Quality Manual 9001 2015
Quality Manual 9001 2015
: - AI/QM/01
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Issue Date: - 01/01/2017
Rev. No. 00
QUALITY MANUAL
(AS PER IS/ISO 9001: 2015)
ALPHA (INDIA)
PLOT NO. 27/83A, LAXMI RATTAN COMPOUND,
INDUSTRIAL AREA, NEAR HARDWARE CHOWK,
N.I.T., FARIDABAD (HARYANA) 121 001
ISSUE NO.: 01
ISSUED BY: MR
This Quality manual and the information contained therein is the property Of
ALPHA (INDIA), FARIDABAD. This must not be reproduced in whole or in
parts or otherwise disclosed without the prior consent in writing from the
Proprietor of the organisation.
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Section 0.1
CONTENTS
Page Rev. ISO-9001:2015
Section Description Issue date
No. No. Clause Ref.
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Section 0.2
Revision History
S. Page Rev. Level Appd.
Section No. Nature of Revision Remarks
No. No. From To By/date
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SECTION: 0.3
DISTRIBUTION SHEET
The CONTROLLED copies are covered by “change control” and are stamped in
blue on all pages. The controlled copies are distributed to Functional Heads.
Copy No. 2
WITH PRODUCTION & QC INCHARGE
Controlled Copy
* All other Sectional heads can refer to the Quality Manual available with
Production and QC Incharge
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SECTION 1.0
SCOPE, PERMISSIBLE EXCLUSIONS AND CONTROL
Scope:
Policies and practices given in this manual are applicable to the operations of ALPHA (INDIA),
FARIDABAD. It covers all aspects and facts for
“Manufacturing of all Types of Plastic Injection Moulded Components
for Home Appliances”.
Permissible Exclusions:
The following requirements of the Quality Management System ISO: 9001:2015 neither affect the
organization’s ability nor absolve it from its responsibility, to provide products that meet customers’
and applicable regulatory requirements. The exclusions are limited, depending on the type of
product, customer requirements and applicable regulatory requirements.
1. Design & Development (Clause 8.3) – As the product design is based on the drawings/
samples/ requirements of Customers, therefore Design activity is excluded from scope of this
manual.
2. Post-delivery activities (Clause 8.5.5) At present, there is no Post delivery activities related to
the Products. So this Clause is excluded from the scope the certifications.
Structure: Structure of the quality manual is as indicated in the contents. Different sections of the manual
Correspond to various sections of ISO: 9001: 2015.
Revisions are formally released to the concerned persons and obsolete copies are withdrawn. The
Management Representative, for future references, retains copy of the earlier versions. Management
Representative maintains records of all these activities.
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SECTION 2.0
QUALITY POLICY
SD/-
Date: 01.01.2017 PROPRIETOR
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SECTION 3.0
QUALITY OBJECTIVES
Top Management of
ALPHA (INDIA), FARIDABAD
Has defined & established Quality Objectives as under: -
OF FINANCIAL YEAR.
EVERY YEAR
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Section-4
4 Context of the organization
4.1 Understanding the organization and its context
The organization has determined external and internal issues (AI/QMS/01) 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.
The organization has monitored and reviewed information about these external and
internal issues.
The organization has determined the processes needed for the quality management
system and their application throughout the organization (Annex.-III), and has:
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a) Determined the inputs required and the outputs expected from these processes
(Annex. IV);
b) Determined the sequence and interaction of these processes;
c) Determined and apply the criteria and methods (including monitoring, measurements
and related performance indicators) needed to ensure the effective operation and
control of these processes;
d) determined the resources needed for these processes and ensure their availability;
e) Assigned the responsibilities and authorities for these processes
f) Addressed the risks and opportunities as determined in accordance with the
requirements of 6.1
g) Evaluated these processes and implement any changes needed to ensure that these
processes achieve their intended results
h) Improved the processes and the quality management system.
Section-5 Leadership
5.1 Leadership and commitment
5.1.1 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 (Section 2.0) and quality objectives (Section 3.0) are
Established for the QMS and are compatible with the context and strategic direction of
the organization;
c) Ensuring the integration of the QMS requirements into the organization’s business
processes;
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 as
& when required;
f) Communicating the importance of effective quality management and of conforming to
the QMS requirements to all interested parties;
g) Ensuring that the quality management system achieves its intended results;
h) Engaging, directing and supporting persons to contribute to the effectiveness of the
QMS;
i) Promoting improvement;
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5.2 Policy
5.2.1 Establishing the quality policy
Top management has established, implemented and maintained a quality policy (Section
2.0) that:
a) is appropriate to the purpose and context of the organization and supports its strategic
direction;
b) provides a framework for setting quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) Includes a commitment to continual improvement of the quality management system.
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Section 6 - Planning
6.1 Actions to address risks and opportunities
6.1.1 When planning for the QMS, the organization shall consider the issues referred to in
4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that
need to be addressed to:
a) give assurance that the quality management system can achieve its intended result(s)
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.
e) Risk & opportunity assessment and actions are defined in Doc. No. AI/QMS/04
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6.2.2 When planning how to achieve its quality objectives, the organization has
determined:
a) what will be done
b) what resources will be required
c) who will be responsible
d) when it will be completed
e) how the results will be evaluated
Documented Information maintained in Quality Objective Achieving Plan Doc. No.
AI/QPL/03.
Section 7- Support
7.1 Resources
7.1.1 General
The organization has determined and provided the resources needed for the establishment,
implementation, maintenance and continual improvement of the quality management
system.
The organization has considered:
a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers.
c) An Resources identification form is filled by department head and send the same to
PROPRIETOR through MR for approval. Records for the same are maintained in Resources
identification form Doc. No. AI/HR/02
The same are reviewed and provided during Management review or as and when required.
7.1.2 People
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The organization has determined and provided the persons necessary for the effective
implementation of its quality management system and for the operation and control of its
processes.
7.1.3 Infrastructure
The organization has determined, provided and maintained the infrastructure necessary
for the operation of its processes and to achieve conformity of products and services.
Infrastructure includes:
a) buildings and associated utilities
b) equipment, including hardware and software
c) transportation resources
d) Information and communication technology
List of Plant and machinery maintained in Doc. No. AI/MAINT/01. Plan for Preventive
Maintenance (PE/QPL/04) of machinery is maintained and Preventive Maintenance of
machines is carried out as per given schedule in Doc. No. AI/MAINT/04. Machine
Breakdown records are maintained in Doc. No. AI/MAINT/06. List of Moulds maintained
in Doc. No. AI/MAINT/02 and Maintenance/Cleaning record of the same maintained in
Doc. No. AI/MAINT/05. Refer Procedure No. AI/PR/09 for Infrastructure.
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7.2 Competence
The organization shall:
a) Determine the necessary competence of person(s) doing work under its control that
affects the performance and effectiveness of the quality management system. Criteria
for recruitment maintained in Doc. No. AI/HR/01.
b) Ensure that these persons are competent on the basis of appropriate education,
training, or experience. Employees Education, Exp., Training and Skill records
maintained in Doc. No. AI/HR/06.
c) Retained appropriate documented information as evidence of competence. (AI/HR/06)
d) Where applicable, take actions to acquire the necessary competence, by providing
Training and evaluate the effectiveness of the actions taken. Training Given to
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7.3 Awareness
The organization provides Trainings as per training plan (AI/HR/05) and ensures that
persons doing work under the organization’s control are aware of:
a) The quality policy
b) Relevant quality objectives
c) Their contribution to the effectiveness of the quality management system, including
the benefits of improved performance
d) The implications of not conforming to the quality management system requirements
7.4 Communication
The organization has determined the method of internal and external communications
(AI/IEC/01) relevant to the quality management system, including:
a) On what it will communicate
b) When to communicate
c) With whom to communicate
d) How to communicate
e) Who communicates
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7.5.3.2 For the control of documented information, the organization has documented a
Procedure for Control of Documented Information (AI/PR/01) and Control of Records
(AI/PR/02), which addresses the following activities, as applicable:
a) Distribution, access, retrieval and use;
b) Storage and preservation, including preservation of legibility;
c) Control of changes (e.g. version control);
d) Retention and disposition.
e) Permission and authority to view and change the documented information
8 Operations
8.1 Operational planning and control
The organization plans, implements and controls the processes needed to meet the
requirements for the provision of products and services, and to implement the actions
determined in Clause 6, by:
a) Determining the requirements for the products and services;
b) Establishing criteria for:
1) Process Flow Charts of prepared in Doc. No. AI/PFC/01
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 as per Quality
Plan for Incoming Raw Material, process Inspections and Final Inspections AI/QPL/01 to
02 respectively.
e) Determining, maintaining and retaining documented information to the extent necessary:
(AI/ML/01)
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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 organization shall control planned changes and review the consequences of
unintended changes, taking action to mitigate any adverse effects, as necessary.
The Organization has planned & manages the outsourced processes in accordance with
the QMS. At present, Calibration of instruments is carried out by external NABL certified
Lab. Outsourced suppliers are asked to maintain good quality system in accordance with
International Standard. The requirements are communicated through Verbal or Purchase
orders. The system shall include a framework for controlling any other process, which
shall be outsourced, as and when required.
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8.2.3.1 The organization ensures that it has the ability to meet the requirements for
products and services to be offered to customers as per agreed quality plan. The
organization has conducted a review before committing to supply products and services
to a customer, to include:
a) Requirements specified by the customer, including the requirements for delivery. No
post delivery activities are applicable
b) Requirements not stated by the customer, but necessary for the specified or intended
use, when known
c) Requirements specified by the organization
d) Statutory and regulatory requirements
e) Contract or order requirements differing from those previously expressed.
All orders are received and reviewed by PROPRIETOR and Documented the same in
AI/ORR/01
The organization shall ensure that contract or order requirements differing from those
previously defined are resolved. The customer’s requirements shall be confirmed by the
organization before acceptance, when the customer does not provide a documented
statement of their requirements. In such case, we communicate the specifications being
followed by us.
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a) Products and services from external providers are intended for incorporation into the
organization’s own products and services;
b) Products and services are provided directly to the customer(s) by external providers
on behalf of the organization; (At Present, this is not applicable)
c) A process, or part of a process, is provided by an external provider as a result of a
decision by the organization.
The organization shall determine and apply criteria for the 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 requirements. The
organization has retained documented information (AI/VRF/01, AI/AVL/01) of these
activities and any necessary actions arising from the evaluations.
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8.5.4 Preservation
The organization preserves the outputs during production and service provision, to the
extent necessary to ensure conformity to requirements. All raw materials are well stored
at defined place in store. Record of Raw material in and out well maintained in Stock
Book doc. no. AI/STR/01
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maintained describing the results of the review of changes, the person(s) authorizing the
change, and any necessary actions arising from the review.
Finished goods are dispatched to customer’s only after all requisite measurements and
monitoring as per Quality Plan is completed and found accepted, unless otherwise
approved by a relevant authority (if any) and, as applicable, by the customer.
The organization retains Copy of Process Log Sheets and Final Inspection Reports as
evidence that all the Inspection /Tests have been carried out. The Process control Record
includes:
a) evidence of conformity with the acceptance criteria;
b) traceability to the person(s) authorizing the release.
The control and related responsibilities and authorities for dealing with non-conformance
products are defined in a documented procedure for Control of non-conforming products
(AI/PR/04)
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9 Performance Evaluations
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
For Products and Processes, the organisation has documented Quality Plans to
determined:
a) What needs to be monitored and measured
b) The methods for monitoring, measurement, analysis and evaluation needed to ensure
valid results
c) When the monitoring and measuring shall be performed
d) When the results from monitoring and measurement shall be analysed and evaluated.
The organization shall evaluate the performance and the effectiveness of the quality
management system during Management Reviews (AI/MRM/01).
The organization retains appropriate documented information in the forms of record as
evidence of the results as defined in Quality Plans.
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9.2.2 The organization has established a procedure for Internal Audits (AI/PR/05),
specifying the responsibilities and requirements for planning and conducting audits, and
for reporting results and maintaining records.
The Organisation retains documented information as evidence of the implementation of
the audit programme and the audit results as defined in Procedure for Internal Audits
AI/IQA/01= IA PLAN
AI/IQA/02= IA SCHEDULE
AI/IQA/03= IA CHECKLIST
AI/IQA/04= IA NC REPORT
10.1 General
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The organization determines and selects opportunities for improvement and implements
any necessary actions to meet customer requirements and enhance customer satisfaction
including;
a) Improving 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.
The same are reviewed during Management Reviews for Implementation and
effectiveness.
10.2.2 The organization has retained documented information (AI/CA/01) as evidence of:
a) The nature of the nonconformities and any subsequent actions taken;
b) The results of any corrective action.
The control and related responsibilities and authorities for dealing with non-conformance
products are defined in a documented procedure for Control of non-conforming products
(AI/PR/04).
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SECURITY
PROD. QC
SUPERVISORS SUPERVISORS
OPERATOR
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Responsible for defining QMS Policy & Ultimate authority for decision making
Objective in all areas of company
Responsible for defining authority & Authorized to take decision related to
responsibility, providing resources and QMS
appointing Management Representative Authorized to update
Responsible for continual improvement of process/machinery
QMS Ultimate authority for decision making
Responsible for complaint handling related to in all areas of company
Service & Quality Authorized to take decision about
Ensuring customer satisfaction contract review & disposal of
Responsible for any technical issue or aid in complaints
the plant Acting as MR in his absence.
Responsible for defining authority and
responsibility
Responsible for providing resources
Responsible for appointing Management
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Selection of Market for purchase of RM
Evaluation of approved suppliers
Responsible for purchase of RM
Responsible for development of markets &
Brand
Responsible for contract review
Responsible for complaint handling related to
Quality
Ensuring customer satisfaction
Communication with regulatory bodies.
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Review of QMS.
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Maintains smooth flow in & out of vehicles in Authorized to check vehicles &
factory premises. personnel from security safety point of
Maintenance of smooth flow at shift change. view.
Security Screening of goods and manpower.
Incharge Deployment of security personal as per plan.
Maintaining food security.
Emergency preparedness for identified
emergency situations.
Gratuity/Bonus management
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STORE Issue and receipt of raw material Give direct orders to suppliers in case
INCHARGE PROPRIETORs not available.
Implement FIFO System in store.
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Housekeeping of store
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ANNEXURE- VI ABBREVATIONS
Abbreviation Description Abbreviation Description
APPD Approved PD/Prod. Production
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