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Quality Manual Confidential

Quality Manual
Created by: Divya Mathur

Creation Date:15-Nov-2018

Reviewed by: Anil Nair

Current version no:1.0

AMENDMENT HISTORY
Version Prepared By Date Description

1.0 Divya Mathur 15-Nov-2018 Draft version

1.1 Anil Nair 23-Jan-2019 Final Manual

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Contents
AUTHORIZATION ...................................................................................................................................... 4
FOREWORD ................................................................................................................................................ 5
LIST OF ABBREVIATIONS & NORMATIVE REFERENCE .................................................................. 6
ORGANIZATION PROFILE ....................................................................................................................... 7
QUALITY POLICY........................................................................................................................................ 9
QUALITY OBJECTIVES .......................................................................................................................... 10
PROCESS APPROACH ............................................................................................................................. 11
1.0 SCOPE .............................................................................................................................................. 13
2.0 Normative Reference ...................................................................................................................... 13
3 Definitions: ........................................................................................................................................... 13
4.0 Context of the Organization ............................................................................................................ 16
4.1 Understanding the organization and its context ........................................................................ 16
4.2 Understanding the needs and expectations of interested parties ............................................. 17
4.3 Determining the scope of the quality management system....................................................... 18
4.4 Quality Management System and its process ............................................................................... 20
5 LEADERSHIP ....................................................................................................................................... 21
5.1 Leadership and Commitment ....................................................................................................... 21
5.2 Policy ........................................................................................................................................... 22
5.3 Organizational roles, responsibilities and authorities................................................................. 23
6.0 PLANNING ......................................................................................................................................... 24
6.1 Actions to address risks and opportunities................................................................................... 24
6.2 Quality Objectives and Planning ................................................................................................... 24
7 SUPPORT .............................................................................................................................................. 25
7.1 Resources ...................................................................................................................................... 25
7.2 Competence ................................................................................................................................ 28
7.3 Awareness ................................................................................................................................... 29
7.4 Communication ........................................................................................................................... 29
7.5 Documented Information ........................................................................................................... 29

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7.5.2 Creating and updating .............................................................................................................. 30


7.5.3 Control of documented information ........................................................................................ 30
8.0 Operation .......................................................................................................................................... 31
8.1 Operational Planning and Control ................................................................................................ 31
8.2 Requirements for products and services ...................................................................................... 31
8.2.4 Changes to requirements for products and services ................................................................. 33
8.3 Design and Development of Products and Services ..................................................................... 33
8.3.1 General ........................................................................................................................................... 33
8.3.2 Design and Development Planning ............................................................................................ 33
8.3.3 Design and Development inputs ................................................................................................ 34
8.3.5 Design and Development Outputs ............................................................................................ 34
8.4 Control of externally provided processes, products and services ................................................ 35
8.4.2 Type and extent of control........................................................................................................ 36
8.4.3 Information for external providers ............................................................................................ 37
8.5 Production and service provision ................................................................................................ 37
8.6 Release of products and services ................................................................................................ 40
8.7 Control of nonconforming outputs ............................................................................................... 40
9.0 Performance Evaluation.................................................................................................................... 41
9.1 Monitoring, measurement, analysis and evaluation .................................................................... 41
9.2 Internal Audit .............................................................................................................................. 42
9.3 Management Review .................................................................................................................. 43
10.0 Improvement................................................................................................................................. 44
10.1 General ........................................................................................................................................ 44
10.2 Nonconformity and corrective action ......................................................................................... 45
10.3 Continual Improvement ............................................................................................................ 45

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AUTHORIZATION

This is the Quality Manual and also the overall controlling document for all aspects of
quality systems operated at Posidex Technologies Private Limited., , Telangana, India.

Quality system is fully integrated and all its activities are designed to meet current and
emerging customer needs in a consistent manner. The achievement of quality is the prime
responsibility of all the Functional Heads for ensuring the compliance of ISO 9001:2015, quality
system standards.

Authorized by

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FOREWORD

Customer Services Management is key to the business objectives of Posidex Technologies Private
Limited, to demonstrate commitment towards “QUALITY” in this context, the organization decided to
implement Quality Management System (Q.M.S) in accordance with the International Standard ISO 9001:
2015.

The Q.M.S. documentation is in the form of two manuals, which describe and drive the Quality
Management System for a defined SCOPE

1. Quality Manual:
It provides details of applicable processes, practices and reference documents at the organization w.r.t.
the requirements of the Standard. It also states the benefits & results obtained / obtainable at the
organization with implementation of Quality Management System.

2. Process Manual:
The Process Manual provides the details of processes in place and Documents, Formats, & Records for the
reference and use at respective departments.
These manuals provide guidance to both the management and operational personnel for reviews and
maintenance of Quality Management System respectively. They also serve as reference documents for all
interested parties viz. customers, suppliers, auditors etc.
For assisting the top management in maintaining and continually improving the quality management
system & related practices at the organization through management reviews or otherwise, a suitable
Management Representative (exclusively for quality management system) has been nominated.
It is noteworthy to mention here that, the top management and employees are committed to achieve the
Quality Policy and Quality Objectives of the organization reflected in this manual.

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LIST OF ABBREVIATIONS & NORMATIVE REFERENCE

Abbreviated
Expanded Form Term Full Form
Term
ADM Administration NC Non-Conformity
A/C Accounts PUR Purchase
Human Resource and
HRD QA Quality Assurance
Development
QC Quality Control QM Quality Manual
QA Quality Assurance QR Quality Records
IA Internal Audit QMS Quality Management System
MGT Management TL Team lead
MKT Marketing SOP Standard Operating Procedures
Corrective and Preventive
CAPA QP Quality Policy
Action
International Standard of
ISO MC Master Copy
organization
Production Planning and
PPC OC Obsolete Copy
Control
Prod. Production CC Controlled Copy
NORMATIVE REFERENCE
1 ISO 9001: 2015 Quality Management Systems - Requirements

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ORGANIZATION PROFILE

Name of the Unit Posidex Technologies Private Limited


6-3-4492/1/1, 8th Floor, Westwing, Block 3, White house building,
Address Bequmpet-500016
(Regd. Office) Regd office: #34, 1st floor, Arvind Nagar, Hyderabad, Telangana, INDIA
(Including Telephone No’s & 500029.
Emails) Phone No.: +91-40-2341-1022
Email: info@posidex.com

Communication Details

Nature of Business

Established on 11-Sep-2003

GSTIN No. 36AADCP0827A1ZY

PAN No. AADCP0827A

TIN No. 36212526229

CST No.

Turn over for last two years


(If Possible)

Major Customers Banking, Non-Banking, Government, Insurance, Telecom, Misc

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Partial list of Posidex Customers


National
S. No Customer Name S. No Customer Name
Banking 15 TATA Capital
1 HDFC 16 Mahindra Finance
2 Axis 17 Aditya Birla Group
3 Airtel
4 ICICI Insurance
5 Dhanalakshmi 1 ICICI Prudential
6 Janalakshmi 2 ICICI Lombard
7 RBL 3 Birla Sun Life Insurance
8 Ujjivan
Government
Non-Banking 1 Govt of AP
1 Reliance 2 Income Tax Dept
2 Bajaj Finserv 3 Telangana State Police
3 TVS 4 Mee seva
4 HDFC Securities 5 GHMC
5 HDFC 6 Govt of West Bengal
6 Capital First
7 Pnb Housing Telecom
8 Bajaj Auto Finance 1 Airtel
9 TATA motors 2 Idea
10 Clix Capital
11 Chola MISC
12 Volkswagen Financial Services 1 CDSL -Depository
13 L&T Finance 2 Asian Paints-Retail
14 MAGMA 3 CIBIL-Credit Bureau

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QUALITY POLICY

Management of Posidex Technologies Private Limited has established following quality policy in
conformance with the requirements of ISO 9001:2015.

Posidex is committed for “TOTAL QUALITY MANAGEMENT” by rendering the services in a professional
way.

We achieve this by:

➢ Developing products and rendering services with high quality standards, professionalism
& human ethics in consistent with customers’ requirement at agreed delivery Schedule.

➢ Providing efficient & highly reliable software product with quality

➢ Maintaining effective internal process controls leading to reliability, scalability &


consistent Performance.

Continually improving effectiveness of quality management system by empowering individuals to


meet the growing future needs of the customers.

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QUALITY OBJECTIVES

Refer Objectives document

The following processes have been identified as "Main Processes” in respective departments at Posidex
in line with the scope of certification viz.:

CORE PROCESS MANAGEMENT PROCESS SUPPORT PROCESS

Purchase
Internal Quality Audit
Business
Development Stores

Management Review
Meetings Control of Non-
conforming Product

Customer Satisfaction

Developing Control of Documents&


Records
[Prod. & Maint] & QC

Monitoring Results of
Corrective & Preventive
Actions Training

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PROCESS APPROACH
A process is a set of interrelated or interacting activities that use inputs to deliver an intended
Result.
Note: Inputs and outputs may be tangible (e.g. materials, components or equipment) or intangible (e.g.
data, information or knowledge).

The process approach includes establishing the organization’s processes to operate as an integrated and
complete system.
• The management system integrates processes and measures to meet objectives.
• Processes define interrelated activities and checks, to deliver intended outputs.
• Detailed planning and controls can be defined and documented as needed, depending on
the organization’s context.

4.1, 4.2, 4.3


10. Continual Improvement
Establish context
define relevant
interested parties &
Scope of QMS

*
5. Leadership

4.4 QMS-General
Customer & Process-Approch
other relevant Customer
interested 9. Performance
6. Planning Satisfaction
parties Evaluation

*
Requirements 8. Operations Products
Inputs Outputs
& Services

7. Support Process

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The Management Review Committee Comprises of:

CEO: Mr. Bhavani Shankar CTO: Mr. Venkat Reddy

VP: Mr. C Suresh Babu Delivery Head: Mr. Anil Nair

Quality Assurance: Ms. Divya Mathur

Members

Anil Kumar Saritha M

Sharath Babu Triveni Kumari

Nageshwar Rao Repala Srilakshmi P

Raja J Divi Srinivas

Ramparad J G Suresh G

Nageshwara Rao Chagala

Prachi P

Internal Quality Auditors


Ms. Divya Mathur

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1.0 SCOPE

The Quality Management System described in this manual is intended to meet the requirements of the
quality management systems standard ISO 9001:2015.

Our policies provide a framework to ensure conformity of Posidex Technologies Private Limited, quality
management system to ISO 9001:2015 the effectiveness of the quality system.

The requirements of this manual will be communicated to all Posidex employees in full or in part,
depending on scope of employee’s responsibilities and impact on the quality system and/or product
integrity.

The Quality Management Systems described in this manual is specific to Posidex software Product & its
servies

2.0 Normative Reference


The following documents were used as reference during the preparation of Quality Management System.
ISO 9001: 2015 : Quality Management Systems - Requirements

3 Definitions:
• Audit program

An audit program (or programme) refers to a set of one or more audits that are planned and carried
out within a specific time frame and are intended to achieve a specific audit purpose.

• Competence

Competence means being able to apply knowledge and skill to achieve intended results.

• Complaint

In the context of ISO 9001, a complaint refers to an expression of dissatisfaction with a product or
service and is filed by a customer and received by an organization.

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• Context of the organization

An organization’s context is its business environment. It includes all the internal and external factors
and conditions that affect its products and services. An organization’s external context includes all
the needs and expectations of interested parties, as well as its social, cultural, legal, technological,
regulatory and competitive environment. An organization’s internal context includes its values,
culture, knowledge, and performance.

• Continual improvement

Continual improvement is a set of recurring activities that are carried out in order to enhance
performance. Continual improvements can be achieved by carrying out audits, self-assessments, and
management reviews.

• Contract

A contract is a binding agreement between two or more parties.

• Corrective action

Corrective actions are steps that are taken to eliminate the causes of existing non-conformities in
order to prevent recurrence. The corrective action process tries to make sure that existing non-
conformities and potentially undesirable situations don’t happen again.

• Design and development

Design and development is a process (or a set of processes) that uses resources to transform general
input requirements for an object into specific output requirements.

• Interested party

An interested party is anyone who can affect, be affected by, or believe that they are affected by a
decision or activity. An interested party is a person, group, or organization that has an interest or
a stake in a decision or activity.

• Management

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The term management refers to all the activities that are used to coordinate, direct, and control
organizations. These activities include developing policies, setting objectives, and establishing
processes to achieve these objectives. In this context, the term management does not refer to
people. It refers to what managers do.

• Process

A process is a set of activities that are interrelated or that interact with one another.

• Process approach

The process approach is a management strategy. When managers use a process approach, it means
that they manage and control the processes that make up their organization, the interaction
between these processes, and the inputs and outputs that tie these processes together.

• Quality management

Quality management includes all the activities that organizations use to direct, control, and
coordinate quality.

• Quality management system

A quality management system (QMS) is a set of interrelated or interacting elements that


organizations use to formulate quality policies and quality objectives and to establish the processes
that are needed to ensure that policies are followed, and objectives are achieved.

• Top management

The term top management normally refers to the people at the top of an organization. It refers to
the people who provide resources and delegate authority and who coordinate, direct and control
organizations.

Labeling: written, printed or graphic matter affixed to a Posidex device or, or accompanying a
Posidex device, related to identification, technical description, and use of the Posidex device, but
excluding shipping documents.

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4.0 Context of the Organization

An organization is the rational coordination of the activities of several people for the achievement of
some common explicit purpose or goal, through division of labor and function, and through a
hierarchy of authority and responsibility.

An organization’s context involves “operating environment.” The context is to determine both


within the organization and external to the organization. It is important to understand the unique
context of an organization before starting the strategic planning.

4.1 Understanding the organization and its context

Posidex establishes the context to define the external and internal factors considering the risks of
the organization.

Organization’s external context includes outside stakeholders, local operating environment, as well
as any external factors that influence the selection of its objectives (goals and targets) or ability to
meet its goals.

Organization’s internal context includes internal stakeholders, approach to governance, contractual


relationships with its customers, and capabilities and culture.

FACTORS INTERNAL EXTERNAL

1) Structure of Organization 1) Contractual Agreements

2) Roles within the Organization 2) Competitive Environment

Positive
3) Availability of reliable qualified
3) Advanced Technology
and competent work force

4) Stability of workforce
4) Standardization and

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certification

5) Relationships with external


5) Staff Retention
interested parties

6) Staff Competency Levels 6) External Inspections/Audits

7) Contractual agreement with


7) Customer Expectations
customer

8) Overall Strength of business 8) Impact on neighbors

9) Overall Economic
9) Assets of organization
Performance

10) Regulatory requirements 10) General levels of customer


required for products expectation

11) Service Level agreements with


customers
-

12) Disposal of Hazardous Waste


-

4.2 Understanding the needs and expectations of interested parties

S.No. Interested Parties Needs & Expectations


Good financial performance, legal
1. Executive Board
compliance/avoidance of fines

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Value for money, high quality, expectations for


2. Customers design innovation, on time, low-cost, quick response,
installation expertise

Professional development, prompt payment health


3. Employees
and safety, work/ life balance, employment security
Prompt payment, work relationship, Increase scope
4. External Providers and volume of purchases/long-term contractual
arrangements/information on future requirements.
Identification of applicable statutory and regulatory
requirements for the products and services,
5. Law Enforces/Regulators understanding of the requirements, application
within the QMS, and update/ maintain them.

Profitability/return on investment/growth in market


6. Stake Holders value of organization

Increased growth, sales & profitability/efficiency &


7. Management effectiveness of operations

Product performance/ease of use/reliability


8. End User
/safety/maintainability

4.3 Determining the scope of the quality management system

Purpose
Posidex Technologies Private Limited

⚫ Our Vision is to empower business enterprises for enabling


customer centricity at the heart of their operations.

⚫ Our Mission is to develop the best platform , solutions with world


class products and services for enabling our clients to discover
and understand more about their customers.

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The company has established, documented and implemented a quality management system for the site,
which is maintained in order to continually improve its effectiveness in accordance with legislation,
international standards and best industry practice. The processes that contribute to meet the
requirements of these standards have been determined.

Scope of Quality Management System


The scope of the Quality Management System includes all products, developed in Posidex and activities
conducted in Posidex.

These requirements are aligned with the policies and objectives of the site and include those of the
international standard ISO 9001:2015. If any process that may affect product conformity to the defined
standards of the Quality Management System then the site will assume control over this process.

⚫ To demonstrate its ability to consistently provide products and services


that meet customer and applicable regulatory requirements
⚫ To enhance customer satisfaction through the:
◆ Effective application of the QMS
◆ Processes for continual improvement of the QMS
◆ Assurance of conformity to customer and applicable statutory and regulatory
requirements.

a) External and Internal Issues

S.No. Internal Issues External Issues


1 General Competence Contractual Agreements
2 Roles within the organization Advanced Technology
3 Contractual Relationships Competitive environment
4 Assets External inspections/audits
5 Resource & Knowledge Standardization and Certification

b) Interested Parties (Refer 4.2)

c) Products and Services of organization

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4.4 Quality Management System and its process

4.4.1 Posidex has established a Quality Management System (QMS) that is documented in this Quality
Policy Manual and the associated procedures and work orders/instructions. Posidex has implemented and
maintains this quality management system ,and is committed to continually improving its effectiveness.
Posidex’s Quality Management System addresses customer and applicable statutory and regulatory QMS
requirements. This quality management system ensures that the product conforms to the type described
in the certificate and the technical documentation.

Level 1

Quality Manual
Level 2

QMS Procedures
Level 3

Standard Operating Procedures

Level 4

Format/Records

Posidex has identified the processes needed for the Quality Management System (including management
activities, provision of resources, product realization and measurement) and their application throughout
the organization.
a) Posidex determines the inputs required and the outputs expected from these processes.
b) Posidex has determined the sequence and interaction of these processes.

Reference the following sections of this manual for the sequence and interaction of specific processes: -
section 9.3 for the management review process,
- section 7.1 for resources,
- section 9.1 for the measurement, analysis and improvement processes,
c) Posidex has determined the criteria and methods needed to ensure that both the operation
and control of these processes are effective.
d) Posidex ensures the availability of resources and information necessary to support the
operation and monitoring of these processes (refer to section 7.1 of this manual).
e) Top Management assign the responsibilities and authorities of the processes.

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f) The risks and opportunities are determined in accordance with the requirement.
g) The processes are evaluated and implemented if any changes to achieve the intended results.
h) Posidex has im plemented actions necessary to achieve planned results, maintain
effectiveness of and continually improve these processes. Continual improvem ent includes
quality objectives, corrective and preventive actions, internal quality audits, monitoring
feedback indicators of customer satisfaction, improvement items resulting from Operation
Group meetings, Management Reviews and actions initiated by t he Opportunity for
Improvement system.

4.4.2 To the extent Posidex:

a) maintains documented information to support the operation of the process.


b) Retain documented information to have confidence that the processes are being carried out as
planned.

5 LEADERSHIP

5.1 Leadership and Commitment

5.1.1 General

The top Management of Posidex provides evidence of its leadership and commitment to the development
and implementation of the quality Management system and continually improving its effectiveness by
ensuring,
• the policy and objectives established for the management system and are compatible with the
strategic direction and the context of the organization.
• the policy is communicated, understood and applied within the organization;
• the integration of the management systems requirements into the organization’s business
processes and promoting the process approach;
• the resources needed for the management system are available;
• the management system achieves its intended results;
• by taking accountability of the effectiveness of the management system;
• by communicating the importance of an effective management system and of conforming to the

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management system requirements;


• by engaging, directing and supporting persons to contribute to the effectiveness of the
management system;
• promoting continual improvement and innovation;
• supporting other relevant management roles to demonstrate their leadership as it applies to their
areas of responsibility.

5.1.2 Customer Focus

The Top Management has ensured that customer requirements are determined and are met with the aim
of enhancing customer satisfaction. And importance of meeting user requirements is communicated to
all staff through an effective communication process. Posidex has devised methods to identify user
requirements, collect and evaluate user satisfaction, thus ensuring that continued customer focus is
maintained.

5.2 Policy
5.2.1 Establishing the quality policy

Quality Policy is established by top management and ensures that the quality policy is communicated to
all employees. In formulating the quality policy, top management ensures that the policy is appropriate
to the purpose of the company and includes a commitment to comply with the requirements and
continually improve the effectiveness of the quality management system.

Quality Policy provides a framework for establishing specific quality objectives and provides direction for
the continual improvement effort. The use of the quality policy in setting quality objectives is addressed
in this manual

Quality policy is posted throughout the company, and its role is explained and discussed at the general
orientation training provided to all employees. The quality policy is also communicated to customers,
consumers and other interested parties. For this purpose, it is displayed in the reception area and posted
on the company’s internet side.

Quality Policy is periodically reviewed within the framework of management reviews of the Quality
system. This is to ensure its continual relevance and suitability.

Senior management shall ensure that the quality policy


a) is appropriate for the context of the organization and our customers, includes a commitment to

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comply with requirements and to maintain the effectiveness of the quality management system;
b) provides a framework for establishing and reviewing quality objectives;
c) addresses the organization’s commitment to good professional practice and to the quality of its
testing in servicing its customers;
d) includes management’s statement of the organization’s standard of service

5.2.2 Communicating the quality policy

The Top Management has ensured that quality policy:

a) is appropriate and maintained to the purpose of the Posidex organization.


b) is communicated and understood within the organization;
c) is appropriate to the relevant interested parties.

Top management ensures that the quality policy is appropriate to the purpose of the organization and is
communicated to all employees. It is included in new employee training and training on the QMS. It
includes a commitment to comply with requirements and to maintain the effectiveness of the QMS.

5.3 Organizational roles, responsibilities and authorities

Top Management has assigned the responsibility and authority to:

a) Ensure the quality management system requirements conforms to ISO 9001:2015.


b) ensuring that processes needed for the quality management system are established, implemented
and maintained
c) reporting to top management on the performance of the quality management system and any need
for improvement
d) ensuring promotion of awareness of customer requirements throughout the organization,
Promotion of customer awareness may include new releases, meetings, training, models and
examples of products demonstrating required attributes.
e) Ensuring the integrity of the quality management system is maintained when changes are
Implemented.

The organization chart defines the internal organization and reporting relationships.

a) Top management has ensured that responsibilities and authorities are defined through the

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organization chart, process matrix, job descriptions, procedures and work instructions and are
communicated within the organization.
b) Quality Services manages, performs and verifies work affecting quality; to assure independence and
authority.
c) The organizational chart specifies the responsibility, authority and interrelationships of all personnel
who manage, perform or verify work affecting the quality of the tests.

6.0 PLANNING
6.1 Actions to address risks and opportunities

6.1.1 The quality management system planning of the organization considers the issues referred in
clause 4.1 and the requirements as per clause 4.2 and also determines the risks and
opportunities that are addressed:

a) to give assurance that quality management system achieved its intended results
b) to enhance desirable effects
c) to prevent or reduce, undesired effects
d) to achieve improvement.

6.1.2 The organization plans


a) the actions to address risk and opportunities
b) integrate and implement the actions into its quality Management System Process.
c) Evaluate the effectiveness of these actions.

The Actions taken by organization addresses the risks and opportunities which are proportionate to the
potential impact on the conformity of product and services.

6.2 Quality Objectives and Planning

6.2.1 Top management establishes quality objectives (including objectives needed to meet requirements
for product) on an annual basis by no later than March 31 of the year . The objectives are established at
relevant functions and levels within the organization, are measurable and consistent with the quality
policy.

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This Clause requires an organization to set quality objectives for relevant areas within its quality
management system. It is for the organization to decide which areas are relevant.

a) The quality objectives must be consistent with the organization’s quality policy and be
relevant to products and services it provides, and the enhancement of customer
satisfaction.
b) Quality objectives must be measurable, taken into account applicable customer,
statutory and regulatory requirements
c) be monitored in order to determine whether they are being met.
d) They must also be communicated across the organization
e) be updated as and when the need arises.

The top Management has translated the quality polic y into quality objectives which are
measurable in nature, for operational effectiveness of processes identified.

The status of the quality objectives is monitored and reviewed/revised for providing
necessary guidance/inputs in the Quality Management meeti ngs by the quality committee.

6.2.2 Quality Management System Planning


Our quality system has been planned and implemented to meet our quality objectives and
requirement of the ISO 9001:2015,. We determine the risks and opportunities that need to be
addressed to give assurance that the QMS can achieve its intended results and enhance
desirable affects. Quality planning takes place, as changes that affect the quality system are
planned and implemented. To prevent, or reduce, undesirable effects and achieve
improvement.

Senior management shall ensure that


a) the planning of the quality management system is carried out in order to achieve quality
objectives and the quality system management requirements, and continual improvement of
the quality management system;
b) the integrity of the quality management system is maintained wh en changes to the quality
management system are planned and implemented

7 Support
7.1 Resources

Human Development
Resources

Infrastructure(Equipm
Management Product Realization
ent, Preventive
Review Maintenance)
Process
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Work Environment

7.1.1 General

Personnel performing work affecting conformity to product quality/requirements shall be competent


based on appropriate education, training, skills and experience. Conformity of product requirements may
be affected by personnel who are directly or indirectly responsible for tasks within the Quality
Management System.

Operations is responsible for training and awareness programs for company-wide participation, such as:
general orientation, rules and regulations, quality system, safety and other company-wide systems and
issues.

Project Heads and Team Leads are responsible for identifying competency requirements and for providing
training in their areas. Competency training is primarily focused on increasing the level of skills in
operating equipment and processes, conducting inspections and testing, computerized data entry, and
other such skills as appropriate for particular positions and jobs.

All personnel performing work affecting conformity to product requirements are ensured to be
competent on the basis of appropriate education, training, skills and experience as needed to successfully
fulfill their responsibilities. Qualifications for personnel are defined in job descriptions, which include
requirements for education, skills and experience.

7.1.2 People

Posidex determines and provides the resources needed to implement and maintain the quality
management system and continually improve its effectiveness, to enhance customer satisfaction by
meeting customer requirements and to meet regulatory requirements.

7.1.3 Infrastructure

Posidex has determined, provided and maintains the infrastructure necessary to achieve conformity to
product and service requirements. Posidex infrastructure includes:

a)Production workspace is equipped with adequate lighting, heat / air conditioning, humidification and
with proper floor.

The entire Posidex facility is equipped with a computer network that runs the company’s business, Posidex
devices and electronic communication software, as well as general office applications.

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b) Posidex depends on external providers for supporting services such as internet access,
telephone service, transportation of materials, supplies and product (incoming & outgoing) and
waste disposal.
d) process water and drinking water comes from Water Company.

7.1.4 Environment for the operation of process

Posidex has determined and manages the work environment needed to achieve conformity to product
requirements.
Posidex work environment includes:
a) A strong emphasis on housekeeping. “Everything has its place and everything in its place”.
b) adequate lighting, suitable for the work being performed.
c) dedicated for each operation, suitable for the type of work being performed.
d) air conditioning in office.
e) properly grounded workstations in areas where static sensitive components are handl ed.

7.1.5 Monitoring and measuring resources

7.1.5.1 General

The methods for monitoring and where applicable, measurement of the quality management system
processes. These methods demonstrate the ability of the processes to achieve planned results. When
planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure
conformity of the product.

Top Management ensures that the resources provided:


a) monitoring, control, and inspection of the process through routine process data review and
testing.
b) suitable environment, facilities, and environmentally controlled conditions to perform quality
operations.
c) adequate buildings of suitable design and sufficient space to perform necessary operations.
d) ensure process integrity, prevent mix-ups, and preserve product condition.
e) automated data processing systems and software, and any changes to said systems or software,
used for production or quality system management, are validated for intended use.

7.1.5.2 Measurement traceability

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Posidex has determined measurement to be undertaken, and the measuring devices needed to provide
evidence of conformity of product to determined requirements.

Posidex maintains a check list, which defines the process employed for their verification

Records of the results of verification are maintained.

7.1.6 Organizational Knowledge

Posidex determines the necessary knowledge 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.
Organization considers current knowledge and determine how to acquire or access the necessary
additional knowledge (when addressing changing needs and trends).
Two sources of organizational knowledge:
a) Internal Sources

- intellectual property

- knowledge gained from experience

- lessons learned from failures and successful projects

- capturing and sharing undocumented knowledge and experience of experts within the
organization

- results of improvements in processes, products and services

b) External Sources

- standards

- academia

- Conferences

- gathering knowledge with customers or external providers

7.2 Competence
Posidex
a) Determines the necessary competence for personnel performing work affecting product quality and
documents in job descriptions and career development plans. Competence is initially evaluated using
information obtained from the employment application and pre-employment interview.
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b) provides training or takes other actions to satisfy competency needs


c) evaluates effectiveness of the actions taken through post training evaluations, a performance appraisal
after a 6 months probation period and annually thereafter and through career development plans.
d) Maintains appropriate records of education, training, skills and experience.

7.3 Awareness
Posidex ensures that personnel under the organizational control are aware of:
a) the quality policy (Refer Section 5.2.1 in this manual);
b) Relevant quality objectives (Refer Section 5.2.1 in this manual);
c) Contribution to the effectiveness of the quality management system, including the benefits of
improved performance.
d) Implications of not conforming with the quality management system requirements.

7.4 Communication
The organization determines the internal and external communications relevant to the quality
management system which includes
a) Communicating regarding the problems or complaints.
b) Can communicate during office hours and through mail after the office hours.
c) Can communicate with sales and service Department members
d) Can communicate through calls and emails
e) Top management and service manager communicates
Top management ensures that appropriate communication methods are established throughout the
organization and that the communication takes place regarding effectiveness of the quality management
system. These communication methods include, but are not limited to: Posidex board, monthly talks
meetings with monthly review data, daily publication of Posidex Minutes Meeting, e-mail, Operations
Group meetings (normally held daily), information board and quality system documentation (Quality
Manual, Work Instructions, Internal Audit Reports, Corrective/Preventive Actions).

7.5 Documented Information

7.5.1 General

Posidex’s quality management system includes the following controlled documentation:


a) the Posidex quality statement and quality policy are documented in section 5.2.1 of this Quality
Policy Manual. Quality objectives are established and documented in section 5.2.1 (Quality
Manual).

b) this Quality Policy Manual,

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c) documented procedures referenced in this Quality Policy Manual, in conformance with the ISO
9001,
d) procedures and work instructions needed to ensure the effective planning, operation and control
of its processes,
e) forms, data and records referenced in this quality assurance manual, procedures and work
instructions.
f) any other documentation specified by national or regional regulations.
g) Posidex ensures that personnel have access to, and are aware of, relevant Quality Management
System documentation and changes.

7.5.2 Creating and updating


Documents required by the Posidex quality management system are controlled. When creating and
updating documented information, the organization ensures that:

a) Posidex procedure , Quality Records defines controls needed for identification, description,
storage, protection, retrieval, retention time and disposition of records (e.g. those arising from
regulatory requirements, customer order, contract review, training records, inspection and test
data, calibration data, sub-contractor evaluation, delivery data), including records that are
created by and/or retained by suppliers.
b) Format and media
Changes and updates to documents are reviewed and approved either by the original approving
function or another designated function which has access to pertinent background information
on which to base its decisions

7.5.3 Control of documented information


7.5.3.1 Documented information required by quality management system and by international
standard 9001:2015 shall be controlled to ensure:
a) it is available and suitable for use, where and when it is needed.
b) It is adequately protected from loss of confidentiality, improper use, or loss of integrity.

7.5.3.2 Posidex addresses the following activities for the control of documented information,
a) Distribution of records/documents, access, retrieval and use.
b) Storage and preservation, including preservation of legibility
c) Changes of the documents are controlled and recorded in SOP Distribution Record.
d) The obsolete copies are retained and disposed off.

Changes and updates to documents are reviewed and approved either by the original approving function
or another designated function which has access to pertinent background information on which to base
its decisions

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8.0 Operation
8.1 Operational Planning and Control
Posidex’s product realization consists of the design, develop / test and service of software products.
Posidex plans and develops the processes needed for these product realizations (refer to flow charts)
which are detailed in quality procedures. Planning of product realization is consistent with the
requirements of the other processes of the Quality Management System.
In planning product realization, Posidex determines the following, as appropriate:
quality objectives and requirements for the product; Quality objectives and requirements for the product
include consideration of aspects such as:
- product and personal safety
- reliability, availability and maintainability
- producibility and inspectability
- selection and development of embedded software
Establishing criteria for:
the need to establish processes, documents, and provide resources specific to the product;
required verification, validation, monitoring, inspection and test activities specific to the product and the
criteria for product acceptance;
The resources need to achieve conformity of the products and services meet the requirements.
Implementing control of the processes in accordance with the criteria.
Determining, maintaining and retaining documented information to the extent necessary:
The process has been carried out as planned.
Where a process that affects conformity with requirements is outsourced, Posidex ensures control over
such processes and identifies control over such processes in the quality management system

8.2 Requirements for products and services


8.2.1 Customer Communication
In keeping with our commitment to customer satisfaction, Posidex views effective customer
communication as an essential element of customer satisfaction. Appropriate handling of
communications can reduce customer dissatisfaction in situations and in many cases turn a dissatisfying
scenario into a satisfying scenario into a satisfying experience.
Posidex has determined and implemented effective arrangements for communicating with customers in
relation to
a) product information,
b) Inquiries, contracts or order handling, including amendments,

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c) Sales and customer service also receive customer feedback, including customer complaints.
d) handling or controlling customer property and
e) specific requirements for contingency actions, when necessary.
- Marketing sales and customer service handle external communications and are the primary contacts
for product information.
- Sales and customer service are responsible for ensuring that customer inquiries, contracts and other
handling, including amendments, are managed expeditiously and professionally.

Critical quality or service related communications with customers are documented and become part of
the quality records.
8.2.2 Determining the requirements for products and services

Posidex determines:
a) Requirements for the products and services which include,
- statutory and regulatory requirements related to the product, and
- Considers which are necessary by the organization
b) The organization can meet the claims for the products and services it offered.

8.2.3 Review of the requirements for products and services

8.2.3.1 The organization ensures that it has the ability to meet requirements for products and services to
be offered to customers. Before committing to supply products and services, conduct a review to include:
a) requirements specified by the customer, including requirements for delivery and post-delivery
activities;
b) requirements not stated by the customer, but necessary for the specified or intended use, when known;
c) the organization has the ability to meet the defined requirements,

d) statutory and regulatory requirements applicable to the products and services;


e) contract or order requirements differing from those previously expressed.
Organization ensures that contract or order requirements differing from those previously expressed are
resolved.
When the customer does not provide a documented statement of their requirements, have the customer
confirm their requirements before acceptance.
8.2.3.2 Retain documented information, as applicable:

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a) on the results of the review;


b) on any new requirements for the products and services.

8.2.4 Changes to requirements for products and services


Top Management 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.

8.3 Design and Development of Products and Services

8.3.1 General

The Research and Development (R&D) phase is the most important phase in the life cycle of a product. In
Posidex phased product development process, the associated phases are the Ideation, Screening and
Development. The inherent quality, effectiveness, safety and customer satisfaction of a product are
established during these phases. To ensure that specified requirements are met, the following activities
as applicable for the design project will be performed:

8.3.2 Design and Development Planning


Posidex plans and controls the design and development of products. Interfaces between different groups
involved in design and development are managed to ensure effective communication and clear
assignment of responsibility.

a) nature, duration, and complexity of the design and development activities;


b) requirements that specify particular process stages, including applicable design and development
reviews;
c) required design and development verification and validation;
d) responsibilities and authorities involved in the design and development process;
e) need to control interfaces between individuals and parties involved in the design and development
process;
f) need for involvement of customer and user groups in the design and development process;
g) necessary documented information to confirm that design and development requirements were met.
h) the requirements for subsequent provision of products and services
i) the level of control expected for the design and development process by customers and other relevant
interested parties.
j) the documented information needed to demonstrate that design and development requirements
have been met.

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8.3.3 Design and Development inputs


The functional and performance requirements of any new design, product, or process shall be developed
through analysis of past quality problems; product failures; contract review documentation; statutory
requirement; and customer or company standards. These findings are to be documented or referenced in
the design plan.
Inputs relating to product requirements are determined and records maintained. These shall include:
a) Functional performance, according to the intended use;
b) Information derived from previous similar designs and development activities, where applicable
c) Applicable statutory and regulatory requirements;
d) Standards or codes of practice that the organization has committed to implement
e) Potential consequences of failure due to the nature of products and services.

The Project Managers shall review these inputs for adequacy and approval. Requirements shall be
complete, unambiguous and not in conflict with each other.

8.3.4 Design and Development Controls

The organization applies the controls to design and development process to ensure that:
a) The results which are achieved are defined.
b) Reviews are conducted to evaluate the ability of the results of design and development to meet the
requirements.
c) Verification activities are conducted to ensure that the design and development outputs meet the input
requirements.
d) Validation activities are conducted to ensure that the resulting products and services meet the
requirements for the specified application or intended use.
e) Any necessary actions are taken on problems determined during the reviews, or verification and
validation activities.
f) Documented information of these activities is retained.

8.3.5 Design and Development Outputs


The outputs of design and development shall be provided in a form that enables verification against
the design and development input and shall be approved prior to release.
Design and development outputs shall
a) meet the input requirements for design and development,
b) adequate for the subsequent process for product and service provision,
c) contain or reference monitoring and measuring requirements, and product acceptance criteria,

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d) specify the characteristics of the product and services that are essential for its safe and proper use.

Records of the design and development outputs shall be maintained. These records can include
specifications, developing procedures.

As part of the design and quality planning process, required data is defined to allow the product to be
identified, developed, inspected, used and maintained; this can include details for preservation of the
product.

8.3.6 Design and Development Changes

Design and development changes shall be identified and records maintained. The changes shall be
reviewed, verified and validated, as appropriate, and approved before implementation. The review of
design and development changes shall include evaluation of the effect of the changes on product already
delivered. Design and development changes to released products shall be controlled in accordance with
Posidex’s configuration management process.
Records of the results of the review of changes and any necessary actions shall be maintained or
documented are:

a) design and development changes


b) the results of reviews the authorization of changes
c) actions taken to prevent adverse impacts.

- Design and Development Verification Design verification is planned and performed to ensure that the
design and development outputs have satisfied the design and development input requirements.

- Design and Development Validation Design and development validation is performed according to the
design plan to ensure that the resulting product is capable of fulfilling the requirements for the specified
or known intended use or application. Validation is completed prior to delivery whenever practicable.

8.4 Control of externally provided processes, products and services


8.4.1 General

Top management ensures that externally provided processes, products, and services conform to
specified requirements.

Organization shall apply the specified requirements for control of externally provided products and
services when:
a) products and services are provided by external providers for incorporation into organization’s own
products and services;

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b) products and services are provided directly to the customer by external providers on behalf of the
organization;
c) a process or part of a process is provided by an external provider as a result of a decision by organization
to outsource a process or function.

Top Management establish and apply criteria for evaluation, selection, monitoring of performance, and
re-evaluation of external providers based on their ability to provide processes or products and services
in accordance with specified requirements.
Retain appropriate documented information of:
➢ results of the evaluations,
➢ monitoring of the performance, and
➢ re-evaluations of the external providers.

8.4.2 Type and extent of control


Posidex ensures that externally provided processes, products and services do not adversely affect the
organization’s ability to consistently deliver conforming products and services to its customers.
a) Posidex ensures that externally provided processes remain within the control of its quality
management system.
b) Posidex defines both the controls that it intends to apply to an external provider and it
intends to apply to the resulting output.
c) In determining type and extent of controls to be applied to external provision of processes,
products and services, Posidex considers:
1) potential impact of the externally provided processes, products, and services on the
organization’s ability to consistently meet customer and applicable legal requirements;
2) perceived effectiveness of the controls applied by the external provider.
d) Determines the verification or other activities, necessary to ensure that the externally provided
processes, products and services meets the requirements.

Verification activities can include:


⚫ obtaining effective evidence of the conformity of the product from the supplier (e.g.
accompanying documentation, certificate of conformance, test records, statistical records,
process control records),
⚫ inspection and audit at the supplier’s facility,
⚫ review of the required documentation,
⚫ inspection of products upon receipt,
⚫ delegation of verification to the supplier or supplier certification.

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8.4.3 Information for external providers

The organization ensures the adequacy of requirements prior to their communication to the external
provider.

Top Management shall communicate to external providers its requirements for:


a) to provide the processes, products and services
b) The approval of
1) Products and services
2) Methods, process and equipment
3) The release of products and services
c) Competence, including any required qualification of persons
d) The external providers interactions with the organization
e) Control and monitoring of the external providers performance to be applied by the organization
f) Verification or validation activities that the organization, or its customer, intends to perform at
the external providers premises.

8.5 Production and service provision


8.5.1 Control of production and service provision

Posidex plans and carries out production and service provisions under controlled conditions. Controlled
conditions include, as applicable

a) availability of documented information that describes characteristics of the product


• the characteristics of the product to be produced, the services to be provided, or the
activities to be performed.
• the results to be achieved
b) The implementation of monitoring measurement activities at appropriate stages to verify that
criteria for control of processes or outputs and acceptance criteria for products and services
(Specified on work instructions and test procedures).
c) The use of suitable infrastructure and environment for the operation of processes.
d) The appointment of competent persons, including any required qualification
e) The validation, and periodic re-validation, of the ability to achieve planned results of the
processes for production and service provision, where the resulting output cannot be verified
by subsequent monitoring or measurement.
f) The implementation of actions to prevent human error
g) The implementation of release, delivery and post-delivery activities.

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Posidex’s planning considers, as appropriate:


⚫ establishing, implementing and maintaining appropriate processes to manage critical items,
⚫ including process controls where key characteristics have been identified,
⚫ designing, developing and using tooling to measure variable data,
⚫ identifying in-process inspection/ verification points when adequate verification of conformance
cannot be performed at later stages of realization.
8.5.2 Identification and Traceability

Posidex identifies the product by suitable means throughout product realization.


Posidex maintains the identification of the configuration of the product in order to identify any differences
between the actual configuration and the agreed configuration.
Posidex has established appropriate controls for acceptance authority (e.g. electronic signatures,
passwords).
Posidex normal traceability policy for serialized products is to provide traceability to the production lot.
Posidex provides traceability to the component level (component lot no.) when invoked by customer
contract.
Traceability requirements can include:
⚫ Unique identification to be maintained throughout product life,
⚫ For an assembly, the ability to trace its components to the assembly, and then to the next higher
assembly, and
⚫ For a product, a sequential record of production (development, assembly, inspection/verification)
to be retrievable.
⚫ Records of traceability are maintained.

During product realization, the product status is identified with respect to the monitoring and
measurement requirements. The product is identified with status with respect to monitoring and
measurement requirements during all stages of production, testing, and repair. Traceability is required
with respect to the final product and its significant parts.

8.5.3 Property belonging to customers or external providers

Posidex exercises care with customer property, including intellectual property and personal data, while it
is under Posidex’s control.

Posidex identifies, verifies, protect and safeguards customer property provided for use or incorporation
into the product.

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If any customer property is lost, damaged or otherwise found to be unsuitable for use, this will be reported
to the customer and records maintained. All Posidex associates are required to sign a Confidential
Information Agreement upon employment. Posidex signs nondisclosure agreements with customers.

Posidex verifies compatibility of such customer-supplied product with the requirements of the Ex
certificate.

8.5.4 Preservation

Posidex preserves the conformity of product during internal processing and delivery to the intended
destination. This preservation includes identification, handling, storage and protection. This preservation
also applies to parts of a product.
Posidex develops products that customer(s) incorporate(s) into end products with Ex Certificates. Posidex
customer provides instructions to the end user.
Preservation of products includes, where applicable in accordance with product specifications and
applicable statutory and regulatory requirements

8.5.5 Post-delivery activities

Posidex determines requirements specified by the customer, including the requirements for delivery
and post-delivery activities,

Determining the extent of post-delivery activities that are required:

a) Statutory and regulatory requirements related to the product

b) the potential undesired consequences associated with its products and services

c) Customer requirements are determined and are met with the aim of enhancing customer

satisfaction

d) Customer feedback (Complaints and etc)

e) Post-delivery support and query handling

8.5.6 Control of changes

Posidex review and control changes for production or service provision, to the extent necessary to
ensure continuing conformity with requirements.

- Ensuring that changes and current revision status of documents are identified,
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- Ensuring that changes to documents are reviewed and approved by appropriate personnel

The design and development procedure defines a process for identifying, recording, verifying, validating
and approving design changes. The review of design and development changes includes an evaluation of
the effect of the changes on constituent parts and delivered product (i.e. schedule cost, etc.). Records
are maintained to show the results of the review and any necessary actions identified during the review.

Changes and updates to documents are reviewed and approved either by the original approving
function or another designated function which has access to pertinent background information on which
to base its decisions.

8.6 Release of products and services


Posidex implement planned arrangements at appropriate stages to verify product and service
requirements which have been met.

Posidex do not release products and services to the customer until the planned arrangements for
verification of conformity have been satisfactorily completed (unless otherwise approved by a relevant
authority and, as applicable, by customer).

The retain documented information on the release of products and services. The documented
information shall include:

-Retain evidence of conformity with acceptance criteria.

-Release notes

-It also provides documented information for traceability to the person(s) authorizing release of
products and services for delivery to the customer.

8.7 Control of nonconforming outputs


8.7.1 Posidex ensures that product which does not conform to product requirements is

identified and controlled to prevent its unintended use or delivery.

Organization takes appropriate action based on the nature of the nonconformity and its effect on the
conformity of the products and services.

Posidex deals with nonconforming product by one or more of the following ways:
a) by taking action to eliminate the detected nonconformity (i.e. rework). When nonconforming product
is corrected through rework, it shall be subject to re-verification to demonstrate conformity to
requirements.
b) By authorizing its use, release or acceptance under
c) By taking action to preclude its original intended use or application

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9.0 Performance Evaluation


9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General

Posidex plans and implements the monitoring, measurement, analysis and evaluation processes of the
quality management system processes. These methods demonstrate the ability of the processes to
achieve planned results. When considering suitable methods, Posidex considers the type and extent of
monitoring or measurement appropriate to each process in relation to their impact on the conformity of
product requirements and on the effectiveness of the quality management system.

This includes determination of applicable methods, including statistical techniques, and extent of their
use.

NOTE: According to the nature of the product and depending on the specified requirements, statistical
techniques can be used to support:

- design verification (reliability, maintainability, safety)

- process control

- selection & inspection of key characteristics

- process capability measurements

- statistical process control

- inspection

9.1.2 Customer Satisfaction

As one of the measurements of the performance of the quality management system, Posidex monitors
information relating to whether Posidex has met customer requirements and whether the customer
perceives Posidex has met customer requirements. Such information is obtained by methods such as, but
not limited to: customer feedback forms, awards, repeat business/ lost business analysis, letters,
measures of product conformity (customer rejections, warranty claims, customer complaints/ corrective
action requests), on time delivery performance and surveys of key personnel at major customers. This
information serves as input to management review meetings and potentially to the corrective action
system and process improvement activity.

9.1.3 Analysis and evaluation

Analyze and evaluate appropriate data and information arising from monitoring,
measurement, and other sources. Use the output of this analysis and evaluation to:

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⚫ demonstrate conformity of products and services to requirements


⚫ assess and enhance customer satisfaction
⚫ ensure conformity and effectiveness of quality management system
⚫ demonstrate that planning has been successfully implemented
⚫ assess the performance of processes
⚫ assess the performance of external providers
⚫ determine need or opportunities for improvements within quality management system

9.2 Internal Audit


9.2.1 Posidex conducts internal audits of the quality management system at planned intervals to
determine whether the quality system
a) conforms to
1) the planned arrangements including customer contractual requirements (see 7.1),
2) the requirements of the ISO 9001 standards, Posidex quality management system requirements
b) is effectively implemented and maintained

9.2.2 The organization must:


a) Plan, establish, implement, and maintain the audit program Including frequency, methods, and
Responsibilities, planning requirements and reporting which consider quality objectives and
importance of concerned processes considering customer feedback and changes impacting the
organization and the results of previous audits
b) Define audit criteria and scope for each audit
c) Select auditors and conduct audits for impartial and objective audit process
d) Ensure results of audits are reported to relevant management
e) Take necessary correction and corrective actions without undue delay
f) Retain evidence of audit program implementation and audit results

Internal audits are conducted in accordance with a planned program, taking into consideration the
status and importance of the processes and areas to be audited, as well as the results of the previous
audits.

Internal audits are necessary to verify the implementation and measure the effectiveness of Posidex total
quality performance. Auditors shall not audit their own areas of responsibility. Each element of the quality
system is audited regularly; a minimum of once per year, in accordance with documented procedures.
Depending on the criticality of the activity/area to be audited and the results of previous audits this
frequency may be increased. The audit criteria, scope, frequency (6 months) and methods are defined.
The results of each audit are documented and distributed to top management, and those persons
responsible for the activities/areas that have been audited. When an audit report identifies significant
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quality failures and/or recommends immediate remedial action, the person responsible for the audited
activity/area is to plan and initiate corrective action in a timely manner.
Follow-up audits, include the verification of the actions taken and the reporting of verification Results,
Corrective Action, and serve to confirm that all necessary corrective actions have been taken.
The person responsible for the area/activity that has been audited shall ensure that actions are taken,
without undue delay, to eliminate detected nonconformities and their causes. The responsibilities and
requirements for reporting results and maintaining records follow paragraph 7.5.3, Control of
documentation Information.

9.3 Management Review

Customer Satisfaction
Human Resources
Analysis of data

Customer Complaints
Equipment, Facilities &
Internal Quality Audits
Process
Recommendations for improvement
Management
Status of Products intended for use in Review Continual Improvement
different Atmospheres
Projects

9.3.1 General

Top management reviews the process measures of the organization’s quality management system at least
once in a month, to ensure continuing suitability of the many processes, adequacy and effectiveness of
the overall quality management system. The entire quality system will be reviewed at least annually, not
to exceed 14 months. This review includes assessing opportunities for improvement and the need for
changes to the quality management system, including quality policy and quality objectives, and changes
in statutory/regulatory requirements.

The management review meeting is chaired by the CEO & CTO or, in his absence, by the Vice President.
The meeting must be attended by the “authorized person” or his deputy. In addition, a quorum of a simple
majority of the Operations Group is required. Records of the management reviews shall be maintained in
the computer database perennially.

9.3.2 Management Review Inputs

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The management review 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.
c) Information on the performance and effectiveness of the quality management system,
including:
1) Customer satisfaction and feedback (complaints, etc)
2) the extent to which quality objectives have been met.
3) process performance and product conformity,
4) Nonconformities and corrective actions
5) Monitoring and measurement results
6) results of internal / external (e.g. bodies responsible for verification of the quality system,
registrars or customers) audits,
7) the performance of external providers
d) adequacy of resources
e) the effectiveness of actions taken to address risks and opportunities (Refer 6.1).
f) opportunities for improvement

9.3.3 Management Review Outputs

The output from the management review shall include any decisions and actions related to:
a) improvement opportunities of the effectiveness of the quality management system and its processes,
b) changes needed for Quality Management system
c) resource needs

10.0 Improvement
10.1 General

Posidex determines and selects the opportunities for improvement and implement any necessary actions
to meet customer requirements and enhance customer satisfaction which include:
a) improve products and services to meet requirements as well as to address future needs and
expectations
b) correcting, preventing or reducing undesired effects,
c) improving the performance and effectiveness of the quality management system.

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10.2 Nonconformity and corrective action


10.2.1 Posidex ensures that product which does not conform to product requirements is identified
and controlled to prevent its unintended use or delivery.
NOTE: The term “nonconforming product” includes nonconforming product returned by a
customer.

Posidex
deals with nonconforming product by one or more of the following ways:
a) by reacting the nonconformity and, as applicable:
1) By taking action to control and correct it.
2) Deal properly with consequences.
b) Evaluate the need for action to eliminate the cause of the nonconformity, in order that it does not
reoccur or occur by:
1) reviewing and analyzing the nonconformity
c) By taking actions necessary to contain the effect of the nonconformity on other processes or
products
d) review the effectiveness of any corrective action taken
e) update risks and opportunities determined during planning, if necessary,
f) make changes to the quality management, if necessary.

Corrective actions shall be appropriate to the effects of the non-conformities encountered


10.2.2 The organization retains the documented information as evidence of:
a) the nature of the non-conformities and any subsequent actions taken,
b) The results of any corrective action.

10.3 Continual Improvement


Posidex identifies and implements any changes necessary to ensure, maintain and improve the continued
suitability and effectiveness of the quality management system through the use of the quality policy,
quality objectives, audit results, analysis of data, corrective and preventive actions and management
review. Continual improvement opportunities can result from lessons learned, problem resolutions and
the bench marking of best practices. Significant or sustained lack of improvement must be met with
corrective action.
Posidex monitors the implementation of improvement activities and evaluates the effectiveness of the
results.

QM Posidex Technologies Page 45

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