Manik Quality Manual

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QUALITY MANUAL Model Effective Date Revision Level Page ISO 9001:2008 04/14/2014 0 1 of 25 Uncontrolled copy if Manik Sabharwal Logistics (MSL) logo is not in BLUE Issued By: QMR Approved By: President ISSUED BY QUALITY MANAGER AUTHORIZED BY COMPANY MANAGEMENT

Transcript of Manik Quality Manual

QUALITY MANUAL

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ISSUED BY

QUALITY MANAGER

AUTHORIZED BY

COMPANY MANAGEMENT

QUALITY MANUAL

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TABLE OF CONTENTS

Clause Description Page

QM 1.0 OVERVIEW AND SCOPE 4

QM 1.1 Overview 4

QM 1.2 Manual Distribution Record 4

QM 1.3 Manual Revision 4

QM 1.4 Scope 4

QM 1.5 Exclusion and Justifications 5

QM 2.0 REFERENCES 5

QM 3.0 TERMS AND DEFINITIONS 6

QM 4.0 QUALITY MANAGEMENT SYSTEM 7

QM 4.1 General Requirements 7

QM 4.2 Documentation Requirements 7

QM 5.0 MANAGEMENT RESPONSIBILITY 8

QM 5.1 Management Commitment 8

QM 5.2 Customer Focus 9

QM 5.3 Quality Policy 9

QM 5.4 Planning 10

QM 5.5 Responsibilities, Authority and Communication 10

QM 5.6 Management Review 12

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Clause Description Page

QM 6.0 RESOURCE MANAGEMENT 14

QM 6.1 General Requirements 14

QM 6.2 Human Resources 14

QM 6.3 Infrastructure 15

QM 6.4 Work Environment 15

QM 7.0 PRODUCT REALIZATION 16

QM 7.1 Planning Product Realization 16

QM 7.2 Customer Related Processes 17

QM 7.4 Purchasing 18

QM 7.5 Production Operations 20

QM 7.6 Control of Monitoring and Measuring Equipment 21

QM 8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT 22

QM 8.1 General 22

QM 8.2 Monitoring and Measurement 22

QM 8.3 Control of Nonconforming Product 23

QM 8.4 Analysis of Data 23

QM 8.5 Improvement 24

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QM 1.0 OVERVIEW AND SCOPE

QM 1.1 Overview

This Quality Manual is a level 1 document that establishes the policies and practices of

Manik Sabharwal Logistics and its management to support a Quality Management

System based on the requirements of ISO 9001:2008.

QM 1.2 Manual Distribution Record

The master copy of this Quality Manual is saved on Quality Manager’s computer. Only

one copy has been printed and kept in the Document Centre for references.

Uncontrolled copies may be allowed for training of the employees and creating

organization-wide awareness of ISO 9001:2008 and also for customer reference.

QM 1.3 Manual Revision

Revision Level – 0, Effective 04/14/2014

This Quality Manual has been rewritten to conform to ISO 9001:2008. This Manual

supersedes all previous versions and become effective as on 04/14/2014.

QM 1.4 Scope

Manik Sabharwal Logistics offers to bridge the gap between manufacturers and

distributers with products and services tailored to meet specific requirements of

customers. We offer a wide selection of cost effective solutions to manage logistics. The

company is located at 20 Automatic Road, Brampton, Ontario, L6S 5N7.

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The scope of the Quality Management System of Manik Sabharwal Logistics extends to

all the processes as required by the ISO 9001:2008, except as explained below:

QM 1.5 Exclusions and Justifications

The QMR has identified exclusions from the scope of the quality system, to the

requirements of ISO 9001:2008, that do not apply to products and services provided by

Manik Sabharwal Logistics. The Manik Sabharwal Logistics Management Team has

evaluated and approved them.

a) Section 7.3 Design and Development – including all sub-sections.

Justification – Manik Sabharwal Logistics does not design or develop any products.

The customers or their consultants provide and specify all requirements with respect

to products (logistics supplies) and services.

b) Section 7.5.2 Validation of processes for production and service provision -

including all sub-sections.

Justification – Manik Sabharwal Logistics verifies all subsequent monitoring or

measurements for each successive process output.

QM 2.0 REFERENCES

Manik Sabharwal Logistics has developed and implemented a Quality Management

System in accordance with:

ISO 10013:2001 – Guidelines for Quality Management System Documentation

ISO 9000:2005 – Quality Management System – Fundamentals and Vocabulary

ISO 9001:2008 – Quality Management System – Requirements

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QM 3.0 TERMS AND DEFINITIONS

Terms and definitions adopted in this Manual are in accordance with those of ISO

9000:2005, and ISO 9001:2008.

Manik Sabharwal Logistics specific terms and abbreviations:

Term For

CAR Corrective Action Request

C of C Certificate of Conformance

CSC Customer Service Coordinator

MSL Manik Sabharwal Logistics

NCP Nonconforming Product

MT Management Team / Company Management

MH Material Handler

MTR Material Test Result

PAR Preventive Action Report

PO Purchase Order

PM Preventive Maintenance

QM Quality Manual

QMR Quality Management Representative

QMS Quality Management System

QSP Quality System Procedure

RFQ Request for Quotation

WI Work Instructions

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QM 4.0 QUALITY MANAGEMENT SYSTEM

QM 4.1 General Requirements

Requirements

MSL has established, documented, implemented, and maintains and continually improves

a quality management system in accordance with the requirements of ISO 9001:2008.

The organization has:

Determined the processes needed for the QMS and their application throughout

the organization

Determined the sequence and interaction of these processes

Determined criteria and methods needed to ensure that both the operation and

control of these processes are effective

Ensured the availability of resources and information necessary to support the

operation and control of these processes

Established a means of monitoring, measuring and analyzing these processes,

where applicable

Established the implementation of actions necessary to achieve planned results

and continual improvement of these processes

QM 4.2 Documentation Requirements

General

MSL’s QMS documentation includes documented statements of a quality policy and

quality objectives, a quality manual, documented procedures and records required by ISO

9001:2008, including records determined by the organization to be necessary to ensure

the effective planning, operation and control of the processes.

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Quality Manual

MSL’s Quality Manual includes:

The scope of the QMS, including applicable exclusions and justifications

The documented procedures established for the QMS or reference to them

Description of the interaction between the processes of the QMS

Control of Documents

MSL has a procedure QSP-01 for establishing, maintaining and controlling all

documentation required to support the QMS and ensure its continued effectiveness.

Control of Records

MSL controls the records established to provide evidence of conformity to requirements

and the effective operation of the QMS. MSL has a procedure QSP-02 for controlling

quality records to ensure that they are:

Identified and stored safely

Legible and readily retrievable and have established retention times

QM 5.0 MANAGEMENT RESPONSIBILITY

QM 5.1 Management Commitment

General

MSL is committed to the development and implementation of the QMS and continually

improving its effectiveness by communicating the importance of meeting customer,

statutory, and regulatory requirements throughout the organization.

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MSL has established a Quality Policy and Quality Objectives. It ensures the continuing

relevance of the QMS and its continual improvement through management reviews.

The management of MSL is committed towards providing sufficient resources to ensure

the effective implementation and maintenance of the QMS throughout the organization.

QM 5.2 Customer Focus

General

MSL is committed towards identifying customer requirements and their fulfillment to

ensure customer satisfaction.

QM 5.3 Quality Policy

General

The Quality Policy provides a framework for establishing and reviewing quality

objectives. The following Quality Policy is communicated throughout the organization.

The Quality Policy is reviewed during management review meetings to ensure its

continuing suitability and effectiveness.

“MSL is committed in providing logistics supplies and services customized to

meet specific requirements of customers (manufacturers). We provide and

customize various logistics products (labeling printers, barcode scanners,

boxes, pump trucks, skids, plastic wraps, e.t.c.). Our aim is to continually

improve the quality of our products / services while meeting and exceeding

customer requirements and ensuring enhanced customer satisfaction”.

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QM 5.4 Planning

Quality Objectives

MSL has established Quality Objectives, particularly those concerning product

requirements. Quality Objectives are measurable and consistent with the Quality Policy.

Measurable objectives are mentioned in the following format separately on QF-25. The

management reviews the objectives during management review meetings. The objective

may be revised if the targets have been achieved or are found to be impractical

considering the changes in business conditions.

Policy Statement Quality Objective Measurable Target

QMS Planning

MSL has developed its QMS with the following priorities in mind:

The requirements given in QM 4.1 and those mentioned in Quality objectives are

satisfied

Any plans for changes will consider their impact on the QMS, and will ensure the

integrity of the QMS is maintained

QM 5.5 Responsibility, Authority and Communication

Responsibility and Authority

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MSL has a semi-formal structure as shown in the following organizational chart. All

employees are communicated of their responsibilities and authorities and the importance

of teamwork.

MSL’s Functional Organizational Chart

Management Representative

As evidence of its commitment to maintain an ISO - compliant QMS, the management of

MSL has appointed Quality Manager as its Quality Management Representative. The

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QMR reports to the President and is responsible for advising the MT of all quality issues,

including its performance and any opportunities for improvements.

The person named below has full responsibility and authority for the implementation and

maintenance of Quality Management System as defined in this Quality Manual and

promoting the awareness of customer requirements throughout the organization.

Manik Sabharwal (QMR)

ASQ-CQE, CQA, CQI, CQPA

Quality Manager

Manik Sabharwal Logistics [MSL]

20 Automatic Road, Brampton, Ontario, L6S 5N7

Tel: (905) 845-9430 ext. 25 | Fax: (905) 845-9340

e-mail: [email protected]

website: www.MSL.ca

Internal Communication

MSL recognizes that all employees and their work activities affect product (service)

quality and the company’s ability to satisfy customer requirements. The Company

communicates all quality issues and quality objectives within the organization via

bulletin boards, periodical meetings with employees, and group trainings regarding the

effectiveness of the QMS.

QM 5.6 Management Review

General

MSL management reviews the organization’s QMS, at least once in a year, to ensure its

continuing suitability, adequacy and effectiveness. This review includes assessing

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opportunities for improvement and the need for changes to the QMS, including the

quality policy and quality objectives.

The QMR chairs the Management Review meetings and records are maintained in

management review form QF-02.

Review Inputs

MSL management, in conducting reviews of its QMS, uses inputs from a variety of

sources such as:

Audit results

Customer feedbacks

Process performance and product conformity

Preventive and corrective action reports

Follow up actions from previous management reviews

Changes that may affect QMS

Recommendation for improvement

Quality Policy and Objectives

Supplier information

Resource requirements

Review Outputs

The management reviews are expected to yield in the following results:

Improvement of the effectiveness of the QMS and its processes

Improvement of product related to customer requirements

Resource needs

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QM 6.0 RESOURCE MANAGEMENT

QM 6.1 General Requirements

Requirements

MSL recognizes the necessity of providing adequate resources, needed to implement and

maintain the QMS and continually improve its effectiveness, and to meet the

requirements.

QM 6.2 Human Resources

General

MSL ensures that personnel performing work affecting conformity to product

requirements are competent on the basis of appropriate education, training, skills and

experience.

Competence, Awareness and Training

MSL ensures that employees are competent to perform work affecting conformity to

product requirements. Where applicable, the provisions of training or other actions are

made to achieve the necessary competence. Personnel are aware of the relevance and

importance of their activities and how they contribute to the quality of the achievement of

the quality objectives.

Appropriate records of employees’ education, training, skills and experience are

maintained. MT members are encouraged to attend all refresher trainings but are exempt

from signing attendance in group training records.

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New employees are provided orientation within the first week of employment by the

management and / or Quality Manager covering the following topics:

General personnel policies

Safety requirements

General ISO 9001:2008 QMS requirements

Job specific requirements

The signatures of employees on a quality document QF-03 are sufficient as evidence of

relevant training.

QM 6.3 Infrastructure

Requirements

MSL reviews and provides the infrastructure needed to achieve conformity to product

requirements.

Infrastructure includes, as applicable:

Buildings, workspaces and associated utilities

Process equipment, both hardware and software

Appropriate supporting services, such as transport, communication or information

system

QM 6.4 Work Environment

Requirements

MSL provides the work environment that is conducive to achieve conformity to product

requirements, including cleanliness.

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QM 7.0 PRODUCT REALIZATION

QM 7.1 Planning Product Realization

MSL plans and develops necessary processes needed for product realization.

All the customer POs and drawings/specifications are directed to the Customer Service

Coordinator (CSC). The CSC creates a folder for each job allotting a unique job number.

This job number acts as primary identifier of that job throughout the entire realization

process. The CSC then creates a folder for each new job using the computer generated

job number. The CSC also enters details of customer name, address, job number, product

name and product number, quantity, price, supplier name and MSL’s PO number in a

Customer Order Form QF-04.

The CSC enters the requisite information from QF-04 required for the customization,

including outsourced activities, from customer PO, drawings, specifications, and

customer requirements in a Custom Requirements Form QF-05, and sends it back to the

supplier. In the absence of CSC, any cross-trained member of the MT assumes this

responsibility. If a C of C is required, the CSC completes the C of C on form QF-07 and

gets it signed by either the QMR or any member of MT in case of absence of QMR.

All (customized) logistics supplies (products) arrive in lots and are received by the

receiver (trained MH) in accordance to MSL’s WI-01. The Incoming Quality Inspector

inspects samples from the lots. The Incoming Quality Inspector records inspection details

for each shipment in the Incoming Inspection Checklist form QF-08. A green tag is

attached to the accepted lots along with a copy of QF-08. A red tag is attached to the

unacceptable lots.

A warehouse associate (trained MH) follows WI-02, which details the movement of

accepted received products into designated inventory. A Forklift or Raymond reach

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operator follows WI-03, which details the movement from of products from inventory

into storage.

An order picker (trained MH) follows designated WI-04 and receives Customer Order

Form QF-04 from the CSC’s outbox. In accordance to the WI-04 and QF-04, the order

picker picks the products from the storage and takes it to shipping. The shipper (trained

MH) responsibilities are out outlined in WI-05. The shipper verifies the ordered products

based on the Customer Order Form QF-04 and ensures everything is shipped in a timely

manner. In addition to their WI, all MHs also must follow Safety Precautions WI-06.

The unacceptable products are handled according to QSP-04. Daily delivered products

are recorded in Daily Performance Log form QF-09.

QM 7.2 Customer Related Processes

Determination of Requirements Related to the Product

MSL determines the requirements specified by the customer and other requirements

applicable to the product and as considered necessary by the organization.

Review of Requirements Related to the Product

MSL reviews the requirements related to the product prior to the organization’s

commitment to supply a product to the customer. Records of such reviews are

maintained. Where the customer provides no documented statement of requirement, the

customer requirements are confirmed by MSL before acceptance. Where product

requirements are changed, MSL ensures that relevant documents are amended and

corresponding personnel are informed of the changed requirements.

Customer Communication

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MSL determines and implements effective arrangements for communicating with

customers in relation to product information, contracts and amendments, and customer

feedback. All customer enquiries / orders are delivered to the CSC. In absence of the

CSC, any member of MT handles order and related enquiries.

MSL encourages its customers to send their enquiries in writing. The necessary

information from written enquiries is transferred to Contract Requirement Review form

QF-06. In case of verbal enquiries, the information is confirmed by repeating statements

and recorded onto form QF-06.

After evaluating and reviewing details in Contract Requirement Review form QF-06 and

QF-04, any member of the MT team checks off YES or NO about MSL’s capability of

meeting all the product related requirements. The CSC ensures that either YES or NO is

checked off before filing the review form QF-06 and QF-04. Formal quotation may be

issued using form QF-10, as required.

In case of customer’s verbal or telephonic proposal for modifications in specifications

(customization) / requirements, formal approval is initiated using form QF-05.

QM 7.3 Design and development

Out of scope and excluded.

QM 7.4 Purchasing

Purchasing Process

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MSL ensures that purchased product conforms to specific purchase requirements. MSL

evaluates and selects suppliers based on their ability to supply product in accordance with

the organization’s requirements.

Quality Manager or any member of the MT evaluates new suppliers based on ISO

registration, supplier system evaluation, or recommendation from a customer or

management. Major existing suppliers are re-evaluated once a year based upon prior

history or ISO registration. MSL maintains records of supplier evaluations using form

QF-11.

Purchasing Information

The requirements for products purchased by MSL are described in purchased orders or

contracts appropriately. Purchase requirements are reviewed for adequacy prior to their

communication to the supplier.

MSL’s supplier is required to maintain MTR for the supplied materials on file, for a

period of one year from the date of supply, and submit to MSL whenever requested to do

so. MTRs received from suppliers may be saved for reference or destroyed as required.

Verification of Purchased Product

Products purchased by MSL meet the specified purchased requirements of the

organization as well as that of customer.

All products received from the approved suppliers are to be inspected prior their

shipment. The Incoming Quality Inspector inspects these products. The Incoming Quality

Inspector records inspection details for each shipment in the Incoming Inspection form

QF-08. A green tag is attached to the accepted products and a red tag for unaccepted

products. The unacceptable products are identified with red tags and handled in

accordance with QSP-04.

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Receiver logs the receipt of materials in the Received Material Log on form QF-12 and

verifies in accordance with the concerned PO and WI-01.

Quality Manager or a qualified member of MT decides for the disposition of the received

unaccepted materials in accordance with QSP-04.

QM 7.5 Production Operation

Control of Production Provision

MSL controls operations involved in the production of all customizable products through

the Custom Requirements Form QF-05. Products are tracked throughout the

customization process. Operators are competent in use of suitable monitoring and

measuring equipment and conduct in-process inspection.

Identification and Traceability

MSL identifies the products throughout the production process appropriately. The

Custom Requirements Form QF-05 comprising all necessary details placed in a plastic

cover and travels along with the product to be customized. Products for inspection are

placed in a designated area clearly marked. Suitable tags, as mentioned in clause 7.1

above are used to identify the products. The tag bears the job number, the date of

inspection and the initials of the person who conducted the inspection.

Customer Property

MSL takes care of all customer-supplied materials and / or products under its control.

MSL identifies, verifies, and protects customer property provided for use or incorporation

into the product.

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Receipts of customer supplied samples / products are recorded in the Customer Material

Log form QF-13 and they are stored safely.

Customer supplied specifications are stored in separate folders of concerned jobs using

the job number as identifier. These specifications are translated onto form QF-05 and

may be photocopied in times of inspections. The Customer service Coordinator (CSC) is

responsible for handling all the specifications; in the absence of CSC, any qualified

member of the MT assumes this responsibility.

Any nonconformity or damage to the customer property is brought to the attention of any

member of the MT who then advises the customer of the situation. A formal decision

about disposition is taken after discussion with customer.

Preservation of Products

MSL preserves the products during internal processing and delivery to the intended

destination in order to maintain conformity to requirements. Courier companies are

responsible for preserving the product while in their custody and corresponding clause

has been incorporated in the contract with the courier companies. As applicable,

preservation includes identification, handling, packaging, storage, and protection.

QM 7.6 Control of Monitoring and Measuring Equipment

MSL ensures that accuracy and the validity of product characteristics by using controlled

monitoring and measuring equipment calibrated periodically to masters traceable to

recognized standards. In the event of non-availability of such standard, the basis used for

calibration or verification and criteria for acceptance is recorded. Calibration record is

maintained on form QF-14 and calibration schedule is maintained on form QF-15.

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The Quality Inspector records the pertinent details of all measuring devices on form QF-

14. The Quality Inspector, based upon the inputs from Quality Manager, Management

Team and manufacturer, decides the calibration schedule and frequency and records in

form QF-15.

QM 8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT

QM 8.1 General

MSL plans and implements appropriate processes, including data analyses needed to:

Demonstrate conformity to product requirements

Ensure conformity of the QMS

Continually improve the effectiveness of the QMS

QM 8.2 Monitoring and Measurement

Customer Satisfaction

MSL monitors information relating to customer perception of meeting requirements as

one of the key indicators of performance of the QMS.

Using annual Customer Satisfaction Surveys and Customer Satisfaction Reports, MSL

regularly reviews the satisfaction / dissatisfaction of its customers. Unresolved issues are

dealt with in Management Reviews.

Internal Audit

MSL conducts internal audits at planned intervals in accordance with Quality System

procedure QSP-03 covering the following:

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Conformity to planned arrangements

Conformity to the requirements of ISO 9001:2008

Conformity to the established QMS requirements

Effectiveness of their implementation and maintenance

An audit program is planned, taking into consideration the status and importance of the

processes and areas to be audited, as well as results of previous audits. Trained personnel

from various areas of the organization are used to conduct internal audits but they cannot

audit any area in which they normally work, to ensure objectivity and impartiality.

Monitoring and Measurement of Processes

QMS processes are monitored and measured to ensure that they achieve planned results.

When planned targets are not achieved, corrective actions are taken as appropriate.

Monitoring and Measurement of Product

Key characteristics of products are measured to verify that product requirements have

been met. This is carried out at appropriate stages of the product realization process in

accordance with the planned arrangements, as mentioned in clause 7.1. Evidence of

conformity and the acceptance criteria are mentioned.

QM 8.3 Control of Nonconforming Product

MSL identifies and controls nonconforming products in accordance with procedure QSP-

04. Records of the nature of nonconformance and any subsequent actions taken, including

concessions obtained, are maintained.

QM 8.4 Analysis of Data

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MSL determines, collects and analyzes appropriate data to demonstrate the suitability and

effectiveness of the QMS and to evaluate where continual improvement of the

effectiveness of the QMS can be made.

The analysis of data provides information relating to:

Customer satisfaction

Conformity to product requirements

Characteristics and trends processes and products including opportunities for

preventive actions

Suppliers

QM 8.5 Improvement

Continual Improvement

MSL continually improves the effectiveness of the QMS through the use of the quality

policy, quality objectives, audit results, analysis of data, training of employees, corrective

and preventive actions and management review.

Corrective action

MSL takes appropriate measures to eliminate the causes of nonconformities encountered

in order to prevent recurrence.

Documented procedure QSP-05 defines the requirements for:

Reviewing nonconformities (including customer complaints)

Determining the root causes of nonconformities

Evaluating the need for action to ensure that nonconformities do not recur

Determining and implementing action needed

Records of results of implemented action

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Reviewing the effectiveness of the implemented corrective action

Preventive Action

MSL determines appropriate actions to eliminate the causes of potential nonconformities

in order to prevent their occurrence.

Documented procedure QSP-06 defines the requirements for:

Determining potential nonconformities and their root causes

Evaluating the need for action to prevent occurrence of nonconformities

Determining and implementing action needed

Records of results of action taken

Reviewing the effectiveness of the implemented preventive action