ISO 9001:

QUALITY MANAGEMENT
PRINCIPLES

BY PARMI GAJJAR
 CONTEXT OF ORGANIZATION
04 An organization must consider both the internal and
external issues that can impact its strategic objectives
and the planning of the QMS.

05 LEADERSHIP
Leadership is about establishing unity of purpose and
direction in an organization.
OBJECTIVE OF CLAUSES

06 PLANNING
The process of conceptualizing the activities required
to achieve a desired goal.

07 SUPPORT
Relating to the resources and support a business requires to
achieve their goals.
CLAUSE NO. 4 : CONTEXT OF ORGANIZATION

4.1 : Understanding the organization and its context

You must establish the aim of your organization, nature of business, and even identify the strengths, weaknesses, threats
and opportunities. Organizations are to assess both internal and external influences in formulating and implementing a
quality management system. In addition to traditional customer, economic and competitive factors, it notes that these
influences can include how laws, technical developments and even political/cultural/social changes might impact the
mission of the organization.

4.2 : Understanding the needs and expectations of interested parties

This requirement addresses the desires and demands of all those who may have interest in the organization and could
impact its mission and who, in turn, would influence its quality management system. You should also list out risks
associated with stakeholders/interested parties. It asks those seeking ISO 9001:2015 certification to have an ongoing
system for determining these interested parties and their requirements.

4.3 : Determining the scope of the quality management system

Defining the scope means to identify the boundaries of your QMS of which your organization will implement and get
certified. As ISO 9001: 2015 is a generic standard, not all requirements may apply to your organization, this is where you
will identify if requirements cannot be applied; you must justify the requirements that cannot be applied. And it must be
documented and centered around the organization’s supplied services and products.

4.4 : Quality management system and its processes

Because the ISO 9001:2015 standard maintains the process approach from previous revisions, it requires understanding
and control of the order of each phase in the QMS processes and how one element affects another. And A process is
needed for determining what capabilities, support and investment will be needed and what by what means this will be
provided.
Documents/references/evidences
for the Clause No. 4

Different methods used to document processes:

Quality manual, Graphical representations, written instructions,
checklists, flow charts, visual media, or electronic methods, etc.

Methods for effective operation and control of processes:

Process flowcharts, block diagrams, set up checklist, machine manuals, etc.

Resources for QMS processes: Facility, material, equipment, labour, supplies, utilities,
Resource details may be identified in specifications, production schedules, bill of
materials, work instructions, etc.

Information for QMS processes will vary from process to process and may include:
production schedules, bill of materials, product acceptance and process performance criteria

Ways to monitor and measure QMS processes may include: Tracking against process
parameters, goals and objectives, using tools and records such as process check-
sheets,production & maintenance records, labour records, etc.
Outsourced processes may be controlled in any number of ways, e.g., providing the vendors with
product specifications, your supplier quality manual that they must meet, asking for inspection and
test results or certificates of compliance, validation of outsourced process, conducting product and
QMS audits of your vendors, etc
CLAUSE NO. 5 : LEADERSHIP

5.1 : Leadership and commitment and Customer focus

Top Management is now required to demonstrate leadership and commitment in regard to the QMS. They should ensure
that the quality policy and objectives are compatible with the business’s strategic direction, that the policy is understood
and followed, and that the QMS is integrated into the organization’s business processes. There are also additional
requirements based on the need to identify and address any risks to conformity of goods and services provided to
customers.

5.2 : Policy

Leadership is to establish, communicate and enforce a quality policy that accomplishes the following:

• Is in line with the purpose, context, and strategic direction of the organization
• Provides a framework for quality objectives
• Includes a commitment to satisfy applicable requirements
• Includes a commitment to continual improvement

5.3 : Organizational roles, responsibilities and authorities

Responsibilities and authorities for relevant roles must be assigned, communicated and understood within the
organization. Specifically, roles that impact the organization’s ability to meet the requirements of 9001:2015, ensure
processes are delivering their intended outputs, report QMS performance and improvement, plan and implement changes
to the QMS, and promote customer focus.
Documents/references/evidences
for the Clause No. 5

01 02 03 04

Role in planning and Documents for the Communicate- meetings, Process for customer focus:
implementing the processes: process map, documented policies, business planning,
processes- business process flow diagram, a memos, directives, email communications, sales and
planning, quality planning, documented procedure, marketing, and customer
management review, business plan, statement satisfaction feedback
internal communication, of policies and objectives
organization structure

05 06

Documents needed for effective Documented statement of

planning, operation and control Quality Policy
of these processes: documented
procedure, business plan,
statement of customer related
policies and objectives
CLAUSE NO. 6 : PLANNING

6.1 : Actions to address risks and opportunities

Building upon the need to include the influence of the wider elements of the organization, planning now fully embraces the risk and
opportunity management concept. This is to be implemented as a key activity to achieve quality goals on a continual basis, including an
evaluation of the risk management process and a priority/scaling of when, how, where and to what level it should be applied.

6.2 : Quality objectives and planning to achieve them

This subsection builds upon an accurate definition and plan to achieve specific quality objectives including:

• Being directly driven by the quality policy itself

• More accurate measuring, monitoring and updating
• Being applied to ensure product and service consistency and customer satisfaction
• Having a sufficiently wide scope to ensure quality performance success
• Specific quality objective documentation

There is to be a conscious approach to changing the QMS itself, using a controlled process that constantly considers the reason and impacts of
the considered change, as well as how it may affect the level and allocation of resources and assignments. The standard requires taking the
general concepts of planning into the operations realm by defining the needs associated with service or product provision, creating supportive
processes, determining customer acceptance criteria and the needed assets to ensure compliance with quality standards.

6.3 : Planning of changes

When changes to the QMS are needed, they must be carried out in a planned manner. Examples of QMS changes include plans to transition
from ISO 9001:2008 to 9001:2015 or make improvements to your existing QMS. Risks, resources needed, re-assignment of employee
responsibility and the integrity of the QMS all need to be considered with developing plans for implementing changes.
Documents/references/evidences
for the Clause No. 6

Product – reduction in defect rates, PPMs

01
Suppliers – material defects; on time (defective parts per million), scrap rates,
delivery, complaints with supplier, etc. rework; improvement in on time delivery

02

06
Process – objectives generally focus on
QMS – customer satisfaction feedback,
improving process productivity through the
internal audit results, improvement
elimination or reduction of variation and

.
03
opportunities; etc.
waste in process.

05
Resources – (includes facility, equipment, Customers – reduction in of complaints,
labor, etc.) – objectives could be 04
. improvement in customer satisfaction
established based on availability, rating, on time delivery, service, support, etc
capability, maintenance, etc.
CLAUSE NO. 7 : SUPPORT

7.1 : Resources

This section takes a broad view of items needed to realize the requirements of ISO 9001:2015, specifically calling for
support in these critical areas:

What resources on hand vs. what needs to be procured including:

• Labor/Skills
• Plant or office facilities/utilities
• Information technology/communications
• Transportation/logistics
• Equipments
• Working conditions/environment (including physical and interpersonnel emotional, intellectual, and motivational
issues)

Measuring the type, level, scope, continuity and suitability of resources including ongoing justification of their need.
Calibrating or verifying monitoring and measuring resources that affect the conformity of products and services.
Determining and maintaining organizational knowledge such as backing up electronic documents, records, or systems and
documenting essential tribal knowledge.

7.2 : Competence

The aptitude of those who execute QMS processes need to be assessed against the requirements for the tasks, and any
deficiencies be addressed through personnel training, exposure, outsourcing or reassignment.
CLAUSE NO. 7 : SUPPORT (CONT....)

7.3 : Awareness

The standard requires that everyone, not just those who administer the QMS, become familiar with its policies and
objectives and know what they must do to achieve its goals, including what happens if they do not adequately meet these
requirements.
7.4 : Communication

A formal plan and activities for informing the organization about the QMS needs to include:

• Who needs to know about each specific QMS element

• How and when that communication will take place
• And who is responsible for the information being transmitted

7.5 : Documented information

The nature of documentation has been expanded in order to both meet that which is required by the standard, but also what is needed by the
organization itself to practically implement the QMS. It does provide these specific documentation criteria:

• It must include a means for proper description including its source, purpose, change history, review/approvals and the method of
communicating (text, audio, video, pictorial, multimedia, interactive, etc.)
• A means must be provided to formally manage the documentation, balancing the need for access versus security
• Going further, there must be a plan and approach governing documentation dissemination (what, when, and where documentation can be
accessed and by whom), integrity/validation, revision, approval, storage and destruction (if applicable).

Much of this criteria can be met using document control software to help you manage all your documented information. Some ERP or MRP
systems include document control capabilities. The most basic method used for document control is maintaining on a shared network with
restricted editing functionality and updates managed manually. Many organizations will assign document control responsibilities to a
designated Document Controller.
Documents/references/evidences for the
Clause No. 7

Training Records & List of employees showing

Training Needs records of education, training,
skills and experience.

List of Housekeeping Skill & Competency Matrix

Records

List of Accident Induction training record

Records

List of Machines & Site Plan List

Equipments