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 organizations 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 organizations ability to
consistently provide products and services that meet customer and applicable statutory
and regulatory requirements or the organizations 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 organizations discretion whether
or not to accept additional requirements to satisfy interested parties beyond what is
required by this Standard.

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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 organizations
ability to consistently provide products and services that meet customer and applicable
statutory and regulatory requirements or the organizations 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 organizations
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 organizations 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 organizations 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 organizations internal context includes its interested parties, its
approach to governance, its contractual relationships with its customers, and its
capabilities and culture.An organizations 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
Organizations culture
Standards, guidelines, and models adopted by the organization and
Form and extent of the organizations 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 Porters 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

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 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

Ethical issues Maturity of organizations products/ services

Example of PEST Analysis

Example Porters 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 contexts micro-
environment consists of the organizations 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 competitors 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. Governments 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 companys image and public relations. A bad
news video or news report can go viral pretty fast, and if your organization doesnt 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

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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 organizations 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 thats 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 organizations ability to consistently provide
products and services that meet customer and applicable statutory and regulatory
requirements or the organizations 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 organizations 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

Local residents
and safety, pollution, waste, employment
 INTERESTED PARTIES REQUIREMENTS

Identification of applicable statutory and

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

Value for money, high quality, expectations for

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

Bank/Finance Good financial performance

Professional development, prompt payment

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

Insurers No claims/prompt payment/risk 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

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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 organizations
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

Organizations purpose and strategic direction
Purpose:

As one of Indias leading Data Communications manufacturers, installers and on-

site managed service providers of ber 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 ber
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 reenforced through sustainable
ethics and workforce integrity throughout all business operations. Co-operation and
collaboration are expected norms within the organizations 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 ofce 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 ofces opening. To employ a motivated workforce that will
embrace the organizations values, and complement the co-operation and collaboration
needed to achieve the effective application of our processes for continual improvement.

2. Organizations 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
Specic 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 conicts
 Processes for resolving conicts
Social customs
Managements 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
Executive Board fines, sustainable, corporate and social
responsible with a suitable governance
framework

Local residents Local employment, good reputable employer

Identification of applicable statutory and

Law enforcers/ Regulators
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
investigations and enquiries

Value for money, high quality, expectations for

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

Bank/Finance Good financial performance and cash flow

 INTERESTED PARTIES REQUIREMENTS

Professional development, employment

Employees security and good employee
working relationships

Insurers No claims/prompt payment/risk management

Clear, unambiguous contracts and scope

External providers
of works, good working relationship

Compliance (applicable laws) and good working

Trade Unions
relationships with management

Products and services of the organization

Fiber optic cable manufacture multimode

Conguring /layout/plans of cable routes within a client building
Installation of IT cabling on client site (ber optic and copper cabling)
Installation of IT cabinets and connect cabling to active IT equipments
Test connectivity and data performance
On-site conguration 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 ber 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 (Ofce)
Spain (Ofce)

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 ber cable (and installs IT cabinets, and
cabling along routes) according to established/dened standards and industry guidance.
Clause 8.3 is therefore not applicable to our Quality Management System.

End of example

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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

a.
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.