Quality Management System - ISO 9001-2015

QUALITY MANAGEMENT
SYSTEM
ISO 9001:2015
Abhishek Raj
abhishek@wazir.in
Abstract
ISO 9001 is a standard that sets out the requirements for a quality management system.
It helps businesses and organizationsto be more efficientand improve customer satisfaction.
A new version of the standard,ISO 9001:2015,has justbeen launched,replacingtheprevious
version (ISO 9001:2008).

Quality Management System: ISO 9001:2015
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ISO 9000 is a family of standards for quality management. It is maintained by the International
Organization for Standardization and is administered by the accreditation and certification
bodies. ISO 9000 addresses quality management standards as to what an organization needs to
fulfil. It assesses the organizations ability to meet customer and regulatory requirements,
quality management system, and provides guidelines for performance improvement. It is one of
the renowned international standards that have been implemented by countless companies in
more than 150 countries.
ISO standards aim at:
 A set of procedures to cover all key processes in the business.
 Monitor the process and ensure its effectiveness.
 Quality requirements of customers.
 Checking outputs for defects, and taking corrective actions in appropriate places.
 Applicable regulatory requirements to enhance customer satisfaction.
 Achieve continuous improvement of performance.
ISO standards is for:
 ISO 9001 is suitable for organizations of all types, sizes and sectors.
 In fact, one of the key improvements of the newly revised ISO 9001:2015 was to make
it more applicable and accessible to all types of enterprises.
 Smaller companies that do not have staff dedicated to quality can still enjoy the benefits
of implementing the standard – ISO has many resources to assist them.
ISO 9000:2000 and ISO 9001:2000:
Earlier till December 2000, there used to be ISO 9000, ISO 9001, ISO 9002 and ISO 9003
standards. During December 2000, the International Organization for Standardization merged
all of them into a revised ISO 9001 standard. To distinguish between the earlier standards and
the revised one, the later was referred to as ISO 9001:2000 or ISO 9000:2000. For all practical
purposes, ISO 9000 and ISO 9001 connote the same, and 2000 indicates the year of its revision.
Application in the Textile and Apparel Industries:
Textile and apparel industries have many complicated activities and challenges involved in the
course of its operation. Their operation incurs heavy expenditure to the manufacturers. Many
textile and apparel industries have implemented ISO standards to lower its operating costs and
improve the quality of its output, ultimately increasing the level of customer satisfaction.
Textile and apparel industries account for a sizable percent of manufacturing jobs in a global
perspective. They employ millions of people directly and indirectly. They form a massive
industrial complex and prove to be a big contributor among the manufacturing industries of any
country.
Some textile and apparel industries view ISO certification is only necessary as a factor for
exports. But, the main matter of concern in textile industry is that an imperative relation exists

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between the quality of the materials and the quality of the final product. ISO standards enable
the industry to enhance the quality of raw material input, thereby strengthening the quality of
the ultimate product. This will result in a systematic approach to management, incessant
performance improvement, factual approach towards the decision-making process, and a
mutually benefiting supplier’s relationship. Thus, is helps the manufacturers in 'Weaving a
Quality Industry'.
Market for ISO Certification:
As every day passes by, global competition is heating up. Textile and apparel industries are in
the midst of major changes. To keep pace with the market scenario, industries rely more on
quality and innovative fabrics, and apparels, and quick response to the needs of the customer.
Innovations in the fields of nanotextiles, nonwovens, electro textiles, medical textiles, and geo
textiles are providing new opportunities for the manufacturers and tap the market.
Simultaneously, these opportunities also encompass them with critical challenges.
Organizations today engage in many international trade activities, and this certification proves
a pre-requisite for their survival in international competition. ISO certification helps the
companies in market creation and penetration.
Benefits of ISO:
Implementation of ISO helps the textile and apparel industries to enhance their product and
process quality, minimizes defective supplies and reworking. Furthermore, it can also be used
as a marketing tool. As it is a well-recognized standard for quality, it shows the customers that
the company takes quality seriously.
ISO certified companies focus more on the quality of its products and operations. It also
motivates the employees in improving quality. The cost of implementing ISO is comparatively
cheaper to the benefits derived out of it. Many ISO certified companies positively assert that
their total costs went down to a considerable extent regarding quality maintenance after the
implementation of ISO.
Implementing a quality management systemwill help you:
 Assess the overall context of your organization to define who is affected by your work
and what they expect from you. This will enable you to clearly state your objectives and
identify new business opportunities.
 Put your customers first, making sure you consistently meet their needs and enhance
their satisfaction. This can lead to repeat custom, new clients and increased business for
your organization
 Work in a more efficient way as all your processes will be aligned and understood by
everyone in the business or organization. This increases productivity and efficiency,
bringing internal costs down.

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 Meet the necessary statutory and regulatory requirements.
 Expand into new markets, as some sectors and clients require ISO 9001 before doing
business.
 Identify and address the risks associated with your organization.
Case Studies:
Some exclusive one on one questions with noted personalities of textile companies which has
been certified under the ISO standards.
How is ISO Certification integral for a Company's Operation? How would you
distinguish yourself from a Non-Certified Company?
Mr. Snehakar Bansal, Director, Prathibha Syntex Pvt Ltd:
"It comes across as no surprise that solution providers today are increasingly opting to go for
the coveted ISO certification in Textile sector. It has a universal appeal and helps improve
various processes in a company, based on customer needs. Further, it increases customer
confidence in the supplier's product quality and delivery commitments, in addition to helping
solution providers penetrate in the global market, thus making the cash registers ring louder.
Price, quality, and service are three primary elements that are carefully monitored at the
Apparel Industry. There are a number of factors on which quality fitness of Apparel industry is
based such as - performance, reliability, and durability, visual and perceived quality of the
garment. Quality needs to be defined in terms of a particular framework of cost."
Mr. Bansal shares his professional expertise regarding the textile sector. He states,
"Competition is the name of the game and staying ahead is the key for survival. Like all else in
the industry, this rule applies to the solutions provider community too. Against the face of
growing business, and hence increased competition, solution providers have begun to realize
the need to provide their customers a differentiation factor in terms of service, products, price
and technology".
"ISO provides a framework and systematic approach to managing business processes to
produce a product/service that conforms to customer expectations. For customers, the
certification of suppliers to ISO standards means that they can be assured that the development
of their products and services are compliant to reference documents that are globally accepted.
This, of course, means that customers and suppliers are able to compete in markets around the
world.
ISO is required for companies that largely design as well as produce and distribute their
products or services. ISO 9002 is meant for companies that produce and distribute their
products or services. ISO 9003 is required for companies that carry out only final inspection
and testing. ISO 14000 is the new Environmental Management Standard (EMS). The ISO 9000
series appears to be sweeping the world and is rapidly becoming the most important quality
standard."

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Mr. P. Sundararajan, Managing Director, SP Apparels:
 "The Management is able to focus on the customer needs, expectations and effective
measures to fulfil Companies Objectives.
 Selection of appropriate and competent manpower.
 Training needs are identified and imparted which guides them properly to achieve
targets.
 Each department has its own measurable objectives. Every individual has defined
responsibilities and authorities.
 Necessary resources like work space, machineries, equipments and other infrastructure
are ensured. Also, the calibration of measuring equipments are monitored effectively"
Mr. P. Sundararajan positively asserts that these advantages cannot be enjoyed by a Non-
Certified Company.
N.Thirukkumarian, CEO, Esstee Exports:
He states that, "If we follow the ISO standards, we can be assured quality product. In a garment
industry, right from the purchase of yarn to packing of the finished garments, the ISO system
will take care. In a non-certified company you cannot trace the various inputs / outputs history."
How does ISO Certification help your company in acquiring a share in the global
market?
Mr. Snehakar Bansal shares his opinion regarding the same. He states, "Pratibha Syntex is
driven by a strong vision and a deep commitment to organic principles. Pratibha is the worlds
first mostly vertically integrated textile manufacturing company, going from raw material to
finished products, including cotton fibre production, spinning, knitting, dyeing and finishing,
and apparel manufacturing".
"Pratibha is accredited with ISO 9002, ISO 14001 Certifications. Certifications like the ISO
undoubtedly turn out to be beneficial to companies that opt for them. These could be both
tangible and intangible benefits. Pratibha has also achieved its benefits from both in tangible
and intangible manner. It has benefited in not only improving the quality base but also in
making a presence in the International market but also increasing customer base, improved
environmental performance, pollution prevention and waste reduction, has also increased its
goodwill in the eye of customers. It has also benefited us measurable process improvements,
which have translated into productivity gains and significant time and cost savings by the virtue
of attaining lower defect rates and lesser rework.
One of the key elements of Pratibha’s success and growth story has been its ability to satisfy
customers with superior quality of service, which has ensured steady growth, repeat business,
positive customer referrals and presence in the global market. For penetrating in this
competitive market, we have to provide and different product not only in the textile sector but
also for every industry, which aims towards quality products and services".
Mr. Sundararajan, shares his notions on how the certification is very helpful for SP Apparels to
improve their 'Quality of Manufacturing, on time processing, and Customer satisfaction'.

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 "Right from yarn purchase to shipment every activity is governed by documented
standard operating procedures and instructions, which complies with the requirements
of ISO 9001.
 Each process is carried out with the PDCA process approach (ie Plan-Do-Check-Act),
which gives better results in achieving better quality and on time shipments
 Inspection and testing at each stage of manufacture assures quality requirements are met
 Internal audit and external audit performed periodically ensures effective
implementation of Quality Management System
 Periodical feedback from customers reveals their level of satisfaction
 Analysis of data towards continual improvement"
Mr. Thirukkumarian accentuates how the certification has helped Esstee Exports to acquire a
slice in the global market pie. He says, "In the global market, the first question raised by any
customer, whether the Factory is certified for ISO 9001-2000. It is a pre-requirement for
obtaining any export order."
With the growing list of companies getting listed under the ISO certification; worldwide, the
polarization of ISO certification is clear as crystal. Religious implementation of ISO standards
in textile and apparel industries will result in a 'cultural transition' of continuous improvement.
The ISO 9001: Quality Management Systems –
Requirements standard sets out the criteria for a quality management system, and can be used
to assess an organisation's ability to meet customer and regulatory requirements. It is the
standard against which third party registration or certification can be achieved. This standard
originally came into existence in 1987. It has been revised four times since then-in 1994, 2000,
2008 and 2015. The 2015 version is the fifth edition of ISO 9001 Quality Management Systems
- Requirements. Currently, there are over a million organisations in over 170 countries certified
to the requirements of this standard.
ISO 9001:2015 was published in September 2015. For those organisations which are certified
to ISO 9001:2008, there is a three-year transition period, starting from September 2015 to get
certified to ISO 9001:2015. That means they have time till September 15, 2018 to make the
transition. Those who fail to do so, would have to go through an entirely new audit and
registration process.
Why was ISO 9001 revised?
 All ISO standards are reviewed and revised regularly to make sure they remain relevant
to the marketplace.

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 ISO 9001 has been updated to take into account the different challenges that businesses
now face.
 For example, increased globalization has changed the way we do business and
organizations often operate more complex supply chains, and there are increased
expectations from customers.
 ISO 9001 needs to reflect these changes in order to remain relevant.
What are the key improvements?
Structure –
ISO 9001:2015 now follows the same overall structure as other ISO management system
standards (High-Level Structure), making it easier for anyone using multiple management
systems.
See Annex SL of ISO/IEC Directives Part 1 (the rules for developing ISO standards) for further
information.
What benefits does the new version bring?
The new version of the standard brings the user a number of benefits.
ISO 9001:2015:
 Puts greater emphasis on leadership engagement
 Helps address organizational risks and opportunities in a structured manner
 Uses simplified language and a common structure and terms, particularly helpful to
organizations using multiple management systems
 Addresses supply chain management more effectively
 Is more user-friendly for service and knowledge-based organizations
Focus on risk-based thinking –
This has always been part of the standard, but the new version gives it increased prominence.
More information can be found on the Website run by ISO/TC 176/SC 2, the group of experts
behind the standard (www.iso.org/tc176/sc2/public).
The purpose of this article is to give an overview of the changes in ISO 9001:2015 version
compared to 2008, so that apparel manufacturers can start working to meet the new
requirements. The International Organization for Standardization (ISO) does not report the

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number of apparel manufacturers certified worldwide. Apparel manufacturers are lumped in the
category 'Textile and Textile Products'.
The 2015 revisions are hailed as "a game changer", "a real improvement that will lead to a
more robust QMS", "this is a wonderful opportunity for organisations to refocus their QMS on
their business operations", "ISO 9001:2015 will have huge impacts across the world", "it will
provide more confidence that quality management systems really work"1. Changes in the ISO
9001:2008 were necessary due to increasingly demanding customers, increased complexity of
the supply chains, emergence of new technology, greater awareness for the need to address
sustainability, etc.
While Table shows an overview of the clause of 9001:2015 and 9001:2008, the major
differences between the two versions are as follows:
 Title of the clauses and their order, and simplified language
 A new clause addressing "Context of the Organisation"
 Process approach strengthened and made more explicit
 Concept of preventive action now addressed throughout the standard by risk
identification and mitigation
 A clause addressing "Leadership" as opposed to "Management Responsibility"
 Fewer prescribed requirements and lesser emphasis on documentation
Title of the clauses and their order –
Title of the clauses and their order in the revised 9001 standards are aligned with other ISO
management systems standards, such as the one on environmental management. All ISO
Management Systems Standards are now required to use a common 10-clause high-level
structure. These changes will make it easier for organisations to address the requirements of
more than one ISO Management Systems Standards within a single integrated system.
The simplified language of the revision makes it easier for service organisations to use this
standard. The term "products and services" is now used throughout the standard to reflect the
far greater use of the standard outside of the manufacturing sector, and to emphasise its
applicability in service industries.
Apparel manufacturers who are already certified to ISO 9001:2008 and are considering
transition to the new standard may want to consider renumbering various quality management
systems documents so that it would be easy to cross-reference them with the revised standard.
Context of the Organisation –
The "context of the organisation" means the environment in which an organisation functions
and various external and internal factors that affect its business. The clause on "context of the
organisation" was included so that the organisations can view themselves strategically which
will influence their quality management practice. This clause requires organisations to have a
high-level understanding of various factors that may affect their business-both positive and
negative.

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These factors are the competitive and regulatory environment, market environment, operational
factors such as labour, facilities, utilities, suppliers, logistics, etc. Clear understanding of how
these factors affect an organisation will influence quality management system and practices of
an organisation. Under this, the management is required to identify the internal and external
issues that are relevant to its purpose and strategic direction, and understand needs and
expectations of the relevant interested parties. "Context of the organisation" is the foundation of
effective quality management system, because an effective quality management system can be
put in place only if an organisation has a clear understanding of the context in which it
operates. What this means for the apparel manufacturers is that they will have to identify their
customers and their code of conduct or labour standards, local labour and environmental laws
and figure out how to meet their customers' expectations while meeting all regulatory
challenges. Thinking about the "context of the organisation" is new to the apparel
manufacturers, ISO 9001:2015 just formalises it.
Process approach –
While there is no specific clause requiring an organisation to use a process approach, the
language throughout the standard is such that it requires an organisation to identify its key
processes for meeting the organisation's objectives as well as customers' needs.
While the concept of the process approach was introduced in ISO 9001:2000, the 2015 revision
makes it explicit through PDCA (plan, do, check, act) as a tool to manage processes and
systems.
"Plan" involves setting objectives of the processes and systems (what to do, how to do) to
deliver results. Clauses 4,5, and 6, that is, context of the organisation, leadership, and planning,
respectively address "Plan" part of the PDCA. "Do" involves actually implementing and
controlling what was planned (operations). Clause 8, operation, addresses the "Do" part of the
PDCA. "Check" involves monitoring the process through measures and comparing those
measures to the requirements.
Clause 9, performance and evaluation, addresses the "check" part of the PDCA. For the apparel
manufacturers, this means all production processes, including quality inspection at various
stages of manufacturing and testing components and final product. "Act" involves taking
actions to improve performance of the processes. Clause 10, improvement, addresses the "Act"
part. For apparel manufacturers, this would mean any actions taken based on the results of
inspection and testing.
Risk identification and mitigation –
One of the key changes in the 2015 revision of ISO 9001 is to establish a systematic approach
to considering risk, rather than treating "prevention" as a separate component of a quality
management system. Identifying and addressing risk in itself is preventive action(s). The
management is expected to identify risks in the processes of the quality management system
that may affect the organisation's ability to meet its objectives, i.e. customer requirements, so
that those risks can be addressed as appropriate. By systematically identifying and addressing
risks an organisation can better meet requirements of its customers. The typical risk that most

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apparel manufacturers face is not being able to deliver merchandise when promised. The
revised 9001 standard requirement would mean that apparel manufacturers must have some
plans in place to address such a situation.
Leadership –
There is a change from "Management Responsibility" in ISO 9001:2008. The revised ISO 9001
standard requiring the leadership of an organisation to be "Leadership" is a significant change,
and will result in organisations producing much better-quality products and services with much
improved operations. This change puts quality management system in front of the top
management like never before.
The revised ISO 9001 standard requires leadership of an organisation to:
 Be accountable for the effectiveness of the quality management system by allocating
adequate resources and engaging, directing and supporting personnel to contribute to
the effectiveness of the quality management system.
 Ensure that the quality policy and quality objectives are compatible with the context and
strategic direction of the organisation.
 Ensure that the quality policy is communicated, understood and applied in the
organisation.
 Ensure the integration of quality management system requirements into the
organisation's business processes.
 Promote the use of process approach and risk-based thinking.
 Communicate the importance of effective quality management and of conforming to
quality management system's requirements.
 Support relevant management roles.
 Ensure that the quality management system achieves its intended results.
 Promote improvement.
What the above means is that the top management can no longer be a "supporter" or "observer"
of the quality management system, but will have to be a "participant" of the quality
management system. This will require a paradigm shift on most top management's part.
According to one observer, "The days when quality managers would be thanked for their QMS
status presentation and then asked to leave the meeting because 'we have business to attend' are
over!" Let me give you an example of how one of the best apparel companies in the US
addresses quality. This company has several manufacturing plants in the US, Mexico and
several Caribbean countries. Every month, they have a plant managers meeting at their
headquarters in the US, chaired by the executive vice-president of operations. Every meeting

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starts with a presentation by the corporate director of quality where he makes presentation on
outgoing quality levels at each plant for the previous month, cost of rework and scrap, what
corrective actions are in place, overall trend for each plant, etc.
It is only after this presentation that other issues are addressed. Conducting a meeting in such a
fashion sends out a very clear signal to all plant managers that the top management of this
company is committed to quality. Since these plant managers' quality performance is reviewed
every month in presence of their peers they have no place to hide. Nobody likes their
weaknesses to be exposed in front of their peers. Therefore, every one of these plant managers
is committed to quality in his respective plant and the quality level in each plant keeps
improving.
Table 1: Overview of ISO 9001:2008 and ISO 9001:2015 –
While the prescriptive title of a management representative has been deleted, it is up to the top
management to ensure that the roles and responsibilities are assigned for reporting on the
performance of the quality management system. Some organisations might find it convenient to
have a single person carry out this role, while others may find some other structure(s)
depending on their organisational context.
Documentation –
The revised ISO 9001 allows organisation flexibility in the way it chooses to document its
quality management system. Specific documented procedures are no longer mentioned. It is the
responsibility of the organisation to maintain documented information to support the operation
of its processes and to retain the documented information necessary to have the confidence that
the processes are being carried out as planned.
Documented information is defined as "information required be controlling and maintaining by
an organisation and the medium on which it is contained." Documented information can

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include documents, records, data, and any other information that might be contained in an
enterprise resource system (ERP) and computer aided design (CAD) programmes.
A quality manual is no longer specifically required. If an organisation finds it convenient and
appropriate to describe its quality management system in a quality manual, then it is perfectly
acceptable.
Because of this flexibility, each organisation will be able to determine the amount of
documented information needed in order to demonstrate effective planning, operation, and
control of its processes as well as implementation of continual improvement of the
effectiveness of the quality management system. While the standard does not prescribe which
documents to maintain, it would be wise for apparel manufacturers to maintain inspection
results, test results, decisions regarding disposition of non-conforming merchandise, standard
operating procedures, minutes of the meetings where quality management system performance
was addressed/discussed, and the like.
Frequently AskedQuestions –
I am currently using ISO 9001:2008. What should I do ?
As ISO 9001 has been revised to meet the needs of today’s business world, we recommend that
you update your quality management system to fit the new version.
Here are some tips that will help you get started on the journey.
 Tip 1 – Familiarize yourself with the new document. A correlation matrix, available
from ISO/TC 176/SC 2, will help you identify if parts of the standard have been moved
to other sections.
 Tip 2 – Identify any organizational gaps which need to be addressed to meet the new
requirements.
 Tip 3 – Develop an implementation plan.
 Tip 4 – Provide appropriate training and awareness for all parties that have an impact on
the effectiveness of the organization.
 Tip 5 – If you are certified to the standard, talk to your certification body about
transitioning to the new version.
I am certified to ISO 9001:2008. What should I do ?
 If you wish to maintain your certification to ISO 9001, you will need to upgrade your
quality management system to the new edition of the standard and seek certification to
it.
 You have a three-year transition period from the date of publication (September 2015)
to move to the 2015 version. This means that, after the end of September 2018, a
certificate to ISO 9001:2008 will no longer be valid.

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ISO 9001:2015
Quality Manual Sample
Format –

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Quality Manual
ISO 9001:2015 Quality Management System
Quality management input comprises the
standard requirements from ISO 9001:2015
which are deployed by our organization to
achieve customer satisfaction through process
control.
Quality management input comprises the
standard requirements from ISO 9001:2015
which are deployed by our organization to
achieve customer satisfaction through process
control.

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Internal Issues External Issues
Market share Customers & suppliers
Markets & competition
Regulatory & statutory
Economic backdrop
Values & culture Technological
Innovation &knowledge Cultural &
social
4 About Our Organisation
4.1 Organizational Context
Your organization is committed to
defining our position in the
marketplace and understanding how
relevant factors arising from legal,
political, economic, social and
technological issues influence our
strategic direction and our
organizational context.
Your organization identifies, analyzes,
monitors and reviews factors that
may affect our ability to satisfy our
customers and stakeholders, as well
as; factors that may adversely affect
the stability of our process, or our
management system’s integrity.
To ensure that our QMS is aligned with our
strategy, whilst taking account of relevant
internal and external factors; we initially
collate and analyze pertinent information in
order to determine potential impact on our context and subsequent business strategy.
Your organization then monitors and reviews this information to ensure that a continual
understanding of each group’s requirements is derived and maintained. To facilitate
the understanding of our context, we regularly consider issues that influence our context
during management review meetings and are conveyed via minutes and business
planning documents.
The output from this activity is evident
as an input to the consideration of
risks and opportunities, and the
actions that we take to address them.
Refer to Section 6.1 for more
information about our risk and
opportunity management framework.
Although we acknowledge that ISO 9001:2015 does not require our organizational
context to be maintained as documented information, we maintain and retain; in addition
to this document, the following documented information to describe our organizational
context:
SWOT Analysis PESTLE Analysis
Organizational Strategy
Local Factors
Issues
MacroEnvironment
Interested
Parties
Figure 1: Typical QMS Input Hierarchy
Business Planning
Quality Policy Managment System
Objectives
KPIs/
Metrics
Context Scope

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1. Analysis of business plans, strategies, and statutory and regulatory commitments;
2. Analysis of technology and competitors;
3. Economic reports from relevant business sectors;
4. Technical reports from technical experts and consultants;
5. SWOT analysis reports or schedules for internal issues;
6. PESTLE analysis reports or schedules for external issues;
7. Minutes of meetings (Management and design review minutes), process maps and
reports, etc.
5 Leadership & Governance
5.1 Leadership and Commitment
5.1.1 Quality Management
Your organization’s leadership
is also responsible for
implementing the QMS, which
includes the development and
deployment of the quality policy,
the quality objectives, and
product/project-specific plans
that are customer focused.
Top management provides the
leadership and governance to all
activities related to the lifecycle
processes including defining the
strategic direction,
responsibility, authority, and
communication to assure the safe
and effective performance.
Your organization’s governance
structure provides necessary
support for creating and
establishing appropriate
processes that are important for
maintaining and achieving our
quality objectives and policies.
In addition, governance activities
include systematic verification of
the effectiveness our QMS by
undertaking internal audits and
analyzing performance data.
Regular management reviews ensure that our quality management system is adequate and
Plan - Establish your
organizational
context and
strategies. Determine
regluatory and
statutory
commitments.
Do - Develop the
policy and objectives.
Provide resources,
assign process
owners. Focus on
improving &
acheiving objectives.
Address risks and
Leadership
Act - Agree changes
and implement
improvements to
maintain the
integrity of the QMS
and its processes.
Check - Review
system and process
performance data,
ensure alignment is
maintained between
context and strategy.
Review your policy
and objectives.
Figure 3: Leadership PDCA Cycle

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effective, and that any necessary adjustments are made as a result.
Top management is committed to implementing and developing the quality management
system and this commitment is defined by our corporate policies and objectives. Your
organization ensures that our policies are understood, implemented and maintained
throughout at all levels of the organization through printed distribution of our policy
statements and through periodic management review of the policy statements and
corporate level improvement objectives. Your organization communicates our mission,
vision, strategy, policies and processes to all employees in order to:
1. Create and sustain shared values of fairness and ethical behavior;
2. Establish a culture of trust and integrity;
3. Encourage commitment to quality;
4. Provide people with the required resources, training and authority to act with
accountability;
5. Inspire, encourage and recognize people’s contribution.
6 Management System Planning
6.1 Addressing Risks & Opportunities
The overall aim of risk and opportunity
management within your organization is to
ensure that organizational capabilities and
resources are employed in an efficient and
effective manner to take advantage of
opportunities and to mitigate risks.
Top management are responsible for
incorporating risk based thinking in to our
organization's culture. This includes the
establishment of risk management policies
and targets to ensure effective
implementation of risk and opportunity
management principles and activities by:
1. Providing sufficient resources to
carry out risk and opportunity
management activities;
2. Assigning responsibilities and
authorities for risk and
opportunity management
activities;
3. Reviewing information and results from audits and risk and opportunity
management activities.
The scope of your organization’s risk and opportunity management process includes the
assessment of the internal and external issues identified in Section 4.1, and the
assessment of the needs and expectations of any interested parties identified in
Figure 4: Risk & Opportunities PDCA Cycle
Plan - Create
plans to
address risk
and
opportunities.
Do -
Implement
plans to
mitigate risks
or to adopt
opportunities.
Risks &
Opportunities
Act -
Implement
changes to the
QMS and
continually
review.
Check -
Monitor risk
management
plans using
measurements
and audits.

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Section 4.2. Risk and opportunity management is undertaken as part of your
organization’s day-to-day operations and is captured at the following hierarchy:
1. Strategic level;
2. Programme level;
3. Department level;
4. Process level;
Establishing such a hierarchy for capturing risk and opportunity ensures that each is
managed at the most appropriate level within our organization. Typically, the following
categories are assigned to each level in the hierarchy as shown in the table opposite.
Your organization has classified its
‘risk appetite’ as the amount of risk that
we are willing to accept in pursuit of
an opportunity or the avoidance of risk
where each pertains to product and/or
system conformity, and which reflect the following considerations:
1. Risk management philosophy per product or process;
2. Capacity to take on or mitigate risk;
3. Our objectives, business plans and respective stakeholder demands;
Business Hierarchy
Strategic level
Programme level
Department level
Process level
Risk/Opportunity
Budgets and profitability
Performance and efficiency
Resources and targets
Evaluation and assurance

18
Appendices
A.1 Correlation Matrix
This section provides a matrix to correlate the requirements of ISO 9001:2015 against the
relevant sections in this document and should be used to determine where the new and
amended clauses are located.
ISO 9001:2015 This Document
4.0 Context of the Organization 4.0 About our Organization
4.1 Understanding the Organization and its
Context
4.1 Organizational Context
4.2 Needs and Expectations of Interested
Parties
4.2 Relevant Interested Parties
4.3 Scope of the Quality Management
System
4.3.1 Management System Scope
4.4 Quality Management System and its
Processes
4.3.2 Management System Processes
5.0 Leadership 5.0 Leadership & Governance
5.1 Leadership and Commitment 5.1 Leadership and Commitment
5.1.1 Quality Management System 5.1.1 Quality Management System
5.1.2 Customer Focus 5.1.2 Customer Focus
5.2 Quality Policy 5.1.3 Quality Policy
5.2.1 Establishing the Quality Policy 5.1.3.1 Establishing the Quality Policy
5.2.2 Communicating the Quality Policy 5.1.3.2 Communicating the Quality Policy
5.3 Roles, Responsibilities and Authorities 5.2 Roles, Responsibilities and Authorities
6.0 Planning for the Quality Management
System
6.0 Management System Planning
6.1 Actions To Address Risks and
Opportunities
6.1 Addressing Risk & Opportunities
6.2 Quality Objectives & Planning To
Achieve Them
6.2 Quality Objectives
6.3 Planning of Changes 6.3 Planning for Change
7.0 Support 7 Support
7.1 Resources 7.1 Resources
7.1.1 General 7.1.1 General
7.1.2 People 7.1.2 People
7.1.3 Infrastructure 7.1.3 Infrastructure
7.1.4 Environment for the Operation Of
Processes
7.1.4 Operational Environment
7.1.5 Monitoring and Measuring Resources 7.1.5 Monitoring and Measuring Tools
7.1.6 Organizational Knowledge 7.1.6 Organizational Knowledge
7.2 Competence 7.1.2.1 Competence
7.3 Awareness 7.1.2.2 Awareness
7.4 Communication 5.3 Communication
7.5 Documented Information 4.3.4 Documented Information
7.5.1 General 4.3.4.1 Management System Documents
7.5.2 Creating and Updating 4.3.4.2 Creating and Updating
7.5.3 Control of Documented Information 4.3.4.3 Controlling Documented Information
8.0 Operation 8.0 Product & Service Development
8.1 Operational Planning and Control 8.1 Operational Planning and Control
8.2 Requirements for Products and Services 8.2 Customer Requirements
8.2.1 Customer Communication 8.2.1 Customer Communication
8.2.2 Determining Requirements Related to
Products
8.2.2 Determining Requirements

19
O 9001:2015 This Document
8.2.3 Review of Requirements Related to the
Products
8.2.3 Review of Requirements
8.2.4 Changes to Requirements for
Products/Services
8.2.4 Changes in Requirements
8.3 Design and Development of Products 8.3 Design and Development of Products
8.3.2 Design and Development Planning 8.3.2 Planning
8.3.3 Design and Development Inputs 8.3.3 Inputs
8.3.4 Design and Development Controls 8.3.4 Controls
8.3.5 Design and Development Outputs 8.3.5 Outputs
8.3.6 Design and Development Changes 8.3.6 Changes
8.4 Externally Provided Products & Services 8.4 Control of Suppliers & External
Processes8.4.1 General 8.4.1 General
8.4.2 Type & Extent of Control of External
Provision
8.4.2 Purchasing Controls
8.4.3 Information for External Providers 8.4.3 Purchasing Information
8.5 Production and Service Provision 8.5 Production & Service Provision
8.5.1 Control of Production and Service
Provision
8.5.1 Control of Production & Service
Provision8.5.2 Identification and Traceability 8.5.2 Identification & Traceability
8.5.3 Customer or External Provider’s Property 8.5.3 3rd Party Property
8.5.4 Preservation 8.5.4 Preservation
8.5.5 Post-Delivery Activities 8.5.5 Post-Delivery Activities
8.5.6 Control of Changes 8.5.6 Control of Changes
8.6 Release of Products and Services 8.6 Release of Products and Services
8.7 Non-conforming Process Outputs and
Products
8.7 Control of Non-conforming Outputs
9.0 Performance Evaluation 9.0 Performance Evaluation
9.1 Monitoring, Measurement, Analysis &
Evaluation
9.1 Monitoring, Measurement, Analysis &
Evaluation9.1.1 General 9.1.1 General
9.1.2 Customer Satisfaction 9.1.2 Customer Satisfaction
9.1.3 Analysis and Evaluation 9.1.3 Analysis and Evaluation
9.2 Internal Audit 9.2 Internal Audit
9.3 Management Review 9.3 Management Review
9.3.2 Management Review Inputs 9.3.2 Inputs
9.3.3 Management Review Outputs 9.3.3 Outputs
10.0 Improvement 10.0 Improvement
10.1 General 10.1 General
10.2 Non-Conformity and Corrective Action 10.2 Non-Conformity & Corrective Action
10.3 Continual Improvement 10.3 Continual Improvement

20
A.1 Sequence & Interaction of Processes
SUPPORT PROCESSES
Communication
Competence &
Awareness
Maintain Facilities
& Equipment
Calibrate
Equipment
Mitigate Risks &
Impacts
Document & Data
Control
Domain
Knowledge
ASSESSMENT
PROCESSES
Continual
Improvement
Corrective Action
Evaluate Risks &
Opportunities
Management
Review
Product & Process
Monitoring
ASSESSMENT
PROCESSES
Evaluation of
Compliance
Internal Auditing
Non-conformities
& Corrective Action
Customer
Feedback &
Satisfaction
Analyze QMS
Process Data
Customer,
Market &
Stakeholder
Feedback
Storage, Dispatch &
Delivery
Incoming
Inpsection, Handling
& Storage
Production
Processes
Customer Related Prcesses
Quote Order
Contract Review
Product & Process
Planning
Design &
Development
Supplier Selection &
Evaluation
MANAGEMENT
PROCESSES
Quality Management
System
Set Objectives &
Targets
Customer, Market, Stakeholder
& Legal Requirements
Provide Resources &
Infrastructure
Identify Risks &
Opportunities
Identify Legal &
Other Requirements
Determine Roles &
Responsibilties
Quality Planning

21
References –
 Fibre2Fashion
 http://www.fibre2fashion.com/industry-article/7911/the-new-standard-for-
change?page=1
 http://www.fibre2fashion.com/industry-article/3746/iso-certification-for-textile-
and-apparel-industries?page=4
 ISO - International Organization for Standardization
 https://www.iso.org/standards-catalogue/browse-by-ics.html
 https://asq.org/quality-resources/iso-9001-quality-manual

Quality Management System - ISO 9001-2015

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