Abci Qms Manual v10

Quality Management System Manual
Standard
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ISO 9001:2008
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Section 1: Page 0 of
1
WORD FIELDS USED:

CATEGORY = ISO 9001:2008
COMPANY NAME = ACCESS BUSINESS COMMUNICATIONS, INC.
SUBJECT = ABCI ( COMPANY
INITIALS )
ACCESS BUSINESS COMMUNICATIONS, INC.

ISO 9001:2008
Printed: 2/27/2013
Document Identification & Version (v#): 247757208.doc

Status: Approved | Printed: 2/27/2013
Total Electronic Document Pages 25

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Table of Contents
0
Introduction 1
Scope 1
1.1
Quality System....................................................................................................1
Application
2.1
Exclusions............................................................................................................1
2.2
About our Quality Management System (QMS)...................................................2
2.3
Regulatory Requirements....................................................................................2
2.4
Standards and Guidelines....................................................................................2
2.5
Use of the QMS and Supporting Documents.......................................................2
Terms and definitions
About ABCI and Our QMS
4.0
4.1
General Requirements.........................................................................................3
4.2
Documentation Requirements.............................................................................3
4.2.1 General Requirements...................................................................................3

4.2.2 Quality Manual (this document)....................................................................3
4.2.2.1 QMS Documentation Pyramid.....................................................................4
4.2.2.2 About the ABCI Quality Management System.............................................5
4.2.2.3 Quality Flow & Interaction Chart.................................................................5
4.2.2.4 Diagram for Quality Processes....................................................................7
4.2.2.5 Table for Sequence and Interaction............................................................8
4.2.2.6 PDCA Table for Continual Improvement......................................................9
4.2.3 Control of Documents..................................................................................10
4.2.4 Control of Records.......................................................................................10
5.0
Management Responsibility
10
5.1
Management Commitment................................................................................10
5.2
Customer Focus.................................................................................................10
5.3
Quality Policy.....................................................................................................11
Quality Policy
5.4
11
Planning............................................................................................................11
5.4.1 Quality Objectives.......................................................................................11


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5.4.2 Quality Management System Planning........................................................12

5.5 Responsibility, Authority and Communications..............................................12
5.5.1 Responsibility and Authority........................................................................12
5.5.2 Management Representative.......................................................................13
5.5.3 Internal Communication..............................................................................14
5.6 Management Review......................................................................................14
5.6.1 General........................................................................................................14
5.6.2 Review Input................................................................................................14
5.6.3 Review Outputs..........................................................................................14
6
Resource Management
6.1
6.0
6.2
14
Provision of resources........................................................................................14
General...........................................................................................................15
Human resources..............................................................................................15
6.2.1 General........................................................................................................15
6.2.2 Competence, Training, and Awareness........................................................15
6.3
Infrastructure....................................................................................................16
6.4
Work Environment.............................................................................................16
Product Realization
16
7.1
Planning of Product Realization.........................................................................16
7.2
Customer-Related Processes.............................................................................16
7.2.1 Determination of Requirements Related to the Product..............................16

7.2.2 Review of Requirements Related to the Product..........................................17
7.2.3 Customer Communication...........................................................................17
7.3
Design and Development..................................................................................17
7.4
Purchasing.........................................................................................................17
7.4.1 Purchasing Process......................................................................................17

7.4.2 Purchasing Information................................................................................18
7.4.3 Verification of Purchased Product................................................................18
7.5
Production and Service Provision......................................................................18
7.5.1 Control of Production and Service Provision................................................18

7.5.2 Validation of Processes for Production and Service Provision......................19
7.5.3 Identification and Traceability......................................................................19

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7.5.4 Customer Property.......................................................................................19

7.5.5 Preservation of Product................................................................................19
7.6
Control of Monitoring and Measuring Equipment..............................................19
7.6.1 Validation of software..................................................................................20

8
Measurement, Analysis, and Improvement 20

8.1
General..............................................................................................................20
8.2
Monitoring and Measurement............................................................................20
8.2.1 Customer Satisfaction.................................................................................20

8.2.2 Internal Audit...............................................................................................20
8.2.3 Monitoring and Measurement of Processes.................................................21
8.2.4 Monitoring and Measurement of Product.....................................................21
8.3
Control of Nonconforming Product....................................................................21
8.4
Analysis of Data................................................................................................22
8.5
Improvement.....................................................................................................22
8.5.1 Continual Improvement...............................................................................22

8.5.2 Corrective Action.........................................................................................22
8.5.3 Preventive Action.........................................................................................23
9
Index of Referenced Quality Procedures and Work Instructions

24

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Proprietary Notice
This document is the property of Access Business Communications, Inc. ABCI and the
information contained herein is confidential. This document is delivered on the
express condition that it is not to be disclosed, reproduced -in the whole or in part -or
used for any purpose for anyone other than ABCI without its written consent, and that
no right is granted to disclose or so use any information contained in said document.
This restriction does not limit the right to use information obtained from another
source. The distribution of this document is strictly controlled by the ABCI Quality
department.

Quality Manual
ABCI
Document Identification &

Revision
Effective Date:
Section & Page
247757208.doc
2/19/2013
Section 4, Page 0 of 3
0 Introduction
This Quality Manual establishes the quality system and related practices used by to
manage its operations and to continually improve customer service, operations and
the quality management system.
The quality management system described within this Quality Manual, combined with
all other documents and/or processes identified by ABCI has been developed to meet
ABCI needs as well as those established by the ISO 9001:2008 Standard.
1 Scope
Quality System
ABCI is committed to meeting customer requirements and enhancing customer
satisfaction through continual improvement of its products and the quality
management system. The scope of this quality system and documentation is to
demonstrate the capability of ABCI to develop, supply, and maintain their products
through compliance and application of the requirements outlined in the ISO 9001:2008
Standard.
2 Application
ABCI developed and implemented a quality management system to demonstrate its
ability to consistently provide product that meets customer and regulatory
requirements, and to address customer satisfaction through the effective application
of the system, including continual improvement and the prevention of nonconformity.
Exclusions
ABCI does not design or control the design of the products that it distributes.
Therefore, Clause 7.3 has been excluded from the system.
All operations and activities related to product realization are capable of verification
through monitoring or measurement applications. Therefore Clause 7.5.2, Validation
of Processes, is not considered applicable to our quality system.
The above exclusions does not affect our ability, nor absolve us from the responsibility,
to provide product that meets specified requirements; and the exclusion may not
affect our ability to Carry out corrective action.
Author:
ABCI-consultants.com | Published Date: 2/19/2013 | Approved

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About our Quality Management System (QMS)

ABCI has established, documented, and implemented a QMS in accordance with the
requirements of ISO 9001:2008. The system is maintained and continually improved
through the use of the quality policy, quality objectives, audit results, analysis of data,
corrective and preventive action and management review.
These processes are managed in accordance with the requirement of ISO 9001:2008.
Where ABCI chooses to outsource any process that affects product conformity with
requirements, ABCI ensures control over such processes. The type and extent of
control of such outsourced processes are identified within the QMS.
Regulatory Requirements
ABCI is committed to track and follow all legal and regulatory requirements in the
manufacture of our products. As such all appropriate governmental and industry
regulations are included in the companys quality management system.
Standards and Guidelines

ISO 9001:2008 Standard
Use of the QMS and Supporting Documents

Use of this manual is covered in the QMS training and awareness activities given to all
ABCI personnel. Personnel shall familiarize themselves with the ABCI QMS, the
requirements of the International Standard, and complete appropriate training. They
must also familiarize themselves with the Procedures Manual, and related procedures,
work instructions, and supporting documentation as is required in the course of their
duties.
3 Terms and definitions

The following list describes terms, definitions and vernacular used in the ABCI QMS.
CAPA Corrective Action & Preventive Action request.
CFR - Code of Federal Regulations of the United States.


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4.0
About ABCI and Our QMS
4.1
General Requirements
4.2
Documentation Requirements
4.2.1 General Requirements

The ABCI Quality Policy calls for continual improvement in its Quality Management
activities, and business will be conducted according to the following principles:
We Comply with all applicable laws and regulations.

We follow a concept of continual improvement and make best use of its
management resources in all quality matters.
We communicate our quality objectives and its performance against these
objectives throughout the company and to interested parties.
We take due care to ensure that activities are safe for employees, associates
and subcontractors, and others who come into contact with our work.
We train our staff in the needs and responsibilities of Quality Management.
4.2.2 Quality Manual (this document)

The QMS quality manual, documented processes and Quality Policy & Objectives
addresses customer and applicable statutory and regulatory QMS requirements. To
design and implement the QMS ABCI has:
Determined the processes needed for the QMS and their application throughout
the organization, and documented them on the QD-700-001 Quality Plan of
Production & Inspection Processes;
Determined the sequence and interaction of these processes, and illustrated
them on the QD-700-001 Quality Plan of Production & Inspection Processes;
Determined criteria and methods needed to ensure that the operation and
control of the processes are effective, and documented them in quality plans,
work instructions and the Measuring, Monitoring and Analysis Table (Measuring
Quality Metrics);
Ensured the continuing availability of resources and information necessary to
achieve planned results and continual improvement of these processes;
Established systems to monitor, measure (if applicable), and analyze these
processes, and;
Established processes to identify and implement actions necessary to achieve
planned results and continual improvement of these processes (Management
Review).

4.2.2.1
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QMS Documentation Pyramid
Level I (Tier 1) - The Quality Manual

The top tier is the quality manual, which contains:
- Statements about managements commitment to quality
- Quality Policies
- Information about responsibilities for quality related processes
Level II (Tier 2) - Procedures Manual and Documented Procedures
Tier-2 of the ISO 9001:2008 Documentation pyramid is the bulk of the quality
procedures, standard operating procedures (SOPs), that explains detailed
responsibilities for process control.
Level III (Tier 3) Work instructions
Work Instructions (WI) will be provided where the lack of such instruction is likely to
affect the quality of the product or service provided.
Level IV (Tier 4) - Quality Records
Quality records include customer specifications, order processing project delivery and
project test results. They are records that should be accurate in their description of
the work completed. Quality records must be maintained to prove compliance to the
standard. The duration for maintaining records is usually defined in the quality
manual.

4.2.2.2
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About the ABCI Quality Management System
ABCIs adoption of a QMS was by means of a strategic decision made as part of the
organizational goals for service excellence, and the initiation of its ongoing continual
improvement program.
ABCI provides evidence of our Top Managements commitment to quality, and their
documented statements of quality (i.e. our quality policy and objectives).
It provides information on, and reference to, the related standard operating
procedures (SOPs), work instructions (WIs), and other supporting documentation
required to be used by ABCI staff when carrying out their duties. This information and
the quality procedures are necessary to ensure that our Quality Objectives are
achieved, and that customer requirements and satisfaction remain at the forefront of
our organizations activities and focus.
The QMS is designed as a system of interrelated processes. All main activities of the
system are defined as Quality System Processes (QSPs) and are grouped into the
following four categories (refer to the Quality System Processes Map on next page):
Product Realization Processes (PRP),

Measurement, & Monitoring Processes (MMP),
Management Responsibility Processes (MRP), and
Resource Management Processes (RMP)
And are organized into a Plan-Do-Check-Act (PDCA) loop.
The sequence and interrelation between the four groups and individual QSPs are
illustrated in the Processes Map diagram. Each QSP is further broken down into its subprocesses, as defined in the Process Map Matrix included after the diagram.
QSPs and their sub-processes are documented in this quality manual and in associated
operational procedures and work instructions. This documentation defines the quality
system processes and their sequence and interaction, and instructs on how to
implement and apply them throughout the organization.
QMS documentation also defines criteria and methods needed to ensure that the
operation and control of quality system processes are effective. This includes
assignment of responsibilities and allocation of resources for the process, instructions
on how to carry out (or operate) the process, and definition of methods for monitoring
and/or measuring the effectiveness of the process.
4.2.2.3
Quality Flow & Interaction Chart
The flow chart on the following page describes the interaction of these processes.


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Customer Requirements
Suppliers
Resource Management Processes (RMP)
Doc. Control & Information
Management
Purchasing
RFQ &
Communicati
ons
Personnel Competence and Skills
Resource
s
Facilities, Equipment & Work

Environment
Occupational Health & Safety
Receiving
Products
Order Processing
Verification of
Purchased
Products
Resource
Inspection, Test
& Metrology
Preparation &
Planning for
Production
Accept
Materials or
Reject
Product
Realization
Inventory &
Reorder Levels
Needs
Policies
&
Objectiv
es
Management Responsibilities
Processes (MRP)
Planning & Objectives
Monitori
ng
Management Review
Identify &
Mark Rejects
Policies
&
Inspection &
Test
QMS Performance
Data
Objectiv
es
Packaging
Measurement, & Monitoring

Processes (MMP)
Packaging
Identify &
Mark Rejects
Quarantine
Rejects
Quarantine
Rejects
Return to
Supplier / scrap
Control of NonConforming
Product
Product/
Process
Internal Audit &

Analysis of Data
Data
Customer
Complaints &
Satisfaction
Dispose Rejects
Customer

Corrective
&Preventive
Action
4.2.2.4
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Diagram for Quality Processes

4.2.2.5
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Table for Sequence and Interaction
Process
Related Procedures
Customer Need is
Identified
Quotations are Sent
and Orders are
Received
Production
Planning
Resources are
procured
- Quotations
- Measuring and Monitoring Customer Satisfaction
- Contract Review Procedure
2
3
4
5
Production,
Verification, Shipment
Support and
Maintenance Services
- Facility Management Procedure

- Product Realization Planning Procedure
- Control of Nonconforming Product Procedure
- Identification and Traceability Procedure
- Purchasing Procedure
- Control of Customer-Supplied Material Procedure
- Control of Monitoring and Measuring Equipment
Procedure
- Control of Nonconforming Product Procedure
- Facility Management Procedure
- Process Control Procedure
- Process Validation Procedure
- Analysis of Data Procedure
- Handling, Storage, Packaging, Preservation, and
Delivery
- Inspection and Test Procedure
- Inspection and Test Status Procedure
- Ongoing support, maintenance

ISO 9001
Clause
7.2.2
8.2
7.2.2
6.3
7.1
8.3
7.5.3
7.4
7.5.3
7.6
8.3
6.3
7.5.1
7.5.2
8.4
7.5.5
8.2.4
8.2.4
8.2
4.2.2.6
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PDCA Table for Continual Improvement
PDCA
Related Procedures
ISO 9001 Clause
Plan
4.2.3
8.4
7.1
6.2.2
Do
- Control of Quality Records Procedure

- Analysis of Data Procedure
- Training Procedure
4.2.4
8.4
6.2.2
Check
Control of Quality Records Procedure

Monitoring and Measuring Customer Satisfaction
Inspection and Test Procedure
Internal Audits Procedure
Management Review Procedure
Process Validation Procedure
Analysis of Data Procedure
Training Procedure
4.2.4
8.2
8.2.4
8.2.2
5.6
7.5.2
8.4
6.2.2
Act
Continual Improvement Procedure

Corrective and Preventive Action Procedure
Internal Communication Procedure
8.5.1
8.5.2
8.4
5.5.3
Control of Documents Procedure

Product Realization Planning Procedure
Training Procedure


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4.2.3 Control of Documents

Our QMS Control Index provides a complete list of documents related to our QMS,
along with the status of documents. The Procedure, QP-423-01 Control of Documents
is established and defines the controls needed to ensure the following:
Documents are approved for adequacy prior to issue;

Documents are reviewed and updated, and re-approved for issue as necessary;
Documents are identified with their changes and current revision status;
Documents are current and available at point of use;
Documents remain legible, readily identifiable, and retrievable;
Relevant documents of external origin which are necessary for the planning and
operation of the Quality Management System are identified and their distribution
is controlled; and
Obsolete documents are prevented from unintended use and are suitably
identified if they are retained for any purpose.
4.2.4 Control of Records

ABCI has established, maintains, and controls quality records to provide evidence of
conformance to requirements and of the effective operation of the QMS. The
Procedure, QP-424-01 Control of Records defines and ensures proper identification,
storage, retrieval, protection, retention time, and disposition of quality records. All
records will be legible, identifiable, and retrievable.
5.0 Management Responsibility

5.1 Management Commitment
ABCI management provides its commitment to the development, and implementation
of the QMS, and continual improvement of its effectiveness by:
Communicating to all employees the importance of meeting Customer, as well

as regulatory, and legal requirements;
Establishing and documenting the Quality Policy as described in the
Management Review Procedure ensuring that quality objectives are established;
Conducting management reviews as described in the Management Review
Procedure to ensure that quality objectives are conformed with and reviewed,
and to continually improve the effectiveness of the Quality Management System;
Ensuring the availability of necessary resources to comply with the Quality
Management System.
5.2 Customer Focus

The Top Management of ABCI ensures that Customer needs and expectations are

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identified, transformed into requirements, and fulfilled with the intent of achieving,
exceeding, and enhancing Customer satisfaction. Customer needs and expectations
are identified during the Product Realization Procedure. ABCI complies with all relevant
regulatory and legal requirements.
5.3 Quality Policy

A Quality Policy has been established and is approved by Top Management. ABCI
ensures that the documented Quality Policy:
Is appropriate to the purpose of ABCI;

Includes a commitment to complying with requirements and to continually
improving the effectiveness of the QMS per the implemented procedures;
Provides a framework for establishing, and reviewing Quality Objectives;
Is communicated and understood within ABCI as per the Training Procedure, and
in addition, it is posted throughout visible areas of ABCI;
Is reviewed for continuing suitability as per the Management Review Procedure.
Quality Policy
Access Business Communications, Inc. is an American manufacturer of premium

products. In our manufacturing facility in Southern California we produce a wide
variety of precision products meeting the needs of hermetic seal production,
electronics assembly, commercial applications, medical device manufacture, and
various research fields.
Our productions runs are small prototype quantities up to thousands or millions
of parts delivered on a weekly basis.
Our goal for a Quality Management System is to ensure that operations are
conducted in a manner that shall provide products which meet all stakeholder
expectations on schedule and at a fair price.
We accomplish these goals by utilizing documented quality assurance processes,
ongoing training, and internal auditing for continual improvement.
Employees at all levels, through training, are expected to understand and follow
procedures, anticipate where correction may be required, and work toward
achieving our quality goals.
By working together within this framework, all stakeholders, customers,
employees, and vendors we shall continually benefit from excellent quality
products.
5.4 Planning
5.4.1 Quality Objectives
ABCI Top Management establishes annual key initiatives, which include Quality
Objectives including those needed to meet requirements for Product Realization. The

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objectives are established via the Management Review Procedure at relevant functions
and levels within the company, and communicated to all levels of the organization for
use in establishing each function and annual key objectives.
Quality Objectives are measurable, include business performance indicators reflecting
requirements for products, and are consistent with the Quality Policy including the
commitment to continual improvement.
Our Quality Objectives are to deliver Zero Defects, On time, with Continual
Improvement.
We accomplish our Quality Objectives by maintaining a documented and
effective Quality Management System Manual, which complies with the
requirements of ISO 9001:2008.
We will ensure that our QMS reflect what we actually do.
We will ensure that all staff is properly trained in our QMS so that they are better
able to serve our Customers.
We will make continual improvement of our processes a part of every day and
every job through the use of valid measurements and monitoring methodologies.
We will invest in our employees and will communicate the importance of
collaboration, empowerment and accountability.
Everyone will be encouraged to recognize the importance of owning their
processes and to clearly communicate initiatives which may contribute to
process improvements.
Everyone will act immediately when they discover problems; emphasis is on the
prevention of defects, non-conformances and Customer dissatisfaction.
We will monitor our Quality Measurements on a regular and systematic basis to
ensure our Quality Objectives are achieved.
5.4.2 Quality Management System Planning

The management of ABCI ensures that QMS planning is executed to meet the
requirements provided in Section 4.1, as well as the Quality Objectives. Quality
planning includes:
The processes of the quality system, including permissible exclusions;

The resources needed; and
Continual improvement of the Quality Management System.
Quality Management System is based upon a process approach to quality

management. For each instance of Quality Management System planning, the output
is documented accordingly, and changes are conducted in a controlled manner. The
integrity of the Quality Management System is maintained when changes to the
Quality Management System are planned and implemented.

5.5
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Responsibility, Authority and Communications
5.5.1 Responsibility and Authority

Top Management has defined and communicates all functions (authorities) and their
responsibilities within the organization, in order to facilitate effective quality
management.
The Quality Management Organization chart is shown below/following page:
5.5.2 Management Representative

ABCI appoints a well-qualified employee as the Quality Management Representative
(QMR). He/she, irrespective of other responsibilities, has the responsibility and
authority for:
Ensuring that the processes of the Quality Management System are established,
implemented, and maintained;
Reporting to Top Management on the performance of the Quality Management
System, including any needs for improvement;

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Ensuring the promotion of awareness of Customer requirements throughout the

organization.
The appointed Quality Management Representative shall:
Have the organizational freedom to resolve matters pertaining to quality, and for
acting as liaison with external parties on matters relating to the Quality
Management System, and
Ensure that Internal Auditors from within the organization have been trained to
undertake the audit requirements of the Standard, and that personnel allocate
the appropriate amount of time for audit completion.
The current appointed QMR is Jack T. Bogle.
5.5.3 Internal Communication

ABCIs Top Management ensures that appropriate communication processes are
established within the companyKing Precision, and that communication takes place
regarding the effectiveness of the QMS, via internal communications, meetings and
training workshops.
5.6
Management Review
5.6.1 General
ABCIs Top Management conducts reviews of the Quality Management System at
planned and agreed intervals, as described in the Management Review Procedure.
The reviews evaluate the systems continuing suitability, adequacy, and effectiveness.
The reviews also include assessing opportunities for improvement, and the need for
any potential changes to the Quality Management System, including the Quality Policy
and Quality Objectives.
ABCI maintains records from the management reviews as per Clause 4.2.4 Control of
Records.
5.6.2 Review Input
Inputs to Management Reviews shall include information on, but are not to be limited
to, current performance data and potential improvement opportunities related to:
Audit results,
Customer feedback,
Process performance and product conformity,
Status of corrective and preventive actions,
Follow-up actions from previous management reviews,
Changes that may affect the Quality Management System, and
Recommendations for improvement.


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5.6.3 Review Outputs

Outputs from Management Reviews include decisions and actions related to:
Improvement of the effectiveness of the Quality Management System and its

processes,
Improvement of product related to Customer requirements, and required
resources.
Results of Management Reviews are recorded as described in the Work
Instruction, WI-560-01 Management Review and maintained as per the Control of
Document and Control of Records procedures.
6 Resource Management
Provision of resources
ABCI determines and provides the necessary resources needed to:
6.0
Implement and maintain the QMS and continually improve its effectiveness,
Enhance Customer satisfaction by meeting their requirements.
General
Human resources
ABCI ensures that all personnel engaged in performing work which affects conformity
to product requirements, are competent on the basis of appropriate education,
training, skills, and experience.
General
Further, ABCI extends this to all personnel who are directly or indirectly involved with
tasks within the Quality Management System. It is recognized that conformity to
product requirements can be affected by a number of people from different functions
within the organization.
Competence, Training, and Awareness
ABCI has established and maintains a Training Program in its Work Instruction, WI-620010 Human Resources Development to:
Determine the competency needs for personnel who perform tasks affecting
quality and conformity to product requirements;
Provide training or take other actions to address these competency needs;
Evaluate the effectiveness of the training provided or actions taken;
Ensure that personnel are aware of the relevance and importance of their
activities, and how they contribute to the achievement of the quality objectives;
and
Maintain records of education, experience, training, and skills per the QMS.


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Infrastructure
ABCI has determined, provides, and maintains the infrastructure needed to achieve
conformity to product requirements. ABCI provides suitably equipped workplaces with
appropriate processing equipment and with supporting services.
Infrastructure shall include, as applicable:
Building, workspace, and associated utilities.

Process equipment (both hardware and software).
Supporting services (communications, and information systems).
Work Environment
All aspects of the human and physical factors of the working environment that may
affect conformity of product requirements have been determined and are managed.
The term working environment relates to those conditions under which work is
performed including physical, environmental, and other factors (such as noise,
temperature, humidity, lighting or weather).
4 Product Realization
Planning of Product Realization
ABCI has established and maintains a Work Instruction, WI-710 Planning for Product
Realization to ensure that processes and sub-processes are conducted under
controlled conditions.
Planning of the product Realization processes is consistent with the requirements of
ABCIs Quality Management System (see Clause 4.1). The planning of product
Realization determines the following:
Quality objectives and requirements for the product, project, or contract;

The need to establish processes and documentation, and provide necessary
resources, infrastructure, and work environment to produce conforming product;
Verification, validation, monitoring, measurement, inspection, and test activities
specific to the product, and the criteria for product acceptance;
The records needed to provide evidence that the Realization processes and
resulting product conform to specified requirements (see Clause 4.2.4).
Customer-Related Processes
Determination of Requirements Related to the Product
ABCI has established a Contract Review process in its Product Realization Procedure for
identifying Customer requirements. These processes determine:
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Requirements specified by the Customer, including the requirements for

delivery, and post-delivery;
Requirements not specified by the Customer but necessary for intended use, if
known;
Obligations related to product, including regulatory and legal requirements;
Any additional requirements determined by ABCI.
Review of Requirements Related to the Product

ABCI reviews the Customer requirements together with additional requirements that
are not specified, but necessary for fitness for use, and governed by laws and
regulations, and requirements for availability, delivery, and support. This review is
conducted prior to commitment to supply a product to the Customer per the Contract
Review in its Work Instruction, WI-720-100 Order Processing. The review process
ensures that:
Product requirements are defined;

Contract or order requirements differing from those previously expressed in a
tender or quotation are resolved;
ABCI has the ability to meet the Customer requirements.
The results of the reviews, pertinent related correspondence, and necessary follow-up
actions are documented by ABCI Customer requirements and confirmed before
acceptance in situations where the customer provides no documented statement of
requirements.
When product requirements are changed, ABCI shall ensure that relevant documents
are amended and that appropriate personnel are informed of the changes.
Customer Communication
ABCI has determined and implemented effective arrangements for communication
with the Customers. Customer communications includes:
Product information as described in the Customer Satisfaction Procedure, and

Continual Improvement Procedure;
Addressing inquiries, contracts or order handling, including amendments as
described in the Contract Review Procedure;
Customer feedback, including Customer complaints as described in the
procedure for handling Customer Complaints.
Design and Development

ABCI does not control the design and development of the products they distribute and
service. Therefore Clause 7.3 has been excluded.
Purchasing

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Purchasing Process
ABCI ensures that the purchasing process is controlled such that purchased products
and subcontracted services, which affect product quality, conform to specified
requirements. The type and extent of methods to manage the purchasing process
depends on the effect on subsequent Realization processes and their output.
ABCI is responsible for the quality of all products purchased from suppliers, including
Customer-designated sources as described in the various procedures for Purchasing.
Also, ABCI evaluates and selects suppliers based on suppliers ability to deliver
products that satisfy all ABCI requirements. Criteria for selection and periodic
evaluation are defined in Work Instruction, WI-740-010 Supplier Evaluations and ABCI
shall:
Maintain a register of approved vendors and suppliers that include the scope of
the approval.
Periodically review supplier performance; records of these reviews shall be used
as a basis for establishing the level of controls to be implemented.
Define the necessary actions to take when dealing with suppliers that do meet
requirements.
Purchasing Information
Purchasing documents shall contain data clearly describing the product to be
purchased, including the following, where appropriate:
Requirements for approval or qualification of product, procedures, processes,

and equipment;
Requirements for qualification of personnel; and
Quality Management System requirements.
ABCI ensures the adequacy of specified requirements contained in the
purchasing documents prior to their release to suppliers.
Verification of Purchased Product

ABCI has identified and implemented verification activities for ensuring that purchased
product conforms to specified requirements. Verification activities are defined in the
Work Instruction, WI-743-010 Verification of Purchased Product. Where the company or
its Customer requests verification activities at the supplier's facility, ABCI specifies the
required verification arrangements and method of product release in the purchasing
documents per the Purchasing Procedure. Verification activities may include:
Obtaining objective evidence of the quality of product from suppliers;

Inspection and audit of suppliers facility;
Review of required documentation;
Inspection of products upon receipt; and


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Delegation of verification to supplier certification.

Production and Service Provision
Control of Production and Service Provision
ABCI will consider planning production and service, to include as applicable:
The establishment of process control and development of control plans where

key characteristics have been identified;
The identification of in-process verification points when adequate verification of
conformance cannot be performed at a later stage of Product Realization.
ABCI has established and maintains Work Instructions, to control the production
of products. Controlled conditions shall include, as applicable, the following:
1. The availability of information that specifies the characteristics of the
product;
2. Where necessary, the availability of work instructions;
3. The implementation of monitoring activities;
4. The implementation of defined processes for product release, and delivery
processes are defined.
Validation of Processes for Production and Service Provision

ABCI will validate any processes for production and service where the resulting output
cannot be verified by subsequent monitoring or measurement. This includes any
processes where deficiencies become apparent only after the product is in use. The
validation of these special processes shall demonstrate the ability to achieve planned
results. ABCI shall establish arrangements for these processes including:
Defining criteria for review and approval of the processes;

Approval of equipment and qualification of personnel;
Use of specific methods and procedures,
Requirements for records; and
Re-validation requirements.
Identification and Traceability

ABCI maintains a documented procedure for identifying the product by suitable means
or Customer requirements throughout all stages of production and delivery.
This process identifies the status of the product with respect to measurement and
monitoring requirements.
Where traceability is a requirement, unique identification of the product is recorded
and controlled in accordance with Clause 4.2.4.
Product identification and traceability are maintained and controlled through a Work
Instruction, WI-753-01 Product Identification and Traceability.

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Customer Property
ABCI exercises care with Customer property while it is under our control or being used
by ABCI as defined in the Control of Customer Supplied Product Procedure. ABCI
ensures identification, verification against specified requirements, protection, and
safeguarding of Customer property provided for use or incorporation into the product.
Any Customer property that is lost, damaged, or otherwise found to be unsuitable for
use, is recorded and reported to the Customer. Such loss shall be handled in
accordance with our terms and conditions.
Preservation of Product
Handling and preservation: Departments and functions configuring, transporting,
storing or otherwise handling products are responsible for developing appropriate
handling techniques and procedures, and for protecting and preserving the product
while in their custody.
Control of Monitoring and Measuring Equipment

Appropriate measuring and monitoring devices are selected to ensure that
measurement capability is consistent with the measurement requirements. Devices
used for ensuring and verifying product conformity are calibrated in accordance with
the Work Instruction, WI-761 Control for Monitoring & Measuring Devices.
The scope of the calibration control system extends to the measuring and test
equipment, to include:
In-process inspections;
Verification of product conformity.
Validation of software
Commercial software is purchased with validation certificates where available.
Software is revalidated or recertified when conditions for which it was initially
validated are materially changed.
5 Measurement, Analysis, and Improvement

General
ABCI plans and implements the monitoring, measurement, analysis and improvement
processes needed:
To verify conformity of the product;

To ensure conformity to the quality system;
To continually improve the effectiveness of the ABCI QMS.
This shall include determination of applicable methods, including statistical

techniques, and the extent of their use.

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Monitoring and Measurement

Customer Satisfaction
A key measure of our quality system performance is the information obtained on
Customer satisfaction. The methodologies for obtaining and using Customer
satisfaction data are documented in the Work Instruction, WI-821-01 Monitoring and
Measuring Customer Satisfaction.
Internal Audit
ABCI conducts periodic planned internal audits, in accordance with the Procedure, QP822-01 Internal Audits to ensure that the quality system:
Conforms to the requirements of the applicable standards and regulations;

Has been effectively implemented and maintained.
ABCI plans, conducts, and reports on internal audits in accordance with the Internal
Audits Procedure. The audit scope, frequency, and methodologies are defined,
including:
Audit plans take into consideration the status and importance of the activities
and areas to be audited as well as the results of previous audits.
Impartial personnel, from within the company and who are independent of the
activities being audited, conduct the audits.
Timely corrective action is taken on deficiencies found during the audits.
Follow-up actions include the verification of the implementation of the corrective
actions and the reporting of verification results per the Corrective and Preventive
Action.
Monitoring and Measurement of Processes

ABCI shall apply suitable methods for monitoring and measurement of the Quality
Management System processes. These methods shall demonstrate the ability of the
processes to achieve planned results. When planned results are not met, correction
and corrective action shall be taken to ensure conformity of product.
Monitoring and Measurement of Product
ABCI measures and monitors the characteristics of the product to verify that
requirements for the product are met. This is carried out at appropriate stages of the
Product Realization process in accordance with a series of inspection and test
processes.
Evidence of Conformity with acceptance criteria is maintained and products are not
released until all planned monitoring and measuring activities have been satisfactorily
completed. Records shall be maintained including the authority responsible for
release of the product (see Clause 4.2.4).

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Inspection Documentation
Measurement requirements for products acceptance shall be documented. This
documentation may be part of the production documentation, and shall include:
Criteria for acceptance and rejection;

Where in the sequence, measurement and testing operations are performed;
A record of the measurement results; type of measurement tool required and
any special instructions required for its use;
Test records shall show actual test results data when required by specification or
acceptance test plan.
Where required to demonstrate product qualification, ABCI shall ensure that records
provide evidence that the product meets the defined requirements.
Control of Nonconforming Product

To ensure that product that does not conform to specified requirements is properly
identified and managed, to prevent unintended use or delivery, ABCI has established
and maintains a documented Procedure, QP-830-01 Control of Nonconforming Product.
Non-conforming product is corrected, where applicable, and subject to verification
after correction to demonstrate conformance.
ABCI shall deal with non-conforming product by one or more of the following ways:
By taking action to eliminate the nonconformity;

By authorizing its use/release by means of a written deviation acceptance from
the Customer;
By taking action to preclude its original use or application.
Records of the nature of nonconformity and any subsequent actions taken, including
concessions obtained, shall be maintained. When nonconforming product is corrected,
it shall subject to re-inspection to demonstrate conformity to all requirements.
When nonconforming product is detected after delivery or use has started, ABCI shall
take action appropriate to the effects, or potential effects, of the non-conformity.
Analysis of Data
ABCI has established and maintains documented procedures to collect and analyze
appropriate data to determine the suitability and effectiveness of the Quality
Management System, and to identify improvements that can be made. This includes
data generated by measuring and monitoring activities and other relevant sources.
ABCI analyses this data to provide information on:
Customer satisfaction;
Conformance to product requirements;

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Characteristics and trends of processes and products including the opportunities

preventive action;
Suppliers.
Improvement
Continual Improvement
It is the overall responsibility of Top Management at ABCI to continually improve the
effectiveness of the Quality Management System. This process of the continual
improvement of the quality system is accomplished through the use of the Quality
Policy, objectives, audit results, analysis of data, corrective and preventive action, and
management review. Each manager/supervisor is responsible for the continual
improvement of the Quality Management System in his or her respective areas.
Effectiveness of continual improvement activity is assessed during the Management
Review Process as described in the Work Instruction, WI-560-01 Management Review.
Corrective Action
ABCI has established and maintains a documented Corrective and Preventive Action
Procedure for eliminating the causes of non-conformance in order to prevent
recurrence. Corrective actions taken are appropriate to the impact of the problems
encountered. Corrective action results are reviewed for effectiveness. The Procedure,
QP-850-01 Corrective & Preventive Action defines requirements for:
Identification of non-conformities, including customer complaints;

Determination of the causes of non-conformities;
Evaluation of the need for actions to ensure that non-conformities do not recur;
Determination and implementation of corrective actions needed;
Recording the results of actions taken;
Reviewing corrective actions taken.
Preventive Action
ABCI has established and maintains documented quality plans, Corrective and
Preventive Action Procedure for eliminating the causes of potential non-conformities to
prevent occurrence. Preventive actions taken are appropriate to the impact of the
potential problems. The Procedure, QP-850-01 Corrective & Preventive Action defines
requirements for:
Identification of potential non-conformities and their causes;

Evaluating the need for action to prevent occurrence of nonconformity;
Determination and implementation of preventive action needed;
Recording results of action taken;
Reviewing preventive action taken.


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6 Index of Referenced Quality Procedures and Work Instructions

ISO 9001:2008 Standard, 2
Procedure, QP-423-01 Control of Documents, 10
Procedure, QP-424-01 Control of Records, 10
Procedure, QP-822 Internal Audits, 20
Procedure, QP-830-01 Control of Nonconforming Product, 22
Procedure, QP-850-01 Corrective & Preventive Action, 23
QD-700-001 Quality Plan of Production & Inspection Processes, 3
Work Instruction, WI-560-01 Management Review, 14
Work Instruction, WI-620-01 Resource Management, 15
Work Instruction, WI-710 Product Realization Planning, 16
Work Instruction, WI-720-100 Order Processing, 17
Work Instruction, WI-740-01 Supplier Evaluations, 18
Work Instruction, WI-743-01 Verification of Purchased Product, 18
Work Instruction, WI-753-01 Product Identification and Traceability, 19
Work Instruction, WI-761-01 Control for Monitoring & Measuring Devices, 20
Work Instruction, WI-821-01 Monitoring and Measuring Customer Satisfaction, 20


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Quality Management System Manual

WORD FIELDS USED:

ACCESS BUSINESS COMMUNICATIONS, INC.

Document Identification & Version (v#): 247757208.doc

Quality Management System Manual

About our Quality Management System (QMS)...................................................2

Standards and Guidelines....................................................................................2

Use of the QMS and Supporting Documents.......................................................2

Terms and definitions

About ABCI and Our QMS

4.2.1 General Requirements...................................................................................3

5.4.1 Quality Objectives.......................................................................................11

Quality Management System Manual

5.4.2 Quality Management System Planning........................................................12

Planning of Product Realization.........................................................................16

7.2.1 Determination of Requirements Related to the Product..............................16

Design and Development..................................................................................17

7.4.1 Purchasing Process......................................................................................17

Production and Service Provision......................................................................18

7.5.1 Control of Production and Service Provision................................................18

Quality Management System Manual

7.5.4 Customer Property.......................................................................................19

Control of Monitoring and Measuring Equipment..............................................19

7.6.1 Validation of software..................................................................................20

Measurement, Analysis, and Improvement 20

Monitoring and Measurement............................................................................20

8.2.1 Customer Satisfaction.................................................................................20

Control of Nonconforming Product....................................................................21

8.5.1 Continual Improvement...............................................................................22

Index of Referenced Quality Procedures and Work Instructions

Document Identification & Version (v#): 247757208.doc

Quality Management System Manual

Document Identification & Version (v#): 247757208.doc

Document Identification &

Section & Page

ABCI-consultants.com | Published Date: 2/19/2013 | Approved

Quality Management System Manual

About our Quality Management System (QMS)

Standards and Guidelines

Use of the QMS and Supporting Documents

3 Terms and definitions

Document Identification & Version (v#): 247757208.doc

Quality Management System Manual

About ABCI and Our QMS

4.2.1 General Requirements

We Comply with all applicable laws and regulations.

4.2.2 Quality Manual (this document)

Document Identification & Version (v#): 247757208.doc

Quality Management System Manual

QMS Documentation Pyramid

Level I (Tier 1) - The Quality Manual

Document Identification & Version (v#): 247757208.doc

Quality Management System Manual

About the ABCI Quality Management System

Product Realization Processes (PRP),

Quality Flow & Interaction Chart

Document Identification & Version (v#): 247757208.doc

Quality Management System Manual

Personnel Competence and Skills

Facilities, Equipment & Work

Planning & Objectives

Measurement, & Monitoring

Internal Audit &

Document Identification & Version (v#): 247757208.doc