ISO 9001:2015 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.
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 |
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 organization’s products/ 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 |
---|---|
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 products and services provided, understanding of the requirements, application within 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 balance, 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 |
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 |
---|---|
Executive Board | Good financial performance, legal compliance/avoidance of fines, sustainable, corporate and social responsible with a suitable governance framework |
Local residents | Local employment, good reputable employer |
Law enforcers/ Regulators | 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 investigations and enquiries |
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 |
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 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)
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 4.4.1d, 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 IS promote 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.
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.
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