ISO 9001:2015

in the
Supply Chain
ISO 9001…
As someone who is involved in the selection
of suppliers and, possibly, responsible for
making purchasing decision, you may have
seen or used products and services that are
promoted using reference to ISO 9001:2015
Example:

What does this mean?

The ISO Story
The ISO story began in 1946 when delegates from 25 countries met at the Institute of Civil Engineers
in London and decided to create a new international organization ‘to facilitate the international
coordination and unification of industrial standards’. On 23 February 1947 the new organization, ISO,
officially began operations.
Since then, we have published over 21773 International Standards covering almost all aspects of
technology and manufacturing.
Today we have members from 163 countries and 786 technical bodies to take care of standards
development. More than 135 people work full time for ISO’s Central Secretariat in Geneva,
Switzerland.

It's all in the name

Because 'International Organization for Standardization' would have different acronyms in different
languages (IOS in English, OIN in French for Organisation internationale de normalisation), our
founders decided to give it the short form ISO. ISO is derived from the Greek isos, meaning equal.
Whatever the country, whatever the language, we are always ISO.

Founders of ISO, London 1946

ISO Management System Standards
What is ISO 9001?
• ISO 9001 is an International Standard that gives
requirements for an organization’s quality
management system (QMS).

• It can be used by any organization, large or small,

regardless of its field of activity.

• Using ISO 9001 helps ensure that customers get

consistent, good quality products and services,
which in turn brings many business benefits.
What is the objective of ISO 9001?
• The objective of ISO 9001 is to provide set of
requirements that, if effectively implemented, will
give you confidence that your supplier can
consistently provide products and services that:
• Meet your needs and expectations
• Comply with applicable regulations

ISO 9001 does not define

specific requirements for the
PRODUCTs or SERVICEs you are
purchasing.
It is up to you to make your own
needs and expectations.
 ISO 9000 Family – Quality Management
• ISO 9001:2015 – Quality management systems - Requirements (sets out
the requirements of a quality management system)
• ISO 9000:2015 – Quality management systems - Fundamentals and
vocabulary (covers the basic concepts and language)
• ISO 9004:2009 – Managing for the sustained success of an organization - A
quality management approach (focuses on how to make a quality
management system more efficient and effective)
• ISO 19011:2011 – Guidelines for auditing management systems (sets out
guidance on internal and external audits of quality management systems)
What does “Conformity to ISO 9001”mean?
• This means that your supplier has established a
systematic approach to quality management and is
managing its business to ensure that your needs are
clearly understood, agreed and fulfilled.

• It is not a declaration or statement of product or

service conformity.
How does ISO 9001 help you select a supplier?
• ISO 9001 provides some requirements for the purchasing
process that include you as the customer.

• These requirements address the following topics:

• Requirements regarding the purchasing information that
you should provide so that suppliers clearly understand
your needs
• Any specific approvals that might be needed to confirm
that the supplied product or services meet your
requirements
Process Approach

Schematic representation of the elements of a single process

Plan-Do-Check-Act

Representation of the structure of this standard in the PDCA cycle

ISO 9001:2015 Standard
ISO 9001:2015 Quality management systems — Requirements is a
document of approximately 30 pages which is available from the
national standards organization in each country.

Contents of ISO 9001:2015 are as follows:

Section 1: Scope
Section 2: Normative references
Section 3: Terms and definitions
Section 4: Context of the organization
Section 5: Leadership
Section 6: Planning
Section 7: Support
Section 8: Operation
Section 9: Performance evaluation
Section 10: Improvement
ISO 9001:2015 Standard
Section 1 - Scope

The requirements of this standard are applicable to any

organizations regardless of its type or size, or the
products and services it provides.

Organization will need to determine their scope of QMS

to demonstrate its ability to consistently provide
products and services that meet customer and applicable
statutory and regulatory requirements
ISO 9001:2015 Standard
Section 2 – Normative References

This standard currently references the following standard:

• ISO 9000:2015, Quality management system – Fundamentals and
vocabulary
ISO 9001:2015 Standard
Section 3 – Terms and definitions

• For the purposes of this document, the terms and definitions

given in ISO 9000:2015 apply.
ISO 9001:2015 Standard
Section 4 – Context of the organization
4.1 Understanding the organization and its context

• The organization shall determine external and internal

issues…. affecting the organization
• Context of the organization:
• WHAT – What does your organization do?
• WHO – Interested parties:
• Employees
• Corporate office
• Shareholders
• Customers
• Suppliers
• Contractors
• Neighbors, etc.
• HOW – manufacture, service distribute, outsource, etc.
• WHERE – 1 or more locations
4.2 Understanding the needs and expectations of interested
parties
• The organization shall determine:
a) The interested parties:
• Customers
• Employees
• Corporate office
• Shareholders
• Neighbors
• Suppliers
• Contractors, etc.

b) The relevant needs and expectations (i.e. requirements) of these

interested parties
c) Which of these needs and expectations become its compliance
obligations.
4.3 Determining the scope of the quality management system

• When determining the scope, the organization shall

consider:
a) The external and internal issues referred to in 4.1
b) The compliance obligations referred to in 4.2
c) The products and services of the organization

The SCOPE shall be maintained as documented information.

4.4 Quality management system and its processes

• The organization shall establish, implement, maintain an

continually improve a quality management system,
including the processes and their interactions, in
accordance with the requirements of this International
Standard.
• 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.
4.4 Quality management system and its processes

• Example:

1st Equipment
Operation Maintenance

2nd
Planning Operation Inspection Shipping

3rd
Corrective
Operation
Action
ISO 9001:2015 Standard
Section 5 – Leadership
5.1 Leadership and commitment

• Top management shall demonstrate leadership and

commitment by:
a) Taking accountability for effectiveness of the QMS;
b) Ensuring that the quality policy and quality objectives are established for
the QMS and are compatible with the context and strategic direction of
the organization;
c) Ensuring integration of the QMS into business processes;
d) Promoting the use of the process approach and risk-based thinking;
e) Ensuring that the resources needed for the QMS are available;
f) Communicating the importance of effective QM and conformance to the
QMS;
g) Ensuring that intended outcomes are achieved;
h) Engaging, directing and supporting persons to contribute to the
effectiveness of the QMS;
i) Promoting improvement; and
j) Supporting other management roles. 23
5.1.2 Customer Focus

• Top management shall demonstrate leadership and

commitment with respect to customer focus by
ensuring that:
a) Customer and applicable statutory and regulatory requirements
are determined, understood and consistently met;
b) The risk and opportunities that can affect conformity of products
and services and the ability to enhance customer satisfaction are
determined and addressed;
c) The focus on enhancing customer satisfaction is maintained

24
5.2 Policy
• Top management shall establish, implement and
maintain a quality policy…
• Maintained as documented information
• To be communicated
• Available to interested parties
5.3 Organizational roles, responsibilities and authorities

• Top management shall ensure that the

responsibilities and authorities for relevant
roles are assigned and communicated within
the organization
ISO 9001:2015 Standard
Section 6 – Planning

PLANNING
6.1 Actions to address risks and opportunities

What kind of risks?

Risks that we cannot achieve the intended
results of the QMS

Examples:
• The requirements of the interested parties are not clear →
the customer(s) won’t receive the expected goods →
customer dissatisfaction
• The planning stage is late → the launch of the new product
will be late → customer dissatisfaction
• Equipment failure in operations → late shipment →
customer dissatisfaction
• Lack of training of the operators → non-conforming product
→ the customer(s) won’t receive the expected goods →
customer dissatisfaction
• Failed inspection → shipping non-conforming products →
customer dissatisfaction
 6.2 Quality objectives and planning to achieve them
• The quality objectives shall:
a) Be consistent with the policy;
b) Be measurable;
c) Take into account applicable requirements;
d) Be relevant to conformity of products and services and to enhancement
of customer satisfaction;
e) Be monitored;
f) Be communicated;
g) Be updated as appropriate;
• The organization shall maintain documented information.

Examples:
100% On-time launches of new products
1% of non-conforming products to be produced
100% On-time delivery
100% Trained operators
90% Customer satisfaction score
6.3 Planning of changes
• When the organization determines the need for changes to the
quality management system, the changes shall be carried out in a
planned manner
• Consider:
• The purpose of the changes and their potential consequences
• The integrity of the QMS
• The availability of resources
• The allocation or relocation of responsibilities and authorities
ISO 9001:2015 Standard
Section 7 – Support
7.1 Resources
• The organization shall determine and provide the
resources needed for the establishment, implementation,
maintenance and continual improvement of the QMS.

32
7.1.5 Monitoring and measuring resources
• When the organization shall determine and provide the resources
needed to ensure valid and reliable results when monitoring or
measuring is used to verify the conformity of products and services
to requirements.

• The organization shall maintain documented information.

7.2 Competence
• The organizations shall:
a) Determine the necessary competence of person(s) doing
work under its control that affects the performance and
effectiveness of the QMS;
b) Ensure that these persons are competent on the basis of
appropriate education, training or experience
c) Where applicable, taken actions to acquire the necessary
competence, and evaluate the effectiveness of the actions
taken
d) Retain appropriate documented information as evidence of
competence.

• NOTE: Applicable actions can include, for example, the provision of

training to, the mentoring of, or the reassignment of currently
employed persons; or the hiring or contracting of competent
persons.
Competence = training OR education OR
experience
7.3 Awareness
• The organizations shall ensure that persons doing work
under the organization’s control are aware of:
a) The quality policy
b) Relevant quality objectives
c) Their contribution to the effectiveness of the
QMS, including the benefits of enhanced
improved performance
d) The implications of not conforming with the QMS
requirements.

Persons doing work under the

organization’s control:
Employees
Contractors
Temporary/Agency people
Suppliers, etc.
7.4 Communication
• The organization shall determine the internal and external
communications relevant to the QMS, including:
a) On what it will communicate
b) When to communicate
c) With whom to communicate
d) How to communicate
e) Who communicates
7.5 Documented information
• The organization’s QMS shall include:
a) Documented information required by this international
standard
b) Documented information determined by the organization as
being necessary for the effectiveness of the QMS
• Note: the extent of documented information for an QMS can differ
from one organization to another due to:
• The size of organization and its type of activities, processes,
products and services
• The complexity of processes and their interactions
• The competence of persons doing work under the
organization’s control.
7.5.2 Creating and updating (documented information)

• When creating and updating documented information, the

organization shall ensure appropriate:
a) Identification and description (e.g. a title, date, author, or
reference number)
b) Format (e.g. language, software version, graphics) and media
(e.g. paper, electronics)
c) Review and approval for suitability and adequacy
7.5.3 Control of documented information
• Documented information required by the QMS and by this
international standard shall be controlled to ensure:
a) It is available and suitable for use, where and when it is
needed
b) It is adequately protected (e.g. from loss of confidentiality,
improper use, or loss of integrity)
• For the control of documented information, the organization shall
address the following activities as applicable:
• Distribution, access, retrieval and use;
• Storage and preservation, including preservation of legibility
• Control of changes (e.g. version control)
• Retention and disposition
• Documented information of external origin determined by the
organization to be necessary for the planning and operation of the
EMS shall be identified, as appropriate, and controlled.
• NOTE: access can imply a decision regarding the permission to view
the documented information only, or the permission and authority to
view and change the documented information.
7.5.3 Control of documented information

Examples:

Access to electronic documented information

Archive room for hard copies of the

documented information
ISO 9001:2015 Standard
Section 8 – Operation
8.1 Operational planning and control

• The organization shall plan, implement and control the processes

needed to meet the requirements for the provision of products and
services, and to implement the actions identified in Clause 6, by:
a) Determining the requirements for the products and services
b) Establishing criteria for:
1) The process
2) The acceptance of products and services
c) Determining the resources needed to achieve conformity to
the product and service requirements;
d) Implementing control of the process(es), in accordance with
the criteria
e) Determining, maintaining and retaining documented
information to the extent necessary:
1) To have confidence that the process have been carried out as
planned
2) To demonstrate the conformity of products and services to their
requirements.
8.1 Operational planning and control

• The output of this planning shall be suitable for the organization’s

operations.
• The organization shall control planned changes and review the
consequences of unintended changes, taking action to mitigate any
adverse effects, as necessary.
• The organization shall ensure that outsourced processes are
controlled.
8.2 Requirements for products and services

• The organization shall ensure that it has the ability to meet the
requirements for products and services to be offered to customer(s).
• The organization shall conduct a review before committing to supply
product and services to a customer(s).

• The customer’s requirements shall be confirmed by the organization

before acceptance, when the customer does not provide a
documented statement of their requirements.
Example: catalog order via phone

• The organization shall maintain documented information.

8.3 Design and development of products and services

DESIGN &
DESIGN INPUTS DESIGN
DEVELOPMENT
OUTPUTS
CONTROLS
VERIFICATION

VALIDATION
8.4 Control of externally provided processes, products and
services (Purchasing and Supplier management)
• The organization shall ensure that externally provided processes,
products and services conform to requirements.
• The organization shall determine the controls to be applied to
externally provided processes, products and services.
• The organization shall determine and apply criteria for the
evaluation, selection, monitoring of performance, and re-evaluation
of external providers, based on their ability to provide processes or
products and services in accordance with requirements.
• The organization shall maintain documented information.
Order wood Receiving inspection against Storage
criteria
Order
_________
__________
_______

________
8.5.1 Control of production and service provision
• The organization shall implement production and service provision under
controlled conditions. Controlled conditions shall include, as applicable:
a) The availability of documented information that defines:
1) The characteristics of products to be produced, the services to be
provided, or the activities to be performed;
2) The results to be achieved;
b) The availability and use of suitable monitoring and measuring
resources;
c) The implementation of monitoring and measurement activities at
appropriate stages to verify that criteria for control of processes or
outputs, and acceptance criteria for products and services, have
been met;
d) The use of suitable infrastructure and environment for the
operation of processes;
e) The appointment of competent persons, including and required
qualifications;
f) The validation, and periodic revalidation, of the ability to achieve
planned results, where the resulting outputs cannot be verified by
subsequent monitoring or measurement;
g) The implementations of actions to prevent human error;
h) The implementation of release, delivery and post delivery activities.
 8.5.1 Control of production and service provision
• Example:

INFRASTRUCTURE

INSTRUCTIONS
COMPETENT
PERSON

MEASURING AT
PACKAGING
APPROPRIATE
STAGES
8.5.2 Identification and traceability
• Example:

8.5.3 Property belonging to customer or external providers

• The organization shall identify, verify, protect and safeguard
customer’s or external provider’s property provided for use or
incorporation into product and services

8.5.4 Preservation
• The organization shall preserve the outputs…
• Preservation can include identification, handling, contamination
control, packaging, storage transmission or transportation, and
protection.
8.5.5 Post-delivery activities
• The organization shall meet the requirements for post-delivery
activities associated with the products and services.
• Example: Post-delivery activities can include actions under warranty
provisions, contractual obligations such as maintenance services, and
supplementary services such as recycling or final disposal.

8.5.6 Control of changes

• The organization shall identify, verify, protect and safeguard
customer’s or external provider’s property provided for use or
incorporation into product and services
8.6 Release of products and services
• The organization shall implement planned arrangements, at
appropriate stages, to verify that the product and service
requirements have been met.
• The organization shall maintain documented information.
8.7 Control of non-conforming outputs
• The organization shall ensure that outputs that do not conform to
their requirements are identified and controlled to prevent
unintended use or delivery.
• The organization shall maintain documented information.
ISO 9001:2015 Standard
Section 9 – Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
• The organization shall determine:
a) What needs to be monitored and measured;
b) The method for monitoring, measurement, analysis and
evaluation needed to ensure valid results;
c) When the monitoring and measuring shall be performed;
d) When the results from monitoring and measuring shall be
analyzed and evaluated.
• The organization shall evaluate the performance and the effectiveness
of the QMS.
• The organization shall maintain documented information as evidence
of the results.
9.1.2 Customer satisfaction
• The organization shall monitor customers’ perceptions of the degree
to which their needs and expectations have been fulfilled. The
organization shall determine the methods for obtaining, monitoring
and reviewing this information.
• Examples: customer surveys, customer feedback on delivered
products and services, meetings with customers, market-share
analysis, compliments, warranty claims and dealer reports.

9.1.3 Analysis and evaluation

• The organization shall evaluate appropriate data and information
arising from monitoring and measurement.
• Methods to analyze data can include statistical techniques.
9.2 Internal audits
• The organization shall conduct internal audits at planned intervals to
provide information on whether the QMS:
a) Conforms to:
a) The organization’s own requirements for its QMS
b) The requirements of this International Standard
b) Is effectively implemented and maintained.
• The organization shall:
a) Plan, establish, implement and maintain audit programme
b) Define the audit criteria
c) Select auditors and conduct audits
d) Audit results are reported to management
e) Take appropriate correction and corrective actions
f) Retain documented information as evidence of the
implementation of the audit programme and the audit
results.
9.2 Internal audits
REVIEW THE PREPARE THE SLECT AUDITOR & PREPARE THE
REQUIREMENTS CHECKLIST CONDUCT AUDIT REPORT &
COMMUNICATE
TO THE
MANAGEMENT

Steps of the audits

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 direction of the organization.

MANAGEMENT REVIEW MANAGEMENT REVIEW

INPUTS OUTPUTS
-Customer satisfaction Decisions and actions related to:
-Quality objectives -Opportunities for improvement
-Process performances -Any need for changes in the QMS
-Non-conformities -Resources needed
-Corrective actions
-Monitoring and
measurement results
-Audit results
-Performance of external
providers
-Status of the actions from
the previous management
reviews
-Changes to QMS
-Adequacy of resources
-Risks and opportunities
-Continual improvements
ISO 9001:2015 Standard
Section 10 – Improvement

60
 10.1 General
• The organization shall determine and select opportunities for improvement
and implement any necessary actions to meet customer requirements and
enhance customer satisfaction.

10.2 Non-conformity and corrective action

• When a non-conformity occurs, including any arising from
complaints, the organization shall:
a) React to the non-conformity
b) Evaluate the need for action to eliminate the cause of the
non-conformity, in order that it does not recur or occur
elsewhere
c) Implement any actions needed
d) Review the effectiveness of any corrective action taken

• The organization shall maintain documented information as

evidence.
 10.2 Non-conformity and corrective action
• Example:

012/2017 Chair assembly

May 13, 2017
M8 set screw became loose after 2 weeks of usage
Valeria Szabo

Replace the screw immediately

Damaged thread on the screw

Implement visual inspection of each screws before assembly

Request certified stock from the Supplier

No complaints since
Bil Monk (Shop Mgr.)
Attached are the pictures of the investigation, the letter send to the Supplier
and the revised Operator Instruction
 10.3 Continual improvement
• The organization shall continually improve the suitability, adequacy and
effectiveness of the QMS.
• The organization shall consider the results of analysis and evaluation, and
the outputs from management review, to determine if there are needs or
opportunities that shall be addressed as part of continual improvement.
• Examples: cost reduction, employee suggestions, optimizing LEAN and 5S
managements, scrap reduction, etc.
Bibliography:
1)
Pictures and clip art: Google Images
2)
ISO images, history and ISO in supply chain: www.iso.org.com
3)
Text copied from the original ISO 9001:2015 standard

Availability:
Valeria Szabo
[email protected]