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.