Major Clauses of ISO 9001:2015

4 5 6 7 8 9 10
Context of the Leadership Planning Support Operation Performance Improvement
Organization Evaluation

Actions to Resources Operation planning & Monitoring, General

Understanding Leadership &
the Organization address risks (7.1) control (8.1) measuremen t (10.1)
Commitment and & evaluation
and its context ( 5.1) opportunities Requirements for (9.1)
(4.1)
(6.1) Competence products & services
Polic y (5.2) 7.2) (8.2)
Internal Non
Understanding
Quality conformity &
the needs and Design & development Audit(9.2)
Objectives Awarenes s corrective
expectations of Organization of products and
and planning (7.3) action (10.2)
interested al roles, services(8.3)
to achieve Management
parties (4.2) responsibilitie them (6.2) Review (9.3) Continual
s and Control of externally
Communica- Improvement
Determining the authority provided processes,
tion (7.4) (10.2)
scope of the (5.3) products & services
Planning of
QMS (4.3) (8.4)
changes (6.3)
Documented
Information Production & service provision (8.5)
QMS and its (7.5)
processes (4.4)
Release of Products & services (8.6)

Control of non conforming outputs (8.6)

Clause 4: Context of the Organization
4.1 Understanding the organization and its context
The organization shall determine external and internal issues relevant to the organization’s
purpose and strategic direction affecting its ability to achieve the QMS’ intended results.

What needs to be done:

Where to start:
Clause 4: Context of the Organization
4.2 Understanding the needs and expectations of interested
parties
Identify, monitor and review
information on relevant interested parties
and relevant their requirements

Interested Parties
The Organization

Citizens Competitors
Top Management
Custome Medi
rs Those accountable for
Sharehold QMS policy and its aCommentat
implementation
ers
Distributors ors
Trade Groups
Those who implement
Investors and maintain the Neighbors
QMS
Owners Pressure
Those who maintain QMS Groups
Insurers and risk procedures
Emergency
Government Services
Other staff Contractors Other Response
Regulators Agencies
Recovery Transport
Service
Suppliers Dependents
of Staff
Clause 4: Context of the Organization
4.3 Determining the scope of the QMS
Who are we?
ISO 9000:2015 defines Identify the nature of the
“organization” as a “person or organization and what parts ofthe
group or people that has its own organization are included in the
1. Consider issues, requirements of functions with responsibilities, management system being developed.
interested parties, and products authorities and relationships to
and services. achieve its objectives.”

2. Be maintained as documented information.

What do we do?
3. State the type of products and services covered.
ISO 9000:2015 defines Identify the type of QMS that needs
“output” as the “result of a to be implemented
4. Provide justification for anyISO 9001:2015 requirement
process.”
that is claimed to be “not applicable” tothe organization.

Availability of Documented Information on: Who are our customers?

ISO 9000:2015 defines
Mandate “customer” as the “organization
Complete the description of the
or person that could or does
interrelationship between the
Products and Services receive a product or a service
“organization” and the “customer”.
that is intended for or required by
this person/org”. The customer
Sites
may be internal or external.

ISO 9001:2015
standard
Clause 4: Context of the Organization
4.4 QMS and its processes
The organization SHALL Process Map
Management Operational
Processes Processes
A process map shows
process-related activities,
including input/output, and
cross-functional interfaces.
The main goal of the map is
to provide an overview of Core Processes Support
the relevant business Processes
processes

…a quality management system, including

the PROCESSES needed and their
interactions
Clause 5: Leadership
5.1 Leadership and Commitment
Top management SHALL demonstrate leadership and commitment by
INTERNAL EXTERNAL
Taking accountability for the
Communicating the a. Customer and
PROCESS
effectiveness of the quality applicable
importance of effective
management system; statutory and
QMS and of conforming
to the QMS requirements regulatory
requirements are Review ORGANIZATIONAL
Ensuring that the quality determined,
policy and quality objectives Ensuring that the QMS
understood and existing STRUCTURE
are established for the QMS consistently met;
and are compatible with the
achieves its intended results;
practices/
context and strategic FUNCTIONAL
direction of the
b. The risks and opportunities
that can affect conformity of
approaches DESCRIPTION
organization; Engaging, directing and
supporting persons to
contribute to the
products and services and
the ability to enhance
on
Ensuring the integration of
the QMS requirements
effectivenessof the QMS; customer satisfaction are
determined and addressed;
leadership QMS STRUCTURE
into the organization’s
business processes; c. The focus on
functions
Promoting improvement enhancing
customer
Promoting the use ofthe satisfaction is
process approach and maintained.
risk-based thinking; Supporting other relevant
management roles to
Ensuring resources demonstrate their
needed for the quality leadership as it applies to
management system are their area of responsibility;
available
Clause 5: Leadership
5.2 Policy
Communicating the quality policy
The quality policy SHALL:
Overall intention and
direction of an
organization related Be available and be maintained as
documented information;
to quality as formally
Be communicated, understood and applied
expressed by top within the organization;
management
Be available to relevant interested
parties, as appropriate;
Vision

Redefining what Mission

Based on Mandate
quality means… and Strategic
Quality Policy Direction
Formulate,
Quality Objectives
review, approve Commitment to
Programs/Strategies satisfy applicable
and requirements
Business/Operations Plan
communicate
Employee Performance Plan the quality policy Commitment to
…is delighting the customer continually improve
…is Single Management System
…is everybody’s responsibility
 Clause 5: Leadership
5.3 Organization Roles, Responsibilities and Authorities
Top management SHALL assign the responsibility and authority for:
Ensuring that the QMS
STEPS
conforms to the requirements
of ISO
• Identify Organizational
Ensuring the integrity of the
QMS is maintained when Ensuring that processes are
responsible for Structure
changes to the QMS are delivering theirintended outputs; process/steps
planned and implemented
• Identify process
for designating
Job Description
personnel
Ensuring the promotion of Reporting on the performance
• Identify
customer focus throughout the of the QMS and on OFIs, in communication
organization; particular to top management;
methods/ Designations/
approaches Assignments

ACTION
 Clause 6: Planning
6.1 Actions to address risks and opportunities
6.1.2 The organization SHALL plan: Actions taken to SWOT 1. Identify what the risks
address risks and ANALYSIS and opportunities are in
• Actions to address these risks and opportunities shall be your organization –
opportunities and proportionate to the PESTLE depending on context
potential impact on ANALYSIS 2. Analyze and prioritize the
• How to integrate and implement
the conformity of risks and opportunities in
the actions into QMS processes and products and your organization – what is
RISK AND
to evaluate the effectiveness of services. OPPORTUNITY acceptable/unacceptable?
these actions. REGISTER 3. Plan actions to address
the risks – how can I avoid
Types of Operational Risks Project risk Process risk or eliminate the
related to the relating directly to risk?/mitigate the risk?
planning and delivery planning and delivery of 4. Implement the plan –
Enterprise risk of a product or service a product or service and take action
related to the and not being able to meet
operation of a not being able to meet 5. Check the effectiveness
project ‘triple constraints’ – 1) stability, 2) capability,
business, execution of the actions – does it
scope/quality, 3) improvement; inability
strategy, systemic work?
schedule, cost including to achieve consistent
issues, material technology others.
6. Learn from experience –
outcomes continual improvement
issues, etc.
 Clause 6: Planning
6.2 Quality objectives and planning to achieve them
Quality Objectives Relevant to conformity of monitored, communicated,
SHALL be: products and services and to and updated as appropriate.
enhance customer
satisfaction
How to establish Quality Objectives
1. Identify * Identify objectives to improve or reduce
SPMS performance something should specify the ideal level
WHAT will be done? Targets. against an established baseline.

What resources will *Identify objectives to eliminate something

should be achieved by a specified date;
be required? Quality 2. Plan for the
Objectives achievement of * Identify objectives to maintain something
Who will be the set targets. should specify the existing level of
responsible? performance.
When it will be 3. Learn from
completed? Quality
experience
How the results will Plan – continual improvement
be evaluated?
 Clause 6: Planning
6.3 Planning of Changes
The changes SHALL be carried out in a planned manner.

Consider Change
#1 Define
the change
#2 Prepare
the change
#3 Implement
the change
#4 Support
the change
Management
• Purpose of the Plan
changes and their * Clarify the * Identify the * Develop the * Reinforce the
1. Identify need for impacts release plan change
potential
performance change
consequences; * Communicate * Prepare * Evaluate and
Targets.
• Integrity of the * Define the the change sources and monitor the
QMS; Change benefits resources change
• Availability of Management * Identify the
resources; and, * Identify the goals *Rollout *Communicate
Process
• Allocation or goals changes the change
results
reallocation of 2. Plan for the
Responsibilities & achievement of
authorities the set targets.
Clause 7: Support
7.1 Resources
The organization SHALL determine and provide the resources needed for:

Establishment
I M
Continual Infrastructure Monitoring
Improvement QMS Implementation
determine, provide and
suitable for the
activities to be
maintain the infrastructure undertaken and

E O
needed to achieve the

P
maintained to
conformity to service and ensure
Maintenance necessary for the continuing fitness
Continual
Implementation operation of processes for use
Improvement

People Environment Org. Knowledge

determine and provide determine, provide and determine, maintain
CONSIDER:
A. Capabilities and Maintenance the persons necessary maintain the environment and ensure availability
constraints of internal for the effective necessary for the operation consider current knowledge
resources implementation and in addressing changing
B. Needs to be obtained of processes and achieve
control of the QMS and conformity to service needs and trends
from external providers
for the operation and requirements determine how to
control of its processes acquire or access any
necessary knowledge and
required updates
Clause 7: Support
7.2 Competence
The organization SHALL:
Determine the necessary competence for personnel performing work affecting
conformity to product and service requirements
Provide training or other actions to achieve the necessary competence
Evaluate the effectiveness of the actions taken
Maintain records of education, experience, training and qualifications

Applicable Actions:
Training Re-assignment
Mentoring Hiring or contracting of competent
persons/providers
Clause 7: Support
7.3 Awareness
Ensure that persons doing work under the organization’s
control are aware of:

Quality Policy
Quality Objectives
Employees are aware of the relevance and importance of their
activities, how they contribute to achieve the quality objectives
Implications of nonconformities
Clause 7: Support
7.4 Communication
The organization SHALL determine the internal and external
communications relevant to the QMS.
What
• What will be communicated
When Whom
• When to communicate
• With whom to communicate
• How to communicate
Who How
• Who communicates
Clause 7: Support
7.5 Documented Information
The organization’s QMS SHALL include documented information:

a. Required by the standard What needs to be addressed: What needs to be ensured:

b. Required by QMS
c. External origin Identification and
Distribution, access,
A retrieval and use
controls for documented
Control of information ofexternal
Creating and origin which are
Documented
updating necessary for the
Information Storage and planning and operation
B preservation, including
of QMS

Appropriate
Ensure availability legibility
and suitability for
identification and
use where and
description
when it is needed
Protection form
C Control of changes unintended alterations of
retained documented
Adequately information as
Appropriate format
protected evidence of conformity
D Retention and
disposition
Review and
approval suitability
and adequacy
Clause 8: Operations
8.1 Operational Planning and Control
To meet the requirements for the
provision of products and services
Plan, Implement, Control
the process (see also 8.4)
Determine, maintain and retain documented information to the extent necessary
To implement the actions determined Clause 6:
(risk and opportunities, quality objectives, changes)
•Determine requirements for products/services
•Establish criteria for process and product/service
•Determine resources needed (5Ms)
•Implement control as per criteria
•Control planned changes and review the
consequences of unintended changes (8.5.6), taking
action to mitigate any adverse effects, as necessary
Clause 8: Operations
8.2 Requirements for Products and Services
Communication with Customers What needs to be reviewed:
 Providing information relating to products and services
 Handling enquiries, contracts or orders, including changes;
 Obtaining customer feedback relating to products and services, including Contract or order
customer complaints; requirements differing from
 Handling or controlling customer property; those previously defined are
 Establishing specific requirements for contingency actions, when relevant.
resolved

The organization SHALL conduct a review

before committing to supply products and Where customer provides
services to a customer
no documented statement
of requirement, the
Customer Requirements Contract of order customer requirements
requirements specified bythe requirements shall be
(specified and organization
Legal differing from
implied), including requirements those previously
confirmed by the
post delivery expressed organization before
activities acceptance
 Clause 8: Operations
8.3 Design and development for products and services
The organization SHALL
a design and development process that is appropriate
to ensure subsequent provision of products and services.
• …retain documented information
ESTABLISH IMPLEMENT MAINTAIN
OUTPUTS
Meet inputs requirements
Adequate for subsequent processes
Include acceptancecriteria
Include or reference monitoring and
measuring requirements
Specific characteristics essential for
its their intended purpose
Safe and proper provision of specific
characteristics
Nature, activities, duration,
Requirements stages, reviews,verification,
THINGS TO CONSIDER: validation, complexities
Functional and performance requirements Customers and relevant
Expectations
Previous and similar activities interested parties
Functional and performance
Legal requirements Involvement, interfaces and Authorities, customers,
requirements
Committed standards or code of practice responsibilities users, interestedparties
Potential consequence of failure Documentation resources Internal and external
THINGS TO ENSURE:
Define results to be achieved
Conduct reviews to evaluate the ability of
meeting requirements
Functional and performance
Verify if the outputs meet the input requirements
requirements
Validate results if capable of meeting requirement
Take action on problems during review, verification
and validation
INPUTS
Adequate for the purpose
Complete Clear
Conflicts areresolved
Clause 8: Operations
8.4 Control of externally provided processes, products
and services
Applied to outsourced products and services that :
 Are intended for incorporation in the organization’s products and services
 Are provided directly to customers by external providers on behalf of the organization
 A process, or part of a process , decided upon by the organization

The organization SHALL

Ensure that externally provided
processes, products and services do
not adversely affect the
organization’s capability
Potential impact that externally
provided processes, products and
services could have on your
organization’s ability to consistently
meet external requirements
The organization SHALL
What is expected from external providers
Controls that external process,
product and service providers have
implemented and think about how
effective their controls actually are
Develop and implement controls for
external providers, processes,
products and services
The organization SHALL clarify
Process and product requirements
Service, Equipment and Interaction
Requirements
Competence and Methodological
Requirements
Monitoring and Control Requirements
Verification or Validation Requirements
 Clause 8: Operations
8.5 Production and Service Provision
Control of production and service provision
I. Identification and traceability PRESERVATION
Availability of Preserve outputs during
Availability and  Identify, where appropriate,the product operations, to the extent
documented
Implementation of use of suitable and service by suitable means throughout necessary to ensure
information conformity to requirements.
release, delivery and monitoring and the service operations.
post delivery activities measurement  Identify the status of the service with POST DELIVERY
1 resources respect to  Legal requirements
8 2 measurement and monitoring  Potential
requirements. undesired
consequences
Validation Implementation  Control unique identification, where  Nature, use and intended
and 7 CONDITIONS 3 of measurement traceability is a requirement. lifetime of products and
revalidation activities services l
 Customer requirements
 Customer feedback
6 4
II. Property belonging to customers or external providers
Use of suitable CONTROL OF CHANGES
Implementation 5 infrastructure  Exercise care with property while it is under the
of human error organization's control or being used by the Review and control changes
and environment for production and services
Appointment organization provision to ensure continuing
of competent  Identify, verify, protect and safeguard the property conformity to requirements

personnel  If property is lost, damaged or otherwise found to be Retain documented

unsuitable for use, this shall be reported and retain information describing the
documented information on the occurrence results of review of changes,
person authorizing the
 Materials, components, tools and equipment, change, and actions (if any)
premises, intellectual property and personal data. arising form the review
Clause 8: Operations
8.6 Release of Products and Services
 Implement planned arrangements on verification against
requirements

 Release shall not proceed until planned arrangements

have completed, unless approved by relevant authority
or the customer

 Retain documented information

Clause 8: Operations
8.7 Control of Non-Conforming Outputs
DEFINING NONCONFORMITY Deal with nonconforming outputs through
any or combination of the following:

REQUIREMENT A
B
VS Correction Segregation,
containment,
C
return, or
Obtaining
authorization D
IMPLEMENTATION suspension of for Informing
provision acceptance the
under customer
concession
* Verify nonconforming outputs when corrected
REQUIREMENT FULFILLED Concession – Permission to use or release nonconforming outputs

YES NO
Descriptions of Description of Deciding
Description of the Action any concession
CONFORMITY NONCONFORMITY the NC
Authority for the
Taken obtained action/s taken

*Retain documented information

 Clause 9: Performance Evaluation
9.1 Monitoring, measurement & evaluation
The organization shall determine: Customer Satisfaction
What can an organization
utilize/apply to determine Monitor information relating to
what to monitor and WHEN customers’ perception of the degree to
measure? WHAT needs to the monitoring which their
be monitored measurement needs and expectations have been
 PROCESS MAP or MODEL this shall be fulfilled.
and measured
provides the highest level of performed WHEN the • Determine the methods
illustrating the organization’s HOW (Methods) results to be for obtaining, monitoring, and reviewing
processes to ensure valid analyzed and the information.
results evaluated
Structured Approach:
What can an organization  Training/program evaluation
 Project /program evaluation
utilize/apply to determine what to
 Client satisfaction/dissatisfaction
monitor and measure? survey
PROCESS CONTROL
MONITORING FREQUENCYOF UNIT
FUNCTION METHOD /
TOOL MONITORING RESPONSIBLE
 Project deliverable acceptance
 PROCESS MATRIX MECHANISM  Regular meetings
Illustrates the basic components •Compensation •Verification of •Attendance • Every payroll •Personnel (briefings/debriefings/as
of an organization key and Benefits attendance (hours sheet, leave Section sessment) with clients
processes such as the inputs, worked, leave taken) ledgers, payslip  Website feedbacktab/window
outputs, key responsibilities, •Review of
 Suggestion box
process controls, etc. compliance to •Government  Focus Group Discussions(FGD)
government communication/
 Documented procedures & work regulations circulars Unstructured Approach:
instructions also provide •Training and •Training Needs •Training & • Quarterly •Personnel Complaints Management Process/Unit
information on M and M. Development Assessment Development Section Public Affairs
Plan Formulation Plan
•Competency • Performance • Semestral
Identification Evaluation System
Clause 9: Performance Evaluation
9.2 Internal Audit
The organization shall conduct internal audit at Take appropriate
Select auditors and conduct Report audit results
planned intervals to provide information on whether the correction and corrective
audit to ensure objectivity to relevant
quality management system: and impartiality management action without undue
a. conforms to: delay
• The organization’s own requirements for its QMS;
• The requirements ofthis International Standard;
b. is effectively implemented and maintained. Retain
Define scope
and criteria AUDIT documented
information

Plan, establish, implement and maintain

an audit program including the:
Importance of the processes concerned
FREQUENCY METHODS

PLANNING Changes affecting the organization

RESPONSIBILITIES REQUIREMENTS

Changes affecting the organization

REPORTING
Clause 9: Performance Evaluation
9.3 Management Review
Top management shall review the organization’s QMS, at planned intervals, to ensure its continuing suitability,
adequacy, effectiveness, and alignment with the strategic directions of the organization.
Information on the performance And effectiveness ofthe QMS
01 Status of actions from previous

I Management Reviews
•
•
Customer satisfaction and feedback from stakeholders
Quality objectives attainment
• Process performance and conformity of products & services

N 02 Changes in QMS-relevant
internal and external issues •
•
Nonconformities and corrective actions
Monitoring and measurement results
•
P 03 Information on the performance
and effectiveness of the QMS •
Audit results
Performance of external providers

U
The outputs of the management review SHALL include The organization
04 Adequacy of resources O decisions and actions related to: SHALL retain
documented
U information as

T 05 Effectiveness of actions taken

T
Opportunities for Any need for
evidence of the
results of
management
to address risks andopportunities P Improvement changes in the Resource needs

S
reviews.
QMS
U Examples:
06 Opportunities for improvement T • Minutes of Meeting
• Action Plan
S • Resolutions
Clause 10: Improvement
10.1 General
The organization shall DETERMINE and SELECT opportunitiesfor improvement and IMPLEMENT any necessary actions to
meet customer requirements and enhance customer satisfaction.

Improving products and services to meet requirements and to

address future needs and expectations;
DETERMINE
and
SELECT OFIs Correcting, preventing or reducing undesired effects;
&
IMPLEMENT
actions Improving performance and effectiveness of the quality
management system.

Examples of improvement:
Correction; Corrective action; Continual improvement;
Breakthrough change; Innovations; Re-organization
Clause 10: Improvement
10.2 Nonconformity and corrective action

The organization SHALL retain

documented information as
Corrective actions evidence of:
SHALL be appropriate
to the effects of the
nonconformities a. The nature of the b. The results of any
encountered. nonconformities and corrective action
any subsequent
actions taken
Clause 10: Improvement
10.3 Continual Improvement

Results of analysis Outputs from

and evaluation management
review
The organization
SHALL continually
improve the suitability,
adequacy, and
effectiveness of the
QMS.

Needs or opportunities to be addressed are

determined as part of continual improvement