Module 2:

QMS Requirements
 Clause 4
Context of the Organization
 The Organization and its Context
Organization’s context often refers to:

• Business environment
• Organizational environment
• Ecosystem

…relative to its products, services, investments and

behavior towards its interested parties
 The Organization and its Context
External and internal issues relevant to the
organization’s purpose and strategic direction
affect its ability to achieve the QMS’ intended
results

What to do?
Determine, monitor and
review information on
these external and internal
issues (per ISO 9000:2015)
 The Organization and its Context
Relevant interested parties provide significant risk
to organizational sustainability if their needs and
expectations are not met

What to do?
Determine, monitor and
review information on these
relevant interested parties and
their relevant requirements
(per ISO 9000:2015)
 The Organization and its Context
The QMS scope defines the boundaries and
applicability in the context of the organization,
requirements of relevant interested parties and its
products and services.

What to do?
Determine the QMS scope and
provide justification (if any) if specific
requirement of the ISO 9001
standards is not applicable. Maintain
and ensure availability of
documented information on these.
(per ISO 9000:2015)
 Interested Party
• Determine relevant interested parties, their
requirements, and the relevance of these requirements
to the QMS
• Monitor and review information

Stakeholder - person or
organization that can affect, be
affected by, or perceive itself to be
affected by a decision or activity
(ISO 9000:2015)
 4.1 Understanding the Organization and its context

Note 1: Issues can include positive and negative factors or

conditions for consideration

Note 2: Understanding the external context can be

facilitated by considering issues arising from legal,
technological, competitive, market, cultural, social and
economic environments, whether international, national,
regional or local

Note 3:Understanding the internal context can be facilitated

by considering issues related to values, culture, knowledge
and performance of the organization.
 4.2 Understanding the Needs and Expectations of Interested Parties

Interested Parties
Citizens The Organization Competitors
Customers Media
Top Management
Shareholders Commentators

Distributors Those accountable for QMS policy

Trade Groups
and its implementation
Investors Neighbors

Owners Those who implement and Pressure Groups

maintain the QMS
Insurers Emergency Services
Those who maintain QMS and risk
Government procedures Other Response
Agencies

Regulators Transport
Other staff Contractors
Recovery Service Dependents of
Suppliers Staff
 Scope of the QMS

• Consider issues, requirements of interested

parties, and products and services
• Maintain as documented information
• Type of products and services covered
• Justification for any ISO 9001:2015 requirement
that is claimed to be “not applicable” to the
organization
Scope – boundaries and applicability
 QMS and its Processes
• processes needed for the QMS and their application
• Required inputs and expected outputs
• Sequence and interaction of these processes
• Apply criteria and methods to ensure effective operation and control
of these processes
• Resources needed for these processes and ensure availability of these
resources
• Assign responsibilities and authorities for these processes
• Address determined risks and opportunities
• Evaluate these processes and implement any change needed to
ensure achievement of intended results
• Improve the processes and the quality management system
 QMS and its Processes
• Maintain documented information to support the
operation of its processes
• Retain documented information to have confidence
that the processes are being carried out as planned

Example Example

Retain: Maintain:
• Files • Manuals
• Reports • Process flowcharts
• Filled-out checklists and • Instructions
forms • Internal issuances
• Blank forms
 Clause 5
Leadership
Leadership and Commitment

a) Taking accountability for the effectiveness of the QMS

b) Ensuring compatibility of the established Quality Policy
and Quality Objectives with the Organization's context
and strategic direction
c) Ensuring integration of the QMS with organizational
processes
d) Promoting the use of process approach and risk-based
thinking
Clause 5.1 Leadership and Commitment

e) Ensuring availability of resources

f) Communicating the importance of an effective QMS and
conforming to the QMS requirements
g) Ensuring that the QMS achieves its intended results
h) Engaging directing and supporting persons to contribute
to the effectiveness of the QMS
i) Promoting improvement
Clause 5.1 Leadership and Commitment
j) Supporting other relevant management roles to
demonstrate their leadership as it applies to their areas
of responsibility
k) Customer and legal requirements are understood and
consistently met
l) Determining and addressing risks and opportunities
that can affect conformity of products and services and
the ability to enhance customer satisfaction
m) Maintaining focus on enhancing customer satisfaction
Clause 5.1.2 Customer Focus
a) Customer and legal requirements are understood and
consistently met
b) Determining and addressing risks and opportunities
that can affect conformity of products and services and
the ability to enhance customer satisfaction
c) Maintaining focus on enhancing customer satisfaction
Clause 5.2 Policy

1. Establishing the Quality Policy

• appropriate to the Organization

• serves as framework for quality objectives
• Commitment to satisfy to applicable
requirements and;
• to the QMS’ continual improvement
Clause 5.2 Policy

2. Communicating the Quality Policy

• Available and Maintained as documented
information
• Communicated, understood and applied within the
Organization
• made available to relevant interested parties, as
appropriate
Clause 5.3 Organizational Roles, Responsibilities and
authorities
Ensure that responsibilities and authorities for relevant roles
are assigned, communicated and understood within the
organization.
a) To ensure QMS conforms to ISO standard
b) To ensure processes are delivering intended outputs
c) Reporting performance of the QMS and OFIs
d) Promoting customer focus
e) Ensuring integrity of QMS of maintained when changes are planned
and implemented
 Exercise
In your groups, discuss:
• Are there additional responsibilities and
authorities need to be defined in the QMS?
• Give a 1-2 minute report on your discussion.
Clause 6
Planning
 Actions to Address Risks and Opportunities
When planning for the QMS:
• Issues and requirements are considered; and,
• Risks and opportunities are determined and
addressed.

Give assurance that the QMS can achieve its intended results

Enhance desirable effects

Prevent, or reduce, undesired effects

Achieve improvement

6.1.1
Actions to Address Risks and Opportunities

Plan how to:

• Integrate and implement the actions into
QMS processes
• Evaluate effectiveness of these actions

Actions shall be proportionate to the

potential impact on the conformity of
products and services

6.1.2
Actions to Address Risks and Opportunities

• Avoid
Options • Take to pursue an opportunity
to • Eliminate source
• Change likelihood or
address consequences
risks: • Share or retain by informed
decision

6.1.2 NOTE 1
Actions to Address Risks and Opportunities

• Adoption of new practice

• New product
• New market
Opportunities:
• New customer
• Build partnership
• Use of new technology

6.1.2 NOTE 2
 Process: ___________
Risk and Opportunities Impact on conformity
Quality Objectives

• Established at relevant functions, levels and

processes
• Consistent with the quality policy
• S. M. A. R. T.
• Relevant to products and services to enhance
customer satisfaction
• Monitored
• Communicated
• Updated, as appropriate
Clause 5
Quality Objectives
Determine:

1. What will be done

2. Resources
3. Responsibilities
4. Timelines
5. How results will be evaluated
Sample Quality Objectives

39
 Planning of Changes
Consider:

1. Purpose and potential consequence

2. Integrity of the QMS
3. Availability of resources
4. Allocation or reallocation of
responsibilities and authorities

Changes to the QMS shall be carried out in a planned manner