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ISO 13485:2016
Safety and quality are non-negotiables in the medical devices
industry. Regulatory requirements are increasingly stringent
throughout every step of a products life cycle, including service
and delivery. More and more, organizations in the industry are

expected to demonstrate their quality management processes

and ensure best practice in everything they do.
ISO 13485, Medical devices Quality management systems
Requirements for regulatory purposes, is an internationally
agreed standard that sets out the requirements for a quality
management system specific to the medical devices industry. It
has recently been revised, with the new version published in
March 2016.
Why was ISO 13485 revised?
All ISO standards are reviewed every five years to establish if a
revision is required in order to keep it current and relevant for
the marketplace. ISO 13485:2016 is designed to respond to latest
quality management system practices, including changes in
technology and regulatory requirements and expectations. You
will have three years to transition from ISO 13485:2003 and the
associated European Standard EN ISO 13485:2012.
ISO 13485:2016 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 and applicable regulatory requirements.
The processes required by ISO 13485:2016 that are applicable to
the organization, but are not performed by the organization, are
the responsibility of the organization and are accounted for in the
organizations quality management system by monitoring,
maintaining, and controlling the processes.
Some of the key changes to ISO 13485:2016 include:

Alignment of global regulatory requirements

Inclusion of risk management and risk based decision

making throughout the quality management system

Additional requirements and clarity with regard to

validation, verification, and design activities

Strengthening of supplier control processes

Increased focus regarding feedback mechanisms

More explicit requirements for software validation for

different applications

Alignment of global regulatory requirements

Validation using pre-clinical and clinical evaluations

Validation of packaging and distribution requirements

A feedback section, including a new complaint-handling

section and other guidance for customer communications

Additional improvement measures: adding the use of postmarket surveillance, risk-based decisions, and timelines

QSG has your training objectives covered! The following

workshops will be available soon?
1.

Transition to ISO 13485:2016

2.

ISO 13485:2016 Overview

3.

ISO 13485 Lead Auditor Training

4.

ISO 13485:2016 Internal Auditor Training

5.

ISO 14971: Introduction to Risk Management

SO 13485:2016 INTERNAL
AUDITING WORKSHOP
Course Description
ISO 13485 is a Quality Management Standard for Medical Devices.
Many medical device companies are utilizing ISO 13485:2016 as a
platform to build their business management systems because of
its benefits or because it is a necessary step to market their
products and services in certain regions. For many companies,

registration to ISO 13485 is the key to securing and maintaining

global business.
Are you an existing auditor with knowledge of ISO 13485:2003
wishing to update your audit program in line with ISO
13485:2016? This course will refresh your auditing techniques
and help you prepare to audit against the new requirements!
Some of the key changes to ISO 13485:2016 include:

Alignment of global regulatory requirements

Inclusion of risk management and risk based decision

making throughout the quality management system

Additional requirements and clarity with regard to

validation, verification, and design activities

Strengthening of supplier control processes

Increased focus regarding feedback mechanisms

More explicit requirements for software validation for

different applications

Alignment of global regulatory requirements

Validation using pre-clinical and clinical evaluations

Validation of packaging and distribution requirements

A feedback section, including a new complaint-handling

section and other guidance for customer communications

Additional improvement measures: adding the use of postmarket surveillance, risk-based decisions, and timelines

Quality Support Groups ISO 13485:2016 Internal Auditing course

meets the training portion of the requirements for certification of
individual internal auditors. The course begins with an
explanation of ISO 13485:2016 and includes training on the
following:

Making a smooth transition to ISO 13485:2016

The auditing process and audit instruments

The documentation process

How to conduct an audit

How to write an audit report and take corrective action

Who Should Attend

This course is designed for Quality Assurance Managers, ISO
13485:2016 Implementation Team Members, Management
Representatives, and individuals who wish to learn how to
perform an audit to ISO 13485.
Learning Objectives
Upon completion of this course, students will understand each
element of ISO 13485:2016 and the registration process. Using
interactive workshops, simulated audits, and case studies,
participants will develop skills necessary to identify
nonconformance, and prepare, perform, and complete an audit to
ISO 13485:2016.
Course Outline
This session includes a comprehensive review of ISO 13485:2016
and audit systems:

The Challenge for Top Management

Eight Quality Management Principles

The ISO Standard Explained

Family of Standards

Detailed read/review/explanation of ISO 13485:2016

Requirements

Exclusions

Overview of ISO 13485:2016 Requirements: Clause 4

Overview of ISO 13485:2016 Requirements: Clause 5

Overview of ISO 13485:2016 Requirements: Clause 6

Overview of ISO 13485:2016 Requirements: Clause 7

Overview of ISO 13485:2016 Requirements: Clause 8

Students will also learn the steps to develop, implement, and

audit an internal quality system that efficiently and effectively
meets the requirements of ISO 13485:2016, including:

The auditing process and audit instruments

The documentation process

How to conduct an audit

How to write the audit report and take corrective action

Auditing case studies to develop skills for identifying

nonconformance

ISO 13485 Internal Auditing Practice

This session begins with an introduction to ISO 13485:2016 Audit
Trails and training on the following topics:

Documentation for ISO 13485:2016

The audit cycle and ISO 19011

Introduction to Quality Audits

Management of Audit Programs

Students apply their knowledge by preparing, performing, and

completing an audit to ISO 13485:2016. Specific activities
include:

Audit Planning and Preparation

Scope and Objectives

Audit Plan

Performing the Audit

Opening Meeting

Quality Audits

Conducting the Audit

Writing Nonconformity Statements

Writing Nonconformities (using CARs)

Closing Meeting

Summary Statement and Closing Meeting

Completing the Audit Report

Corrective Action and Close Out (using CARs)

Verification and Close Out

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Verification
Verification Verification is a process. It uses objective evidence to confirm that specified
requirements have been met. Whenever specified requirements have been met, a verified
status is achieved. There are many ways to verify that requirements have been met. For
example you could inspect something, you could do tests, you could carry out alternative
calculations, or you could examine documents before you issue them....
Read More

1 commentundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Validation
Validation Validation is a process. It uses objective evidence to confirm that the requirements
which define an intended use or application have been met. Whenever all requirements have
been met, a validated status is established. Validation can be carried out under realistic use
conditions or within a simulated use environment. There are several ways to confirm that the
requirements which define an intended use or application have been met. For example you
could do tests, you could carry out alternative calculations, or you could...
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Traceability
Traceability Traceability is the ability to identify and trace the history, distribution, location,
and application of products, parts, materials, and services. A traceability system records and
follows the trail as products, parts, materials, and services come from suppliers and are
processed and ultimately distributed as final products and services...
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Top management
Top management The term top management normally refers to the people at the top of an
organization. It refers to the people who provide resources and delegate authority and who
coordinate, direct, and control organizations. However, if the scope of a management system
covers only part of an organization, then the term top management refers, instead, to the
people who direct and control that part of the organization...
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

System
System A system is defined as a set of interrelated or interacting elements. A management
system is one type of system. It is a set of interrelated or interacting elements that
organizations use to formulate policies and objectives and to establish the processes that are
needed to ensure that policies are followed and objectives are achieved....
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Supplier
Supplier A supplier is a person or an organization that provides products or services.
Suppliers can be either internal or external to an organization. Internal suppliers provide
products or services to people within their own organization while external suppliers provide
products or services to other organizations. Examples of suppliers include organizations and
people who produce, distribute, or market products, provide services, or publish information.
While ISO still includes a definition for this term, the new ISO 9001 2015 ...
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Strategy
Strategy A strategy is a plan for achieving an objectiv...
Read More

0 commentsundefinedundefined

Integrated Safety Inspection SystemTerm & Definition

Statutory requirement
Statutory requirement A statutory requirement is defined by a legislative body and is
obligatory. &nbs...
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Service
Service A service is an intangible output and is the result of a process that includes at least
one activity that is carried out at the interface between the supplier (provider) and the
customer. Service provision can take many forms. Service can be provided to support an
organizations own products (e.g. warranty service or the serving of meals). Conversely, it can
be provided for a product supplied by a customer (e.g. a repair service or a delivery service). It
can also involve the provision of an intangible thing to a customer...
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Risk-based thinking
Risk-based thinking Risk-based thinking refers to a coordinated set of activities and methods
that organizations use to manage and control the many risks that affect its ability to achieve
objectives. Risk-based thinking replaces what the old standard used to call preventive action.
While risk-based thinking is now an essential part of the new standard, it does not actually
expect you to implement a formal risk management process nor does it expect you to
document your organizations risk-based approach...
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Risk
Risk According to ISO 9000, risk is the effect of uncertainty on an expected result and an
effect is a positive or negative deviation from what is expected. The following two paragraphs
will explain what this means. This definition recognizes that all of us operate in an uncertain
world. Whenever we try to achieve something, theres always the chance that things will not go

according to plan. Sometimes we get positive results and sometimes we get negative results
and occasionally we get both. Because of this, we need to reduce uncertainty...
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Review
Review A review is an activity. Its purpose is to figure out how well the thing being reviewed is
capable of achieving established objectives. Reviews ask the following question: is the
subject (or object) of the review a suitable, adequate, effective, and efficient way of achieving
established objectives? There are many kinds of reviews. Some of these include management
reviews, design and development reviews, customer requirement reviews, nonconformity
reviews, and peer reviews....
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Requirement
Requirement A requirement is a need, expectation, or obligation. It can be stated or implied by
an organization, its customers, or other interested parties. A specified requirement is one that
has been stated (in a document for example), whereas an implied requirement is a need,
expectation, or obligation that is common practice or customary. There are many types of
requirements. Some of these include customer requirements, quality requirements, quality
management requirements, management requirements, product requirements, service...
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Release
Release To release means to grant permission to proceed to the next stage of a process. The
term release is also used to refer to a version of software or documented information...
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Regulatory requirement
Regulatory requirement A regulatory requirement is an obligation that is specified by an
authority which gets its mandate from a legislative body...
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Quality policy
Quality policy A quality policy should express top management's commitment to the quality
management system (QMS) and should allow managers to set quality objectives. It should be
based on ISOs quality management principles and should be compatible with your
organizations other policies and be consistent with its vision and mission. ISO's quality
management principles ask you to focus on customers and interested parties, to provide
leadership, to engage and involve people, to use a process approach, to encourage
improvement, to...
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Quality objective
Quality objective A quality objective is a quality result that you intend to achieve. Quality
objectives are based on or derived from an organizations quality policy and must be
consistent with it. They are usually formulated at all relevant levels within the organization and
for all relevant functions. The adjective quality applies to objects and refers to the degree to
which a set of inherent characteristics fulfills a set of requirements; and an object is any entity
that is either conceivable or perceivable. Therefore, a quality...
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Quality management system

Quality management system A quality management system (QMS) is a set of interrelated or
interacting elements that organizations use to formulate quality policies and quality objectives
and to establish the processes that are needed to ensure that policies are followed and
objectives are achieved. These elements include structures, programs, practices, procedures,

plans, rules, roles, responsibilities, relationships, contracts, agreements, documents, records,

methods, tools, techniques, technologies, and resources. ...
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Quality management
Quality management Quality management includes all the activities that organizations use to
direct, control, and coordinate quality. These activities include formulating a quality policy and
setting quality objectives. They also include quality planning, quality control, quality
assurance, and quality improvement. ...
Read More

0 commentsundefinedundefined
Integrated Safety Inspection SystemTerm & Definition

Quality
Quality The adjective quality applies to objects and refers to the degree to which a set of
inherent characteristics fulfills a set of requirements. An object is any entity that is either
conceivable or perceivable and an inherent characteristic is a feature that exists in an object.
The quality of an object can be determined by comparing a set of inherent characteristics
against a set of requirements. If those characteristics meet all requirements, high or excellent
quality is achieved but if those characteristics do not meet...

Who are interested parties?

Typically these would include:

Shareholders

Owners

Management

Employees

Trade unions

Suppliers

Partners

Client

Government agencies

Media

Society

any other person or organization interested in the organization

Are all interested parties equally interested in the organization?

No. Once you have identified the interested parties the next step you can take is to
analyze these interested parties on two parameters (the standard does not require this
but this might help you in understanding your interested parties better).

Power

Interest

Depending upon these two factors you can choose the appropriate
approach. Stakeholder analysis

is typically used in the project management.

Stakeholder analysis in conflict resolution, project management, and business

administration, is the process of identifying the individuals or groups that are likely to
affect or be affected by a proposed action, and sorting them according to their impact on
the action and the impact the action will have on them. This information is used to assess
how the interests of those stakeholders should be addressed in a project plan, policy,
program, or other action. Stakeholder analysis is a key part of stakeholder management. A
stakeholder analysis of an issue consists of weighing and balancing all of the competing
demands on a firm by each of those who have a claim on it, in order to arrive at the firm's
obligation in a particular case. A stakeholder analysis does not preclude the interests of
the stakeholders overriding the interests of the other stakeholders affected, but it ensures
that all affected will be considered.[1]
Stakeholder analysis is frequently used during the preparation phase of a project to
assess the attitudes of the stakeholders regarding the potential changes. Stakeholder
analysis can be done once or on a regular basis to track changes in stakeholder attitudes
over time.
Contents
[hide]

1Types

2Methods of Stakeholder Mapping

3Benefits

4See also

5References

6Further reading

Types[edit]
Types of stakeholders include:

Primary stakeholders: are those ultimately affected, either positively or negatively

by an organization's actions.

Secondary stakeholders: are the intermediaries, that is, persons or organizations

who are indirectly affected by an organization's actions.

Key stakeholders: who can also belong to the first two groups have significant
influence upon or importance within an organization.

Therefore, stakeholder analysis has the goal of developing cooperation between the
stakeholder and the project team and, ultimately, assuring successful outcomes for the
project

Methods of Stakeholder Mapping[edit]

A stakeholders matrix showing which strategies to use.

The following list identifies some of the best known and most commonly used methods
for stakeholder mapping:

(Mitchell, Agle et al. 1997) proposed a classification of stakeholders based on

power to influence, the legitimacy of each stakeholders relationship with the
organization, and the urgency of the stakeholders claim on the organization. The
results of this classification may assess the fundamental question of "which groups
are stakeholders deserving or requiring managers attention, and which are not?" This
is salience - "the degree to which managers give priority to competing stakeholder
claims" (Mitchell, Agle et al., 1997:854)

(Fletcher, Guthrie et al. 2003) defined a process for mapping stakeholder

expectations based on value hierarchies and Key Performance Areas (KPA),

(Cameron, Crawley et al. 2010) defined a process for ranking stakeholders based
on needs and the relative importance of stakeholders to others in the network.

(Savage, Nix et al. 1991) offer a way to classify stakeholders according to potential
for threat and potential for cooperation.

(Turner, Kristoffer and Thurloway, 2002) have developed a process of identification,

assessment of awareness, support, influence leading to strategies for communication
and assessing stakeholder satisfaction, and who is aware or ignorant and whether
their attitude is supportive or opposing.[citation needed]

Mapping techniques include the following sub-set of results from a Web search of
analysis techniques being used by aid agencies, governments or consultant groups:

Influence-interest grid (Imperial College London)

Power-impact grid (Office of Government Commerce UK 2003)

Mendelow's Power-interest grid (Aubrey L. Mendelow, Kent State University, Ohio

1991)

Three-dimensional grouping of power, interest and attitude (Murray-Webster and

Simon 2005)

The Stakeholder Circle ([2] Bourne 2007)

The first step in building any stakeholder map is to develop a categorised list of the
members of the stakeholder community. Once the list is reasonably complete it is then
possible to assign priorities in some way, and then to translate the highest priority
stakeholders into a table or a picture. The potential list of stakeholders for any project will
always exceed both the time available for analysis and the capability of the mapping tool
to sensibly display the results, the challenge is to focus on the right stakeholders who
are currently important and to use the tool to visualise this critical sub-set of the total
community.
The most common presentation styles use a matrix to represent two dimensions of
interest with frequently a third dimension shown by the colour or size of the symbol
representing the individual stakeholders.
Some of the commonly used dimensions include:

Power (high, medium, low)

Support (positive, neutral, negative)

Influence (high or low)

Need (strong, medium, weak)

Benefits[edit]
Stakeholder analysis helps with the identification of the following:[3]

Stakeholders' interests

Mechanisms to influence other stakeholders

Potential risks

Key people to be informed about the project during the execution phase

Negative stakeholders as well as their adverse effects on the project

Determine the boundaries and applicability of the QMS.

It means explaining what is covered under the system and what is not.
For example some companies may want to not include the design in the scope of
certification.
It was open in the previous version of the standard for the organization to decide on
what to include and what not to include (exclusions in ISO 9001:2008

).

However in this version the scope has to be determined considering the following facts:
a) external and internal issues (see 4.1

b) requirements of relevant interested parties (see 4.2

c) the products and services of the organization

Unlike previously the organization can not exclude any requirement from the quality
management system. They can only exclude a requirement, if that is not applicable and
does not affect the product quality (conformity to requirements and customer
satisfaction).
And yes! the organization would need to document this.

What has changed from ISO 9001:2008

In ISO 9001:2008 the organization could decide to exclude any requirement from their
QMS as long as that requirement was from clause 7 of the standard.
Unlike previously the organization can not exclude any requirement from the quality
management system. They can only exclude a requirement, if that is not applicable and
does not affect the product quality (conformity to requirements and customer
satisfaction).

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ISO 9001 Knowledge base

Home / Knowledge base / QMS Implementation / How to identify the
context of the organization in ISO 9001:2015

How to identify the context of the

organization in ISO 9001:2015
Author: Strahinja Stojanovic
512

Context of the organization is a new requirement in ISO 9001, stating an

organization must consider both the internal and external issues that can
impact its strategic objectives and the planning of the QMS. It pretty much
changes the concept and application of clause 4, and requirements
regarding the context of the organization do sound a little bit vague, so
what does this clause actually require?
Clause 4 of ISO 9001:2015 Context of the organization requires the
organization to evaluate itself and its context. This means that you need to
define influences of various elements on the organization and how they
reflect on the QMS, the companys culture, objectives and goals,
complexity of products, flow of processes and information, size of the
organization, markets, customers, etc. It is also a means to detect risks
and opportunities regarding the business context.

Where to start?
Although the standard doesnt prescribe the method for determining the
context of the organization, there are some logical steps and milestones.
First, you need to determine which of the new requirements are already
met in your existing documentation, because some of the requirements
related to the Quality Manual in ISO 9001:2008 are now transferred into
this new clause (for more information, read The future of the Quality
Manual in ISO 9001:2015).
If you have already implemented ISO 9001:2008, then you probably have
already defined the scope of the QMS in the Quality Manual and the
sequence of processes and their interaction, either in the form of text or
flowchart (see How to create an ISO 9001 process flowchart (PDF). If you
are implementing the standard from scratch, then you need to determine
the scope of your QMS and identify the processes and their interactions
(for more information, read Four things you need to start your ISO 9001
project).
Once the scope of the QMS is defined, together with exclusions (for more
information, see What is an acceptable exclusion in Clause 7 of ISO 9001?,
and processes and their relations are identified, the following steps need
to be taken:

What are internal and external issues?

This requirement of clause 4 can seem too general, and there is a risk of
going too wide when defining the internal and external issues. In fulfilling
this clause, you should focus only on issues that can affect the customer
satisfaction and delivery of quality product and/or service.
An organizations internal context is the environment in which it aims to
achieve its objectives. Internal context can include its approach to
governance, its contractual relationships with customers, and its
interested parties. Things that need to be considered are related to the
culture, beliefs, values, or principles inside the organization, as well as
complexity of processes and organizational structure.
To determine external context, you should consider issues arising from its
social, technological, environmental, ethical, political, legal, and economic
environment. Examples of external context may include:

government regulations and changes in the law

economic shifts in the organizations market

the organizations competition

events that may affect corporate image

changes in technology

Basically, all this information is in the heads of the CEO and other members
of management, but it was never put on paper; the best way to gather it is
by organizing some brainstorming. Systematization of all this information
can be very valuable and demonstrate where you stand as an organization.

Should we care about other peoples opinions?

In simple terms, the requirement for identifying relevant interested parties
means that you need to decide whose opinion about your company you
should care about.
Interested parties include direct customers, end users, suppliers and
partners, regulators, and others. Others could include people in the
organization, owners/shareholders, and even society. These parties add
value to the organization or are impacted by the activities within the
organization. Identifying and meeting their needs is important to
implementing an efficient and effective quality management system. Their
feedback can really help you to determine what can be improved in your
organization, and how.

Lets put it on paper

Once all this information is gathered, it should be documented; the
standard is pretty explicit about it. But where it should be documented?
The first choice is to create a new document, and this document will be
something that the certification body will require instead of a Quality
Manual prior to the audit. The second choice is to include these new
requirements in the existing Quality Manual. This can be very practical,
since the Quality Manual contains some of the old requirements, so youll
only have to add the part with internal and external issues and interested
parties. Another advantage of this approach is that everyone is already
familiar with the Quality Manual, so it wouldnt be some great change in
documentation structure; also, the certification auditors may ask for it out
of habit.

Last, but not least

Regular management review is necessary to monitor the organizations
internal or external issues. Once the internal context is understood,
management can conduct an external analysis using PEST (political,
economic, social, technological) and SWOT (strengths, weaknesses,
opportunities, threats) analyses and really benefit from this new
requirement, instead of just formally fulfilling it.
The context of the organization seems like one of the document and
forget about it requirements, but it shouldnt be. Information gathered
through defining context can be very useful for identifying room for
improvement, and it shouldnt be taken for granted. Knowing the context
of your organization and opinions of your interested parties can help you
improve your organization and make it even better.
For more information on the differences between the 2008 and 2015
revisions of ISO 9001, see this free whitepaper: FDIS ISO 9001:2015 vs. ISO
9001:2008 matrix.

RELATED ARTICLES
The 2015 ISO 9001 Survey & Infographic
List of mandatory documents required by ISO 9001:2015

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