By Core Business Solutions

Co-Founder and President

Small business success hangs on one major factor - customer and client trust. The ISO 9001
Standard for Quality helps organizations create, implement, and maintain a high-functioning
Quality Management System (QMS) that guides the day to day function of the business.

An ISO QMS helps companies constantly refine their day-to-day systems and create targeted
long-term goals for success. Led by the stringent quality requirements of the standard, that
QMS in turn helps guide the ultimate achievement for business growth - constantly improving
customer experiences and satisfaction.

Through ten clauses, the ISO standard guides companies toward improved internal function
and cultural growth. We specialize in coming alongside businesses like yours, helping you
understand these clauses and their requirements, and to implement an ISO-certified system that
will help your business thrive.
An Introduction to the
ISO 9001 Standard
What is ISO 9001? Who needs to be involved?
ISO 9001 is a global quality standard focused on For truly successful ISO success, all members
defining minimum best practices for the production of the organization should be involved with the
and delivery of a company’s goods and/or services. implementation of the new QMS.
It focuses on efficiency, customer satisfaction, and
Certification to ISO 9001 is achievable by any
continuous improvement, and guides organizations
organization, regardless of industry or size. The
to the development of a formal quality management
process can be implemented by the internal team,
system (QMS). The QMS is made up of processes and
but some companies choose to utilize outside
documentation that control operations and ensure
consulting resources to ensure they are able to
that requirements are met.
appropriately translate the standard’s requirements
Who wrote it? to their business.

The International Organization for Standardization Is this the only certification?

(ISO) which is made up of the national standard
ISO 9001 is the baseline standard that can catapult
bodies from more than 160 countries.
organizations into excellence in safety, environmental
Who uses it? sustainability, information security, and more. By first
certifying to the original quality standard (9001),
ISO 9001 can be implemented by any company of companies position themselves for success through
any size. Currently there are more than a million further standard pursuit and certification.
organizations certified to the standard world-wide.
What requirements are included?
What are the benefits?
ISO 9001 requirements are organized into the
Achieving certification to the ISO 9001 standard following sections:
offers organizations the ability constantly and • Context of the Organization
consistently improve their processes, refine their
• Leadership
deliverable, and grow their business. • Planning
• Support
Who issues the certificate? • Operation
ISO 9001 certificates are issued by a third-party • Performance Evaluation
registrar after an extensive audit of a company’s QMS. • Improvement
During the audit, they will evaluate compliance with the
standard’s requirements. Surveillance audits must be
repeated on an annual basis to maintain certification.

Together, these requirements make up the Quality Management System (QMS) described in company
documentation and include the quality manual, procedures, work instructions, records, and other information
used for day-to-day operational excellence. An effective QMS is one where a company follows its processes and
documentation consistently, achieves the desired results of its objectives and key performance indicators, and
continually improves to perform better for its customers.
 During the ISO 9001 certification process you
will evaluate and monitor six possible controls
and check points:
• Source of Inputs - the processes and
policies those who impact inputs
• Inputs - the physical materials, information,
or resources acquired to produce products
and/or services
• Activities - actions performed in the creation
of goods and services
• Outputs - the quality of the final deliverable
The ISO 9001 standard employs the • Receivers of Outputs - the processes of the
Process Approach, or the way in which businesses or individuals that use the final
product or service
the processes and activities in a company
work together to deliver quality products Sources
of inputs
and/or services.

By examining and improving key business

Inputs
processes, organizations are able to
directly impact the way they serve Possible controls
and checkpoints to
their customer. By improving the way monitor and measure Activities
performance
procedures are done, they are also able
to improve the overall quality of their Outputs

deliverable.

Hinging on the PDCA cycle (Plan, Receivers

of outputs
Do, Check, Act), the implementation
of processes improvements must be Things to Remember

thoroughly thought through, documented, • A process is a set of work steps that transform
parts, materials, or information (inputs) into
and monitored for continued success. a more complete form, such as assemblies,
products, or reports with outputs based on
specific requirements.
What’s Required? • The output of one process can be the input to
“… the systematic definition and management another process. All of your company’s processes
of processes, and their interactions, so as to interact and affect the final result.
achieve the intended results in accordance with • Each process is assigned a process owner
the quality policy and strategic direction of the who is responsible for monitoring performance
organization. Management of the processes and objectives and KPIs and for leading improvement
the system as a whole can be achieved using the of the process.
PDCA cycle (see 0.3.2) with an overall focus on
risk-based thinking (see 0.3.3) aimed at taking ISO 9001 Certification Requirements:
advantage of opportunities and preventing 0.3 Process Approach
undesirable results.” (0.3.1) 4.4 Quality Management System and Its Processes
Risk-based thinking is the driving factor Things to Remember

of decisions made by organizations • Looking for operational risks is everyone’s

responsibility and affects every company process.
working to implement an ISO 9001 • Operational risk management allows for better
QMS. By identifying potential risks and planning and improved results.
• Risk assessment is required for operational
rewards, the approach helps to shape
activities such as product requirements review,
the culture of the organization into one contract negotiations, operations management,
focused on proactive processes designed design and development, purchasing, work
transfer, etc.
to mitigate potential risks and capitalize
on improvements for reward.
ISO 9001 Requirements:
0.3.3 Risk-Based Thinking
What are the ISO 9001:2015 Risk Based Thinking 6.1 Actions to Address Risks and Opportunities
Requirements? 8.1.1 Operational Risk Management
“To conform to the requirements of this
International Standard, an organization needs
to plan and implement actions to address risks
and opportunities. Addressing both risks and
opportunities establishes a basis for increasing
the effectiveness of the quality management
system, achieving improved results and
preventing negative effects.” (0.3.3)
 Things to Remember
• Defining the context of your organization will
require wide-reaching evaluation of all the ways
your business is impacted by both internal and
Every company is influenced by both external factors:
internal and external factors. The ISO o Internal factors include: company culture
and size, objectives and goals, product or
9001 standard requires organizations
process complexity
to evaluate all the ways in which their o External factors include: customers and
actions and deliverables influence their markets served, communities, industry
trends, technology, regulations and
stakeholders by examining the web of requirements, and the greater economy
connectedness that determines how • Companies must define the relevant interested
parties and determine their responsibly to each:
decisions are made in the pursuit of
o Employees, unions, management > labor
growth and success. laws, company culture, safety
o Customers and partners > contractual
How the ISO 9001 standard applies to agreements, service expectations,
requirements
each business is based on the context
o Owners, shareholders > applicable laws,
of that specific organization, helping to expectations
o Suppliers > contractual agreements,
define exactly how the QMS should be
good-faith business practices, professional
developed and implemented so that courtesy
is directly impacts business needs and o Authorities > regulations
o Certification bodies > standards
goals.
• The scope of the QMS may or may not include
the entirety of the business. It is intended to
define the boundaries and applicability of the
What’s Required?
QMS, outline what will and will not be included
“The organization shall determine external and in the system’s requirements.
internal issues that are relevant to its purpose
and its strategic direction and that affect its ability
to achieve the intended result(s) of its quality ISO 9001 Requirements:
management system.
4 Context of the organization
4.1 Understanding the organization and its
“The organization shall monitor and review
context
information about these external and internal
4.2 Understanding the needs and expectations
issues.” (4.1)
of interested parties
4.3 Determining the scope of the quality
management system
 Things to Remember
• Leadership is responsible for creating the
Management involvement is crucial to quality policy - the document that communicates
the importance of meeting high quality standards.
the success of your QMS development
• Top management must define measurable
and implementation. Through a series of quality objectives and KPIs for each process in
required leadership meetings, the top order to provide benchmarks for improvement.
• Roles, responsibilities, and authority need to be
executives at your company will drive assigned appropriately to allow for delegation of
the initiative from the top down. They tasks, decision making, and accountability.
• Routine management, process, and document
must take full, hands-on ownership for
reviews are necessary to ensure the effectiveness
the success of the standard certification of the system.
and create priority in the organization • Leadership is responsible for providing
adequate resources to support the QMS,
to adhere to processes, procedures, and including workforce, equipment, infrastructure,
requirements. and environment.

What’s Required? ISO 9001 Requirements:

“Top management shall demonstrate leadership 5 Leadership

and commitment with respect to the quality 5.1 Leadership and commitment
management system… Top management shall 5.1.1 Leadership And Commitment For The
demonstrate leadership and commitment with Quality Management System
respect to customer focus…” (5.1.1, 5.1.2) 5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities, and
authorities
6.2 Quality objectives and planning to achieve them
7.1 Resources

Quality Management System (4)

Support (7) &
Organization and
Operation (8)
its Context (4)
PLAN DO Customer
Satisfaction
Customer Performance
Requirements Planning (6)) Leadership (5)
Evaluation (9)
Results of
ACT CHECK the QMS
Needs and
Expectations of Improvement
Relevant Interested (10)
Parties (4)
Planning to implement a new system into Things to Remember

your business requires careful thought. • All actions should be proportionate to the risk
they address and the impact that risk may have
Leadership must take the identified risks on product service or conformity.
and develop structured and measurable • All planning should be results-driven.
• Planning is handled by managers and process
quality objectives to address each one
owners on an ongoing basis.
based on the risk management evaluations • Details of all actions, including tasks to
held early in the QMS development completed, needed resources, responsibilities,
dates for completion, and evaluation of
process. Additionally, companies must effectiveness must be documented.
plan for any changes to the QMS to
reevaluate potential consequences and
ISO 9001 Requirements:
to continuous work toward constant
6.0 Planning
improvement. 6.3 Planning of changes

What’s Required?
“When planning for the quality management
system, the organization shall consider the issues
referred to in 4.1 (context) and the requirements
referred to in 4.2 (expectations of interested
parties) and determine the risks and opportunities
that need to be addressed… The organization
shall establish quality objectives at relevant
functions, levels, and processes needed for the
quality management system.” (6.1.1, 6.2.1)
 Things to Remember
People, competence, and knowledge
• Provide sufficient human resources and ensure
needed levels of competency through training
and documentation.
• Identify and maintain knowledge required by
the business.
The leadership team is responsible
Awareness and communication
for ensuring that the proper resources • Establish effective methods for communication
and support are in place to provide a to ensure employee awareness of and
involvement in the QMS
solid foundation on which to build and
implement an effective QMS. This includes Control of documents and records
• Control documented information that affects
equipment and facilities that result in an the QMS, including product quality and safety.
effective work environment, up-to-date • Communicate changes in relevant
documentation as needed.
process documentation, and a sufficient
workforce. Further, all equipment must Infrastructure and work environment
• Maintain needed infrastructure such as
be well-maintained and kept in order facilities, equipment, transportation resources,
with regulations for function to ensure and technology.
• Provide a suitable working environment for
accuracy, proper calibration, safety, and
people, processes, equipment and materials.
producing the desired results. • Identify, maintain, and calibrate equipment
used to monitor and measure process results.

What’s are the Support and Resources

Requirements for ISO 9001? ISO 9001 Requirements:
“The organization shall determine and provide 7 Support
the resources needed for the establishment, 7.1.1 General
implementation, maintenance, and continual 7.1.2 People
improvement of the quality management 7.1.3 Infrastructure
system.” (7.1.1) 7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating documented
information
7.5.3 Control of documented information
The quality of the organization’s Things to Remember

deliverable must meet the expectations • Customer satisfaction starts with understanding
their needs and requirements.
of the customer. This is the ultimate • Your QMS should address customer, statutory,
test of your QMS - ensuring customer and regulatory requirements.
• The entire workforce is responsible for keeping
satisfaction and keeping their needs at
the focus of the QMS on customer satisfaction.
the forefront of your focus. • All planning, objectives, operational processes,
and communication procedures should support
The entirety of the QMS must be geared customer satisfaction.
• Processes should be established to protect
toward customer needs and centered on
customers from receiving nonconforming
the understanding of their requirements. outputs.
• Specific objectives for product quality and on-
Each plan and process should have the
time delivery are required.
ultimate goal of pleasing the customer • All feedback from customers should be utilized
and the entire organization should to determine customer satisfaction and to provide
guidance on action items for improvement.
ensure that all actions are rooted in the
same. Open communication is key to
success, as are the careful monitoring ISO 9001 Requirements:
5.1.2 Customer Focus
and measurement of quality levels and
9.1.2 Customer Satisfaction
customer satisfaction.

What’s Required?
“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.” (9.1.2)
Operations is a blanket term covering Things to Remember

all the activities that go into the • Controls are far-reaching in the QMS and must
be carefully determined to affect each step of
creation of a product or service, from the production process.
customer requirement review to post- • If design and development are part of the
company’s processes, special attention must
shipment activities. Controls in the ISO
be paid to the stages of design and resulting
9001 Standard include requirements intellectual property.
for products and services, design and • Controls must help ensure that desired results
are being achieved.
development, external processes, • Controls work to ensure that externally
products, and services, production and provided resources, products, and services meet
the needed requirement to uphold quality.
service provision, release of products and
• Controls should be put in place to protect
services, and control of nonconforming processes from error.
outputs. • Release of products and services should be
carefully controlled to ensure that only top-
quality deliverables are received by the customer.
What’s Required?
“The organization shall plan, implement, and
ISO 9001 Requirements:
control the processes (see 4.4) needed to meet
the requirements for the provision of products 8 Operation
and services, and to implement the actions 8.1 Operational planning and control
determined in Clause 6… 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 (see 8.4).” (8.1)
 Things to Remember
Design and development
• Control product development steps including
planning, reviews, verification and validation.
• Ensure product changes are managed effectively.
• Consider part/material obsolescence.
Each process within your business that
Control of external providers
impacts the product life-cycle must
• Ensure adequacy of requirements communicated
be controlled and improved. They are to suppliers.
dependent on your specific organization • Verify compliance of purchased products.
• Monitor and evaluate supplier performance.
and upon the nature of the product and
• Manage risks associated with external providers.
or service you provide.
Production, service provision, inspection and
release
• Ensure proper planning and preparation of
What’s Required?
manufacturing/service provision.
“The organization shall plan, implement and • Conduct inspections and control quality.
control the processes (see 4.4) needed to meet • Control the release and delivery of products to
the requirements for the provision of products customers.
and services, and to implement the actions • Manage production/service delivery transactions
determined” (8.1) to ensure on-time delivery within acceptable
levels of risk and resource constraints.

Post-delivery support
• Provide customer assistance and product
support according to requirements.

ISO 9001 Requirements:

8.2 Requirements for products and services
8.3 Design and development of products and
services
8.4 Control of externally provided processes,
products and services
8.5 Productions and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
 Things to Remember
• Creating and implementing careful processes
to monitor, measure, analyze, and evaluate your
processes will help to ensure you are meeting
The overall goal of the ISO 9001 process operational goals and KPIs, and that you’re in
is to develop a QMS that is long-standing compliance with ISO requirements.
• Regular management reviews help maintain
and helps your business progress far QMS effectiveness and alignment with strategic
into the future. In order to create such direction by focusing on improvement and
addressing issues with inputs and outputs.
a system, you must constantly monitor,
• Trained, qualified internal auditors help to
evaluate, and improve your activities, ensure compliance of your QMS to ISO standards,
and work to remain compliant to ISO both prior to your first audit and in order to
maintain certification.
requirements. The effectiveness and • Processes are required to handle all
maintenance of your system must receive nonconforming outputs and nonconformities
(defective products/services) through a series of
constant attention from all members of
corrective actions to address the root cause.
your team, and your top management • Focus on implementing new system processes
should focus efforts on routine attention and protocols that work toward continual
improvement and system innovation.
for improvement processes. • All information related to customer satisfaction
should be monitored and evaluated including
quality, delivery performance, customer
What’s Required? complaints, and requests for corrective action.
“The organization shall determine and
select opportunities for improvement and
implement any necessary actions to meet ISO 9001 Requirements:
customer requirements and enhance customer 9 Performance evaluation
satisfaction.” (10.1) 9.1 Monitoring, measurement, analysis and
evaluation
9.2 Internal Audit
9.3 Management Review
10 Improvement
10.1 General
10.2 Nonconformity in ISO 9001
10.2 What is Non-conformance?
10.2 Corrective Action
10.3 Continual Improvement
If you are interested in pursuing certification,
contact Core Business Solutions to talk to an
ISO 9001 consultant today!

© Core Business Solutions, Inc.

Lewisburg, PA
866-354-0300 | info@thecoresolution.com
www.thecoresolution.com