ISO 9001:2015 –
An introduction to the world’s
most popular standard
Presented by:
Joseph W. Krolikowski
QMS Program Manager
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Overview of topics
What is ISO 9001?/Deconstructing the Scope Statement of ISO 9001
Where do ISO standards come from?
The impact of Annex SL
ISO 9001:2015 “Cover to Cover”
ISO 9001:2015 Key Ideas
Concluding remarks/Questions
What is ISO 9001?
ISO 9001 is officially titled “Quality management systems –
requirements.”
It’s intent is provided in Section 1.0 “Scope” (this statement in
unchanged in the past three editions of ISO 9001)
“This International Standard specifies requirements for a quality
management system when an 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 through the effective
application of the system, including processes for improvement of
the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.”
Deconstructing the scope
statement
Let’s examine this scope piece by piece, as it is a vital part of
understanding what ISO 9001 is all about.
“This International Standard specifies requirements for a quality
management system…”
The opening declaration establishes a key requirement for the
entire standard and any person/party that wishes to use it.
Namely, that ISO 9001 is not a product standard. It does not seek
or intend to define how a product is manufactured.
The organization that seeks certification to ISO 9001 is still expected
to define for itself how the products are made and controlled.
Deconstructing the scope
statement
“…when an organization needs to demonstrate its ability to
consistently provide products and services …”
The scope continues with another key statement – the
inclusion of services.
In the early years of ISO 9001, the thought was that it was
primarily geared to organizations that manufactured tangible
products. As time progressed, it was clear that the principles of
ISO 9001 offered equal benefit to services based organizations.
Deconstructing the scope
statement
“…that meet customer and applicable statutory and
regulatory requirements, and aims to enhance customer
satisfaction…”
Perhaps the central cornerstone of the ISO 9001 standard is its
demand that organizations be attuned, receptive, and
responsive to the needs of their customers.
Deconstructing the scope
statement
“…through the effective application of the system, including
processes for improvement of the system and the assurance of
conformity to customer and applicable statutory and regulatory
requirements.”
These final statements acknowledge the ongoing nature of a
quality management system (it’s not something you implement
and forget about!)
Additionally, the inclusion of “improvement” as a direct callout is
also foreshadowing the importance of improvement on the overall
nature of ISO 9001.
Where do these standards come
from?
The International Organization for Standardization (ISO) is a
collective made up of numerous international members;
Each standard is assigned a Technical Committee (TC) for
authorship;
TC 176 is the Technical Committee assigned to ISO 9001;
TC 176 includes members from each of the major industrialized
nations;
American National Standards Institute (ANSI)
How is ISO 9001:2015 organized?
To understand the ordering of clauses and content within ISO
9001:2015, we must first explore a key document that was
developed three years before ISO 9001:2015’s publication –
Annex SL.
What is Annex SL?
Annex SL has also been referred to as the “High Level Outline”
or “Annex XL.”
Annex SL is part of a larger ISO publication called “ISO/IEC
Directives Part 1 – Consolidated ISO Supplement – Procedures
Specific to ISO.”
ISO/IEC Directives Part 1 (and Annex SL therein) can be
downloaded for free from the ISO website – www.iso.org
More details about Annex SL
Annex SL was first published in 2012 and represented the output of
a special committee of the ISO called the Joint Technical
Coordination Group (JTCG.)
A 10 section “blueprint” for authoring all of the ISO family of
standards.
Annex SL promotes (among other things) utilization of common
terms and core definitions.
Nearly every standard published by ISO has completed it’s
transition to Annex SL format.
Some are still being rolled out or have transition deadlines that extent
into 2020 and 2021.
Example of how Annex SL works
Annex SL Clause 9.2.1 ISO 9001:2015 Clause 9.2.1
9.2.1 The organization shall conduct internal 9.2.1 The organization shall conduct internal
audits at planned intervals to provide information audits at planned intervals to provide information
on whether the XXX management system:
on whether the quality management system:
a)conforms to:
a) conforms to:
the organization’s own requirements for its XXX
management system;
1) the organization’s own requirements for its
quality management system;
the requirements of this International
Standard/this part of ISO XXXX/this Technical
Specification; 2) the requirements of this International Standard;
b) is effectively implemented and maintained.
b) is effectively implemented and maintained.
Annex SL includes 7 auditable
sections – beginning with Section 4
4 Context of the organization
understanding the organization and its context
understanding the needs and expectations of interested parties
determining the scope of the quality management system
quality management system and its processes
Annex SL Sections 5 and 6
5 Leadership and Commitment
general
customer focus
policy
organizational roles, responsibility and authority
6 Planning
actions to address risks and opportunities
quality objectives and planning to achieve them
planning of changes
Annex SL Sections 7 and 8
7 Support
resources
competence
awareness
communication
documented information
8 Operation
operational planning and control
requirements for products and services
design and development of products and services
control of externally provided processes, products, and services
production and service provision
release of products and services
control of nonconforming outputs
Annex SL Sections 9 and 10
9 Performance evaluation
monitoring, measurement, analysis and evaluation
internal audit
management review
10 Improvement
general
non-conformity and corrective action
continual improvement
ISO 9001:2015 – Cover to Cover
Introduction Section
0.1 – General: Provides an overview statement, intentions on whom the
standard benefits, introduces the ideas of Risk Based Thinking, PDCA, and
explains four key terms (three of these are getting official definitions for the
first time):
Shall – mandatory requirement (numerous instances);
Should – recommendation (no uses within the auditable content);
May – permission (this term appears once in the auditable content); and
Can – possibility or capability – numerous instances.
ISO 9001:2015 – Cover to Cover
Introduction Section
0.2 – Seven Quality Management Principles – reference to the ISO 9000
standard is given:
Customer Focus;
Leadership;
Engagement of People;
Process Approach;
Improvement;
Evidence-Based Decision Making; and
Relationship Management.
0.3 – Process Approach – reinforcement of the process approach an
improved graphic therein. Reinforcement of Plan-Do-Check-Act
(PDCA) and an improved graphic therein.
ISO 9001:2015 – Cover to Cover
Introduction Section
0.3.3 – Risk Based Thinking – definition and explanation of
importance
0.4 – Relationship with other management system standards (ISO
9000 and ISO 9004)
ISO 9001:2015 – Cover to Cover
Section 1 – Scope – General verbiage related to the
applicability of ISO 9001;
Section 2 – Normative Reference – Linkage to ISO 9000:2015 for
all official terms and definitions;
Section 3 – Terms and Definitions – currently without content,
but could be used as a future placeholder for ISO 9001 specific
definitions.
ISO 9001:2015 – Cover to Cover
Sections 4-10 – As previously reviewed;
Annex A – Informative – Several key points of information and counsel to be
found here, including:
A.1 – Structure and terminology – reinforces the doctrine that an
organization does not have to align their documentation to match ISO
9001:2015, nor does it have to use the specific terms found in the standard;
A.2 – Products and services – a fuller explanation of intent in changing all
references of “product” to read “products and services”;
A.3 – Understanding the needs and expectations of interested parties – a
more full explanation of intent in the identification of interested parties;
A.4 – Risk based thinking- an extensive section intended to assist in the more
full understanding of this concept, emphasizing that a formal
structure/process for Risk Management is not required;
ISO 9001:2015 – Cover to Cover
Annex A continued
A.5 – Applicability – Further discussion on the logic for removing “exclusions”
from the ISO 9001 standard and the new concept of “non-applicables”
A.6 – Documented Information – Further discussion on the new term that has
replaced “Procedure”, “Record”, and “Document”;
A.7 – Organizational Knowledge – An explanation of requirements pertaining
to competency and ongoing competency through various challenges an
organization might face;
A.8 – Control of externally provided products and services – Provides an
expansive explanation of this phrase and who it applies to.
ISO 9001:2015 – Cover to Cover
Annex B – Further, extensive discussion on the relationship
between ISO 9001 and other publications (ISO 9004, ISO 10001,
etc.)
Bibliography
Key ideas found in ISO 9001
Over the next several slides, I’d like to give you an introduction
to some of the more important fundamental ideas postulated
by ISO 9001, including clausal linkages where possible.
Scope
Processes
Accountability
Effectiveness
Improvement
Key Idea 1 - Scope
Early in the standard (Section 4.3) the Organization is directed to
develop a “Scope Statement.”
A Scope statement represents the extent and boundaries of your
quality management system. Here are a few examples:
Design, Fabrication and Assembly of Collapsible Tripods;
Distribution of Fasteners;
Plating, Heat Treating, Sorting of Metal Stampings.
Key Idea 1 - Scope
Ideally, the scope statement that you develop will eventually be
the same as that shown on the ISO 9001:2015 certificate issued by
PJR.
Don’t list an item on your scope that won’t be available for audit.
An organization that has “Field Installation” in their scope statement
needs to provide for a remote audit of the “Field Installation” activity if
it is to be listed on the certificate.
An organization that has purchased new equipment that isn’t up and
running yet.
Key Idea 1 - Scope
Be careful about being too “wordy” in your scope statement. Consider the following
scenario. An organization has the following as their scope statement:
“Laser Cutting, Waterjet Cutting, Progressive Die Cutting, Plating, Heat Treating, and Distribution of Flanges,
Springs, Shims, Bolts, and Barrels.”
In the above example – PJR has to audit:
Laser Cutting,
Waterjet Cutting,
Progressive Die Cutting,
Plating,
Heat Treating, and
Distribution
We also have to ensure the following product groups are sampled:
Flanges,
Springs,
Shims,
Bolts, and
Barrels.
Key Idea 2 - Processes
Another core idea that is first mentioned early (Section 4.4) is
the directive that organizations determine what their processes
are and how they interface with each other.
Section 4.4 states that a quality management system is made
up of processes.
The concept of “Process” is a key one in the world of ISO
standards. PJR has an entire webinar called “The Interaction
of Processes and its importance to a successful audit” that
covers this topic in great depth.
Key Idea 2 – Processes
The concept of Processes cascades throughout the ISO 9001 standard,
including (but not limited to) the following clauses:
“Use of the process approach” is first mentioned in clause 5.1.1d;
Aligning quality objectives to processes is discussed in clause 6.2.1;
Ensuring competent staff for available for all processes is discussed in clauses
7.1.2 and 7.1.6
Ensuring effective infrastructure for all processes is discussed in clause 7.1.3
Control over “external” processes is discussed in clause 8.4
Review of process performance is specified in clause 9.3.2c3
Key Idea 2 - Processes
PJR encourages you to make your processes as personal and
unique to your business as possible.
This will go a long way to ensuring that your quality management
system is adding value to your organization and that you
understand it.
Resist the urge to name your processes after the sections of the
ISO 9001 standard!
Key Idea 3 – Accountability
ISO 9001:2015 demands inclusion of all persons that fall within
the scope of the quality management system.
This inclusion is most directly addressed in Section 5.1.1, where
the standard demands that Top Management make itself
accountable for the effectiveness of the quality management
system.
Key Idea 3 - Accountability
Other key places where accountability is demanded:
Product release records must “name names” (clause 8.6);
Problems (including complaints) must be responded to with
appropriate systemic action (clause 10.2);
Organizations must define roles, responsibilities, and authorities (clause
5.3);
All personnel must be cognizant of the quality policy (clause 5.2.2B),
and how they contribute to the effectiveness of the quality
management system (clause 7.3.)
Key Idea 4 – Effectiveness
ISO 9001:2015 has numerous requirements that require the
organization to measure the effectiveness of something.
The idea is that the organization should know at any given time
how well (or how poorly) things are going in their operation.
Key Idea 4 - Effectiveness
This basic idea of effectiveness measures begins and is most
succinctly established in clause 4.4.1c where it states that the
organization must
“determine and apply the criteria and methods (including
monitoring, measurements and related performance indicators)
needed to ensure the effective operation and control of
processes”
Key Idea 4 - Effectiveness
Other key areas where the idea of effectiveness measures is
discussed:
Tracking of quality objectives (6.2.1);
Evaluation of competency actions (7.2);
Evaluation of external provider performance (8.4);
Product/service inspection (8.6);
Customer satisfaction (9.1.2);
Overall trending of the quality management system (9.1.3);
Assessment of the system via internal audit (9.2);
Review of key system aspects via management review (9.3); and
Efforts targeting improvement (10.1)
Key Idea 5 – Improvement
The final cornerstone concept we will explore today is
Improvement.
As currently referenced, Improvement represents an evolution
of an older concept called “Continual Improvement.”
The current concept of Improvement acknowledges that
improvement is possible is a number of key ways (continual
improvement, reactive changes, breakthroughs, etc.)
Key Idea 5 - Improvement
Improvement is explored primarily in section 10.1 of ISO
9001:2015. This clause indicates that that organization must:
“The organization shall determine and select opportunities for
improvement and implement any necessary actions to meet
customer requirements and enhance customer satisfaction.”
Key Idea 5 – Improvement
Like the other key ideas we’ve discussed today, Improvement is revisited as
a concept again and again throughout the ISO 9001:2015 standard.
Section 4.4 – states that the organization must “continually improve” its
quality management system.
Section 5.1.1 – states that management must “promote improvement”;
Section 5.2.1D – states that the Quality Policy must address continual
improvement;
(list continued on the next slide)
Key Idea 5 – Improvement
Section 5.3C – states that assigned responsibilities must include
reporting on opportunities for improvement;
Section 6.1.1D – states that risk action efforts should target
improvement;
Section 7.1.1 – states that resources should enable the organization to
achieve continual improvement;
Section 7.3 – states that persons who work for the organizations should
be aware that their efforts impact improvement; and
Section 9.3.2F – statement that opportunities for improvement should
be among the items discussed in management review meetings.
Conclusion
ISO 9001:2015 remains the world’s most utilized standard (just
over 1.3 million registered companies.)
Organizations seeking certification to ISO 9001:2015 would do
well to bear in mind the “big picture” of what ISO 9001:2015
seeks to promote.
Ready for a deeper dive?
PJR is working on an new course that will provide a “clause by
clause” primer for anyone who is new to ISO 9001:2015 and needs
to have a better understanding in preparation for audit or other
purposes.
The pending title for this course is “ISO 9001:2015 Clausal Overview”
The course will be online and free of charge.
Look for an announcement on when registration will be available
(anticipated launch is mid-year 2019)
Please tune in for one of our
other webinars
“ISO 9001:2015 – Anticipating Auditor Expectations in Key Areas” is presented on a
quarterly basis.
This webinar explores what some of the more common “issues” are in ISO 9001:2015 audits and
what is typically expected for these areas.
“Non-Applicable Clauses, Permissible Exclusions, Exemptions - Developing a better
understanding of what can and what cannot be excused in an audit assessment” is
presented on a quarterly basis.
This webinar explores the critical topic of exemptions and the right approach to take in
determining which apply to you.
“The Interaction of Processes and its importance to a successful audit.”
This webinar explores the crucial topic of processes and how to correctly understand them.
We offer a variety of webinars on other topics including Stage 1 Audits, AS9100, ISO
13485:2016, IATF 16949, and ISO 14001:2015.
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Reminders:
Copies of today’s presentation will
be available for download shortly.
This webinar (and all other past PJR
webinars) will also be available for
re-viewing on our website under
“Previously Recorded Webinars.”
Questions?
Learn more at www.pjr.com
