Clause-By-Clause Explanation of ISO 9001:2015: Qcs Management Pvt. LTD
Clause-By-Clause Explanation of ISO 9001:2015: Qcs Management Pvt. LTD
Clause-By-Clause Explanation of ISO 9001:2015: Qcs Management Pvt. LTD
Clause-by-clause explanation
of ISO 9001:2015
PAPER
Prepared By
Aloke Ganguly
QCS MANAGEMENT PVT. LTD.
Table of Contents
Executive Summary.....................................................................................................................................3
Introduction................................................................................................................................................3
1. Process approach....................................................................................................................................4
2. Plan-Do-Check-Act cycle..........................................................................................................................5
3. Terms and definitions..............................................................................................................................6
4. Context of the organization.....................................................................................................................7
5. Leadership...............................................................................................................................................9
6. Planning.................................................................................................................................................10
7. Support..................................................................................................................................................11
8. Operation..............................................................................................................................................13
9. Performance evaluation........................................................................................................................17
10. Improvements.....................................................................................................................................19
Conclusion.................................................................................................................................................20
Executive Summary
Striving toward quality and customer satisfaction is the mission of every modern company. ISO 9001
provides a framework on how to achieve this, and the first step in the implementation is to really
understand what the standard requires. This white paper is designed to help top management and
employees in organizations that decided to establish and maintain an ISO 9001:2015-based Quality
Management System and clear up any misconceptions regarding the standard requirements.
In this document you will find each clause of ISO 9001 explained in plain English in order to facilitate
understanding of the standard, in the same order and number of the clauses as ISO 9001:2015, and in
addition, you’ll see links to additional learning materials.
Introduction
Management systems are often seen as a difficult administrative burden that has marginal contribution
to a business. This could be because some people think that ISO 9001 separates them from the way they
do their “business” and limits their management system to simple checklists and work instructions. By
sticking to these beliefs, organizations are missing significant chances to improve their business.
In this white paper you’ll find the explanation of each clause of the ISO 9001:2015 standard in plain
English, so that you’ll be able to use those requirements to improve your processes. You’ll notice that
the numbers of the subtitles are the same as the clauses in the standard.
1. Process approach
The process approach is the key to an effective Quality Management System. It basically means that
every operation of the company must be observed as a process, meaning you should identify all inputs,
necessary resources, documents, activities, and outputs from each operation. Once you set up your
system based on the processes, you will be able to monitor and measure your processes, their
effectiveness, and efficiency and improve them, which is the reason why it is emphasized at the
beginning of the implementation, before going into any other details regarding the standard
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requirements.
In simple terms, the process approach represents the concept of observing all operations in the
company as processes. This includes breaking the company down into its processes, and determining
their sequence, interaction, inputs, and outputs; as well as identifying the processes in the company,
which processes can start before other processes are finished, resources and information needed to
start the process, and what results we expect from the process.
The best way to start implementing the process approach is to create a process map that will include all
processes in your company and their interconnections. For example, the delivery process cannot be
done before the production and sales process, and the production cannot be done before the
purchasing of raw materials. Once you create this global process map and identify all the processes and
their interrelations, you can start defining your processes in terms of what are necessary inputs, what
controls need to be applied, and what are the outputs of the process. But this will be done throughout
the implementation; it doesn’t have to be done at once.
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2. Plan-Do-Check-Act cycle
The core of this standard, and many other management system standards, is the so-called Plan-Do-
Check- Act (PDCA) cycle, which says that, in order to have an effective management system. The first
step in the cycle is planning, which includes defining objectives, policies, procedures, and processes,
including measuring aimed to show whether the processes are delivering the expected results. The next
step is the Do phase, which represents the realization of the planned arrangements, applying policies
and procedures, performing processes, and producing records. After the Do phase comes the Check
phase, where the results of the Do phase are analyzed to determine performance and effectiveness of
the activities and actions that were taken during the Do phase, which includes analyzing, monitoring,
and measuring results, audits, and management reviews. As the final stage of the cycle, the Act phase is
where the organization needs to take actions according to the results of the Act phase in order to
achieve continual improvement. The PDCA cycle should be an ongoing cycle that drives the organization
towards continual improvement.
Customer
requirements
Planning Performance
Leadership
(6) Evaluation
(5)
(9)
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Top management – An individual or group of individuals who coordinate and control an organization at
the highest level. In cases when the scope of the management system covers just part of an
organization, then top management refers to the individuals who direct and control that part of the
organization.
Organization – A person or group of people who has their own functions with responsibilities,
authorities, and relationships to achieve the objectives.
Context of the organization – A combination of internal and external factors that can have an effect on
purpose, objectives, performance, and sustainability of the organization. Internal factors include values,
culture, knowledge, and performance of the organization. External factors include legal, technological,
competitive, market, cultural, social, and economic environment.
Process – A sequence of activities that use inputs to deliver an intended result. For example, the
production process has several steps that must be conducted in the appropriate sequence; inputs in this
process are raw materials, product specifications, and work instructions, while the outputs are the
product, quality check report, etc.
Procedure – A defined way to execute an activity or a process. Procedures can be documented or not.
Quality – Quality is the difference between a customer’s expectations and the customer’s perception of
the product or service that he received – the higher the difference, the better perceived quality.
Risk – Risk is the “effect of uncertainty on objectives,” and an effect is a positive or negative deviation
from what is expected. For example, the company plans to deliver its products to the customers, but
there is a risk of product nonconformity due to a poorly controlled production process.
Effectiveness – The level of success in achieving or producing a desired result. For example, the
production process is effective if it is able to produce the products.
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Additional required considerations for the QMS scope are products, services, and organizational size,
nature and complexity. The scope and justified exclusions must be kept as documented information.
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This is where the process approach comes into action. The organization will need to determine inputs
and outputs of the processes, sequence and interaction of the processes, resources needed, and
responsibilities, and ensure the effectiveness of the processes.
In addition, the organization will have to maintain necessary documented information to support the
operation of the processes and keep records to evidence that the processes were carried out as
planned.
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5. Leadership
5.2 Policy
The Quality Policy is a high-level document containing statements about the general direction of the
organization, and its commitment to quality and customer satisfaction. It provides a framework for
quality objectives. Meeting compliance and regulatory factors is obviously a key element. Finally, and
vitally, the policy must provide a commitment to the continual improvement of the QMS and its results.
Critically, the Quality Policy must be maintained as documented information, be communicated within
the organization, and be available to all interested parties.
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6. Planning
The purpose of addressing risks and opportunities is to ensure that the QMS will achieve the intended
results, enhance desirable effects, and achieve improvements. The actions have to be planned and
implemented in the QMS, and later evaluated for their effectiveness.
Quality objectives must be measurable, quantitative, and timed. They must be in line with the Quality
Policy so it can be determined whether objectives are met, and if not, what should be done.
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7. Support
7.1 Resources
The standard requires the organization to determine and provide resources for the establishment,
implementation, maintenance, and continual improvement of the QMS, taking into account the
capabilities and constraints of existing internal resources and the need to obtain additional resources
from external providers.
Resources to be obtained include people, infrastructure, environment for operation of the processes,
monitoring and measuring resources, and organizational knowledge.
7.2 Competence
The organization needs to determine the necessary competence of its employees, and ensure those
employees are competent on the basis of appropriate education, training, and experience. This means
that the organization will need to have a process for determining the necessary competence and
achieving it through trainings and other means.
7.3 Awareness
Awareness is closely related to competence in the standard. Employees must be made aware of the
Quality Policy and its contents, any current and future impacts that may affect their tasks, what their
personal performance means to the QMS and its objectives, including the positives or improved
performance, and what the implications of poor performance may be to the QMS.
7.4 Communication
Processes for internal and external communication need to be established within the QMS. The key
elements that need to be decided and actioned are what needs to be communicated, when it needs to
be communicated, how it should be done, who needs to receive the communication, and who will
communicate. It should be noted here that any communication outputs should be consistent with
related information and content generated by the QMS for the sake of consistency.
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The standard requires that documented information created or updated in the scope of the QMS must
be properly identified and described, also considering its content presentation, and media used. All
documented information must go under proper review and approval procedures to ensure it is fit for its
intended purpose.
For proper control of documented information, the organization must consider the provision of
processes regarding the distribution, retention, access, usage, retrieval, preservation and storage,
control, and disposition of such information.
It should also be noted that there must be controls in place to prevent the unintentional use of obsolete
information.
8. Operation
Before offering the product or service to the customer, the organization needs to ensure that the
requirements for the products and services are defined, and that the organization is able to deliver such
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products or services. Requirements for products and services include any applicable legislation and the
requirements that the organization considers to be necessary.
After receiving the order, the organization must, prior to delivery, review the requirements related to
the product and keep records about the review. If the customer changes its requirements, these also
must be reviewed and recorded. In case of changes, the organization must ensure that all documented
information is amended and all relevant persons are aware of the changes.
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During design and development planning, all its phases must be defined with appropriate activities of
reviewing, verification, and validation for each phase. Considering that ISO 9001 refers to design and
development of product (not design and development of processes), design and development inputs
relate to product requirements that include:
Design and development outputs must be in a form suitable for verification related to input elements,
and must be approved before acceptance. They can be in the form of a drawing, engineering
documentation, plans, etc.
The organization also needs to define design and development review activities. The purpose of these
activities is to determine whether the design and development process goes in the intended direction.
The review can be done in appropriate phases or at the end of project. The review identifies problems
during design and development and suggests actions to resolve them; it can include other interested
parties. The design and development review must be documented.
Also, the company needs to identify, review, and control changes during the design and development of
products and services. Documented information should be kept regarding the changes, results of
reviews, authorization of the change, and actions taken to prevent adverse effects.
In order to ensure that externally provided processes, products, and services do not have an adverse
effect on the conformance of the organization’s products and services, the organization needs to
establish controls including verification and other activities. As part of the controls, the organization
needs to communicate to external providers its requirements for:
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The organization must use suitable means to identify outputs when it is necessary to ensure products
and services conformance. When the traceability is a requirement, the organization needs to control the
unique identification of outputs and retain documented information necessary to enable traceability.
In cases when the organization uses property belonging to a customer or external provider, it is required
to identify, verify, protect, and safeguard this property. When the property of the customer or external
provider is lost or damaged, the organization will have to report to the owner and retain documented
information on what has occurred.
The decision on the extent of post-delivery activities will be affected by the following:
In case of changes in the production and service provision process, the organization must review and
control the changes in order to ensure continuing conformity with the requirements.
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correction
segregation, containment, return, or suspension of provision of products and services
informing the customer
obtaining authorization for acceptance under concession
Conformity to the requirements must be verified when the nonconforming output is corrected. The
organization also needs to keep documented information that describes the nonconformity, the action
taken, concessions obtained, and the authority deciding the action with respect to the nonconformity.
9. Performance evaluation
The organization needs to determine what needs to be monitored and measured, how, and when, as
well as when the results will be analyzed.
It is required to measure your own performance as a supplier in order to get information about users’
observations, and the extent to which you fulfilled their requirements. Monitoring customer satisfaction
levels must be a constant activity in order to determine trends, and because opinions about your
performance can change. Information about customer satisfaction can be collected via phone, interview
or questionnaire, direct contact with the user on the field, etc.
Once the monitoring and measuring is performed and the results are gathered, the organization needs
to analyze the results in order to evaluate conformity of products and services, degree of customer
satisfaction, performance of the QMS, effectiveness of actions taken to address risks and opportunities,
performance of external providers, and need for improvements to the QMS.
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a) complies with the requirements of ISO 9001 and the requirements of your organization
b) is effectively implemented and maintained
At the end of the audit, you will get audit results by evaluating the data you collected during the audit.
Audit results can be manifested as: praise, recommendations for improvements, and nonconformities
(major and minor). Verification of actions taken may be needed, and in that case, the next step is a
follow- up audit.
Appropriateness – does it serve its purpose and satisfy the needs of the organization?
Adequacy – does the QMS conform to standard requirements?
Applicability – are activities performed according to procedures?
Effectiveness – does it accomplish the planned results?
This review must evaluate possibilities for improvement and needs for changing the QMS, Quality
Policy, and objectives. Considering the inputs for the management review, such as the results of the
previous management reviews, changes in the context, customer satisfaction survey results,
performance of the QMS and suppliers, etc., the top management must make decisions regarding
opportunities for improvement, need for changes in the QMS, and resources needed for the upcoming
period.
10. Improvements
10.1 General
Based on the results of the management review, the organization must make decisions and take actions
that will drive it towards continual improvement. Those actions can be in the form of corrective actions,
trainings, reorganization, innovation, and so on.
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The effectiveness of actions taken must be evaluated and documented, along with the originally
reported information about the nonconformity / corrective action and the results achieved.
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Conclusion
ISO 9001:2015 provides organizations with guidance as to the quality of their products and services,
with the ultimate goal of achieving customer satisfaction. Delivering all of the clauses of the standard
and truly understanding them can benefit your organization, and drive your company on the road of
continual improvement. Certification and compliance can bring reputational, motivational, and financial
benefits to your organization through improved efficiency, quality of products and services, and
avoiding nonconformities and customer complaints, along with improvements in your supply chain. All
of these elements are closely related to your organization’s ability to deliver satisfaction to your
customers, and fulfill the expectations and wishes of your stakeholders. Having all this in mind, can your
organization afford not to have ISO 9001:2015?
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