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From a Series of e-Books published by deGRANDSON Global

The ISO Standard for Quality Management System

From deGRANDSON Global – the e-Learning Company

October 2023
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Contents
The ISO 9001 Standard ......................................................................................................... 4
What is ISO? ...................................................................................................................... 4
What is ISO 9001? ............................................................................................................. 5
What is the purpose of ISO 9001? ..................................................................................... 6
What is a Quality Management System or QMS? ............................................................. 7
What is the Purpose of a Quality Management System or QMS? ..................................... 8
Who needs a Quality Management System or QMS? ....................................................... 9
What are the benefits of a formal Quality Management System or QMS? ...................... 10
Certification to ISO 9001 ..................................................................................................... 12
What is ISO 9001 Certification? ........................................................................................ 12
Do You Need ISO 9001 Certification? ............................................................................... 13
Who can benefit from ISO 9001 Certification? ................................................................. 14
What are the Benefits of Having ISO 9001 Certification? ................................................. 15
How much does ISO 9001 Certification Cost? .................................................................. 17
What is the Latest ISO 9001 Version?............................................................................... 19
Who Issues ISO 9001 Certification?................................................................................. 20
How to Get an ISO 9001 Certificate? ................................................................................... 21
How to Choose a Certification Body? ..............................................................................22
Are £600 ISO 9001 Certificates You Can Get Within Seven Days Legitimate? ................. 23
Why is it Important to Get Certified by the Proper Certification Body? .......................... 24
How does the ISO 9001 Certification Process Go? .......................................................... 25
How to check the ISO 9001 Certification of an organization?..........................................27
Do Management Representatives or others responsible for a Quality Management
System or QMS need training? ....................................................................................... 28

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Do Internal Auditors need training?................................................................................ 29

Can I get ISO 9001 Training Online? ................................................................................ 30
Got a question we haven't answered? ................................................................................ 31

The Author:

Dr John FitzGerald
Director and founder of deGRANDSON Global. After 15 years in
manufacturing industry, John has spent the past 25 years training,
consulting, and auditing ISO 9001, ISO 14001, ISO 13485, ISO 27001,
ISO 45001, ISO 17025, and other management systems. 'Our
objective is to be a world-class provider of e-training using the best-
proven technology to satisfy and, hopefully, delight all of our
Learners. Great commercial success and professional esteem will
surely follow.' Please find me on Facebook and LinkedIn.

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The ISO 9001 Standard

What is ISO?
The International Organization for Standardization (ISO for short) is the world's largest
developer of voluntary International Standards. Their 21,000+ standards offer solutions
and best practice guidance for all types of technology and businesses, helping companies
and organizations increase performance while protecting consumers and the planet.
While most are product and technical standards, the ISO has developed 40+ management
system standards.
The best known of these include ISO 9001 (quality), ISO 14001 (environment), ISO 45001
(health & safety) and ISO 27001 (information security management). The feature they all
have in common is that they are auditable. They are written to facilitate auditing by an
independent third party (e.g., CAB) to confirm compliance with the standards’
requirements.
ISO 13485 is a quality management system standard based on ISO 9001, considered the
parent of all the other standards.
For more, visit ISO 9001 on the ISO website.
Enjoy!

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What is ISO 9001?

ISO 9001 (or, to give it its full title, ISO 9001:2015, Quality management systems -
requirements) is an internationally recognized standard that sets out the requirements for
an ISO Quality Management System (QMS).
It was initially developed by the British Standards Institute and was known as BS 5750. It
became an international standard in 1991 when published under the auspices of the
International Standards Organization (ISO).
While originally product-focused (and mainly of interest to manufacturing businesses), it
has evolved through several iterations into a standard focused on managing the
processes that make up an organization’s activities. As such, it is now globally applicable
to all kinds of organizations.

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What is the purpose of ISO 9001?

The purpose of the standard is to provide a framework for an organization to develop a
management system that will…
1. Consistently meet customer requirements, that is, always provide a product or
service that meets specifications or other agreed/recognized criteria and
2. Enhance customer satisfaction through continual improvement of the
management system.
Fundamental to fulfilling achieving these objectives are two features…
1. A Quality Policy - the intentions and direction of an organization as formally
expressed by its top management and consistent with the context of the
organization and
2. Quality Objectives – measurable targets, generally specified for relevant
organizational functions, levels, and processes – focused on improvements.
External Auditors will persistently pay great attention to these four issues.
For more, visit ISO 9000, Quality Management Systems – Fundamentals and vocabulary

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What is a Quality Management System or

QMS?
An ISO quality management system (QMS) is defined as a formalized system
that documents processes, procedures, and responsibilities for achieving quality policies
and objectives. It is expressed as the organizational goals, aspirations, and resources
needed to implement and maintain them.

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What is the Purpose of a Quality

Management System or QMS?
A QMS helps coordinate and direct an organization’s activities to meet customer and
regulatory requirements and improve its effectiveness and efficiency on a continuous
basis.

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Who needs a Quality Management System

or QMS?
Whether you realize it or not, you already have an informal QMS. You look after your
customers, don’t you? You strive to provide customers with good products or services
consistently. You are always trying to improve to stay ahead of competitors?

So, you have a QMS, and the fundamental question is, do we need to formalize the
system? Most organizations asking themselves this question say yes. And currently, more
than 1 million organizations globally have a formal QMS certified to ISO 9001.

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What are the benefits of a formal Quality

Management System or QMS?
There are at least sixteen benefits that organizations with a quality management system
in place can enjoy, such as:

1. Immediate benefits: Management systems are designed to a) Get it right the first
time, b) Be consistent and reliable, c) Seek out the root causes of problems, and
d) Not to repeat mistakes.

2. Immediate benefit #2: Continual Improvement is driven by reliable metrics

(statistics)

3. Organized management: An organization certified to the standard is managed in a

standard and structured way

4. Clarity of Purpose: Staff are clear as to their responsibilities, authorities, and

accountabilities

5. Processes and procedures suited to the Mission and strategic objectives you have
set for the organization.
6. Internal audits to monitor compliance with requirements and highlight
deficiencies.
7. Corrective actions to prevent the recurrence of errors - try to make mistakes only
once, if at all.
8. Informed Board of Directors, knowing that the organization is focused on strategic
objectives while satisfying customers and planning and acting to address future
challenges.

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9. Management satisfaction knowing that the organization is functioning in line with

strategic objectives and satisfying customers.
10. Minimal costs for maximum gain: the costs of maintaining Certification are minimal
compared to the potential created by having an ISO 9001-compliant Quality
Management System.
11. Reduce errors: Fewer costly errors, less rework, replacement of goods and/or
services, and increased productivity.
12. Fewer customer complaints as fewer errors occur.
13. Better retention of customers: again, a consequence of reduced errors.
14. Management performance improved as less time is spent apologizing to
customers and managing the unnecessary repetition of work.

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Certification to ISO 9001

What is ISO 9001 Certification?

An ISO 9001 certification is issued by an accredited Certification Body which has carried
out an independent third-party audit. Having ISO 9001 certification proves that an
organization has implemented and is maintaining a quality management system that
meets the requirements of ISO 9001:2015.

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Do You Need ISO 9001 Certification?

Yes and No.

In many cases, ISO 9001 Certification is not mandatory but can be a valuable tool to add
credibility by demonstrating that your product or service meets your customers'
expectations. For some industries, Certification is a legal or contractual requirement.

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Who can benefit from ISO 9001

Certification?
Organizations, regardless of the industry they specialize in or the region in which they
operate, can all benefit from having a formal Quality Management System compliant with
the requirements of ISO 9001. Aiming for ISO 9001 certification is therefore
recommended whenever possible.

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What are the Benefits of Having ISO 9001

Certification?
The effective implementation and maintenance of ISO 9001 certification come with
many benefits, like those that come with having a formal Quality Management System.
These include:

1. Management systems become more efficient, consistent, and reliable.

2. Continual improvement is driven by reliable metrics (statistics).
3. Organized management: An organization certified to the standard is managed in a
standard and structured way
4. Clarity of Purpose: Staff know their responsibilities, authorities, and
accountabilities.
5. Processes and procedures suited to the Mission and strategic objectives you have
set for the organization.
6. Internal audits to monitor compliance with requirements and highlight
deficiencies.
7. Corrective actions to prevent the recurrence of errors - try to make mistakes only
once, if at all.
8. Informed Board of Directors, knowing that the organization is focused on strategic
objectives while satisfying customers and planning and acting to address future
challenges.
9. Management satisfaction knowing that the organization is functioning in line with
strategic objectives and satisfying customers.
10. Minimal costs for maximum gain: the costs of maintaining Certification are minimal
compared to the potential created by having an ISO 9001-compliant Quality
Management System.

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11. Reduce errors: Fewer costly errors, less rework, replacement of goods and/or
services, and increased productivity.
12. Fewer customer complaints as fewer errors occur.
13. Better retention of customers: again, a consequence of reduced errors.
14. Management performance improved as less time is spent apologizing to
customers and managing the unnecessary repetition of work.

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How much does ISO 9001 Certification

Cost?
The cost of ISO 9001 certification varies hugely based on the organization's size,
geographical location, and economic prosperity.

Let’s take the example of an SME with ten employees. Here are some typical prices from
the UK for 2023, where we consider three scenarios …

Minimum Consultancy Maximum Consultancy

Scenario (1) Do-it-yourself (2)
Support (3) Support (4)
Develop QMS (8 days) £800 £1600 £4000
Implement QMS (8 days) £800 £1600 £4000
Maintain QMS (2 x 3 years) £600 £600 £3000
Certification Year 1 £2500 £2500 £2500
Year 2 £1000 £1000 £1000
Year 3 £1000 £1000 £1000
Total 3-year cost £6700 £8300 £15500
Typical duration to Certification 11 months 5 months 4 months

Notes:
1.

1. It is necessary to examine a 3-year horizon as CABs play games with their quotations that
can be confusing. What is a given, however, is that CAB Audits and the associated contract
must, under IAF rules, be based on a 3-year cycle.

2. No outside help. The project leader would need ISO 9001 Lead Implementer Training.

3. Four days of consultancy support are included here. Priced at £ 500 p.d., consultancy costs
range from £300 to £700 per day. Satisfactory references must be obtained for previous
ISO 9001 projects.

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4. Maintenance here includes two days annually for internal auditing and Management
Review support.

The best advice for controlling costs is to shop around and recheck the competitiveness
of your chosen CAB regularly.
For more, visit the ISO 9001 Lead Implementer Certification Course. Also, see Steps to ISO
9001 Certification.

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What is the Latest ISO 9001 Version?

The latest ISO 9001 version as of this writing is ISO 9001:2015 -- the revision of the previous
ISO 9001:2008, which, itself, was a revision of ISO 9001:2000.
At the time of writing, October 2023, initial steps are being taken by the relevant ISO
Committee to initiate a revision of the standard. However, based on previous experience,
it will be at least three years before such a revision is published, with an additional 3 year
transition period to follow.

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Who Issues ISO 9001 Certification?

The ISO develops International Standards, such as ISO 9001 and ISO 14001, but is not
involved in their Certification. It does not issue certificates. ISO 9001 certification is
performed by external certification bodies; so a company or organization cannot be
certified by the ISO organization itself.

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How to Get an ISO 9001

Certificate?
Certificates are issued by CABs after they have gone through an ISO Certification
process. This process is based on a comprehensive 2-stage audit (itself based on
the auditing standard, ISO 19011), which involves a documentation review and an
independent on-site audit.
The CAB gathers and documents objective evidence of compliance with the requirements
of ISO 9001. After the CAB has confirmed that all the requirements of the ISO 9001
Standard have been implemented and are being maintained, a Certificate is issued as is
permission to use logos to publicize the fact.
For more, visit Expected Outcomes for Accredited Certification…. ISO 9001 …

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How to Choose a Certification Body?

The choice of CAB is important. An accredited CAB (e.g., BSI) should be used wherever
possible, and with ISO 9001, one won’t be difficult to find.
Accreditation, issued by a nationally recognized Accreditation Board (e.g., UKAS), is an
essential confirmation of the legitimacy of the CAB. To help ensure an international ‘level
playing field’ for CAB auditing standards, National Accreditation Boards have their own
international organization, the International Accreditation Forum (IAF), which oversees an
ongoing program of witnessed self-assessment of IAF Members of each others’ activities.
A Certificate from an accredited CAB will carry three logos. #1 the CAB’s own logo, #2 the
Accreditation Boards logo, and #3 the IAF logo. If you present an ISO 9001 Certificate to a
customer or potential customer that does not carry all three logos, expect to be
challenged. Without a plausible explanation, you can expect your approach to be
rejected.

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Are £600 ISO 9001 Certificates You Can Get

Within Seven Days Legitimate?
Legally speaking? Yes. But the Certificate is worthless. There are ‘cowboy’ CABs (whom
you should ask to explain how an organization can create three months of records, the
minimum needed to prove maintenance of a QMS, in 7 days) and even ‘cowboy’
Accreditation Bodies.
With ISO 9001 Certificates, making sure you have the real thing fundamentally means
choosing a CAB that will get you an IAF logo for your Certificate. Ask about it by name
and accept nothing else (for Labs, seek out the IAF’s sister organization, ILAC –
International Laboratory Accreditation Cooperation).

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Why is it Important to Get Certified by the

Proper Certification Body?
Remember that those reviewing tender documents are unlikely to be inexperienced.
They will recognize a phony Certification instantly. And your offering will go directly into
the rubbish bin with the hard work you’ve expended to develop products and services
you are proud of totally wasted. Most importantly, you wouldn't want an ISO Auditor to
find such bogus Certificates when checking your evaluation of external providers
(suppliers).
For more, visit Is IAF Accreditation possible for all ISO Standards? and Your Accreditation
Body must follow IAF Guidance.

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How does the ISO 9001 Certification

Process Go?
As you will have seen in the cost data above, there are two stages in securing ISO 9001
Certification:

Stage 1. Develop, implement, and maintain a suitable QMS for your organization and
Stage 2. Engage the services of a CAB to undertake the necessary evaluations and ISO
Certification Audits.

Stage 1. Develop, implement, and maintain a suitable QMS for your organization:
Our Infographic shown here nicely illustrates the multi-step process of preparing for
Certification (click on the infographic image to get a copy for yourself). Whichever of the
three approaches you choose (or variants thereof), you will benefit from our ISO 9001
Lead Implementer Course in managing and directing your ISO 9001 Project.
Stage 2. Engage the services of a CAB to undertake the necessary evaluations and
audits:
When choosing a certification body, you should:
• Evaluate several certification bodies.
• Check if the certification body auditing activities include ISO 9001:2015.
• Check if it is accredited. Accreditation is not compulsory, and non-accreditation
does not necessarily mean it is not reputable, but it does provide independent
confirmation of competence. To find an accredited certification body, contact the
national accreditation body in your country or visit the International Accreditation
Forum.

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Note: the terms certification and accreditation cannot be used interchangeably, though it
is not uncommon to do so. The differences between Certification and accreditation are as
follows:
Certification – the provision by an independent body of written assurance (a certificate)
that the product, service, or system in question meets specific requirements.
Accreditation – the formal recognition by an independent body, generally known as an
accreditation body, that a certification body operates according to international
standards.
For more, visit the International Accreditation Forum/about us/ and 10 Reasons to change
your ISO Certification Body.

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How to check the ISO 9001 Certification of

an organization?
The IAF, after struggling with the issue for many years, launched IAF CertSearch. This is an
exclusive global database for accredited management system certifications. Other
databases, irrespective of the organization publishing them, should be treated with
skepticism or, better still, ignored.
Currently, CertSearch has over 400,000 valid certifications across more than 150
economies covering a range of sectors, 4,000 certification bodies, and 68 IAF MLA
signatory accreditation bodies. While highly dependable, this database is a long way from
being complete when one considers that there are one million-plus organizations certified
to ISO 9001:2015 alone.
Businesses and governments can digitally validate an organization’s Certification (s) to
determine if a certificate is valid and if the Certification Body issuing the Certificate is
accredited to issue certifications to that standard.
The direct route is, of course, always open to you – ask the organization for a copy of their
current Certificate. Many will have their Certificate on display on their website.
For more, visit IAF CertSearch.

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Do Management Representatives or
others responsible for a Quality
Management System or QMS need
training?
The training of a Management Representative or others with day-to-day responsibility to
maintain a QMS is NOT mandatory. Training is implied as part of developing competence
but not a specific stand-alone requirement. So, unless you are determined to outsource
this support indefinitely (technically, that’s not permitted), you must train your
Management Representative. And you’re in luck. We’ve got precisely the Course you
need.
For more, visit our ISO 9001 Lead Implementer Course page.

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Do Internal Auditors need training?

Again, training here is not mandatory. However, effective internal audits are essential to
doing a professional job in maintaining your QMS and avoiding nasty surprises at your
next Certification Body audit. Also, if you don’t train them, your auditors won’t have any
of the skills necessary to ‘harvest’ those improvement suggestions from the people in
your organization who actually do the work.
For more, visit the ISO 9001 Internal Auditor Course.

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Can I get ISO 9001 Training Online?

Yes, you can. deGRANDSON Global provides online ISO 9001 training for internal auditors,
lead auditors, and lead implementers via our web-based learning management system.
Since 2015, we have been certified to ISO 21001 (formerly ISO 29990), ISO 29993, and ISO
29994. The three standards are used globally by schools, colleges, and universities to
demonstrate their competence, with the latter two specifically designed for online
learning providers and other non-formal teaching types.
Read on to know how deGRANDSON's e-Training courses differ from those of others and
why it works.

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Got a question we haven't

answered?
We'd love to hear it and, if possible, answer it for you. Just use our Support Ticket
System. You'll find a Knowledge Base there that might have an immediate answer for
you. Otherwise, fill in a Ticket.
For more, visit deGRANDSON Support Ticket.

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