ISO 9001:2015 CLAUSE 4 CONTEXT OF

THE ORGANIZATION
 
 
 
 
 

Definition
As per  ISO 9000, the definition of Context of the Organization is “business environment“,
“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 organization, public service organization and governmental organization. Also
in normal language this concept is also known as 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 organisation and the changes in that context. The
changes in the context can be with respect to its specific objectives, the risks associated
with its context 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 an organization 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 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.

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.

 There are a new clause relating to the context of the

organization,
Clause 4 Context of the organization 
This clauses require the organization to determine the issues and requirements that can
impact on 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 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.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 organization and should be clear in 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

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.Management Review required the monitoring of external and internal issues.
The organization must consider issues related to values, culture knowledge and performance
of the organization for 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
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 the 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 is the internal environment
within which 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)
 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 as anything within the 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 they 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

 Taxation to activities, products,

 Anticipated future legislation services

 International legislation (global

influences)  Seasonality or other weather issues

 Regulatory bodies and processes  Market and trade cycles

 Government policies, terms and

change  Specific sector factors

 Funding, grants, and initiatives  Customer/end-user drivers

 Market lobbying groups  Interest and exchange rates

 International trade and monetary

 Wars and conflicts 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 behaviors  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

 Buying access and trends  Intellectual property issues

 Ethnic/Religious factors  Global communication

 Advertising and publicity  Social media use

Maturity of  organization’s products/

 Ethical issues services

Example of PEST Analysis

Example Porter’s “Five Forces Model.”

Although organizations cannot control macro-environment factors they need to manage
them to their advantage. They also need to protect themselves from PEST factors which
may increase operational costs or affect their reputation. The external context’s micro-
environment consists of the organization’s immediate operations and how they affect 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 micor-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 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.

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 context 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. 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 product 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 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 it 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 is fast paced and leading edge or in a stable or
mature industry. Therefore variability in these issues depicts uncertainty about their
future behaviour. 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 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 adopt to demands?
 Availability of reliable qualified and competent work force — 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
 Overall strength of business to support funding needs -etc
 Relationship with investors . -etc
 Credit terms available .-etc
 Service level agreements with customers -etc
 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 price
 Operating Permits becoming tighter on emission levels — technology demands
 Overall economic performance in the country — above EU norm (positive)
 Competitive environment — overall low-cost of entry in to the market
 Economic plans for future -etc
 The nature and impact of economy on market -etc
 Customer demographic -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 neighbors. -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 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 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 can decide 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.

INTERESTED PARTIES  REQUIREMENTS

Good  financial performance, legal

Executive Board compliance/avoidance of fines

No complaints relating to : noise,

parking, health and safety, pollution,
Local residents waste, employment

Identification of applicable statutory and

regulatory requirements for the products
and services provided, understanding of
the requirements, application within the
Law enforcers/ Regulators QMS, and update/ maintenance of them

Value for money, high quality,

expectations for design innovation,
on time, low-cost, quick response,
installation expertise, health and
Customers safety/EMS

Bank/Finance Good financial performance

Professional development, prompt

payment health and safety, work/ life
Employees balance, employment security

No claims/prompt payment/risk
Insurers management

Prompt payment, health and safety, work

External providers 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

Clause 4.3 Determining the scope of the quality management
system
The organization must establish 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 standards that can be applied by the
organization shall be applied within the scope of the QMS. Requirements from this
International standards 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.
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 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, economical
and environmental), responsible governance, and equal opportunity   are all expected values
within our organization. These are re—enforced 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 certification to 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
 From the Scope of the Standard:
 To demonstrate its ability to consistently provide products and services that
meet customer and applicable regulatory requirements
 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
 Specific to our 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
 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
 External inspections/audits
 Competitors ceases 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 workforce
 Staff retention
 Staff training levels
 External providers competence and availability
 Availability and quality of candidates to fulfill our vacancies
 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
 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 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

Good   financial performance, legal

compliance/avoidance of fines,
sustainable,  corporate and social
responsible with a suitable governance
Executive Board framework

Local employment, good reputable

Local residents employer

Identification of applicable statutory and

regulatory requirements for the products
and services provided, understanding of
the requirements,  application within the
QMS, and update/ maintenance of
them,Legal compliance, prompt responses
to
Law  enforcers/ Regulators investigations and enquiries

Value for money, high quality,

expectations for design innovation,
on time, low-cost, quick response,
Customers installation expertise, legal compliance

Good financial performance  and cash

Bank/Finance flow

Employees Professional development, employment

 INTERESTED PARTIES  REQUIREMENTS

security  and good employee

working relationships

No claims/prompt payment/risk
Insurers management

Clear, unambiguous contracts and scope

External providers of  works, good working relationship

Compliance (applicable laws) and

good working relationships with
Trade Unions management

Products and services of the organization

 Fiber 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 equipments
 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:
 India (Manufacturing)
 Germany (Office)
 Spain (Office)
Applicability:
All clause requirements are applicable to the above scope, except: 8.3 (Design and development
of products and services). This is because the organization does not design its products 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  this standards by determining the process
needed and its application through out 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 effective operation of
these processes.The personnel having authorities and responsibilities for these processes must
be identified. As per clause 6.1, the organization must determine risk and opportunities,
analysis them and must take appropriate action to address them.There must be methods for
monitoring, measuring, as appropriate, and evaluation of these processes. The organization
must make changes in its process if it fails to achieve intended result. The organization must
look opportunities for improve for these process and for 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 primary focus of clause 4.4.1 requirements is to manage 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, complexity of products
and processes, effect on quality,risk of customer dissatisfaction, economic
risk,effectiveness and efficiency, 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 it. 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 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 inputs, outputs and resources used. For
example

 Raw materials as an input to production would have acceptance criteria that it must
meet before it can be used.
 Finished product as an output of the production process must meet acceptance criteria
before it can be shipped to the customer;
 The equipment used to transform raw materials into finished product may have set-up
and capability criteria or parameters that it must meet in order to produce conforming
product.
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
sheet; specifications and drawings; SPC charts; set up checklist; machine manuals; etc.
Note these control methods may apply to any or all of 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; labor 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,
labor, 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 travelers or routers, work instructions, etc. Information for
QMS processes will vary from process to process and may include -production
schedules, bill of materials, product acceptance and process performance criteria,
production traveler 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 has to ensure that adequate responsibilities and
authorities are assigned as per as the requirements given in the clause 5.3.

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 a
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 evaluate of QMS processes as per the requirement 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 process as per as the requirement 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 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.

Example of Quality Manual

Example of quality manual of Shah Promotors & Developers