ISO 9001 2015 Clause 4 context of the organization

1. ISO 9001:2015 Clause 4
context of
the organization
preteshbiswas Uncategorized May 10, 2019 25 Minutes
by Pretesh Biswas
Definition
As per ISO 9000, the definition of Context of the Organization is
“business environment“, a “combination of internal and external
factors and conditions that can have an effect on an organization’s
approach to its products, services and investments and interested
Parties“. The note states that this concept of Context of Organization is
equally applicable to Not-for-profit organizations, public service
organizations,s, and governmental organizations. Also in normal
language, this concept is also known as the business
environment, organizational environment, or ecosystem of an
organization.
Introduction
The implementation of QMS should be the strategic decision of the
organization and is influenced by the context of the organization and
the changes in that context. The changes in the context can be with
respect to itsspecific objectives, the risks associated with itscontext and
objectives, the needs and expectations of its customers and other
relevant interested parties, the products and services it provides, the
complexity of processes it employs, and their interactions, the
competence of persons within or working on behalf of the organization
and its size and organizational structure. The context of anorganization
will include internal factors such as organizational culture and external
factors such as the socio-economic conditions under which it operates.
The scope of ISO DIS 9001:2015 states that an organization needs to
demonstrate its ability to consistently provide products and services
that meet customer and applicable statutory and regulatory
requirements and aims to enhance customer satisfaction.

2. Any interested party which is not relevant to the quality management
system need not be considered and similarly, any requirement of the
interested party not relevant to the quality management system need
not be considered. Determining what is relevant or not relevant
is dependent on whether or not it has an impact on the organization’s
ability to consistently provide products and services that meet
customer and applicable statutory and regulatory requirements or
the organization’s aim to enhance customer satisfaction. The
organization can decide to determine additional needs and
expectations that will meet its quality objectives. However, it is at the
organization’s discretion whether or not to accept
additional requirements to satisfy interested parties beyond what is
required by this Standard.
Clause 4 Context of the organization
These clauses require the organization to determine the issues and
requirements that can impact the planning of the quality management
system. Interested parties cannot go beyond the scope of ISO 9001.
There is no requirement to go beyond interested parties that are
relevant to the quality management system. Consider the impact on the
organization’s abilityto consistently provide products and services that
meet customer and applicable statutory and regulatory requirements or
the organization’s aim to enhance customer satisfaction. Organizations
can go beyond the minimum requirements to determine additional
needs and expectations for interested parties that would not be
“relevant” at the discretion of the organization and should be clear in
the quality management system. The “Context of Organization” clause
has four sub-clauses ie
 Clause 4.1 Understanding the Organization and its context
 Clause 4.2 Understanding the needs and expectations of
interested parties
 Clause 4.3 Determining the scope of the quality
management system
 Clause 4.4 Quality management system and its processes
Clause 4.1 Understanding the Organization and its
context

3. The organization should determine external and internal
issues for the organization relevant to its purpose, strategic
planning and which affect the organization’s ability to
achieve its objectives. The Organization should monitor and
review the information about external and internal issues.
The organization must consider issues related to values,
cultural knowledge, and performance of the organization
for the understanding of internal issues. The organization
must consider issues related to arising from legal,
technological, competitive, market, cultural, social, and
economic environments, whether international, national,
regional, or local for the understanding of external context.
For considering internal context as well as external factors
both positive as well as negative factors must be considered.
An organization’s context involves its “operating environment.” The
context must be determined both within the organization and external
to the organization. It is important to understand the unique context of
an organization before starting strategic planning. To establish the
context means to define the external and internal factors that the
organizations must consider when they manage risks. An organization’s
external context includes its outside stakeholders, its local operating
environment, as well as any external factors that influence the selection
of its objectives (goals and targets) or its ability to meet its goals. An
organization’s internal context includes its interested parties, its
approach to governance, its contractual relationships with its
customers, and its capabilities and culture. An organization’s internal
context isthe internal environment withinwhich the organization seeks
to achieve its sustainability goals. The internal context may include,
 Product and service offerings
 Governance, organizational structure, roles, and accountability
 Regulatory requirements
 Policies and goals, and the strategies that are in place to achieve
them,
 Assets (e.g., facilities, property, equipment and technology)
 Capabilities understood in terms of resources and knowledge (e.g.,
capital, time, people, processes, systems, and technologies)
 Information systems, information flows, and decision-making
processes (both formal and informal)

4.  Relationships of the staff/volunteers/members and the perceptions
and values of their internal stakeholders including suppliers and
partners
 Organization’s culture
 Standards, guidelines, and models adopted by the organization and
 Form and extent of the organization’s contractual relationships.
Internal context can also be defined asanything withinthe organization
that may influence the way in which the organization manages its
internal risks. Once the internal context is understood, one can conduct
the macro-environmental external analysis using “PEST” (political,
economic, social, and technological) analysis. This analysis determines
which factors are can influence how the organization operates. The
organization cannot control these factors, but it must seek to adapt to
them. The PEST factors can be classified as opportunities and threats
in a SWOT (strengths, weaknesses, opportunities, and threats) analysis.
Alternatively, some organizations might use Porter’s “Five Forces
Model.” These methods are used to review a strategy or position or
direction of an organization. Completing a pest analysis is simple and
helps the individuals involved in the organization to understand and
find ways to deal with the context.
Political Factors Economic Factors
Ecological/Environmental Issues National economies and trends
Current legislation General taxation issues
Anticipated future legislation Taxation to activities, products, services
International legislation (global influences) Seasonality or other weather issues
Regulatory bodies and processes Market and trade cycles

5. Government policies, terms, and change Specific sector factors
Funding, grants, and initiatives Customer/end-user drivers
Market lobbying groups Interest and exchange rates
Wars and conflicts International trade and monetary issues
Social Factors Technology Factors
Lifestyle trends Competing technology development
Demographics Associated/Dependent technologies
Consumer attitudes and opinions Replacement technology/Solutions
Media views Maturity of Technology
Law changes affecting social behaviours Information and communications
Image of the organization Consumer buying mechanisms
Consumer buying patterns Technology legislation
Fashion and role models Innovation potential
Major events and influences Technology access, licensing, patents

6. Buying access and trends Intellectual property issues
Ethnic/Religious factors Global communication
Advertising and publicity Social media use
Ethical issues Maturity of the organization’s products/ services
Example of PEST Analysis
Example Porter’s “Five Forces Model.”
Although organizations cannot control the macro-environment factors
they need to manage them to their advantage. They also need to protect
themselves from PEST factors that may increase operational costs or
affect their reputation. The external context’s micro-environment
consists of the organization’s immediateoperations and how they affect

7. its performance and decision-making. These factors have a direct
impact on the success of the organization. It is important to have a full
analysis of the micro-environment before moving to strategy
development. Here are some of the micro-environmental context
factors.
 Customers:
Organizations must attract and retain customers by offering
products services that meet their needs along with providing
excellent customer service
 Employees:
There must be the availability of people with the motivation to
remain as contributing members of the organization and develop
the skills necessary to provide a competitive edge
 Suppliers:
Suppliers provide organizations with the resources they need to
carry out their activities. If a supplier provides bad service, this
affects the way the organization operates. Close supplier
relationships are an effective way to remain competitive and secure
the resources needed
 Investors:
All organizations require investment to grow. They may borrow the
money from a bank or have people invest in their work.
Relationships with investors need to be managed carefully as
problems can detrimentally affect the long-term success of the
organization
 Media:
Positive media attention can bring success to the organization by
maintaining its reputational strength. Managing the media
(including the presence in social media) is a challenge.
 Competitors:
 Members of the organization need to have a sense of belonging. Can
the organization offer benefits that are better than those offered by
the competitors? Is there a strong value proposition? Competitor
analysis and monitoring is crucial if an organization is to maintain
or improve its position in the competitive landscape of the
community. The organization must always be aware of its
competitor’s activities. The landscape can change quickly.

8. As in the case of the macro-environmental context, the organization
cannot always control its micro-environment factors. But they must be
carefully managed together and with the internal context
understanding. Both internal and external contexts can have influence
over the organization. Customer pressures and complaints can force
organizations to change various policies such as product returns and
customer and technical support. Technological changes can provide
new and more effective ways to handle communications, operations,
shipping, and logistics. Cultural and religious differences may hinder
product or service entry into certain countries. The government’s
regulatory and trade policies can play a significant role in determining
how businesses operate, especially in regard to international trade,
taxation, and regulations. The media, including social media, can have
a huge impact on a company’s image and public relations. A bad news
video or news report can go viral pretty fast, and if your organization
doesn’t provide an acceptable response, the negative publicity and
effects can last a long time. Sociological forces often drive what, where
and how consumers buy products and services. There is an increasing
trend in the number of consumers purchasing products online and
reading reviews before making a purchase. The multinational and
multicultural trend in workforce composition can cause significant
changes in the hiring and retention of competent human resources. If
the response to these situations is unplanned, weak, or untimely, it
might have a dramatic impact on the future of the business – loss of
customers, serious production interruption or disruption, permanent
loss of organizational knowledge, even loss or bankruptcy of the
business. Contextual issues can have a positive impact, as they may
present opportunities such as new, improved, or increased availability
of previously scarce resources, opening up of or access to new markets,
availability of new technologies leading to reduced costs, improved
product quality, services, and operational efficiency. Many of these
contextual issues can be viewed as variables some changing faster,
others slower, depending on whether the organization isfast-paced and
leading-edge or in a stable or mature industry. Therefore variability in
these issues depicts uncertainty about their future behavior. Such
uncertainty can be quite diverse, complex and at times highly
unpredictable. This presents a dilemma to organizations in terms of
tracking and adapting to changes in these issues. This uncertainty
introduces the need for understanding and use of risk evaluation,
mitigation, and management. Thus each organizational contextual
issue will have its own specific set of uncertainties with different levels

9. of complexity and risk and the need for specific controls to mitigate or
eliminate the risk.
Example internal issues could include, but are not limited to:
 Structure of the organization — limited flexibility when
dealing with varying demands
 Roles within the organization — Rigid, personnel willing to
adapt to demands?
 Availability of reliable qualified and competent
workforce — very good (positive)
 Stability of workforce – Wage benchmarking is not consistent
with competitors
 Staff retention — very high (positive)
 Impact of unionization – Uncordial
 Staff competency levels– high(positive)
 Contractual arrangements with customer-beneficial
 Payment terms from customers-high credit
 Solvency of customers -etc
 Expansion of customer base-etc
 The overall strength of the business to support funding
needs -etc
 Relationship with investors. -etc
 Credit terms available .-etc
 Service level agreements with customers -etc
 The culture within the organization -etc
Example external issues could include, but are not limited to:
 Political, economic, social, technological, legal and
regulatory — Laws changing, affecting product conformity,
minimum wage changing, evolutions in more efficient machinery
affecting the price
 Operating Permits becoming tighter on emission levels —
technology demands
 Overall economic performance in the country — above EU
norm (positive)

10.  Competitive environment — overall low-cost of entry into the
market
 Economic plans for future -etc
 The nature and impact of the economy on the market -etc
 Customer demographics -etc
 General levels of consumer confidence -etc
 Customer expectation -etc
 Standardization and certification within the industry -etc
 Regulation within the industry generally -etc
 Trade associations and lobbying powers -etc
 Impact on neighbours. -etc
Clause 4.2 Understanding the needs and
expectations of interested parties
The organization shall determine relevant interested
parties and relevant requirements of relevant interested
parties. Relevant interested parties to be considered are
those that could affect or potentially affect the
organization’s ability to constantly provide products and
services that meet customer and applicable statutory and
regulatory requirements. Monitor and review information
related to interested parties and relevant requirements.
Firstly, the organization will need to determine external and internal
issues that are relevant to its purpose, i.e. what are the relevant issues,
both inside and out, that have an impact on what the organization does,
that would affect its ability to achieve the intended outcome(s) of its
management system. It should be noted that the term ‘issue’ covers not
only problems, which would have been the subject of the preventive
action in previous standards, but also important topics for the
management system to address, such as any market assurance and
governance goals that the organization might set for its management
system. Next, the organization has to determine relevant interested
parties and relevant requirements of relevant interested parties.
An interested party is a person or organization that can affect, be
affected by, or perceive themselves to be affected by a decision or
activity that’s within the scope of the management system. There will

11. be those external interested parties that impose specific legal,
regulatory, or contractual requirements in an organization. There may
also be requirements specified by internal interested parties, for
example, management and staff (permanent and temporary). 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
There is no requirement in this International Standard for the
organization to consider interested parties which have been
determined by the organization not to be relevant to its quality
management system. Similarly, there is no requirement to address a
particular requirement of a relevant interested party if the organization
considers that the requirement is not relevant. Determining what is
relevant or not relevant is dependent on whether or not it has an impact
on the organization’s ability to consistently provide products and
services that meet customer and applicable statutory and regulatory
requirements or the organization’s aim to enhance customer
satisfaction. The organization candecide to determine additional needs
and expectations that will assist it to meet its quality objectives.
However, it is at the organization’s discretion whether or not to accept
additional requirements to satisfy interested parties beyond what is
required by this International Standard.

12. Interested parties Requirements
Executive Board Good financial performance, legal compliance/ avoidance of fines
Local residents
No complaints relating to noise, parking, health and safety, pollution,
waste, employment
Law enforcers/
Regulators
Identification of applicable statutory and regulatory requirements for the produ
and services provided, understanding of the requirements, the application with
the QMS, and update/ maintenance of them
Customers
Value for money, high quality, expectations for design innovation, on time, low
cost, quick response, installation expertise, health and
safety/EMS
Bank/Finance Good financial performance
Employees
Professional development, prompt payment health, and safety, work/ life balan
employment security
Insurers No claims/prompt payment/risk management
External providers Prompt payment, health, and safety, work relationship
Trade Unions Compliance (employment law)
One tool which can be used for determining the relevant requirement
of relevant interested parties is Stakeholder analysis
Example of Stakeholder analysis

13. Clause 4.3 Determining the scope of the quality
management system
The organization must establish the scope of the quality
management system by determining the boundaries and
applicability of the quality management system. While
determining the scope the organization must consider the
internal and external issues determined in 4.1., the
requirements of relevant interested parties in 4.2. and the
products and services of the organization. Requirements
from this International standard that can be applied by the
organization shall be applied within the scope of the QMS.
Requirements from this International standard that cannot
be applied by the organization and which does not affect the
organization’s ability or responsibility to provide product
and services that meet the conformity of its product and
services and enhancement of the customer satisfaction. The
organization must make available the scope and must
maintain scope as documented information stating the
Products and services covered by the QMS and any
Justification where a requirement of this International
Standard cannot be applied.
Determining the scope of the Quality Management System (QMS) has
been a part of the ISO 9001 requirements for a long time. This scope is
a vital part of the QMS, as it defines how far the QMS extends within
the company’s operations and details any exclusion from the ISO 9001
requirements and the justificationfor these. It is through the scope that
you define what your Quality Management System covers within your
organization. With the release of the new update to the ISO 9001
requirements, ISO 9001:2015, there is some additional clarification on
defining the scope of the QMS. These clarifications will help to
standardize how companies define the scope of their QMS, even if they
choose not to have a quality manual, which is no longer a stated
requirement in the standard. Section 4.3 of the standard details the
requirements for determining the scope of the Quality Management
System. In a note about the QMS, it is stated that the QMS can include
the whole organization, specifically identified functions of the
organization, specifically identified sections of the organization, or one
or more functions across a group of organizations. To start, there are
three considerations to be included when determining the scope:

14. 1. External and internal issues that are relevant to the purpose of the
organization, the strategic direction, and the ability to achieve
intended results
2. Requirements of relevant interested parties
3. The product and service of the organization
In addition, the scope is to include any requirements of the ISO 9001
standard that can be applied, and if a requirement is determined to not
apply, the organization will not use this as a reason for not ensuring
conformity of product and service. The scope is to state the products
and services covered by the QMS, and justification for any instances
where the ISO 9001 standard cannot be applied. It is most common that
the scope of the QMS covers the entire organization. Some noted
exceptions are when your QMS only covers one physical location of a
multi-location company, or when your manufacturing or service is
distinctly split between industries (e.g., in a plant with three assembly
lines where assembly lines 1 and 2 are for automotive and need to have
a QMS certified to the ISO/TS 16949 QMS standard for automotive, but
you want line 3 to be certified toISO 9001 since many of the automotive
requirements do not apply). So, your scope should identify the physical
locations of the QMS, products or services that are created within the
QMS processes, and the industries that are applicable if this is relevant.
It should be clear enough to identify what your business does, and ifnot
all parts of the business are applicable, it should be easily identified
which parts are. Some examples could be:
1. XYZ Manufacturing located in London, England, producing
machined components in the aerospace and automotive industry
within Europe.
2. XYZ Consultants located in offices in Europe, Asia, and North
American provide Information Technology Support to companies
in any industry.
3. XYZ Computing provides software development services to
companies in the automotive and heavy machinery industries
within North and South America.
4. XYZ Industries is a division of XYZ International that operates in
Indonesia and provides paper products to the Asian market.
Your scope does not have a size limit and should include enough
information to determine what is covered by the processes of the QMS.
However, it is important to make it clear what is included and what is

15. not. If it is not clear to you what processes in your company are covered
by your QMS, then how will it be clear to an outside auditor or other
interested parties? Making your scope statement simple and easy to
read can help to focus your QMS efforts and prevent unnecessary
questions about activities that you may perform that may not be
applicable to your QMS certification.
The scope of ISO 9001 is given in clause 1 Scope and defines the scope
of the standard itself. This should not be confused with the scope of the
QMS, which is a term commonly used to describe the organization’s
processes, products (and /or services), and related sites, departments,
divisions, etc., to which the organization applies a formal QMS. (Note,
this does not necessarily include all the processes, products, sites,
departments, or divisions, etc. of the organization). The scope of the
QMS should be based on the nature of the organization’s products and
their realization processes, the result of risk assessment, commercial
considerations, and contractual, statutory, and regulatory
requirements. While ISO 9001 is generic and is applicable to all
organizations (regardless of their type, size, or product category), under
certain circumstances, an organization may exclude complying with
some specific ISO 9001 requirements, while being permitted to claim
conformity to the standard. This is because it has been recognized that
not all the requirements in this clause of the standard are relevant to all
organizations. ISO 9001 itself makes allowance for such situations.
Consequently, the scope of registration/certification encompasses the
scope of the QMS, as well as describing any excluded ISO 9001
requirements. As the terms scope of the QMS and scope of
registration/certification are often used interchangeably, this can lead
to confusion when a customer or end-user is trying to identify what
parts of an organization have been registered/certified to ISO 9001,
what product lines or processes are covered by the QMS, or what ISO
9001 requirements have been excluded. In order to dissipate such
confusion and to enable identification of what has been
registered/certified, the scope of registration/certification should
clearly define:
1. the scope of the QMS (including details of the product lines and
related sites, departments, divisions, etc. that are covered by it).
2. the organization’s main processes for its product realization or
service delivery activities (such as design, manufacture, and
delivery), for the product lines that are covered,

16. 3. any ISO 9001 requirement that has been excluded
(It should be noted that the scope of registration/certificationis not
the same as the certificate that is awarded to the organization after
successful demonstration of conformity to ISO 9001. The certificate
will usually include a synthesized description of the scope of
registration/certification, but not the details of the ISO 9001
requirements that have been excluded; however, it may include a
note to refer to the fact that the exclusions are detailed in the
organization’s Quality Manual.)
It is essential that a scope of registration/certification be drafted by the
organization prior to applying for registration/certification. This
should then be analyzed by the CRB during the Stage 1 audit, for
appropriate planning of the Stage 2 audit. It is the responsibility of the
auditor:
1. to ensure that the final statement of the scope of registration/
certification is not misleading;
2. to verify that this scope only refers to the processes, products, sites,
departments, or divisions, etc. of the organization that were
assessed during the registration/ certification audit; and
3. to verify that this scope defines any excluded requirements from
ISO 9001 and that justification for such exclusions is provided and
is reasonable.
As an additional measure to combat potential confusion among
customers and end-users, the scope of registration/certificationshould
be clearly defined in the organization’s Quality Manual and any publicly
available documents (this includes, for example, promotional and
marketing material). However, promotional statements should never
be included in the scope of registration/ certification.
An example of how a scope could be derived
Organization’s purpose and strategic direction
Purpose:
“As one of India’s leading Data Communications manufacturers,
installers and on-site managed service providers of fiber optic cabling
(for Information Technology connectivity): as well as installer and
on-site managed service provider of copper cabling and IT

17. cabinets; our reason for ‘being’ is a combination of our vision, mission,
and values.“
What is our vision?
“To become the most trusted manufacturer, installer, and
service provider of fiber optic/copper cabling (IT cabling) and IT
cabinets within India and Europe.“
What is our mission?
“To expand our operations by Consistently meeting
customers’ expectations, and our legal requirements, which includes
the enhancement of customer satisfaction through the effective
application of our processes for continual improvement.“
What are our values?
“Sustainable business practices including corporate social
responsibility ( social, economic, and environmental), responsible
governance, and equal opportunity are all expected values within our
organization. These are reinforced through sustainable ethics and
workforce integrity throughout all business operations. Co-operation
and collaboration are expected norms within the organization’s
management, with recognition provided for all through regular
appraisals. We encourage and embrace any values which enforce the
behaviors that employees cherish.“
Strategic Direction:
“To open two new offices in India, and one new office in Germany, and
Spain this year. To implement and gain accredited certificationto ISO
9001 and ISO 14001 in these new offices, within a year of the offices
opening. To employ a motivated workforce that will embrace
the organization’s values, and complement the co-operation and
collaboration needed to achieve the effective application of our
processes for continual improvement.“
2. Organization’s intended result(s) of its QMS
1.From the Scope of the Standard:
1. To demonstrate its ability to consistently provide products and
services that meet customer and applicable regulatory requirements

18. 2. To enhance customer satisfaction through the:
 Effective application of the QMS
 Processes for continual improvement of the QMS
 Assurance of conformity to customer and applicable statutory
and regulatory requirements
2. Specific to the organization:
 Reduction in waste, during manufacturing, through reduced
rejects, effective corrective action and improvements in process
understanding and compliance
 To assist in the creation of an effective knowledge database for the
consistent provision of product and service, and for business
continuity purposes
External issues
 Contractual arrangements – generally within the sector
 Competitive environment – overall low cost of entry into the
market
 Legislation, e.g. employment of non-nationals
 Regulation within the industry generally
 Overall competition within the recruitment sector
 The overall economic climate in the country
 Countries environmental requirements affecting products and
service
 Technology advances
 Standardization and certification within the industry
 Client consideration of bringing expertise in-house
 Client working environment other trades working alongside us,
 Client configuration changes during installation
 Relationships with external interested parties
 Perceptions/values of external interested parties
 Key drivers and trends
 Workforce culture within the sector and country
 Construction delays

19.  External inspections/audits
 Competitors cease trading
 Availability of raw materials
 Power cuts in countries
 Availability of external providers – machinery maintenance, etc.
Internal issues
 Structure of the organization
 Roles within the organization
 Availability of reliable, qualified and competent workforce
 Stability of the workforce
 Staff retention
 Staff training levels
 External providers competence and availability
 Availability and quality of candidates to fulfil our vacancies
 The culture within the organization
 Working hours
 Staff morale
 Internal politics
 Governance, Policies, objectives
 Strategies
 Capabilities
 Resources
 Knowledge
 General competence
 Technologies
 Information systems
 Decision-making processes
 Relationships with interested parties
 Perceptions/values of interested parties
 Standards, guidelines, and models adopted
 Contractual relationships

20.  Potential conflicts
 Processes for resolving conflicts
 Social customs
 Management’s abilities
 Priorities
 Database skills
 Root cause analysis abilities
 Improvement tools and abilities to apply
 Ability to motivate the workforce
 Project management expertise – new offices
 Understanding and experience in implementing ISO 9001
 Co-operation of workforce
Interested parties and relevant requirements
INTERESTED
PARTIES
REQUIREMENTS
Executive Board
Good financial performance, legal compliance/ avoidance of
fines, sustainable, corporate and social responsibility with a suitable governa
framework
Local residents Local employment, a good reputable employer
Law enforcers/
Regulators
Identification of applicable statutory and regulatory requirements for the prod
and services provided, understanding of the requirements, the application with
the QMS, and update/ maintenance of them, Legal compliance, prompt respon
to investigations and inquiries
Customers
Value for money, high quality, expectations for design innovation, on time, low
cost, quick response, installation expertise, legal compliance
Bank/Finance Good financial performance and cash flow

21. INTERESTED
PARTIES
REQUIREMENTS
Employees
Professional development, employment security, and good employee working
relationships
Insurers No claims/prompt payment/risk management
External
providers
Clear, unambiguous contracts and scope of works, good working relationship
Trade Unions Compliance (applicable laws) and good working relationships with manageme
Products and services of the organization
 Fibre optic cable manufacture – multimode
 Configuring /layout/plans of cable routes within a client building
 Installation of IT cabling on client site (fiber optic and copper
cabling)
 Installation of IT cabinets and connect cabling to active IT
equipment
 Test connectivity and data performance
 On-site configuration management – moves, and changes
 On-site network incident management
 Provision/management of on-site IT human resource
 IT client disaster recovery service and help desk
Determined scope
The production, installation, and on-site managed service of fiber
optic cabling (for Information Technology connectivity), and the
installation and on-site managed service of copper cabling and IT
cabinets, at client sites in India, Germany, and Spain.
Manufacturing sites/Offices:

22.  India (Manufacturing)
 Germany (Office)
 Spain (Office)
Applicability:
All clause requirements are applicable to the above scope, except for
8.3 (Design and development of products and services). This is
because the organization does not design itsproducts and services, but
produces fiber cable (and installs IT cabinets, and cabling along
routes) according to established/defined standards and industry
guidance. Clause 8.3 is therefore not applicable to our Quality
Management System.
—————————End of example—————————————
Clause 4.4 Quality management system and its
processes
Clause 4.4.1
The organization must establish, implement, maintain and
continually improve its quality management system as per
the requirement of these standards by determining the
process needed and its application throughout the
organization. While determining the processes, the
organization must determine the inputs required and the
outputs expected from these processes, the sequence, and
interaction of these processes, The organization must
control these processes to ensure its effective operation. The
organization must establish the criteria and methods which
include monitoring, measurements, and other related
performance indicators to ensure the effective operation
and control of these processes. The organization must
determine and ensure the availability of the resources
needed for the effective operation of these processes. The
personnel having authority and responsibilities for these
processes must be identified. As per clause 6.1, the
organization must determine risks and opportunities,
analyze them, and must take appropriate action to address
them. There must be methods for monitoring, measuring, as

23. appropriate, and evaluating these processes. The
organization must make changes in its process if it fails to
achieve the intended result. The organization must look for
opportunities for improvement for these processes and for
the Quality management system as a whole.
Clause 4.4.2
The organization shall maintain documented information
to the extent necessary to support the operation of processes
and retain documented information to the extent necessary
to have confidence that the processes are being carried out
as planned.
The primaryfocus of clause 4.4.1 requirements is tomanage and control
all your QMS processes including processes for operations.
QMS includes processes for management(leadership) activities,
Planning which includes risk assessment, support processes (such
provision of resources, communication, etc), Operation, performance
evaluation, and Improvement as part of QMS. Clause 4.4.1 requires the
‘Process Approach’ to be used in defining your QMS. Documentation of
QMS processes and the need for and detail of specific process
documentation is determined by ISO 9001, customer, regulatory and
your own organizational requirements, the complexity of products and
processes, effect on quality, the risk of customer dissatisfaction,
economic risk, effectiveness and efficiency, the competence of
personnel. Clause 4.4.2 requires you to have documents needed to
ensure the effective planning, operation, and control for QMS
processes. Based on these factors, you must determine what processes
need to be documented and how you will document them. Not all
processes need to be documented; your documents must also include a
description of the interaction between your QMS processes. A number
of different methods can be used to document processes, such as
graphical representations, written instructions, checklists, flow charts,
visual media, or electronic methods, etc. Process flowcharts or block
diagrams can show how policies, objectives, influential factors, job
functions, activities, material, equipment, resources, information,
people and decision making interact and/or interrelate in a logical
order. Procedures may be an acceptable way to document processes
provided they describe inputs and outputs, appropriate
responsibilities, controls, and resources needed to satisfy customer
requirements. Regardless of whether or not you document all of your

24. processes, you must provide evidence of effective implementation of all
your QMS processes. Such evidence does not necessarily need to be
documented.
Clause 4.4 c requires you to determine criteria for effective process
operation and control. You could determine criteria to control the
inputs, outputs, and resources used. For example, Raw materials as an
input to production would have acceptance criteria that they must meet
before they can be used.
These criteria (controls) must be established for each QMS process.
Note that such controls may also come from the customer, regulatory,
or industry bodies. Equally important are the specific methods required
for effective operation and control of each process. These may include
job travelers; work instructions; in-process inspection sheets;
specifications and drawings; SPC charts; set up checklists; machine
manuals; etc. Note these control methods may apply to any or all
inputs, outputs, or conversion activities.
This clause also requires you to monitor and measure your QMS
processes. Clause 9.1 provides requirements to plan and implement
these controls for monitoring and measuring conformity to process
performance criteria determined above. Ways to monitor and measure
QMS processes may include – tracking against process parameters,
goals and objectives, using tools and records such as process check-
sheets; product acceptance criteria; SPC records; production records;
maintenance records; labour records, etc. More details on monitoring
and measuring controls are covered in clause 9.1.
Under 4.4.1d, resources for QMS processes may include facility,
material, equipment, labour, supplies, utilities, etc. Every QMS process
will require a different combination of resources. Resource details may
be identified in specifications, production schedules, bill of materials,
production travellers or routers, work instructions, etc. Information for
QMS processes will vary from process to process and may include -
production schedules, bill of materials, product acceptanceand process
performance criteria, production traveller or router, work instructions,
etc. Use clause 7.5 and other relevant clauses to control process
information.
Under 4.4.1 e the organization shall have to ensure that adequate
responsibilities and authorities are assigned as per as the
requirements given in the clause 5.3.

25. This promotes the use of risk-based thinking. Risk is defined as the
“effect of uncertainty.” Notes in the definition further describe risk as a
“deviation from the expected,” either positive or negative. The term
“uncertainty” is defined as a lack of information or knowledge about a
potential event that can be expressed as a result of the likelihood and
consequence of such an event. A positive deviation arising from risk
can provide an opportunity, but not all positive effects of risk result in
opportunities. Actions to address opportunities can also include
consideration of associated risks. Clause 4.4.1 f requires that when
planning its QMS, the top management must implement and promote
a culture of risk-based thinking throughout the organization to
determine and address the risks and opportunities associated with
providing assurance that the QMS can achieve its intended result(s);
provide conforming products and services, enhance customer
satisfaction; promote desirable effects and improvement; and prevent,
or mitigate, undesired effects.
Clause 4.4.1 g requires to evaluate of QMS processes as per the
requirement is given in clause 9.1.3 and evaluation may be done
through a review of measurement and monitoring records and
performance indicators for each process. These reviews must identify
opportunities to improve QMS processes, use of resources and product
quality. Clause 4.4.1 h calls for improvement in the process as per the
requirement is given in clause 10. When process nonconformities
occur, then corrective action is required to bring the QMS process
under control. Remember, the corrective action process is not just for
product related nonconformities. Processes must be continually
improved through the setting of incrementally realistic, measurable
objectives. Planning for continual improvement requires a review of
process data, resources and controls to bring about the desired change.
Clause 4.4.1a – 4.4.1h must be applied to all QMS processes. Note also
that many ISO 9001 clauses (e.g. clause 8.2; 8.4; 8.6; etc.), require
specific processes to be established within your QMS, These processes
must also be identified and controlled in your QMS.