How Many Clauses Are In ISO 9001? (hint there are 10!

)
How many clauses are in ISO 9001? In the most recent 2015 version of ISO 9001, there are 10 separate, top-level
clause headings. Below those headings are 56 sub-clauses that each define over 300 individual requirements.

The adoption and compliance of these common requirements allows businesses of any type to implement and maintain
their own quality management system in order to better achieve customer satisfaction and attain recognized
certification.

Contents
 What Are The ISO 9001 Clause Headings?
 1. Scope 2. References 3.Terms and Definition
 4. Context of the Organization
 5. Leadership
 6. Planning
 7. Support
 8. Operation
 9. Performance Evaluation
 10. Improvement
 Are The ISO 9001 Clauses Also Requirements?
 The Seven Mandatory Clauses
 Are There Any Exceptions?
 How Have The ISO 9001 Clauses Changed Over The Years?
Unlike the previous version of ISO 9001, the current 2015 revision contains a total of 10 headings or clauses, with 7 of
them containing the 'mandatory' requirements (Clauses 4 to 10). The first three clauses provide general information
but they are no less important.

Each of these sub-clauses contain individual requirements and processes that must be followed in order for the business
to successfully attain certification, as well as benefit from everything that comes from a properly executed quality
management system.

What Are The ISO 9001 Clause Headings?

Take a look at the list down below to learn the specific names of each ISO 9001 clause, and keep reading to get an idea
of what each one is all about.

1. Scope
2. Normative References
3. Terms and Definitions
4. Context of the Organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance Evaluation
10. Improvement
Let’s take a look at each one of these clauses, starting from number one all the way to ten. The lists throughout the rest
of this section will give you a general idea of what is included within each sub-clause.
 1. 2. & 3. Scope, References, Terms and Definitions
 1 Scope of the standard
 2 Normative references
 3 Terms and definitions
The first three clauses in ISO 9001:2015 are scope, references, and terms and definitions. These are informational
clauses, rather than clauses that outline any kind of actions or requirements. This is something we will get into in a later
sections.

1 Scope of the standard

The scope of the standard highlights the two basic tenets of what quality management is intended to achieve.

The standard encourages businesses to implement processes and systems to ensure consistent product and service
output, while ensuring that customer satisfaction is enhanced through conformity and improvement.

2 Normative references

Normative references provide a better understanding of the terms used in ISO 9001:2015 through relatable comparisons
to the vocabulary that are used in the ISO 9000:2015 standard.

3 Terms and definitions

References for better understanding of basic terms by highlighting vocabulary and definitions from ISO 9000:2015. Refer
to ISO 9000:2015 Quality Management Systems Fundamentals and Vocabulary.

Other related and applicable standards that you could refer to might include, among others:

 ISO 9004-2018 Quality management — Quality of an organization — Guidance to achieve sustained success
 ISO 19011-2018 Guidelines for auditing management systems
 ISO 10004-2018 Quality management — Customer satisfaction — Guidelines for monitoring and measuring
These were the informational clauses, rather than clauses that outline any kind of actions or requirements. The
following section will now focus on discussing the requirements in more detail.

4. Context of the Organization

 4.1 Understanding organizational context
 4.2 Understanding the needs and expectations of relevant stakeholders
 4.3 Determining the scope of the management system
 4.4 The quality management system and its processes
The fourth clause in ISO 9001 outlines the general requirements for the entire quality management system as a whole.

4.1 Understanding organizational context

Collate evidence to provide assurance that your organization is regularly, or as necessary, reviewing and updating
information relating to its external and internal issues.

Although there is no requirement for documented information to define the context of the organization, your
organization will find it helpful to retain the types of documented information listed below to help demonstrate
compliance:

 Business plans and strategy reviews

 Competitor analysis
 SWOT analysis for internal issues
 PESTLE analysis for external issues
 A list of external and internal quality issues and conditions
 QMS action plans and objectives
 Annual reports
 Minutes of meetings (e.g. management review, design review minutes, etc.)
 Process maps, tables, spreadsheets, and turtle diagrams, etc.
Reviewing your organization’s context should include interviews with senior management, questionnaires, surveys and
research. Cross-functional input is essential for gaining the expertise to identify the full range of issues, such as finance,
training, human resources, commercial, engineering and design, etc.

4.2 Understanding the needs and expectations of relevant stakeholders

Similar to the context review discussed above, cross functional input is vital, as certain functions will identify with
particular stakeholders, for example procurement with suppliers, and sales with customers.

A workshop approach should be encouraged which can be undertaken independent to, or in conjunction with the
context review workshop.

Once stakeholders and their requirements are identified, the next step is to consider which stakeholder requirements
generate compliance obligations. Legal requirements should be identified before other requirements.

This process of adopting requirements will allow you to focus and coordinate on what’s important.

4.3 Determining the scope of the management system

You will need to verify that your organization’s scope exists as documented information (which may be contained in the
quality manual) in accordance with Clause 7.5.1a.

Verify that the organization’s scope has been established in consideration of organization’s boundaries and applicability
of the quality management system.
 Look for confirmation that your organization has determined the boundaries and applicability of the quality
management system to establish its scope with reference to any external and internal issues referred to in 4.1 and the
requirements of relevant interested parties referred to in 4.2.

The scope of your quality management system may include the whole of the organization, specific and identified
functions within the organization, specific sections of the organization, or one or more functions across a group of
organizations.

4.4 The quality management system and its processes

ISO 9001:2015 include specific requirements necessary for the adoption of processes when developing, implementing
and improving a quality management system.

This requires your organization to systematically define and manage processes and their interactions so as to achieve
the intended results in accordance with both the policy and strategic direction.

 How well is the ‘process approach’ understood in the organization?

 Is the quality management system in line with the organization’s context, and requirements of interested parties?
 Is it likely the established quality management system will achieve its intended outcomes and enhance quality
performance?
 Does it include the enhancement of quality management system performance?
 Does it include the desire to fulfill of compliance obligations and objectives?
Existing operational procedures, work instructions and flow charts are valid examples of documented information and
can be used to evidence the requirement for ‘documented information to support the operation of processes is being
met’.

When an outsourced process is controlled through purchasing, there must be documented information to ensure that
the processes are being controlled - using techniques like:

 Auditing and inspections

 Contractual agreements
 Trend monitoring
 Quality and commercial reviews
 Process performance data review on an on-going basis

5. Leadership
 5.1 Demonstrating leadership and commitment, and customer focus
 5.2 Establishing and communicating the quality policy
 5.3 Establishing roles of authority and responsibility in the workplace
Management responsibility has to do, mainly, with customer commitment requirements. This is basically the company’s
commitment to serving the customer and building a more loyal following.

5.1 Demonstrating leadership and commitment, and customer focus

 This section also establishes a general focus of the company, in terms of the customer. In other words, the company is
pledging to always keep the customer happy, and do what they can to improve their products, services, and procedures
accordingly.

Without solid management commitment, you will not have a successful quality management system. This is not a
commitment in words; it is the continuous and active demonstration to everyone in the organization that the need to
meet customers' expectations is vital.

The actions required of Top management include:

 Supporting the quality management system and actively promoting the agenda
 Encouraging the goal of meeting, customer, regulatory and statutory requirements
Develop and support the quality management system by:

 Defining and communicating the quality policy

 Establishing organizational quality objectives
 Ensuring appropriate resources are available
Implement and improve the quality management system by:

 Encouraging employees to achieve requirements

 Reviewing QMS performance
 Ensuring resources are available to improve the QMS
Customer focus involves determining customer requirements and ensuring that processes exist to meet the
requirements and achieve customer satisfaction. Enhance customer satisfaction by ensuring that customer
requirements are identified and cascaded.

5.2 Establishing and communicating the quality policy

Management responsibility also helps a company define a quality policy and objective guidelines, and provides help with
QMS planning as a whole.

ISO 9001:2015 requires an organization’s policies to be appropriate to both its purpose and context. This means that
once your organization has determined its context and the relevant requirements of its interested parties, Top
management must review the policies in light of that information.

ISO 9001:2015 also requires that the policies are maintained as documented information, refer to Clause 7.5.1a. You
should check whether the policies have been established communicated and understood throughout your organization.
The policies must also be available to any relevant interested parties.

A quick and convenient way to promote and communicate the policy might be to create a shortened version of main
policy; try condensing it to five key words or even a couple of short sentences.

This can be posted on bulletin boards in each department. You could even add it to the reverse side of staff security
passes or ID badges.

5.3 Establishing roles of authority and responsibility in the workplace

The definition of authority and responsibility in the workplace is another vital aspect of ISO 9001.
 Each employee needs to know who is responsible for the various elements of the quality management system to ensure
successful implementation, operation and maintenance.

You should develop and make available to all employees a list of personnel and their job descriptions, competence
requirements, responsibilities, along with an organizational chart of employees as they relate to the QMS.

6. Planning
 6.1 Actions to address risks and opportunities
 6.2 Management system objectives and plans to achieve them
 6.3 Planning for change/change management
Risks and opportunities flow directly from clause 4.1 and 4.2. Determine, consider, and where necessary, take action to
address any risks or opportunities that might impact the quality management system’s ability to deliver conformance.

Addressing the risks and opportunities will ensure the quality management system is able to achieve its planned
objectives!

6.1 Actions to address risks and opportunities

The risks and opportunities should be relevant to the context of your organization (Clause 4.1), as well as, any interested
parties (Clause 4.2). You should ensure that your organization has applied this risk identification methodology
consistently and effectively.

Understanding the risks and managing them appropriately will enhance your organization’s ability to make better
decisions, safeguard assets, and enhance your ability to provide products and services and to achieve your mission and
goals.

Although developing and implementing a formal risk management process is not a requirement, it is encouraged that
the identification and management of risks and opportunities are formally undertaken and documented. Consequence
and likelihood tables should be used in conjunction with a risk level matrix.

6.2 Management system objectives and plans to achieve them

An effectively implemented quality management system aligns the policies with strategic and management system
objectives and provides the framework upon which to translate these objectives into functional targets and measures.

Establish and maintain documented quality objectives and indicators, at each relevant function and level within the
organization. The objectives and indicators help establish an important link between the quality policy and the
management programme.

The objectives and targets must be consistent with the quality policy. It is also important to ensure that the quality
objectives and associated key performance indicators (KPIs) are mutually consistent.
 It is important to ensure KPIs are meaningful to all key stakeholders including the customer(s), top management,
supervisors and the staff who actually produce the products and services.

Properly designed and implemented, management programme should achieve the objectives and, consequently,
improve your organization’s performance. The management programme must:

 Address each objective and target

 Designate personnel responsible for achieving targets at each function/level of the organization
 Provide an action plan describing how each target will be achieved
 Establish a time-frame or a schedule for achieving each target
Establishing an action plan for each objective may require considerable effort on the part of the personnel at relevant
levels within your organization.

To ensure the progress of the action plan and a coordinated effort, a target leader should be selected for each target
who will be responsible for ensuring a target is achieved within the specified time-frame

6.3 Planning for change/change management

Changes are intended to be beneficial but they need to be carried out when determined by your organization as relevant
and achievable. In addition, consideration of newly introduced risks and opportunities should also be taken into account.

To achieve the benefits associated with changes, your organization should consider all types of change that may occur.
These changes may be generated, for example by:

 Processes and procedures

 Documented information
 Infrastructure
 Tooling
 Process equipment
 Employee training
 Supplier evaluation
 Stakeholder management
 Interested party requirements

7. Support
 7.1 Resources
 7.2 Competence
 7.3 Awareness
 7.4 Communication
 7.5 Documented information
 It is really important that a business has the proper resources for everyone who is involved, no matter if they make
purchases with the company or go to work there every day. An organized and professional workplace is paramount to
the successful implementation of a quality management system!

7.1 Resources

There are six sub-clauses in clause 7.1, and include general (7.1.1), people (7.1.2), infrastructure (7.1.3), work
environment (7.1.4), monitoring and measuring resources (7.1.5), and organizational knowledge (7.1.6).

Ensure that your organization has determined and provided the resources needed for the establishment,
implementation, maintenance and continual improvement of the QMS. Resources will often include raw materials,
infrastructure, finance, personnel and IT, all of which can be either internally or externally provided.

Check that your organization has identified which resources and the staff necessary for the effective implementation of
the QMS and for the operation and control of its processes.

Most organizations determine resource requirements during management review meetings; you should review the
management review minutes for evidence of resource allocation.

Provide and maintain infrastructure necessary to achieve product conformance:

 Buildings and workspaces

 Tools and process equipment, e.g. hardware or software
 Supporting services, e.g. transport, I.T. and communication
Ensure that documented information is maintained in order to demonstrate suitability of monitoring and measuring
equipment. While this is not required, all equipment requiring calibration must be identified

Sources of internal knowledge often include the organization’s intellectual property; knowledge gained from experience;
lessons learned from failures and successes; capturing and sharing undocumented knowledge and experience; the
results of improvements in processes, products and services.

Sources of external knowledge often include other ISO standards; research papers; conferences; or knowledge gathered
from customers or external parties.

7.2 Competence

Identification of employee training needs is typically the first step in developing a competency-based training
programme. In addition to existing workers, new hires, temporary workers and outside contractors must be included
when identifying training needs.

After developing a list of these employees, the management representative or human resources manager should
establish the appropriate training programme for each person based on the type of employee interaction with each
significant impact, hazard or risk.

Even though some personnel may have the same job, the type or level of training may vary according to each person’s
past education, training, and experience.

Training options may be as simple as on-the-job training, administered by senior/experienced members; formal training,
including classroom instruction; training provided by external consultants. For some situations, commercially available
training courses may be another alternative.
7.3 Awareness

The awareness training does not need to follow the format of classroom sessions, techniques can include short training
segments supplemented with videos and hands-on demonstrations that address key elements of the QMS.

Other methods to promote and reinforce the quality awareness training sessions include communication via electronic
bulletin boards, posters, newsletters and informational meetings.

Awareness training is intended to provide an overview of your organization’s policy, objectives and targets, and overall
QMS.

All well as briefing employees during introductory presentations, try using a combination of other methods to promote
awareness, such as posters placed on notice boards and leaflets with pay-slips, etc. Use training sessions to inform
employees of the plan, how they will be expected to contribute.

7.4 Communication

Communications may relate to your organization’s ongoing compliance to various obligations, milestone achievements,
or sustainable resourcing.

Communication is the key; communicate goals, plans, progress and milestones. Listen first then ask for feedback. Lack of
communication seems to be one of the main root causes for errors in business.

Keep people informed of the progress of the project; e.g. what’s been done, what’s to be done next and how the project
is progressing against the plan.

Internally, your organization needs to communicate information relevant to the QMS amongst all levels and functions,
including information on any change, as appropriate, and have to establish a mechanism to enable all persons
performing work under the organization’s control to contribute to continual improvement.

7.5 Documented information

A robust document control process invariably lies at the heart of any compliant management system; almost every
aspect of auditing and compliance verification is determined through the scrutiny of documented information.

With this in mind, it becomes apparent that the on-going maintenance of an efficient document management system
must not be overlooked!

Departmental managers should always be responsible for promoting good documented information practices in their
area whilst supporting overall compliance to the requirements.

Individuals and their line managers should be responsible for the information that they create, as well as being
responsible for their retention and disposal in line with legislative requirements and organizational needs.

The terms ‘documented procedure’ and ‘record’ used ISO 9001:2015 have both been replaced by the term ‘documented
information’, which is defined as information required to be controlled and maintained by an organization, as well as the
medium on which it is contained.
 Operational procedures, work instructions, flow charts, process maps, signs, placards, container markings, labels etc. are
all examples of ‘documented information’. Documented information can be in any format and media, and from any
source.

Organizations should determine the level of documented information necessary to control their QMS. ‘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.

8. Operation
 8.1 Operational planning and control
 8.2 Determining requirements for products
 8.3 Design and development of products and services
 8.4 Control of external processes, such as suppliers and contractors
 8.5 Production and service provision
 8.6 Release of products and services
 8.7 Nonconforming products or services
Clause 8 is comparable to the requirements from ISO 9001:2008 Clause 7.1 – Product Realization Planning, but it has
been extended to include implementation and control, as well planning, evidence of controls, acceptance criteria and
resources to address risks and opportunities.

8.1 Operational planning and control

For those risks and opportunities that your organization has identified, you should seek evidence that these actions have
been integrated into the quality management system.

These actions should be verifiable at process level – for example, evidence of controls, acceptance criteria and resources
to address the risks and opportunities, as such this clause links to the following clauses: 4.4, 6 and 8.4.

8.2 Determining requirements for products

Meeting customer identified needs is a key objective. Establish effective arrangements for providing the customer with
product information, a means of handling inquiries and orders and a method for handling customer comments that
includes both compliments and complaints, as such this clause links to the following clauses: 5.1, 7.4 and 8.4.

Establish processes for communicating with your customers:

 Develop a process to control communications with customers

 Implement your customer communications process
 Communicate with your customers
 Maintain records
Identification of any applicable statutory and regulatory requirements in terms of the products and services being
offered is crucial.

The sub-clause mandates that your organization should not issue a quotation or accept an order until it has been
reviewed to ensure requirements are defined, and that the organization has the capability to meet the defined
requirements.

It goes on to require that records of the review and any subsequent actions be maintained.

Where changes in requirements occur, ensure that all relevant documented information that relates to the changed
product or service requirements, is amended and those relevant personnel are made aware of the changed
requirements.

If the customer’s requirements have changed, all related documents must be amended and the relevant personnel must
be informed.

8.3 Design and development of products and services

This clause focuses on the need to develop, implement and maintain a design and development process that is
appropriate to the requirements for the provision of products and services.

Many companies perform some enhancements or minor reconfigurations to existing, mature designs; such organizations
may have to introduce a comprehensive design system and related or processes.

Design plans must specify the design and development stages, activities and tasks; responsibilities; time-line and
resources; specific tests, validations and reviews; and outcomes.

You should also ensure that your organization has retained documented information to confirm the identified design
and development requirements were met and that design reviews were undertaken.

Define which inputs are required to carry out the design and development process. The inputs should be determined
according to the design and development activities. For example, which employees are required, or what information is
required for every step of the development.

The verification could consist of calculations, simulations, prototype evaluation, tests or comparison against samples.

You must maintain records of design verification as these records will indicate the results of verifications and determine
any necessary corrective actions.

Validation is similar to verification, except this time you should check the designed product under conditions of actual
use.

The design and development output is the result of design and development process. The output is a clear description of
the product, containing detailed information for production. Design and development outputs must reconcile with
design and development inputs.

It is as important to control design changes throughout the design and development process and it should be clear how
these changes are handled and what effects they have on the product.
Ensure control over design and development changes, design changes must be identified, recorded, reviewed, verified,
validated, and approved.

8.4 Control of external processes, such as suppliers and contractors

Organizations need to identify which materials and services that they buy can affect the quality of their products. Then
they need to establish criteria for selection of suppliers that can provide these materials and services.

Purchased product is any product procured by an organization from another source that is incorporated or used in the
production of the final product. Note that products need not be procured from an 'independent source', in some cases
sister companies supply each other and are not totally independent.

You could consider dividing your suppliers into groups based on the product or service they provide and what effect it
has on the quality of your products or processes, e.g. level I/II/III/etc.

Based on those categories, you can define the criteria for supplier evaluation and approval. You are free to define your
supplier levels and approval parameters accordingly, but, whatever rationale is opted for, it should be properly
documented.

There is no ‘right way’ for vetting suppliers. To meet the intent of the clause you simply need to establish a process with
properly documented criteria which are based upon customer requirements. ISO 9001 requires that the purchasing
documentation contains the correct information before it is issued to a supplier.

8.5 Production and service provision

You should seek and record evidence that your organization has controlled the conditions by which products or services
are provided, for example by ensuring that monitoring and measurement take place at appropriate points in the
production process to ensure that both the processes themselves and the process outputs meet the organization’s
acceptance criteria.

There are several ways of identifying products. The most obvious is using tags or stickers with part numbers, bar codes,
job numbers, etc. The identification may be engraved in the product itself, or the product may simply be marked by a
color.

Where traceability is a requirement, you should expect to see that your organization is controlling and recording the
unique identification of the product.

Check that your organization communicates with its customers in regard to the handling and treatment of their
property. You should also check that contingency plans and, where relevant, actions are undertaken when non-
conformities occur with customer property.

Preserve the product during internal processing and delivery to the intended destination. Preservation, packaging and
other product specific handling methods are likely to an output of the product design process.

Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance
services, and supplementary services such as recycling or final disposal.

Organizations need to make changes in a thoughtful manner and to consider the potential impact to other process,
products and possibly the customer.
 Respond to unplanned changes that are considered essential in order to ensure that products or services continue to
meet their specified requirements, in such a way that conformity with requirements is maintained.

8.6 Release of products and services

The release of product or delivery of service must not be completed until the planned requirements have been met.
‘Release’ of product may include, according to product planning and the verification stages, release to the next
operation, release to an internal customer, release to final customer, etc.

8.7 Nonconforming products or services

Every once in a while, there will be some product or service produced by the company that is not up to the standard
protocol that is defined by the ISO 9001:2015 standard. This is also known as a non-conforming product/service, or a
non-conformity.

If you have manufactured a product, inspected it and found it to be out of specification, it is most likely to be deemed
nonconforming product. In some instances, you will have to scrap the defective product but in other situations you may
be able to do some remedial work and bring it back into specification.

Capture data on nonconformities and feedback information at the appropriate management level, for the effective
definition and implementation of corrective actions.

9. Performance Evaluation
 9.1 Monitoring, measurement, analysis and evaluation
 9.2 Internal auditing
 9.3 Management review
The measurement, analysis, and improvement clause allows the company personnel to step back after executing their
product or service, and see how the customer has reacted to these positive changes.

9.1 Monitoring, measurement, analysis and evaluation

Monitoring and measuring QMS operations and activities will establish a mechanism to ensure that your organization is
meeting its policies, objectives and targets. In order to meet this requirement, your organization must perform six steps:

1. Identify the activities that can have a significant risk

2. Determine key characteristics of the activity to be monitored
3. Select the best way to measure the key characteristics
4. Record data on performance, controls and conformance with objectives and targets
5. Determine the frequency with which to measure the key characteristics
6. Establish management review and reporting
Establish the monitoring and tracking criteria for each activity that has a significant risk and review the action plan. You
should incorporate any monitoring and measurement information to cover these same activities.
 Implemented a consistent and systematic approach to dealing with customer feedback and is obtaining information on
customer perception.

Just collecting data on customer perceptions is not sufficient, you should seek and record evidence that your
organization has analyzed and evaluated customer data and that conclusions have been made with regard to the
effectiveness of the QMS.

 Are there any trends?

 Is the situation stable, improving, or deteriorating?
 Are customer needs and expectations changing?
Ensure there are defined responsibilities for logging and tracking customer complaints, clearing issues, determining the
root-causes of problems, and actions to address them.

Analyze and evaluate data from both internal and external sources such as quality records, monitoring and measuring
results, process performance results, objectives, internal audit findings, customer surveys and feedback, 2nd or 3rd-
party audit results, competitor and benchmarking information, product test results, complaints, supplier performance
information, etc.

9.2 Internal auditing

These sub-clauses provide a clear framework for planning and conducting internal audits. The internal audit process is a
primary tool ensure the QMS is operating effectively.

During the early stages of implementing ISO 9001:2015, or any other management system standard, the internal audit
programme often focuses on ensuring that any compliance issues or non-conformities are discovered and rectified prior
to the Certification Body assessment.

However, once your organization becomes certified, the audit programme must evolve. The focus of the internal audit
programme should be re-directed, away from 'elemental' compliance with ISO 9001:2015, to an audit strategy that
considers the 'status and importance' of each process comprising the quality management system.

If your current internal audit programme been developed on an annual calendar that merely forecasts which aspects of
your quality management system are going to be audited, you should stop!

Begin programming your internal audits by basing the audit frequency upon current process performance data,
feedback from customers, etc.

9.3 Management review

Here's what ISO 9001:2015 is really all about: defining a policy, creating a plan devising with relevant objectives.
Implement the QMS according to the plan, begin auditing, monitoring and measuring performance against the plan and
reacting to your findings.

Bi-annual management reviews are insufficient in frequency to be able react to any issues effectively. Performance
metrics should be monitored with varying frequencies, some hourly, some daily, some weekly and some monthly.

Management cannot wait for six months to respond, if they do, it will be too late. Every time management convenes to
review and react to performance, it is considered as a management review.
 Whether they are reviewing an individual's performance, departmental programmes and projects, etc., this should be
considered as valid management review.

Some companies have multiple review levels, whereby, each review may require multiple subjects and rely upon
multiple metrics as inputs. Sometimes subjects are reviewed at more than one level, e.g. production numbers might be
reviewed by the production teams during daily production meetings and then by senior management, possibly weekly.

Top management might conduct weekly meetings in which they review metrics and objectives to determine if any
corrective action is required. The process owner is then responsible for reporting close out progress in the meeting a
week later.

Management review meeting minutes should be retained as documented information!

10. Improvement
 10.1 Improvement
 10.2 Nonconformity and corrective action
 10.3 Continual improvement
The final clause in the ISO 9001:2015 standard focuses mainly on improvement of the company. While it is true that you
can go through the entire process of ISO certification to get the final stamp of approval from the organization, you won’t
be able to keep it for long if you ignore the guidelines in this clause.

10.1 Improvement

Improvement often does not take place on a ‘continual’ basis. Sometimes improvement can be affected reactively
through corrective actions, incrementally overtime.

Look out for objective evidence that improvement is taking place. However, while improvement does not need to be
continuous, it does need to be evidenced as occurring.

10.2 Nonconformity and corrective action

Your organization is required to take whatever action is necessary to control and correct the non-conformity, and to deal
with any resulting impact by determining what caused the nonconformity and considering whether the potential for a
similar problem remains.

This is done by considering whether any further action is required to prevent a similar nonconformity arising at the same
place or occurring somewhere else, at some point in the future and by determining if similar non-conformities have
occurred elsewhere; and consequently, whether it needs to take similar corrective action.

Taking appropriate action to address the effects of the problem may require a simple correction by the process owner or
operator where it was discovered, or, if a major failure or defect exists, more significant levels of resource would be
needed for problem solving and corrective action.
 10.3 Continual improvement

Determine whether your organization identifies improvement opportunities and QMS under-performance using the
data output from its processes, such as from analysis and evaluation, internal auditing, management review, and the use
of appropriate tools and methodologies to support validate findings.

Improving your business will include assessing everything that is going on, deciding how you can make it better, and
implementing those positive changes. This does not necessarily mean that anything is wrong with what you are doing,
only that you want to get better every day.

The PDCA cycle is a perfect way of introducing continual improvement to your organization’s activities. Each step to
improvement can be defined by four sub steps, Plan, Do, Check and Act:

1. Plan: Establish a timetable for internal audits and management reviews. Establish the objectives and processes
necessary to deliver results in accordance with your customer’s requirements and your organization’s policies.
2. Do: Implement changes designed to solve the problems on a small scale first to see the effect. This minimizes
disruption to routine activity while testing whether the changes will work or not.
3. Check: Monitor and measure processes and product against policies, objectives and requirements and report the
results. Also check on key activities to ensure that the quality of the output is conforming and not influenced by the
changes.
4. Act: Take actions to continually improve process performance. Implement the changes on a larger scale, if the
experimental changes have proven to be successful. This means making the changes a routine part of the activity.

ISO 9001 Clauses - PLAN

 1 Scope
 2 Normative references
 3 Terms and Definitions
 4 Context of the organization
 4.1 Understanding Context of the Organization
 4.2 Understanding the needs and expectations of interested parties
 4.3 Determining the scope of the quality management system
 4.4 Quality management system and its processes
 5 Leadership
 5.1 Leadership and commitment
 5.1.1 Leadership And Commitment For The Quality Management System
 5.1.2 Customer Focus
 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 Planning
 6.1 Actions to address risks and opportunities
 How to address risk in ISO 90001
 6.2 Quality objectives and planning to achieve them
 6.3 Planning of changes
 ISO 9001 Clauses - DO
 7 Support
 7.1 Resources
 7.1.1 General
 7.1.2 People
 7.1.3 Infrastructure
 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
 8 Operation

 8.1 Operational planning and control

 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 Product and service provision
 8.6 Release of products and services
 8.7 Control of nonconforming outputs
ISO 9001 Clauses - CHECK
 9 Performance evaluation
 9.1 Monitoring, measurement, analysis and evaluation
 9.1.2 Customer Satisfaction
 9.2 Internal Audit
 9.3 Management Review
ISO 9001 Clauses - ACT
 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

Are The ISO 9001 Clauses Also Requirements?

So, now that you have read through the names of all 10 ISO 9001 clauses, as well as a brief explanation of what each one
entails, you might be wondering if the clauses are also requirements.
 If you know anything about ISO 9001, then you probably understand how specific it can get.

When a business wants to become certified with ISO 9001, they are required to abide by a long list of very detailed
processes that include defining the scope, performing surveillance and analysis, and going through internal audits before
they can be considered ISO 9001 accredited.

With that being said, it is justified to assume that you must follow all of these standards line by line as a business owner,
in order to gain and hold onto your ISO 9001 certification.

To clear this up, take a look at the list down below to find out the answer to the questions of whether or not all ISO 9001
clauses are requirements, and which ones are mandatory, if not.

ISO 9001 Clause Requirements

 Not all 10 clauses are required

 Clauses 4-10 are considered requirements
 Clauses 1-3 provide general information/terminology
First of all, not all 10 clauses of ISO 9001 are requirements for the business. The only mandatory clauses are
everything between 4-10. Clauses 1, 2, and 3 are not requirements.

At this point, you might be wondering why the first three clauses are excluded from the certification requirements. If
they are not required for certification, then what is the point of even reading them, right?

Clauses 1-3 are not requirements, only due to the fact that their purpose is to provide general information and
terminology that will be used throughout the remainder of the standard.

In other words, clauses 1,2, and 3 of ISO 9001 do not outline any actionable requirements at all, making them non-
mandatory for company personnel.

To recap on what was discussed in the previous section and provide a more clear distinction between the clauses, the
list down below will highlight the mandatory clauses of ISO 9001.

The Seven ISO 9001 Mandatory Clauses

 Context of the Organization
 Leadership
 Planning
 Support
 Operation
 Performance Evaluation
 Improvement
 Are There Any Exceptions To Required ISO 9001 Clauses?
After discussing the ISO 9001 clauses that are mandatory requirements, there is still the question of what a requirement
necessarily means.

For all of the required clauses, must a business owner and company personnel follow everything line by line? Generally,
the answer to this question is yes, but there is one small exception, which is contained in Clause number 7.

Let’s take a closer look at this clause, in particular. Refer to the list down below to get a detailed outline on the Product
Realization section of the ISO 9001:2015 standard.

Clause 8 - Operation

 Design and development

The design and development clause consists of a six-step process, beginning with planning. This is when the company
personnel decides on what their product or service output will consist of.

During this time, the requirements for the product will be defined. This includes what it is supposed to do and how it will
be executed. The same process goes for services as well, but in a slightly different manner.

Then, the product will be designed and developed before the products are purchased and everything is produced and
supplied to customers.

Following these standard procedures, the company personnel must maintain control of the equipment, by measuring
inventory and resources, along with closely monitoring everything else.

How Have The ISO 9001 Clauses Changed Over The Years?
As you might have caught already, there are several different versions of the ISO 9001 standard, with two in particular.

This is due to the fact that the ISO 9001 quality management system is constantly changing and evolving to be more
beneficial to everyone who is involved in a business, from the owner and employees to the regular customers.

While the years are steadily progressing, so is the ISO 9001 standard. Let’s take a look at what the two most recent
versions of ISO 9001 are, before we get deeper into each one.
 These are the two most recent versions of ISO 9001

1. ISO 9001:2008
2. ISO 9001:2015
The two most recent versions of the ISO 9001 standard include ISO 9001:2008 and ISO 9001:2015. The older one was
updated in the year 2008, while the most up to date came out in 2015.

With these changes going on, there were a lot of alterations in the amount of clauses between the two, as well as which
clauses are considered to be requirements. Let’s start with ISO 9001:2008.

ISO 9001:2008

 8 clauses in total
 Clauses 4-8 were requirements
The 2008 version of ISO 9001 contained 8 total clauses, instead of the 10 that are contained in ISO 9001:2015.

Out of the total 8 clauses in ISO 9001:2008, there were only 5 required clauses, which were 4-8.

ISO 9001:2015

 10 clauses in total
 Clauses 4-10 are requirements
 More clauses and more requirements in the updated version
The 2015 version of ISO 9001, on the other hand, has 10 total clauses - meaning that two of them were recently added
on to the standard in order to improve the system further.

Out of all 10, there are a total of 7 requirements, also meaning that the additional clauses became mandatory to ISO
9001 users.

ISO 9001:2015 has more individual clauses as well as more requirements than the older version from 2008.
So, now that you have learned everything there is to know about all 10 ISO 9001:2015 clauses, as well as which ones are
required and how they have changed over the years, you might be wondering how you can benefit from gaining
certification.

There are a multitude of benefits that come with ISO 9001 certification, for you as the business owner, as well as your
employees and customers.

When a solid quality management system is in place and working exactly how it is supposed to, you will notice rewards
coming from almost every avenue.

Whether you are most excited about gaining a loyal customer base and growing your following or establishing long-term
employees who are enthusiastic about their positions, there is no doubt that both your business and revenue numbers
will increase exponentially when you do it right.

With a good grasp on what the ISO 9001 clauses consist of, as well as what is expected from you within each section,
you will be on your way to gaining an ISO 9001 certification and using the world-renowned quality management system
in the favor of your growing business as you excel toward a more quality future.
Is ISO 9001 a Legal Requirement?
ISO 9000 is a series of standards to ensure that a business is upholding and working towards improved quality in every
aspect of their business. This set of standards is used as a quality management system to provide the best products and
services to a client. The ISO 9001 standard, in particular, requires certification.

Is ISO 9001 a legal requirement? The ISO 9001 is not a legal requirement. Although recognized as important in many
industries, companies may operate without the certification.

This certification does help in maintaining many legal requirements that companies face to ensure quality, but the
standard itself is not required.

ISO 9001 is followed by a significant number of companies in many countries across the world. It allows companies to
maintain high standards of quality assurance and is recognized as an important indicator of a company’s commitment to
running their business in an efficient manner.

Is ISO 9001 a Legal Requirement?

ISO 9001 is the only standard in the ISO 9000 series that requires a certification. ISO 9000 defines the standards for
quality management and ISO 9001 maps out the requirements for meeting these standards.

While many companies abide by these principles, ISO 9001 is not a legal requirement to operate a business. Many
companies do benefit from being ISO 9001 certified.
 ISO 9001 is a quality management system (QMS) that allows businesses to keep a high level of productivity and quality
while delivering products and services to customers. Quality is not associated with a specific product that is sold, but is
applied to the process that goes into making this product.

All aspects of a supply chain and operation in a business are compared to the ISO 9001 standards to ensure that quality
is upheld.

The standards that need to be met in this system are focused on:

 Customer driven-outlook
 Leadership
 Engagement
 Improvement
 Decision Making
 Relationship Management
 Process Approach
Details in all of these areas are required to maintain a ISO 9001 certification. In order make sure these standards are
met, companies undergo an audit. This audit is driven by a third party to ensure objectivity.

The auditors will test all these metrics to ensure a company is following the standards laid out in the ISO 9001
guidelines. Having this certification can be very beneficial to a company’s success and reputation.

Who Needs ISO 9001 Certification?

While no company needs a certification to operate, many companies will find significantly greater success if they are
certified.

The ISO 9001 is applicable in both production and service industries. Quality management can be very useful in
manufacturing and customer-based companies.

Particular industries in which an ISO 9001 is incredibly beneficial

 Construction
 Engineering
 Manufacturing
 Technology
 Hospitality
 Healthcare
All of these industries either operate hardware processes to bring value to customers or are highly service-based. With
many working parts across all areas of the business, these industries would see substantial improvements in efficiency if
they are held to ISO 9001 standards.

All companies will benefit from such adherence, but these specific industries should most definitely be incorporating
these policies.

Especially with businesses that involve manufacturing or significant customer contact, there are always ways to evaluate
efficiency and quality inspection in order to deliver the best product or service to the client or customer.
How Can You Become ISO 9001 Certified?
Like any route to obtaining certification, there are certain steps you must follow in order to be properly accomplish
this goal.

While there are specific steps, the ISO quality management system leaves some freedom for decisions that make the
most sense for your organization.

Choose a strategy

When first deciding to become certified, there are different approaches one can take in terms of implementation.

You must decide who will be in charge of implementing and executing the certification. Appointing a specific person will
help make sure the company stays on track.

Some companies choose to appoint an in-house lead for certification, which keeps costs low but requires significant
energy from an employee. Others will hire a consultant, which will hasten the rate at which the certification is
completed, but this can be costly to a company and separate the process and its value from Top Management.

There should be one person within the company (the Project Manager) responsible for ISO 9001 monitoring and
scheduling management reviews to ensure the requirements are met.

Get Company Buy-In

ISO 9001 is designed to improve and ensure quality throughout all processes in an organization.

This implementation may result in changes for how your firm is currently operating. Change can often be threatening or
unwelcome by management and employees. When deciding to implement these standards, it is important to keep your
team in the loop!

Both Top Management and all employees should be aware of the new standards and well as their impacts.

Keeping people informed early, showing them what changes will be made, and how they will positively benefit the firm
will allow for support. Including everyone in the process early will result in less push back. Without support, standards
will be difficult to execute.

Documentation

Quality looks different in every firm. Some processes may be successful in some businesses but not others.
Documentation is a key aspect of certification, but it is specific to an organization.

This is meant to detail the way in which procedures should be conducted in order to reach maximum quality. Giving
clear descriptions of how you wish processes to work will keep standards consistent.
Being prepared for all processes and how they should be executed will result in more efficiency across all aspects of the
business. It also keeps employees and the firm accountable! They have something to compare themselves to and push
toward continued improvement.

While each set of documents is specific to a firm, they should all include: a policy regarding quality, a flowchart of how
these plans are executed, instructions for jobs, goals and objectives, and clear procedures.

The only requirement is that a firm must abide by their documents to maintain certification. This means that rules and
regulations should be meaningful to the success of the organization and not implemented without a clear and effective
purpose.

Writing these documents is very straightforward with the use of templates such as our ISO Quality Manual Template.

Implementing

Start simple. Explain to employees how the documents should be adhered to and the clear benefits

Then begin to teach and show employees what changes must be made to meet these standards.

This will require a “retooling” of work processes and instructions. It may be helpful to get input from employees
beforehand to see how they best think changes can be made to add value. Including employees in the process will also
enhance support.

Internal Auditing

An audit is used to ensure that the plans created are actually being followed. Internal audits should be conducted within
the company to make sure requirements are met.

Those performing the audit should be well-versed in ISO 9001 regulations and auditing. Auditing skills can be acquired
easily through good training.

Having multiple auditors is a good idea to provide more input and perspectives in making sure all standards are met.

Obtaining Certification

The internal audit is a good tool to ensure you are adhering to standards. To officially obtain ISO 9001 certification, an
outside and objective auditor is required.

They will come to a company and randomly observe and check that departments are adhering to requirements.

You will also need to select a third-party registrar to execute the certification. Make sure this body is accredited as there
are many companies providing this service. If there are significant issues with the audit, there is an opportunity to fix
them and obtain certification after they are resolved.

You can prepare employees by making sure they are well-versed in their job functions and procedures. This will allow for
a more successful audit.

Maintaining Certification
 If your system is designed correctly, it should continually improve upon itself. Your registrar will perform audits at least
once a year to ensure the requirements are still being met as time passes.

It is quite easy to lose your certification if attention is not continually paid to the maintenance of quality. A primary
purpose of this certification is to continually improve upon procedures to increase efficiency.

Following each of these steps is important in obtaining certification and keeping it! Always keep the best interest of your
employees and your end user in mind. Efficiency and quality benefits the firm both internally and externally.

Is ISO 9001 Certification Worth It?

ISO certification is beneficial for companies because it instills trust in the company and establishes a reputation of
quality!

Industry leaders and consumers will recognize this certification as a commitment to constant improvement and
efficiency. This creates a positive relationship on both the business and client-side.

Customers will know they are receiving a product or service that is built upon high standards! Similarly, companies will
be opened up to a larger client base who only work with ISO 9001-certified firms.

ISO 9001 Certification creates opportunity for

 Increased productivity
 More efficiency
 Lower costs
 Higher quality products and services
ISO 9001 certification is great marketing tool to raise brand value. Taking the time to become certified and stay
committed to its goals will only enhance your firm’s image and reputation for clients and other businesses!

Becoming certified is another step in raising profits and delivering a valuable product!
What Is The Meaning Of 9001 in ISO 9001?
ISO 9001 is an ISO number that many people the world over are familiar with. It refers to a specific standard
that outlines the requirements for certifying a quality management system within an organization. But even if you know
what ISO 9001 refers to you may be wondering what the significance of the number 9001 is.

What is the meaning of 9001 in ISO 9001? The 9001 in the title is simply the identification number of the standard. ISO
9001 is part of the ISO 9000 family of standards and follows the same line of numbering so it is obvious they are
related.

Every document published by the International Organization for Standardization has a unique number assigned to it so
that it can be easily located by anyone that needs it. Most times, these numbers are randomly generated with no true
logic behind them. It's important that no two documents share the same number.

There are a number of standards related to ISO 9001, a lot of which don't share similar numbers with it (such as ISO
14001 or ISO 45001). Continue reading to learn more about ISO 9001 and the standards surrounding it.

The Meaning of 9001 in ISO 9001

The International Organization for Standardization has many different standards, of which ISO 9001 is one of the most
recognizable. It is part of the ISO 9000 family of quality standards and is the only standard that you must be certified for.

The 9001 in the title is simply the identification number of the specific document. It is followed by a revision number
that shows what version is the most recent. ISO 9001:2015 is the most up to date version of the standard currently.

When it comes to the numbering of documents, no number can be used more than once. There isn't truly any rhyme or
reason for why 9001 was used for this specific document. It correlates to being part of the ISO 9000 series of standards
for quality management systems.

The ISO 9000 Family

The ISO 9000 series is a group of quality management standards that were first established in 1987. They set out certain
guidelines and requirements for how a quality management system should be run. The standards apply to a company's
process of production and not the products themselves.

The ISO 9000 Family of Standards

1. ISO 9000 - Fundamentals and Vocabulary

2. ISO 9001 - Requirements for Certification
3. ISO 9002 - Guidelines for Applying ISO 9001
4. ISO 9004 - Guidelines for Maintaining the Success of an Organization
ISO 9001 is the main structure for the ISO 9000 series of documents with the other standards providing further
information and guidelines. These standards are not specific to a certain industry. They can apply to any manufacturing,
distribution, or service organization.

There were once three different quality management system standards that were separated by what their function was.
These three standards were eventually combined into the ISO 9001 standard that we know today.
Industry-Specific Quality Standards
There have been different standards based upon ISO 9001 that are geared toward certain industries. These standards
were developed so that the ISO 9001 quality standards would be better tailored to their specific requirements.

These different interpretations are incredibly useful in making sure auditors are trained to look for the requirements
that apply only to that industry. It keeps every single organization within that field from having to modify the ISO 9001
standard themselves.

Standards Developed From ISO 9001

1. AS9100 - Aircraft, Space, and Defense Industry

2. AS9110 - Aerospace Maintenance Repair
3. AS9120 - Aircraft Distributors
4. ISO 13485 - Medical Industry
5. IATF 16949 - Automotive Industry
6. ISO 14001 - Environmental Management System Standard
7. ISO 45001 - Occupational Health and Safety Management Systems
8. ISO/IEC/IEEE 90003:2018 - International Standard for Software Engineering Document
Depending on the nature of each of these documents, they may contain all of the same standards of ISO 9001 with
additional requirements on top or they may be integrated along with ISO 9001.

Standards That Support the ISO 9000 Family

There are a number of other standards that were created in order to support the ISO 9000 series and provide even more
information for anyone pursuing certification. These standards don't share in the same numbering process for their
documents.

Supporting Standards:

1. ISO 10000 Series - A series of 16 standards that detail guidelines for everything from codes of conduct to training.
2. ISO 19011 - A standard that details guidelines for quality or environmental system auditing.
3. ISO/IEC 17021 - A standard created for assessing certification bodies to ensure they are competent.
These standards were developed to further aid in the understanding of ISO 9000 and the requirements put forth by ISO
9001. They give a clearer picture to certain areas of the certification process for anyone that wants to know more.

The Contents of ISO 9001

If your organization is interested in registering to certify your quality management system, ISO 9001 is where you should
turn. It is the standard that outlines all of the requirements your system will have to meet to receive certification.
Sections 4-10 are the sections that specify what requirements an organization must comply with in order to be certified.

The Main Sections of ISO 9001

1. Scope - The scope of the ISO 9001 standard

2. Normative References - Supporting standards for ISO 9001
3. Terms and Definitions - Terms used throughout the standard
4. Context of the Organization - Thoroughly align your business objectives and intent with the quality management
system
5. Leadership - Secure the full commitment of Top Management within the organization
6. Planning - Make a plan for the quality management system to address risks, opportunities, changes, and
objectives.
7. Support - What resources are needed for the quality management system
8. Operation - The processes needed to meet the requirements for products and services.
9. Performance Evaluation - Monitor, measure, analyze, and evaluate the quality management system
10. Improvement - Continually improve the quality management system
It is vital to the certification process for anyone involved in it to understand all of the requirements in the ISO 9001
standard. It pays off to buy and thoroughly read all of the clauses within the standard to get a good grasp on them.

The Benefits of ISO 9001

Organizations become certified in ISO 9001 to prove to their customers that they are committed to consistently provide
products and services that meet satisfactory requirements. ISO 9001 is a support system for your organization in keeping
up with your quality management system.

Transitioning to an entirely new system or even adapting an existing system to meet requirements can seem a daunting
task. In the end, the process is extremely worth it and provides your organization with greater efficiency in getting
things done. Once everything is set into motion your quality management system will flow seamlessly together.

With defined responsibilities, there will be an increase in the overall morale of your employees. Following the
standard requirements ensures that consistency and dedicated quality which makes customers happier as well.

Being required to keep certain records and documentation up to date holds everyone accountable and makes the
process of record-keeping much easier. Having a solid paper trail provides stability within your organization.

An important part of the ISO 9001 requirements is that there is evidence that your quality management system is
continually improving. Emphasis on audits, reviews, and data collection make identifying room and need for
improvement easy to pick out and implement. This ensures only the best decisions are made on behalf of your
organization.

There are plenty of reasons why ISO 9001 could benefit your organization. Even if it seems like a large undertaking at
first, it will be worth it once that certification is in hand.

ISO 9001 Means Quality

Regardless of the meaning of the number within its title, ISO 9001 remains to be the highest standard in providing
quality throughout the globe. The requirements it sets in place within an organization ensures everything is kept in
balance.
ISO 9001 is just one part of the larger ISO 9000 family, and its number is its identification. The 9001 makes the
standard easy to find and relates it to the series its part of. Not all related documents share similar numbers though. No
one number can be reused as that would create confusion.

Now you can see the expansive scope of ISO 9001 and the standards that help support it and make it more easily
understood. All of these things together will aid you in implementing ISO 9001 in your organization.

Are The ISO 9001 Clauses Also Requirements?

So, now that you have read through the names of all 10 ISO 9001 clauses, as well as a brief explanation of what each one
entails, you might be wondering if the clauses are also requirements.

If you know anything about ISO 9001, then you probably understand how specific it can get.
 When a business wants to become certified with ISO 9001, they are required to abide by a long list of very detailed
processes that include defining the scope, performing surveillance and analysis, and going through internal audits before
they can be considered ISO 9001 accredited.

With that being said, it is justified to assume that you must follow all of these standards line by line as a business owner,
in order to gain and hold onto your ISO 9001 certification.

To clear this up, take a look at the list down below to find out the answer to the questions of whether or not all ISO 9001
clauses are requirements, and which ones are mandatory, if not.

ISO 9001 Clause Requirements

 Not all 10 clauses are required

 Clauses 4-10 are considered requirements
 Clauses 1-3 provide general information/terminology
First of all, not all 10 clauses of ISO 9001 are requirements for the business. The only mandatory clauses are
everything between 4-10. Clauses 1, 2, and 3 are not requirements.

At this point, you might be wondering why the first three clauses are excluded from the certification requirements. If
they are not required for certification, then what is the point of even reading them, right?

Clauses 1-3 are not requirements, only due to the fact that their purpose is to provide general information and
terminology that will be used throughout the remainder of the standard.

In other words, clauses 1,2, and 3 of ISO 9001 do not outline any actionable requirements at all, making them non-
mandatory for company personnel.

To recap on what was discussed in the previous section and provide a more clear distinction between the clauses, the
list down below will highlight the mandatory clauses of ISO 9001.

The Seven ISO 9001 Mandatory Clauses

 Context of the Organization
 Leadership
 Planning
 Support
 Operation
 Performance Evaluation
 Improvement

Are There Any Exceptions To Required ISO 9001 Clauses?

After discussing the ISO 9001 clauses that are mandatory requirements, there is still the question of what a requirement
necessarily means.
 For all of the required clauses, must a business owner and company personnel follow everything line by line? Generally,
the answer to this question is yes, but there is one small exception, which is contained in Clause number 7.

Let’s take a closer look at this clause, in particular. Refer to the list down below to get a detailed outline on the Product
Realization section of the ISO 9001:2015 standard.

Clause 8 - Operation

 Design and development

The design and development clause consists of a six-step process, beginning with planning. This is when the company
personnel decides on what their product or service output will consist of.

During this time, the requirements for the product will be defined. This includes what it is supposed to do and how it will
be executed. The same process goes for services as well, but in a slightly different manner.

Then, the product will be designed and developed before the products are purchased and everything is produced and
supplied to customers.

Following these standard procedures, the company personnel must maintain control of the equipment, by measuring
inventory and resources, along with closely monitoring everything else.

How Have The ISO 9001 Clauses Changed Over The Years?
As you might have caught already, there are several different versions of the ISO 9001 standard, with two in particular.

This is due to the fact that the ISO 9001 quality management system is constantly changing and evolving to be more
beneficial to everyone who is involved in a business, from the owner and employees to the regular customers.

While the years are steadily progressing, so is the ISO 9001 standard. Let’s take a look at what the two most recent
versions of ISO 9001 are, before we get deeper into each one.

These are the two most recent versions of ISO 9001

1. ISO 9001:2008
2. ISO 9001:2015
The two most recent versions of the ISO 9001 standard include ISO 9001:2008 and ISO 9001:2015. The older one was
updated in the year 2008, while the most up to date came out in 2015.

With these changes going on, there were a lot of alterations in the amount of clauses between the two, as well as which
clauses are considered to be requirements. Let’s start with ISO 9001:2008.

ISO 9001:2008

 8 clauses in total
 Clauses 4-8 were requirements
The 2008 version of ISO 9001 contained 8 total clauses, instead of the 10 that are contained in ISO 9001:2015.
 Out of the total 8 clauses in ISO 9001:2008, there were only 5 required clauses, which were 4-8.

ISO 9001:2015

 10 clauses in total
 Clauses 4-10 are requirements
 More clauses and more requirements in the updated version
The 2015 version of ISO 9001, on the other hand, has 10 total clauses - meaning that two of them were recently added
on to the standard in order to improve the system further.

Out of all 10, there are a total of 7 requirements, also meaning that the additional clauses became mandatory to ISO
9001 users.

ISO 9001:2015 has more individual clauses as well as more requirements than the older version from 2008.

So, now that you have learned everything there is to know about all 10 ISO 9001:2015 clauses, as well as which ones are
required and how they have changed over the years, you might be wondering how you can benefit from gaining
certification.

There are a multitude of benefits that come with ISO 9001 certification, for you as the business owner, as well as your
employees and customers.

When a solid quality management system is in place and working exactly how it is supposed to, you will notice rewards
coming from almost every avenue.

Whether you are most excited about gaining a loyal customer base and growing your following or establishing long-term
employees who are enthusiastic about their positions, there is no doubt that both your business and revenue numbers
will increase exponentially when you do it right.

With a good grasp on what the ISO 9001 clauses consist of, as well as what is expected from you within each section,
you will be on your way to gaining an ISO 9001 certification and using the world-renowned quality management system
in the favor of your growing business as you excel toward a more quality future.