
devices and related technologies.

xiii
1. Scope

Clause 1 of the ISO 13485 Standard is used to present the purposes and
concepts of the standard and define the scope of application of the standard
to your quality management system. The following aspects are covered in
this clause:

• The goals and purposes of the standard

• The types of organizations to which the standard applies
• The approach and reference to customer requirements
• Which types of products may be controlled by this standard
• The responsibility of the organization when using partners like
suppliers in the realization of the medical device (MD)
• The approach and reference to regulatory or statutory requirements
• Applicability of design and development controls
• Possibilities for exclusions of the standard requirements

Before we start to understand the requirements of clause 1—Scope, let

us review them first:

• This International Standard specifies requirements for a quality

management system where an organization needs to demonstrate
its ability to provide medical devices and related services that
consistently meet customer, safety, and applicable regulatory
requirements.
• The ISO 13465 Standard is an international standard for the
establishment, design, and implementation of a quality management
system (QMS) for organizations that are involved in one or more
stages of the life-cycle of the MD, including design and development,
production, storage and distribution, installation, or servicing
of a medical device and design and development or provision of
associated activities (e.g., technical support).
• The ISO 13485 Standard can also be implemented by suppliers
or external parties that provide services, processes, materials, or
components for the medical device.
• The requirements of this standard apply and may be implemented
in any organization regardless of its size or the type of its products
or services, except where explicitly stated.

1
2 ISO 13485:2016

• The requirements of this Standard apply to the associated services as

supplied by the organization and are related to the MD.
• Where requirements of this standard, which are applicable to
the product or service, are performed externally, it is under the
responsibility of the organization to prove conformity to these
requirements by monitoring, maintaining, and controlling these
processes.
• Applicable regulatory requirements that permit the exclusion of
design and development controls may be used as a justification for
their exclusion from the quality management system.
• When applicable regulatory requirements allow, or suggest other
controls for design and development, the organization may plan and
include them in the design and development.
• When exclusions to design and development requirements are made,
it is the responsibility of the organization to prove conformity to the
ISO 13485 Standard requirements.
• When requirements from clauses 6, 7, or 8 of this standard are not
applicable to the QMS of the organization due to its nature, activities,
or operations of MD type or nature, it may exclude this requirement
from its QMS.
• Any exclusion will be provided with a sufficient documented
justification. The exclusion and justification shall be documented in
the quality manual according to the requirement of clause 4.2.2—
Quality manual.

The principles of the ISO 13485 Standard

Clause 1—Scope presents us with the principles and concepts of the
standard. The ISO 13485 Standard aims to enable the organization to
provide an adequate MD to the end users by fulfilling its requirements,
initiating risk management activities, and meeting applicable international
and national regulations. This is expressed through four principles:

• The goal of the standard is to initiate a QMS that acts to consistently

meet customer requirements and safety requirements, as well as
applicable regulatory requirements.
• The requirements of this standard initiate an effective integration
between a QMS of an organization and applicable regulatory
requirements.
• The requirements suggested in the ISO 13485 Standard facilitate an
improvement of processes included in the QMS and assurance of
conformity to customer or regulatory requirements.
• The standard covers all the related phases and their derived activities
of the life-cycle of the MD. The requirements suggested in the ISO
1. Scope 3

13485 Standard are applicable to all sorts of organizations regardless

of their size or type, the type of their customers, and the type of
products or services that they provide.

Stages of life-cycle of the medical device

Organizations that choose to implement the ISO 13485 Standard
requirements may participate in one of more of the stages of the MD.
Basically, these stages derive the activities that the organization must
perform and the QMS must control, including design and development,
production, storage and distribution, installation, or servicing of a medical
device and design and development or provision of associated activities
(e.g., technical support). All these stages represent different processes,
activities, and operation that are needed for the realization of the MD. The
requirements of the standard cover all these related activities. Please refer
to Chapter 4.1.1.8 for detailed information and an explanation about the
different life-cycle stages of the MD and how the organization knows in
which life-cycle stage it is involved.

The ability to provide appropriate medical devices

What are the actual requirements of clause 1? When an organization
decides to implement the ISO 13485 Standard, it is required, through the
use and application of the methods and quality instruments presented in
this standard, to prove its ability to

• Identify customer requirements

• Identify regional regulatory requirements
• Initiate a risk management approach and system
• Implement any activities or controls required by those regulatory
requirements
• Establish a QMS according to the requirements of the ISO 13485
Standard
• Provide safe MDs that meet the applicable regulatory, safety, and
standard requirements

In other words, the purpose of the standard presented in clause 1 must

be reflected through the quality management system of your organization.
How? Through applying the quality management tools and instruments
that are suggested in the standard, like setting and defining quality
policy and objectives, applying the process approach, planning processes,
establishing a system to control risks, and meeting any other standard
requirement presented in the standard.
4 ISO 13485:2016

A quality management system is a combination of various activities

and processes—marketing, design and development, production,
technical activities, storage, and distribution—operated by various
functions and roles that demand certain conditions and qualifications.
Determining what is to be included under the QMS will define which
organizational aspects will be designed, managed, and controlled
under the quality requirements: products, processes, activities, sites,
information and data, tools and equipment, and human resources.
The determination of what and how from the standard requirements
must be translated, put into operational activities, and implemented
in the organization will frame the scope of your quality management
system and define which of the standard requirements are applicable to
your organization. A description of the scope and a detailed list of the
standard requirements related to the QMS will be included in the quality
manual, where it is required to include a list of the operations, processes,
and products that are included. The objective is to describe all the
quality operations and processes that are applicable to the organization:
planning of product realization, customer-related processes, purchasing,
and so on.

Size and type of the organization

Another statement of clause 1 defines the appointment and adequacy
of the ISO 13485 Standard requirements to organizations that provide
medical devices. The statement indicates that the size and type of an
organization do not affect the application of the standard except where
explicitly stated. In other words, when you are defining the application
of the standard requirements to your processes, activities, and products,
the size and type of the organization are not factors that will determine
whether a requirement is needed, except where explicitly stated.

Integrating regulatory requirements in the QMS

One of the main objectives of the ISO 13485 Standard is to integrate
applicable regulatory requirements or other international standards,
or internal standards with quality management system requirements.
To integrate means to identify the applicable regulatory requirements
and their operational, legal, administrative, and any other demands
and to implement them into the QMS activities. The objective is to
systematically identify all the regulatory requirements and understand
(as well as implement) how they affect or implicate the QMS elements:
processes, activities, human resources, documentations, records, and risk
1. Scope 5

management. These may have special demands regarding the extent,

structural activities, and documentation of the QMS.

Exclusions and justifications

The ISO 13485:2016 Standard is intended to be a standard for medical
device manufacturers and other organizations that participate in the life-
cycle of the MD that are expected to demonstrate their ability to provide
medical devices and related services that consistently meet customer
and applicable regulatory requirements. It is recognized, however, that
not all the requirements of this standard will necessarily be relevant
to all organizations. Thus, the ISO 13485 Standard permits, under
certain circumstances and limitations, the exclusion of certain standard
requirements: the omission of quality or realization activities that are
normally required from the QMS. Exclusion means that certain standard
requirements (one or more) are not applicable to the organization due to
the activities and processes undertaken by the organization or the nature
of the medical device for which the quality management system is applied,
and the organization decided not to implement these requirements in its
QMS. The implication of the exclusion is that certain quality activities
specified in the standard will not be developed in the QMS and will not
be implemented. The exclusions will be referred to and justified in the
quality manual.
Exclusions are very important because they set the degree of effort
and amount of resources that you will have to invest in implementing and
maintaining the QMS. The application of the ISO 13485 Standard refers
to how the QMS defines what users are allowed to do and how, instructs
them, and provides them with quality tools to accomplish processes,
operations, activities, and tasks. The determination of the application will
frame the scope of your quality management system and define which of
the standard requirements are applicable to your organization and which
may you exclude. The organization is allowed to exclude only requirements
that appear in clauses 6, 7, or 8 of the ISO 13485 Standard. All other clauses
are obligatory for meeting the ISO 13485 Standard requirements and will
be implemented. In other words, the organization must consider whether
all the requirements of the standard are relevant to its activities, based
on the nature of the organization itself, the type and class of the MD, the
realization activities and safety requirements (that are derived), and the
statutory and regulatory requirements.
The justification for the exclusions must prove beyond any doubt that
the exclusions do not affect the ability or responsibility to consistently
provide a product that meets customer, safety, and applicable regulatory
requirements. Furthermore, the exclusions must be consistent with the
6 ISO 13485:2016

scope of the QMS, as mentioned in the quality manual. For example, you
may not exclude clause 7.5.10—Customer property and claim management
of customer property in the scope. Considering the justifications, the
organization shall evaluate the implications of the exclusions and how the
exclusions will prevent it from meeting applicable safety and regulatory
requirements. The documentation and approval of the exclusions will be
documented in the quality manual. Each standard requirement that was
left out will be justified or referred to another documented justification.
The justification shall confirm that the exclusion does not affect the quality
of the activities, processes, and products.
It is very tempting to exclude, but the experience, the reality, and,
above all, the external audit show that exclusions are often mistakenly
applied. For example:

• The company manufactures, markets, and delivers a medical device.

The design and the development are done by an external company. The
company may not exclude the design and the development require­
ments (7.3), since it holds the responsibility for the medical device, its
functionality, performance, safety, and intended use.
• The company manufactures components for a medical device as
a subcontractor. The design and the development are done by an
external company. The company may exclude the design and the
development requirements (7.3), since it holds no responsibility
for the medical device, its functionality, performance, safety, and
intended use.
• The company manufactures the medical device, but the purchasing
is done by the parent company. The company may not exclude the
purchase requirements (7.4), since it handles information regarding
the purchase: type, product, supplier, schedules, and quantities.
• The company designs and develops a medical device according
to the customer specifications. The company may not exclude the
customer’s property requirements (7.5.10), since it manages the
customers’ documents, diagrams, and technical specifications.

It can be very confusing, and each case shall be evaluated on its own
merits. I advise you to consult the auditor regarding the exclusions. The
exclusion and justification shall be documented in the quality manual
according to the requirement of clause 4.2.2—Quality manual.

Exclusion of design and development controls

The organization is required to implement design controls through a
design and development process, and the design controls are normally
executed while the design and development proceed. The organization
1. Scope 7

may exclude the requirements for the design and development controls
presented in Chapter 7.3 when other regulation allows the exclusion of
these requirements. Nevertheless, this regulation must submit alternative
design and development controls. There is no doubt that designing and
developing the medical device must be controlled. However, it may be that
the manufacturer designs and develops its medical devices in a region with
certain regulatory systems and controls of the processes that have already
been implemented. There is no logic in maintaining two sets of controls.
Thus, the ISO 13485 Standard allows the organization to implement other
regulatory controls and to exclude the design and development controls
specified in clause 7.3. For example, if the organization is developing the
medical device while implementing the requirements of the FDA QSR21
CFR820.30: Design Controls, it may exclude the controls of clause 7.3. The
exclusion must be documented and justified. But it is still the responsibility
of the organization to provide sufficient evidence of the ability of the QMS
to meet the ISO 13485 Standard requirements (including clause 7.3) despite
the exclusion of the design and development controls.

Outsourced processes
The application of the standard requirements includes processes related to
the organization and the realization of medical devices that are performed
outside the organization. Such processes are applicable to the quality
management system and must be identified, documented (if and where
appropriate), controlled, and verified. This does not relate to purchased
goods, materials, or components, but to the provision of core processes
needed for the realization of the product supplied by suppliers or
contractors: design and development, production, assembly, sterilization,
cleaning, accreditation, storage, and transportation:

• These processes will be identified and included in the quality manual

and in the description of the interrelations between other processes
of the quality system.
• These processes will be implemented and the necessary realization
requirements shall be defined and allocated: production means,
human resources, verification, and validations, in order to verify that
they meet the ISO 13485 Standard requirements. It is allowed to let the
supplier of those processes allocate the resources. The organization
then will be informed, take part in the planning of those processes,
and approve the allocation of the resources.
• These processes will be appropriately controlled, and the
manufacturer shall acquire the minimal knowledge and technical
abilities to control these processes and will receive from the supplier
sufficient information regarding the processes and their results.
2. Normative references

The meaning and purpose of normative references is the indication that

the terminology and nomenclature specified in this standard are not open
for debate or an interpretive discussion. A normative reference refers to
a document that includes terms, fundamental concepts, principles, and
vocabulary that are essential for the application of the ISO 13485 Standard.
The ISO 13485 Standard requirements are as follows:

• When dated normative references are used, only the edition cited
applies (the ISO 9000:2015 Standard).
• When undated normative references are used, the latest edition of
this referenced document (including any amendments) applies.
• The document ISO 9000:2015, Quality management systems—
Fundamentals and vocabulary is to be normatively referred to while
establishing a quality management system according to the ISO
13485 Standard requirements.

A normative reference lists other ISO or IEC documents or standards

that are necessary for the application of the standard, in other words, the
documentation that may assist you in how to comply with the requirements
stated in the ISO 13485 Standard. The objective of a normative reference is
to relate to a standard that is applicable to the implementation of the ISO
13485 Standard and to relate to directives, definitions, or understanding
of the ISO 13485 Standard.
The ISO 13485 Standard refers us to a specific document, ISO 9000:2015:
Quality management systems—Fundamentals and vocabulary. In case
questions or misunderstanding regarding the definitions or requirements
of the ISO 13485 Standard arise during the implementation and application
of the standard requirements, you can turn to this document. For example,
when you are discussing and planning activities related to customer focus
and you are not sure what the definition of customer focus is, you may turn
to the ISO 9000 Standard and learn how the ISO 13485 Standard interprets
the issue of customer focus.

9
3. Terms and definitions

Clause 3—Terms and definitions is necessary in order to clarify terms and

definitions mentioned in the ISO 13485 Standard. In order to clear matters
and disputes, the standard presents its interpretations and explanations
regarding terms and definitions presented throughout the standard. These
are an inseparable and integral part of the standard. The explanations
provided are very descriptive and clear; therefore, there is no need to
repeat them. Please refer to clause 3 of the ISO 13485 Standard—Terms
and definitions for the exact definitions.

11
4. Quality management system

4.1 General requirements

4.1.1
In clause 4.1.1, the general requirements and main principles of a quality
management system are presented. In this clause are the foundations of
the QMS presented. First, let me review the basic requirements.

• The organization shall establish and maintain, document, and

implement a documented quality management system within the
organization with conformity to the requirements of the ISO 13485
Standard and applicable regulatory requirements.
• The organization is required to maintain the effectiveness of the
quality management system in accordance with the requirements
of the ISO 13485 Standard and applicable regulatory requirements.
• Any requirement, processes, activity, arrangement, or procedure
required by the ISO 13485 Standard and applicable regulatory
requirements shall be identified, included, planned, implemented,
and controlled in the QMS.
• The organization shall document the role or several roles undertaken
by the organization in relation to the applicable regulatory
requirements.
• Note—Roles undertaken by the organization can include
manufacturer, authorized representative, importer, or distributor.

Terms and definitions

Before we start to unveil the requirements of clause 4.1.1 and their
implementation, it is important to know some terms and definitions:

• Process—A set of interrelated or interacting activities that convert

inputs into outputs and accomplish a specific organizational goal.
These activities require allocation of resources such as people and
materials.
• Role of the organization—The role of the organization determines
which quality and regulatory activities and controls the
organization must plan and implement in its QMS. The role of the

13
14 ISO 13485:2016

organization is determined according to the phase of the life-cycle

of the medical device in which the organization is taking part
and the activities that the organization is executing in the supply,
provision, maintenance, after-sales obligations, and relations with
the user or patient of the MD. The organization must provide a
documentation of its role.
• Scope of a process—Scope of the process defines precisely where a
process starts and ends, what its related inputs and outputs are, and
which activities are included and excluded.
• Supplier of a process—The deliverer of inputs to a process (data,
information, goods, or services). The supplier may be an external
supplier that delivers, for instance, goods or material, or an
internal supplier—an organizational unit that delivers inputs to
a process.
• Customer of a process—The receiver of the outputs of a process (data,
information, goods, or services). The customer defines what outputs
are expected according to its needs. Customers may be external
customers, end customers, or internal customers.
• Inputs—Specified requirements needed to be put into a process in
order to start the process. The input will be processed by a process
or activity.
• Output—Specified expected or intended result of a process.
• Risk—Combination of the probability of the occurrence of not
fulfilling process specifications or customer requirements.
• Monitoring of processes—A continuous, sequential, and periodic
examination of processes and their outputs.
• Measurement of processes—Determining a physical measurement of
processes and their outputs based on data.
• Process owner—An organizational function responsible for a process
or subprocesses.

Establishing a QMS according to clear principles

The ISO 13485 Standard declares in clause 4.1.1 quite clearly with which
principles the QMS shall be established:

• Establishment of a QMS according to the ISO 13485:2016 Standard

• Identification and integration of relevant regulatory requirements in
the QMS
• Definition of processes and their interactions needed for the operation
of this QMS
• Identification of the resources needed for the QMS or required by
regulatory requirements
• Ensuring achievement of planned results
Another random document with
no related content on Scribd:
 jokaisen on elettävä kaunein laulunsa todellisuudeksi, ja
mitä kauniimpi on laulu, sitä raskaampi on elämän arvan
lunastaminen.

ILTARUSKO

Veritas,
minä tahtoisin suudella sinua,
ja se suudelma olisi kuin iltarusko,
joka äsken kuvastui syviin vesiin.

Virta kulki vuolaana, mustana, ylpeänä voimastaan,

varmana määrästään, yksinäisenä. Valahti taivaan rannalle
hehkuva iltarusko, painoi punaisen suudelman tummiin vesiin.

Ja katso! Syvyys alkoi liekehtiä lämpimänä, riemuitsevana.

Niin syvälle kuin silmä kantoi alaspäin, näkyi vain iltaruskon
hehkua, niin kauas kuin virta vieri, väikkyi purppurainen
veriaalto, mereen asti se ulottui. Ympärillä rannat hymyilivät ja
kukat nyökyttivät päätään.

Veritas,
minä tahtoisin olla sinulle iltarusko,
sillä sinä olet yksinäinen, voimakas ihminen,
joka elät syvää elämää
ja katsot hetken lapsiin alaspäin.
Minä tahtoisin kuin iltarusko
painaa oman vereni punaisen hehkun sinuun,
 niin että se ulottuisi sisimpääsi asti
ja täyttäisi olemuksesi elämisen riemulla.

Veritas,
minä tahtoisin suudella sinua —

KIELONKUKKIA

Herätkää, kielonkukat, avatkaa kellonne!

Armas astuu ylitsenne,
ja hänen silmistään säteilee lämmin aurinko.
Herätkää, kielonkukat, avatkaa kellonne!

Tuoksukaa, kielonkukat, tuoksukaa kesää!

Armas astuu ylitsenne,
ja hänen huuliaan polttavat suudelmat,
joiden aika nyt on käsissä.
Tuoksukaa, kielonkukat, tuoksukaa kesää!

Kuolkaa, kielonkukat, kuolkaa ilman kaipausta! Armas astui

ylitsenne ja kosketti minua huulillaan. Minun sieluni ja ruumiini
tunsi hänet ja tervehti valtiastaan.

Kuolkaa, kielonkukat, kuolkaa ilman kaipausta!

SUUDELMA
 Veritas, sinä suutelit minua
kuin ruumiinsa verille ruoskinut hurskas
Pyhää Neitsyttä:
kunnioittavin, aroin huulin.
Sinä suutelit minua uudelleen
kuin erakko,
joka luopuu maailmasta ja lähtee korpeen:
alistuen.
Ja minä otin suutelosi vastaan mitään ymmärtämättä,
mutta tuntien kaikki kuoleman edelliset kauhut.

Veritas, silloin kävi lävitseni aavistus, ikäänkuin voisin

minäkin tuntea sen Kaikkivaltiaan Voiman, josta Kirjojen Kirja
sanoo: »Ei etsi omaansa, ei katkeroidu.»

Veritas — minä, minä soisin, että sinä olisit krusifiksi, jota

voisin alati kantaa povellani, palvoa hartaudessa, löytää levon
sielulleni antaumuksessa — ja suudella syntisin, janoisin
huulin päivin ja öin —

VASTAAMATTA JÄÄNYT KYSYMYS

Miksi olet niin kalpea tänään? kysyit.

En voinut vastata, enhän tiennyt sitä itsekään; tunsin vain

epämääräistä tuskaa rinnassani ja pyysin: Mene!

Ystävä:
minussa kehittyy jokin, jolle en löydä nimeä,
 jokin sanomattoman suloinen ja surullinen,
joka nostaa kyyneleet silmiini ja hymyn huulilleni,
jota en soisi kenenkään arvaavan
ja josta tahtoisin laulaa koko maailmalle,
jokin, josta en tiedä,
onko se Elämän vaiko Kuoleman lähetti.

YÖSSÄ

Yö äänetön ympärilläni, kädet viileät painaa se otsallein. Mitä

tein, mitä päivän tein? kysyn kyynelin itseltäni.

Meni aurinko mailleen kauan sitten.

Hyvä on.
Ah, eessä sen säteitten kirkkahitten
olen alaston:
olen tahrannut valkean vaippani lokaan,
olen pettänyt parasta itseäni,
olen kieltänyt Pyhän,
olen veljilleni ollut tyly,
ah, ylitse käynyt oon käskyt kaikki.

Meni aurinko mailleen kauan sitten.

Yks synti mua painaa kuin kuoleman taakka: sydämeen,

joka lempii mua, olen pistänyt okaan —

Miks tein, miks väärin tein? kysyn murheisna itseltäni. Ja

mä katselen kylmiä tähtiä ikkunasta: kuin nuo ovat vakavat,
 niin oli rakkautein.

Yö tummuu ympärilläni.

LÄHTIESSÄ

Sinun käsivarsiltasi tahtoisin kerran, kun hetki on tullut, siirtyä

rajan taakse.

Ruumiini on hauras kuin lasi, ja sieluni on siinä; perin

heikoilla siteillä kiinni. Luulenpa, että keväinen tuulenpuuska
voisi ne eroittaa toisistansa.

Kuljen täällä unissakävijän tavoin. Teen vaistomaisesti

samaa kuin muutkin, mutta kotonani en ole. Olen kuullut
kutsun, tosin loitolta, olen tuntenut Näkymättömän
läheisyyden enkä ole enää entiseni.

Mutta sinä hetkenä, Veritas, tahtoisin levätä sylissäsi,

tahtoisin haihtuvan tuokion ajan uskoa sinun rakastavan
minua yli kaiken maallisen, tahtoisin, että viimeinen, minkä
katoava tajuni tältä puolen rajan käsittää, olisit sinä.

KUVASTIN

Ystävät, jos luotatte minuun, niin luottakaa eheästi.

Olen luotu niin, että vastaan samalla mitalla.
Jos te ette ole rehellisiä, miksi vaaditte sitä minulta?
Ellette te anna kokonaista, kuinka voisin minä sitä antaa?
Ystäväni, ettekö jo aikaa huomanneet:
heijastan teille jokaiselle vain itseänne.
EPILOGI

RESIGNAATIO

Ketä Jumala rakastaa, sen käteen hän laskee matkasauvan,

se kuulee pakottavan kutsun: »Lähde maaltasi ja isäsi
huoneesta sille maalle, jonka minä sinulle osoitan!»

Ketä Jumala rakastaa, sen tie vie avaraan maailmaan.

Ikuinen ikävä ajaa häntä. Lepopaikkaan ei hän jäädä voi.
Päämäärä odottaa häntä jossakin kaukana, jonne vain
aavistus yltää.

Ketä Jumala rakastaa, sen sydän on helisevä harppu.

Kaikki muuttuu siinä säveliksi, ilon kultasoinnuiksi tai surun
hopeisiksi. Väliin ne soivat ilmi. Ken ymmärtää, hänen
harppunsa virittyy samaan sointuun. Ken ei ymmärrä, kulkee
kuurona ohi.

Ketä Jumala rakastaa, hän ei ole onnellinen eikä onneton.

Suuri Tyytymys vallitsee häntä. Hän on uusi ihminen, joka
entisyytensä unohtaen taivaltaa kohti lupauksen
Kaanaanmaata.
 *** END OF THE PROJECT GUTENBERG EBOOK KUVASTIN ***

Updated editions will replace the previous one—the old editions will
be renamed.

Creating the works from print editions not protected by U.S.

copyright law means that no one owns a United States copyright in
these works, so the Foundation (and you!) can copy and distribute it
in the United States without permission and without paying copyright
royalties. Special rules, set forth in the General Terms of Use part of
this license, apply to copying and distributing Project Gutenberg™
electronic works to protect the PROJECT GUTENBERG™ concept
and trademark. Project Gutenberg is a registered trademark, and
may not be used if you charge for an eBook, except by following the
terms of the trademark license, including paying royalties for use of
the Project Gutenberg trademark. If you do not charge anything for
copies of this eBook, complying with the trademark license is very
easy. You may use this eBook for nearly any purpose such as
creation of derivative works, reports, performances and research.
Project Gutenberg eBooks may be modified and printed and given
away—you may do practically ANYTHING in the United States with
eBooks not protected by U.S. copyright law. Redistribution is subject
to the trademark license, especially commercial redistribution.

START: FULL LICENSE

THE FULL PROJECT GUTENBERG LICENSE
 PLEASE READ THIS BEFORE YOU DISTRIBUTE OR USE THIS WORK

To protect the Project Gutenberg™ mission of promoting the free

distribution of electronic works, by using or distributing this work (or
any other work associated in any way with the phrase “Project
Gutenberg”), you agree to comply with all the terms of the Full
Project Gutenberg™ License available with this file or online at
www.gutenberg.org/license.

Section 1. General Terms of Use and

Redistributing Project Gutenberg™
electronic works
1.A. By reading or using any part of this Project Gutenberg™
electronic work, you indicate that you have read, understand, agree
to and accept all the terms of this license and intellectual property
(trademark/copyright) agreement. If you do not agree to abide by all
the terms of this agreement, you must cease using and return or
destroy all copies of Project Gutenberg™ electronic works in your
possession. If you paid a fee for obtaining a copy of or access to a
Project Gutenberg™ electronic work and you do not agree to be
bound by the terms of this agreement, you may obtain a refund from
the person or entity to whom you paid the fee as set forth in
paragraph 1.E.8.

1.B. “Project Gutenberg” is a registered trademark. It may only be

used on or associated in any way with an electronic work by people
who agree to be bound by the terms of this agreement. There are a
few things that you can do with most Project Gutenberg™ electronic
works even without complying with the full terms of this agreement.
See paragraph 1.C below. There are a lot of things you can do with
Project Gutenberg™ electronic works if you follow the terms of this
agreement and help preserve free future access to Project
Gutenberg™ electronic works. See paragraph 1.E below.
1.C. The Project Gutenberg Literary Archive Foundation (“the
Foundation” or PGLAF), owns a compilation copyright in the
collection of Project Gutenberg™ electronic works. Nearly all the
individual works in the collection are in the public domain in the
United States. If an individual work is unprotected by copyright law in
the United States and you are located in the United States, we do
not claim a right to prevent you from copying, distributing,
performing, displaying or creating derivative works based on the
work as long as all references to Project Gutenberg are removed. Of
course, we hope that you will support the Project Gutenberg™
mission of promoting free access to electronic works by freely
sharing Project Gutenberg™ works in compliance with the terms of
this agreement for keeping the Project Gutenberg™ name
associated with the work. You can easily comply with the terms of
this agreement by keeping this work in the same format with its
attached full Project Gutenberg™ License when you share it without
charge with others.

1.D. The copyright laws of the place where you are located also
govern what you can do with this work. Copyright laws in most
countries are in a constant state of change. If you are outside the
United States, check the laws of your country in addition to the terms
of this agreement before downloading, copying, displaying,
performing, distributing or creating derivative works based on this
work or any other Project Gutenberg™ work. The Foundation makes
no representations concerning the copyright status of any work in
any country other than the United States.

1.E. Unless you have removed all references to Project Gutenberg:

1.E.1. The following sentence, with active links to, or other

immediate access to, the full Project Gutenberg™ License must
appear prominently whenever any copy of a Project Gutenberg™
work (any work on which the phrase “Project Gutenberg” appears, or
with which the phrase “Project Gutenberg” is associated) is
accessed, displayed, performed, viewed, copied or distributed:
 This eBook is for the use of anyone anywhere in the United
States and most other parts of the world at no cost and with
almost no restrictions whatsoever. You may copy it, give it away
or re-use it under the terms of the Project Gutenberg License
included with this eBook or online at www.gutenberg.org. If you
are not located in the United States, you will have to check the
laws of the country where you are located before using this
eBook.

1.E.2. If an individual Project Gutenberg™ electronic work is derived

from texts not protected by U.S. copyright law (does not contain a
notice indicating that it is posted with permission of the copyright
holder), the work can be copied and distributed to anyone in the
United States without paying any fees or charges. If you are
redistributing or providing access to a work with the phrase “Project
Gutenberg” associated with or appearing on the work, you must
comply either with the requirements of paragraphs 1.E.1 through
1.E.7 or obtain permission for the use of the work and the Project
Gutenberg™ trademark as set forth in paragraphs 1.E.8 or 1.E.9.

1.E.3. If an individual Project Gutenberg™ electronic work is posted

with the permission of the copyright holder, your use and distribution
must comply with both paragraphs 1.E.1 through 1.E.7 and any
additional terms imposed by the copyright holder. Additional terms
will be linked to the Project Gutenberg™ License for all works posted
with the permission of the copyright holder found at the beginning of
this work.

1.E.4. Do not unlink or detach or remove the full Project

Gutenberg™ License terms from this work, or any files containing a
part of this work or any other work associated with Project
Gutenberg™.

1.E.5. Do not copy, display, perform, distribute or redistribute this

electronic work, or any part of this electronic work, without
prominently displaying the sentence set forth in paragraph 1.E.1 with
active links or immediate access to the full terms of the Project
Gutenberg™ License.
1.E.6. You may convert to and distribute this work in any binary,
compressed, marked up, nonproprietary or proprietary form,
including any word processing or hypertext form. However, if you
provide access to or distribute copies of a Project Gutenberg™ work
in a format other than “Plain Vanilla ASCII” or other format used in
the official version posted on the official Project Gutenberg™ website
(www.gutenberg.org), you must, at no additional cost, fee or expense
to the user, provide a copy, a means of exporting a copy, or a means
of obtaining a copy upon request, of the work in its original “Plain
Vanilla ASCII” or other form. Any alternate format must include the
full Project Gutenberg™ License as specified in paragraph 1.E.1.

1.E.7. Do not charge a fee for access to, viewing, displaying,

performing, copying or distributing any Project Gutenberg™ works
unless you comply with paragraph 1.E.8 or 1.E.9.

1.E.8. You may charge a reasonable fee for copies of or providing

access to or distributing Project Gutenberg™ electronic works
provided that:

• You pay a royalty fee of 20% of the gross profits you derive from
the use of Project Gutenberg™ works calculated using the
method you already use to calculate your applicable taxes. The
fee is owed to the owner of the Project Gutenberg™ trademark,
but he has agreed to donate royalties under this paragraph to
the Project Gutenberg Literary Archive Foundation. Royalty
payments must be paid within 60 days following each date on
which you prepare (or are legally required to prepare) your
periodic tax returns. Royalty payments should be clearly marked
as such and sent to the Project Gutenberg Literary Archive
Foundation at the address specified in Section 4, “Information
about donations to the Project Gutenberg Literary Archive
Foundation.”

• You provide a full refund of any money paid by a user who

notifies you in writing (or by e-mail) within 30 days of receipt that
s/he does not agree to the terms of the full Project Gutenberg™
 License. You must require such a user to return or destroy all
copies of the works possessed in a physical medium and
discontinue all use of and all access to other copies of Project
Gutenberg™ works.

• You provide, in accordance with paragraph 1.F.3, a full refund of

any money paid for a work or a replacement copy, if a defect in
the electronic work is discovered and reported to you within 90
days of receipt of the work.

• You comply with all other terms of this agreement for free
distribution of Project Gutenberg™ works.

1.E.9. If you wish to charge a fee or distribute a Project Gutenberg™

electronic work or group of works on different terms than are set
forth in this agreement, you must obtain permission in writing from
the Project Gutenberg Literary Archive Foundation, the manager of
the Project Gutenberg™ trademark. Contact the Foundation as set
forth in Section 3 below.

1.F.

1.F.1. Project Gutenberg volunteers and employees expend

considerable effort to identify, do copyright research on, transcribe
and proofread works not protected by U.S. copyright law in creating
the Project Gutenberg™ collection. Despite these efforts, Project
Gutenberg™ electronic works, and the medium on which they may
be stored, may contain “Defects,” such as, but not limited to,
incomplete, inaccurate or corrupt data, transcription errors, a
copyright or other intellectual property infringement, a defective or
damaged disk or other medium, a computer virus, or computer
codes that damage or cannot be read by your equipment.

1.F.2. LIMITED WARRANTY, DISCLAIMER OF DAMAGES - Except

for the “Right of Replacement or Refund” described in paragraph
1.F.3, the Project Gutenberg Literary Archive Foundation, the owner
of the Project Gutenberg™ trademark, and any other party
distributing a Project Gutenberg™ electronic work under this
agreement, disclaim all liability to you for damages, costs and
expenses, including legal fees. YOU AGREE THAT YOU HAVE NO
REMEDIES FOR NEGLIGENCE, STRICT LIABILITY, BREACH OF
WARRANTY OR BREACH OF CONTRACT EXCEPT THOSE
PROVIDED IN PARAGRAPH 1.F.3. YOU AGREE THAT THE
FOUNDATION, THE TRADEMARK OWNER, AND ANY
DISTRIBUTOR UNDER THIS AGREEMENT WILL NOT BE LIABLE
TO YOU FOR ACTUAL, DIRECT, INDIRECT, CONSEQUENTIAL,
PUNITIVE OR INCIDENTAL DAMAGES EVEN IF YOU GIVE
NOTICE OF THE POSSIBILITY OF SUCH DAMAGE.

1.F.3. LIMITED RIGHT OF REPLACEMENT OR REFUND - If you

discover a defect in this electronic work within 90 days of receiving it,
you can receive a refund of the money (if any) you paid for it by
sending a written explanation to the person you received the work
from. If you received the work on a physical medium, you must
return the medium with your written explanation. The person or entity
that provided you with the defective work may elect to provide a
replacement copy in lieu of a refund. If you received the work
electronically, the person or entity providing it to you may choose to
give you a second opportunity to receive the work electronically in
lieu of a refund. If the second copy is also defective, you may
demand a refund in writing without further opportunities to fix the
problem.

1.F.4. Except for the limited right of replacement or refund set forth in
paragraph 1.F.3, this work is provided to you ‘AS-IS’, WITH NO
OTHER WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR ANY PURPOSE.

1.F.5. Some states do not allow disclaimers of certain implied

warranties or the exclusion or limitation of certain types of damages.
If any disclaimer or limitation set forth in this agreement violates the
law of the state applicable to this agreement, the agreement shall be
interpreted to make the maximum disclaimer or limitation permitted
by the applicable state law. The invalidity or unenforceability of any
provision of this agreement shall not void the remaining provisions.

1.F.6. INDEMNITY - You agree to indemnify and hold the

Foundation, the trademark owner, any agent or employee of the
Foundation, anyone providing copies of Project Gutenberg™
electronic works in accordance with this agreement, and any
volunteers associated with the production, promotion and distribution
of Project Gutenberg™ electronic works, harmless from all liability,
costs and expenses, including legal fees, that arise directly or
indirectly from any of the following which you do or cause to occur:
(a) distribution of this or any Project Gutenberg™ work, (b)
alteration, modification, or additions or deletions to any Project
Gutenberg™ work, and (c) any Defect you cause.

Section 2. Information about the Mission of

Project Gutenberg™
Project Gutenberg™ is synonymous with the free distribution of
electronic works in formats readable by the widest variety of
computers including obsolete, old, middle-aged and new computers.
It exists because of the efforts of hundreds of volunteers and
donations from people in all walks of life.

Volunteers and financial support to provide volunteers with the

assistance they need are critical to reaching Project Gutenberg™’s
goals and ensuring that the Project Gutenberg™ collection will
remain freely available for generations to come. In 2001, the Project
Gutenberg Literary Archive Foundation was created to provide a
secure and permanent future for Project Gutenberg™ and future
generations. To learn more about the Project Gutenberg Literary
Archive Foundation and how your efforts and donations can help,
see Sections 3 and 4 and the Foundation information page at
www.gutenberg.org.
 Section 3. Information about the Project
Gutenberg Literary Archive Foundation
The Project Gutenberg Literary Archive Foundation is a non-profit
501(c)(3) educational corporation organized under the laws of the
state of Mississippi and granted tax exempt status by the Internal
Revenue Service. The Foundation’s EIN or federal tax identification
number is 64-6221541. Contributions to the Project Gutenberg
Literary Archive Foundation are tax deductible to the full extent
permitted by U.S. federal laws and your state’s laws.

The Foundation’s business office is located at 809 North 1500 West,

Salt Lake City, UT 84116, (801) 596-1887. Email contact links and up
to date contact information can be found at the Foundation’s website
and official page at www.gutenberg.org/contact

Section 4. Information about Donations to

the Project Gutenberg Literary Archive
Foundation
Project Gutenberg™ depends upon and cannot survive without
widespread public support and donations to carry out its mission of
increasing the number of public domain and licensed works that can
be freely distributed in machine-readable form accessible by the
widest array of equipment including outdated equipment. Many small
donations ($1 to $5,000) are particularly important to maintaining tax
exempt status with the IRS.

The Foundation is committed to complying with the laws regulating

charities and charitable donations in all 50 states of the United
States. Compliance requirements are not uniform and it takes a
considerable effort, much paperwork and many fees to meet and
keep up with these requirements. We do not solicit donations in
locations where we have not received written confirmation of
compliance. To SEND DONATIONS or determine the status of
compliance for any particular state visit www.gutenberg.org/donate.

While we cannot and do not solicit contributions from states where

we have not met the solicitation requirements, we know of no
prohibition against accepting unsolicited donations from donors in
such states who approach us with offers to donate.

International donations are gratefully accepted, but we cannot make

any statements concerning tax treatment of donations received from
outside the United States. U.S. laws alone swamp our small staff.

Please check the Project Gutenberg web pages for current donation
methods and addresses. Donations are accepted in a number of
other ways including checks, online payments and credit card
donations. To donate, please visit: www.gutenberg.org/donate.

Section 5. General Information About Project

Gutenberg™ electronic works
Professor Michael S. Hart was the originator of the Project
Gutenberg™ concept of a library of electronic works that could be
freely shared with anyone. For forty years, he produced and
distributed Project Gutenberg™ eBooks with only a loose network of
volunteer support.

Project Gutenberg™ eBooks are often created from several printed

editions, all of which are confirmed as not protected by copyright in
the U.S. unless a copyright notice is included. Thus, we do not
necessarily keep eBooks in compliance with any particular paper
edition.

Most people start at our website which has the main PG search
facility: www.gutenberg.org.

This website includes information about Project Gutenberg™,

including how to make donations to the Project Gutenberg Literary
Archive Foundation, how to help produce our new eBooks, and how
to subscribe to our email newsletter to hear about new eBooks.