E4-E5 - Text - Chapter 2. ISO 9001-2015 QUALITY MANAGEMENT SYSTEM

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E4-E5/Management ISO 9001:2015 Quality Management System

2 ISO 9001:2015 QUALITY MANAGEMENT SYSTEM

2.1 LEARNING OBJECTIVES:


At the end of this session, participants will be able to:
• Explain what is ISO 9001 standard
• Explain benefits of obtaining ISO 9001: 2015 certification
• Define Quality and understand ISO9001: 2015 quality principles
• Understand BSNL approach to ISO 9001 certification

2.2 INTRODUCTION:
Everyone wants to achieve profits. Profits can come by more sales with some profit
margin and by cutting down costs. While good quality can lead to more sales, yet the poor
processes can increase the cost to achieve that quality level thereby reducing profits. Cost
cutting is possible through better processes while ensuring quality output. Quality cannot be
compromised at any cost, as it dents the company image and paves the path for demise of
company. Many techniques for improving the processes are available to modern managers.
ISO 9001 is one such technique, widely accepted across the world being an international
standard and is applicable to all types of industries, business and organizations. Latest
version of this standard is ISO 9001:2015. In today‘s scenario, many organizations decide to
buy products/services (including Telecom solutions) only from ISO 9001 certified suppliers.
Therefore, ISO 9001 certification for BSNL is necessary.

2.3 WHAT IS ISO 9001 STANDARD?


ISO stands for international organization for standardization. Across the world, page
A4 is of same size, size 40 of a shirt is expected to be of same size irrespective of the place of
purchase. All such things require adherence to certain standards by the manufacturers. ISO
headquartered at Geneva defines standard for almost all the items being sold in the market. In
fact, ISO in Greek means equal. ISO has come up with product standards as well as process
standards. In India Bureau of Indian Standards (BIS) defines the product standards [ISI
mark], which are based on international standard. The process standard of ISO for ensuring
quality is called as ISO 9001. At present 2015 version is in effect commonly known as ISO
9001:2015.This standard helps the organizations to develop, establish, implement and
maintain a quality management system capable of delivering consistent quality output with
focus on continual improvements.

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2.4 BENEFITS OF OBTAINING ISO 9001:2015 CERTIFICATION:


Implementing a quality management system brings internal benefits to most
Organizations, as well as opening up opportunities vis-à-vis the outside world.

Internal benefits to the company include:


• improved customer focus and process orientation within the company;
• improved management commitment and decision-making;
• better working conditions for employees;
• increased motivation of employees;
• reduced cost of internal failures (lower rates of rework, rejection, etc.) and
• external failures (fewer customer returns, replacements, etc.); and last but not
least,
• continual improvement of the quality management system.
The following external benefits are generated:
• customers are more confident that they will receive products conforming to their
requirements, which in turn results in higher customer satisfaction;
• an improved image of the company;
• more aggressive publicity, as customers can be informed of the benefits of their
doing business with a company that manages the quality of its outputs;
• more confidence that the company‘s products meet relevant regulatory
requirements;
• better objective evidence to defend product liability charges if such are brought by
customers.
2.4.1 QUALITY:
Quality is not absolute, unique, static and by chance. It must be defined, be
measurable, achieve able and link to customer satisfaction. As per ISO standard, ―quality is
defined as the ‗degree to which, a set of inherent characteristic fulfils requirements of a
process, product or system‖. There are ten quality management principles on which the
quality management system standards of the ISO 9001:2015 are based. The ten quality
management principles, Quality management systems Guidelines for performance
improvements are detailed.

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2.5 TEN QUALITY MANAGEMENT CLAUSES IN ISO 9001:2015:


ISO 9001:2015 has ten clauses instead of eight. The following table shows the relationship of
the ISO 9001:2008 clauses to those in ISO 9001:2015
Table 7. Quality management clauses
S.N. ISO 9001:2008 ISO 9001:2015

1. Scope Scope

2. Normative Reference Normative Reference

3. Terms & Conditions Terms & Conditions

4. Quality Management System Context of the organisation

5. Management responsibility Leadership

6. Resource management Planning

7. Product realisation Support

8. Measurement, analysis and improvement Operation

9. - Performance evaluation

10. - Improvement

The first three clauses in ISO 9001:2015 are the same as those in ISO 9001:2008, but
there are considerable differences between ISO 9001:2008 and ISO 9001:2015 from the
fourth clause onwards.
2.5.1 SCOPE (FIRST CLAUSE):
This Quality Manual specifies requirements for a quality management system:
a) Needs to demonstrate its ability to consistently provide product and services that
meet customer and applicable statutory and regulatory requirements, and
b) Aims to enhance customer satisfaction through the effective application of the
system, including processes for improvement of the system and the assurance of
conformity to customer and applicable statutory and regulatory requirements.
All the requirements of this ISO 9001:2015 are generic and are intended to be
applicable to any organization, regardless of its type or size, or the products and services it
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provides;
2.5.2 NORMATIVE REFERENCES (SECOND CLAUSE):
The following documents, in whole or in part, are normatively referenced in this
document and are indispensable for its application. For dated references, only the edition
cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 9001:2015, Quality management systems — Fundamentals and vocabulary

2.5.3 TERMS AND DEFINITIONS (THIRD CLAUSE):


The terms and definitions given in ISO 9001:2015 apply.
Context of the organization (Fourth Clause):
 Understanding the Organization and its Context:
It has determined external and internal issues that are relevant to its purpose and its strategic
direction and that affect its ability to achieve the intended result(s) of its quality management
system.
It monitors and reviews information about these external and internal issues.

 Understanding the Needs and Expectations of Interested Parties:


Due to their effect or potential effect on its ability to consistently provide products and
services that meet customer and applicable statutory and regulatory requirements, it
determined:
a) The interested parties that relevant to the quality management system;
b) The requirements of these interested parties that are relevant to the quality
management system.
It monitors and reviews the information about these interested parties and their relevant
requirements.

 Determining the Scope of the Quality Management System:


It has determined the boundaries and applicability of the quality management system to
establish its scope. When determining this scope, it considered:
a) The external and internal issues.
b) The requirements of relevant interested parties.
c) The products and services.

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It applies all the requirements of this International Standard if they are applicable within the
determined scope of its quality management system.
The scope of its quality management system is available and maintained as
documented information. The scope states the types of products and services covered, and
provides justification for any requirements that it has determined is not applicable to the
scope of its quality management system.
Conformity to ISO 9001 is only claimed if the requirements determined as not being
applicable do not affect its ability to ensure the conformity of its product and services and the
enhancement of customer satisfaction.

2.6 LEADERSHIP (FIFTH CLAUSE):


2.6.1 LEADERSHIP AND COMMITMENT
 General
Top management demonstrates leadership and commitment with respect to the quality
management system by:
a) Taking accountability for the effectiveness of the quality management system;
b) Ensuring that the quality policy and quality objectiveness are established for the
quality management system and are compatible with the context and strategic
direction of It;
c) Ensuring the integration of the quality management system requirements into its
business process;
d) Promoting the use of the process approach and risk-based thinking;
e) Ensuring that the resources needed for the quality management system are available;
f) Communicating the importance of effective quality management and of
conforming to the quality management system requirements;
g) Ensuring that the quality management system achieves its intended results;
h) Engaging, directing and supporting persons to contribute to the effectiveness of the
quality management system;
i) Promoting improvement; and
j) Supporting other relevant management roles to demonstrate their leadership as it
applies to their areas of responsibility.
 Customer Focus:
Top management demonstrates leadership and commitment with respect to customer focus
by ensuring that:
a) Customer and applicable statutory and regulatory requirements are determined,
understood and consistently met;

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b) The risks and opportunities that can affect conformity of products and services and
the ability to enhance customer satisfaction are determined and addressed; and
c) The focus on enhancing customer satisfaction is maintained.

2.6.2 POLICY:
 Developing the Quality Policy:
Top management has established, implemented and maintains a quality policy that:
a) Is appropriate to the purpose and context of It and supports its strategic
direction;
b) Provides a framework for setting quality objectives;
c) Includes a commitment to satisfy applicable requirements; and
d) Includes a commitment to continual improvement of the quality
management system.

 Communicating the Quality Policy:


The Quality Policy:
a) is available and maintained as documented information;
b) is communicated, understood and applied within the organization; and
c) is available to relevant interested parties, as appropriate.

2.6.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES, AND AUTHORITIES:


Top management ensures that the responsibilities and authorities for relevant roles are
assigned, communicated and understood within it.
Top management assigns the responsibility and authority for:
a) Ensuring that the quality management system conforms to the
requirements of this International Standard;
b) Ensuring that the processes are delivering their intended outputs;
c) Reporting on the performance of the quality management system and
on opportunities for improvement, in particular to top
management;
d) Ensuring the promotion of customer focus throughout It; and
e) Ensuring that the integrity of the quality management system is
maintained when changes to the quality management system are
planned and implemented.
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2.7 PLANNING (SIXTH CLAUSE):


2.7.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES
 When planning for the quality management system, it considered the issues referred
to in quality management system and its process and determined the risks and
opportunities that need to be addressed to:
a) Give assurance that the quality management system can achieve its intended
results.
b) Enhance desirable effects.
c) Prevent, or reduce, undesired effects; and
d) Achieve improvement.
 It plans:
a) Actions to address these risks and opportunities;
b) How to:
1. Integrate
and implement the actions into its quality management
system processes.
2. Evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities are proportionate to the potential impact on
the conformity of products and services.

2.7.2 QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM:


 It has established quality objectives at relevant functions, levels and processes needed
for the quality management system.
The quality objectives are:
a) Consistent with the quality policy;
b) Measurable;
c) Taken into account applicable requirements;
d) Relevant to conformity of products and services and to enhancement
of customer satisfaction;
e) Monitored;
f) Communicated; and
g) Updated as appropriate.
It maintains documented information on the quality objectives.
 When planning how to achieve its quality objectives, it has determined:
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a) What will be done;


b) What resources will be required;
c) Who will be responsible;
d) When it will be completed; and
e) How the results will be evaluated.

2.7.3 PLANNING OF CHANGES:


When it determines the need for changes to the quality management system, the changes are
carried out in a planned manner.
It considers:
a) The purpose of the changes and their potential consequences;
b) The integrity of the quality management system;
c) The availability of resources; and
d) The allocation or reallocation of responsibilities and authorities.

2.8 SUPPORT (SEVENTH CLAUSE):


2.8.1 RESOURCES:
 General:
It determines and provides the resources needed for the establishment, implementation,
maintenance and continual improvement of the quality management system.
It considers:
a) The capabilities of, and constraints on, existing internal resources; and
b) What needs to be obtained from the external providers?

 People
It determines and provides the persons necessary for the effective implementation of its
quality management system and for the operation and control of its processes.

 Infrastructure
It determines, provides, and maintains the environment necessary for the operation of its
processes and to achieve conformity of products and services.
a) Buildings and associated utilities;
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b) Equipment, including hardware and software;


c) Transportation resources; and
d) Information and communication technology.
 Environment for the Operation of Processes:
It determines, provides and maintains the environment necessary for the operation of its
processes and to achieve conformity of products and services.
a) Social (e.g. non-discriminatory, calm, non-confrontational);
b) Psychological (e.g. stress reducing, burnout prevention, emotionally
protective);
c) Physical (e.g. temperature, heat, humidity, light, airflow, hygiene,
noise).
These factors can differ substantially depending on the products and services provided.

 Monitoring and Measuring Resources:


o General:
It determines and provides the resources needed to ensure valid and reliable results when
monitoring or measuring is used to verify the conformity of products and services to
requirements. It ensures that the resources provided:
a) Are suitable for the specific type of monitoring and measurement
activities being undertaken; and
b) Are maintained to ensure their continuing fitness for their purpose.
It retains appropriate documented information as evidence of fitness for purpose of the
monitoring and measurement resources.

o Measurement Traceability:
When measurement traceability is a requirement, or is considered by it to be an essential part
of providing confidence in the validity of measurement results, measuring equipment are:
a) Calibrated or verified, or both, at specified intervals, or prior to use,
against measurement standards traceable to international or national
measurement standards; when no such standard exist, the basis used for
calibration or verification is retained as documented information;
b) Identified in order to determine their status; and
c) Safeguarded from adjustments, damage or deterioration that would
invalidate the calibration status and subsequent measurement results.

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It determines if the validity of previous measurement results has been adversely affected
when measuring equipment is found to be unfit for its intended purpose, and takes
appropriate action as necessary.

 Organizational Knowledge:
It determines the knowledge necessary for the operation of its processes and to achieve
conformity of products and services.
This knowledge is maintained and made available to the extent necessary.
When addressing changing needs and trends, it considers its current knowledge and
determines how to acquire or access any necessary additional knowledge and required
updates.

2.8.2 DOCUMENTED INFORMATION:


 General:
It‘s quality management system includes:
a) Documented information required by ISO 9001:2015; and
b) Documented information determined by it as being necessary for the
effectiveness of the quality management system.
Creating and Updating:
When creating an updating documented information, it ensures appropriate:
a) Identification and description (e.g. title, date, author, or reference
number);
b) Format (e.g. language, software version, graphics) and media (e.g.
paper, electronic); and
c) Review and approval for suitability and adequacy.

 Control of Documented Information:


o Documented information required by the quality management system and by ISO
9001:2015 are controlled to ensure:
a) Availability and suitable for use, where and when it is needed; and
b) It is adequately protected (e.g., from loss of confidentiality, improper
use, or loss of integrity).
o For the control of documented information, it has addressed the following
activities, as applicable.
a) Distribution, access, retrieval and use;

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b) Storage and preservation, including preservation of legibility;


c) Control of changes (e.g. version control); and
d) Retention and disposition.
Documented information of external origin determined by it to be necessary for the planning
and operation of the quality management system is identified as appropriate and controlled.
Documented information retained as evidence of conformity are protected from unintended
alterations.

2.9 OPERATION (EIGHTH CLAUSE):


2.9.1 OPERATIONAL PLANNING AND CONTROL:
It planned, implemented and controls the processes needed to meet the requirements for the
provision of products and services, and implemented the actions determined in Clause 6, by:
a) Determining the requirements for the products and services;
b) Establishing criteria for:
1. The processes;
2. The acceptance of products and services;
c) Determining the resources needed to achieve conformity to the product
and service requirements;
d) Implementing control of the processes in accordance with the criteria;
e) Determining and keeping documented information to the extent
necessary:
1. To have confidence that the processes have been carried out as
planned;
2. To demonstrate the conformity of products and services to their
requirements.
The output of this planning is in a form suitable to its method of operations. It ensures that
outsourced processes are controlled.

2.9.2 REQUIREMENTS FOR PRODUCTS AND SERVICES:


 Customer Communication:
Communication with Customers includes:
a) Providing information relating to products and services;
b) Handling inquiries, contracts or orders, including changes;
c) Obtaining customer feedback relating to products and services,
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including customer complaints;


d) Handling or controlling customer property; and
e) Establishing specific requirements for contingency actions, when
relevant.

 Determining the Requirements Related to Products and Services:


When determining the requirements for the product and services to be offered to customers,
it ensures that:
a) The requirements for the product and services are defined, including:
a) Any applicable statutory and regulatory requirements;
b) Those considered necessary by It;
b) It can meet the claims for the product and services it offers.

 Review of Requirements Related to Products and Services:


o It ensures that it has the ability to meet the requirements for products and services
offered to customers. It conducts a review before committing to supply products
and services to a customer, to include:
a) Requirements specified by customer, including the requirements for
delivery and post-delivery activities;
b) Requirements not stated by the customer, but necessary for the
specified intended use, when known;
c) Requirements specified by It;
d) Statutory and regulatory requirements applicable to the products and
services; and
e) Contract or order requirements differing from those previously
expressed.
It ensures that the contract or order requirements differing from those previously defined are
resolved. The customer‘s requirements are confirmed by it before acceptance, when the
customer does not provide a documented statement of their requirements.
o It retains documented information, as applicable:
a) On the results of the review; and
b) On any new requirements for the products and services;

 Changes to Requirements for Products and Services:


It ensures that relevant documented information is amended, and that relevant persons are
made aware of the changed requirements, when the requirements for products and services
are changed.

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2.9.3 CONTROL OF NONCONFORMING OUTPUTS:


 It ensures that outputs that do not conform to their requirements are identified and
controlled to prevent their unintended use or delivery. It takes appropriate action
based on the nature of the nonconformity and its effect on the conformity of products
and services. This also applies to nonconforming products and services detected after
delivery of products, during or after the provision of services. It deals with
nonconforming outputs in one or more of the following ways:
Correction;
Segregation, containment, return or suspension of provision of products and services;
Informing the customer; and
Obtaining authorization for acceptance under concession.
Conformity to the requirements are verified when nonconforming outputs are corrected.
 It retains documented information that:
a) Describes the nonconformity;
b) Describes the actions taken;
c) Describes any concessions obtained; and
d) Identifies the authority deciding the action in respect of the
nonconformity.

2.10 PERFORMANCE EVALUATION (NINTH CLAUSE):


2.10.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION:
 General:
It determines:
a) What needs to be monitored and measured;
b) The methods for monitoring, measurement, analysis and evaluation
needed to measure valid results;
c) When the monitoring and measuring is performed;
d) When the results form monitoring and measurement are analysed and
evaluated.
It evaluates the performance and the effectiveness of the quality management system. It
retains appropriate documented information as evidence of the results.

 Customer Satisfaction:
It monitors customers‘ perceptions of the degree to which their needs and expectation have
been fulfilled. It determines the methods for obtaining, monitoring and reviewing this
information.
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 Analysis and Evaluation:


It analyses and evaluates appropriate data and information arising form monitoring and
measurement. The results of analysis are used to evaluate:
a) Conformity of products and services;
b) The degree of customer satisfaction;
c) The performance and effectiveness of the quality management system;
d) If planning has been implemented effectively;
e) The effectiveness of actions taken to address risks and opportunities;
f) The performance of external providers; and
g) The need for improvements to the quality management system.

2.10.2 INTERNAL AUDIT:


 It conducts internal audits at planned intervals to provide information on whether the
quality management system:
a) Conforms to:
1. It‘s own requirements for its quality management system;
2. The requirements of ISO 9001:2015
b) Is effectively implemented and maintained.
 It has:
a) Planned, established, implemented and maintains an audit program
including the frequency, methods, responsibilities, planning
requirements and reporting, which is taken into consideration the
importance of the processes concerned, changes affecting It, and the
results of previous audits;
b) Defined the audit criteria and scope of each audit;
c) Selected auditors and conducts audits to ensure objectively and the
impartiality of the audit process;
d) Ensured that the results of the audits are reported to relevant
management;
e) Take appropriate correction and corrective actions without undue
delay; and
f) Retain documented information as evidence of the implementation of
the audit program and the audit results.

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2.10.3 MANAGEMENT REVIEW:


 General:
Top management reviews its quality management system, at planned intervals, to ensure its
continuing suitability, adequacy, effectiveness and alignment with the strategic direction of
it.
 Management Review Inputs:
Management review is planned and carried out taking into consideration:
a) The status of actions from previous management reviews;
b) Changes in external and internal issues that are relevant to the quality
management system;
1.Information on the performance and effectiveness of the quality
management system, including trends in:
2. Customer satisfaction and feedback from relevant interested parties;
3. The extent to which quality objectives have been met;
4. Process performance and conformity of products and services;
5. Nonconformities and corrective actions;
6. Monitoring and measurement results;
7. Audit results;
8. The performance of external providers;
c) The adequacy of resources;
d) The effectiveness of actions taken to address risks and opportunities;
e) Opportunities for improvement
 Management Review Outputs:
The outputs of the management review include decisions and actions related to:
a) Opportunities for improvement;
b) Any need for changes to the quality management system; and
c) Resource needs.
It retains documented information as evidence of the results of management reviews.

2.11 IMPROVEMENT (TENTH CLAUSE):


2.11.1 GENERAL:
It determines and selects opportunities for improvement and implements any necessary
actions to meet customer requirements and enhance customer satisfaction.

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These include:
a)Improving products and services to meet requirements as well as to
address future needs and expectations;
b) Correcting, preventing or reducing undesired effects; and
c)Improving the performance and effectiveness of the quality
management system.
 Nonconformity and Corrective Action
o When a nonconformity occurs, including any arising from complaints, It:
a) Reacts to the nonconformity and, as applicable:
1. Takes action to control and correct it;
2. Deals with the consequences;
b)Evaluates the need for action to eliminate the cause(s) of the
nonconformity, in order that it does not recur or occur elsewhere, by:
1. Reviewing and analyzing the nonconformity;
2. Determining the causes of the nonconformity;
3. Determining if similar nonconformities exist, or could
potentially occur;
c) Implements any action needed;
d) Reviews the effectiveness of any corrective action taken;
e)Updates risks and opportunities determined during planning, if
necessary; and
f) Makes changes to the quality management system, if necessary.
Corrective actions are appropriate to the effects of the nonconformities encountered.
2.11.2 CONTINUAL IMPROVEMENT:
It continually improves the suitability, adequacy and effectiveness of the quality
management system. It considers the results of analysis and evaluations, and the outputs from
the management review, to determine if there are needs or opportunities that are addressed as
part of the continual improvement.

2.12 CONCLUSION
ALTTC was the first unit of BSNL to obtain ISO 9001 certification in 2001. Since
then BRBRAITT and other training centres, Maintenance regions & project circles, Civil and
electrical wings, Telecom Factories have obtained this certificate. In 2007, BSNL corporate
office directed Circles to obtain ISO 9001 certification for all SSAs. Apart from SSAs,
circles have also been asked to obtain this certification for customer related sections such as

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Enterprise Business, CS, Commercial, PG cell etc. Similarly at BSNL Corporate office,
initially CS, EB, PG, Commercial and T&C sections have to get ISO 9001 certification.
Various training centers of BSNL are imparting training to BSNL executives for
helping field units in obtaining ISO certification.

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