Quality Manual
Quality Manual
iBiz, Inc. Quality Manual
Date October 19, 2012
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Quality Manual
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Table of Contents
1 Introduction ................................................................................................................. 1 2 Quality Policy and Quality Objectives ....................................................................... 2 3 Scope ........................................................................................................................... 3 3.1 4 Referenced Documents ........................................................................................ 4 Quality Management System (QMS).......................................................................... 5 4.1 General Requirements .......................................................................................... 5 4.1.1 4.2 5 Documentation Requirements .............................................................................. 6 4.2.1 General .......................................................................................................... 6 4.2.2 Quality Manual (QM) ................................................................................... 6 4.2.3 Control of Documents ................................................................................... 7 4.2.4 Control of Records ...................................................................................... 10 Management Responsibility...................................................................................... 16 5.1 Management Commitment ................................................................................. 16 5.2 Customer Focus .................................................................................................. 16 5.3 Implementation of Quality Policy ...................................................................... 16 5.4 Planning.............................................................................................................. 17 5.4.1 Implementation of Quality Objectives ........................................................ 17 5.4.2 QMS Planning............................................................................................. 17 5.5 Responsibility, Authority, and Communication................................................. 18 5.5.1 Responsibility and Authority ...................................................................... 18 5.5.2 Management Representative ....................................................................... 18 5.5.3 Internal Communication ............................................................................. 18 5.6 6 iBiz Configuration Management Policy ....................................................... 5 Management Review .......................................................................................... 18 5.6.1 Review Input ............................................................................................... 19 5.6.2 Review Output ............................................................................................ 19 Resource Management .............................................................................................. 20 6.1 Provision of Resources ....................................................................................... 20 6.2 Human Resources............................................................................................... 20 Company Proprietary
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7 6.2.1 General ........................................................................................................ 20 6.2.2 Competence, Training, and Awareness ...................................................... 20 6.3 Infrastructure ...................................................................................................... 21 6.4 Work Environment ............................................................................................. 21 Product Realization ................................................................................................... 22 7.1 Planning of Product Realization......................................................................... 22 7.2 Customer-Related Processes .............................................................................. 22 7.2.1 Determination of Requirements Related to the Product ............................. 22 7.2.2 Review of Requirements Related to the Product ........................................ 22 7.2.3 Customer Communication .......................................................................... 23 7.3 7.3.1 Design and Development Planning ............................................................ 23 7.3.2 Design and Development Inputs ................................................................. 24 7.3.3 Design and Development Outputs .............................................................. 24 7.3.4 Design and Development Review................................................................ 24 7.3.5 Design and Development Verification ........................................................ 25 7.3.6 Design and Development Validation .......................................................... 25 7.3.7 Control of Design and Development Changes............................................ 25 7.4 Purchasing .......................................................................................................... 25 7.4.1 Purchasing Process...................................................................................... 25 7.4.2 Purchasing Information............................................................................... 26 7.4.3 Verification of Purchased Product .............................................................. 26 7.5 Production and Service Provision ...................................................................... 26 7.5.1 Control of Production and Service Provision ............................................. 26 7.5.2 Validation of Processes for Production and Service Provision.................. 27 7.5.3 Identification and Traceability .................................................................... 27 7.5.4 Customer Property ...................................................................................... 28 7.5.5 Preservation of Product ............................................................................... 28 7.6 8 Design and Development ................................................................................... 23 Control of Monitoring and Measuring Equipment ............................................ 28 Measurement, Analysis, and Improvement .............................................................. 30 Company Proprietary
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8.1 General ............................................................................................................... 30 8.2 Monitoring and Measurement ............................................................................ 30 8.2.1 Customer Satisfaction ................................................................................. 30 8.2.2 Internal Audit .............................................................................................. 31 8.2.3 Monitoring and Measurement of Processes ................................................ 31 8.2.4 Monitoring and Measurement of Product ................................................... 31 8.3 Control of Nonconforming Product ................................................................... 32 8.4 Analysis of Data ................................................................................................. 33 8.5 Improvement ...................................................................................................... 33 8.5.1 Continual Improvement .............................................................................. 33 8.5.2 Corrective Action ........................................................................................ 34 8.5.3 Preventive Action........................................................................................ 34 Appendix A. Acronym List........................................................................................... 36 List of Figures
Figure 4–1: Quality Management System Diagram ........................................................... 7
List of Tables
Table 3.1: Referenced Documents ...................................................................................... 4
Table 4.2.3: Matrix of Controlled Records ....................................................................... 11
Table A-1: Abbreviations, Acronyms, and Terms ............................................................ 37
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Quality Manual
1 Introduction
This document serves as the Quality Manual for DIGITALiBiz, Inc. (iBiz). This
document provides high-level guidance and provisions for maintenance and
implementation of our Quality Management System (QMS). Our quality management
approach is based upon principles found in the International Organization for
Standardization’s (ISO) 9001:2008 Quality Management Systems – Requirements
document and is designed to achieve compliance with that guidance in both letter and
spirit.
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2 Quality Policy and Quality Objectives
The goal of this Quality Manual is to support the following iBiz Quality Policy and
Quality Objectives:
DIGITALiBiz, Inc.
Quality Policy
DIGITALiBiz, Inc. is committed to the principles of quality and to the continual
improvement of our Quality Management System. Our success is measured by our
ability to serve our customer’s needs, and to provide superior services and consistently
high levels of quality that meet or exceed their expectations. Our success is driven by our
staff’s abilities; and the retention and development of the highest caliber of professionals.
Approved by: Michael Wu, President
DIGITALiBiz, Inc.
Quality Objectives
Customer
Obtain Outstanding Past Performance Ratings from All of Our Customers
Exercise all Optional Periods on all Contracts
Achieve 100% Retention of Customers
Employees
Retain 100% of Employees rated as Exceptional on their Annual Reviews
Continual Improvement
Reduce the Number of Audit Findings Every Year
Improve Processes Through the Elimination of Recurring Deficiencies
Approved by: Michael Wu, President
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3 Scope
iBiz provides services to the Federal Government in the areas of Information
Technology, Program/Project Services, Help/Support Desk and Administrative Support.
Our Quality Management System covers the process of analyzing customer requirements
(as received from the Government) and delivering services to meet those requirements.
All projects or contracts where iBiz is the prime contract holder with the U.S. Federal
Government fall under the scope of this Quality Manual and our Quality Management
System.
iBiz is excluding the following International Organization for Standardization (ISO) 9001
clauses:
•
7.3 Product/Process Design and Development
iBiz does not design or develop any products; we are a service provider to the Federal
Government.
•
7.5.2 Validation of Processes for Production and Service Provision
All of the services delivered by iBiz are reviewed and accepted by the Government at
the time of delivery or provision.
•
7.6 Calibration
iBiz has no requirement for control or monitoring of calibrated equipment.
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3.1 Referenced Documents
The following documents are referenced within this Quality Manual.
Table 3.1: Referenced Documents & Artifacts
Document Name
Internal Audit Tracking List and Calendar (SharePoint
artifacts)
Internal Audit Process
In Progress Review List (SharePoint artifact)
Project Management Handbook
Proposal Process
Quality Management Review List (SharePoint artifact)
NC-CA-CA Process
Quality Policy and Quality Objectives
Risk Management Process
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4 Quality Management System (QMS)
4.1 General Requirements
iBiz shall establish, document, implement, and maintain a QMS and continually improve
its effectiveness in accordance with the requirements of ISO 9001:2008. iBiz shall:
Determine the processes needed for the QMS, as well as their application throughout the
organization.
Determine the sequence and interaction of these processes.
Determine criteria and methods needed to ensure that both the operation and control of
these processes are effective.
Ensure the availability of resources and information necessary to support the operation
and monitoring of these processes.
Monitor, measure (where applicable), and analyze these processes.
Implement actions necessary to achieve planned results and continual improvement of
these processes.
4.1.1 iBiz Configuration Management Policy
Scope:
This Policy applies to all iBiz created and/or modified documents and artifacts used to
document or perform the functions of iBiz’s QMS and the deliverables and services we
provide to our customers under our QMS.
Purpose:
The purpose of iBiz’s Configuration Management (CM) Policy is to establish and
maintain the integrity of work products using configuration identification and
configuration control.
CM Policies:
1. All Configuration Items (CI) will be identified, managed and tracked.
a. The CI for the iBiz QMS are shown in Table 4.2.3, below
b. All project deliverables are CI
c. Additional CI for each individual project shall be identified in the Project
Configuration Management Plan – a required element of the Project
Binder
2. All CI will be clearly labeled or named to indicate the version and status of the
artifact. iBiz ISO CI will use file name and date time stamping to label manage
the configuration version of artifacts:
a. All CI file names will include the revision date and status of the artifact.
The following formats will be used
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i. Date: YYYY MM DD (e.g. 2011 04 27)
ii. Status: DRAFT, APPROVED, ARCHIVED (archived may be
waived if a separate folder or container is used for all obsolete
versions)
b. All CI will contain a Revision History table within the CI
i. The Revision History must contain at least the following fields:
Version, Description of Changes, Revised by, Reviewed/Approved
by, and Effective Date.
ii. Where the Revision History cannot or is not maintained in the CI,
a separate record containing the Revision History must be
maintained and referenced in the Project Configuration
Management Plan
3. Requests for Changes will be logged as Action Items, Issues, NC-CA-CA, based
upon Audits and/or reviews. The Revision History will reflect why changes were
required/requested and, where applicable, specify the Action Item, Issue ID, NCCA-CA Log ID or Audit that resulted in the Change Request.
4. CI will be stored on iBiz servers or Customer approved servers.
5. iBiz Project CI will conform to customer requirements for version and
configuration management first, then use best efforts to apply the standards
described here, without contradicting customer requirements.
4.2 Documentation Requirements
4.2.1 General
QMS documentation shall include:
•
Documented statements of a Quality Policy and Quality Objectives
•
A Quality Manual
•
Documented procedures and records required by ISO 9001:2008
•
Documents, including records, determined by the organization to be necessary to
ensure the effective planning, operation, and control of its processes
4.2.2 Quality Manual (QM)
iBiz shall maintain this QM, which includes:
•
The scope of the QMS, including details of and justification for any exclusions (see
section 3 above)
•
The documented procedures established for the QMS, or reference to them
•
A description of the interaction between the processes of the QMS
(refer to)
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Management Commitment
iBiz Quality Policy and Objectives
Recruitment
Proposal Process
RFP
WBS
Candidate
Eval Form
Resource
Plan
Offer Request
Form
Proposal
Project Binder/
Policies
WBS
Staffing Plan
Communications
List
HR Hiring
Process
(excluded)
Preventative Action
Risk
Mgmt
Process
CONTRACT
Training Program
GOVT
Evaluation
Bid Plan
Project Management
Job
Requisition
Form
Requirements
Quality Management Reviews (QMRs)
Dedicated VP of Quality Assurance
Project Issue Management
Project Issue
Log
ISO Training
Proposal
Review Form
Internal Risk
Auditor
Pre-Bid
Training
Analysis
PM Training
Monitoring and Measurement
Deliverable
Tracking
ISO Training
Log
Supplier Management
Internal Audit
Tracking List
Control of Documents (4.2.3)
Improvement
In-Progress
Reviews
SubCont.
Evals.
Internal Audit
Tracking List
Audit Process
Checklists
Non-Conformance, Causal Analysis, Corrective Action Process
Action Item
Log
Satisfaction
Surveys
Supplier
Mgmt
Pocess
Internal Audit Process
Project
Risk Log
NC-CA-CA
Process
QMS NC Log
Control of Records (4.2.4)
External Audits – Certification – Feedback/Non-Conformance Identification
Figure 4–1: Quality Management System (QMS) Diagram
4.2.3 Control of Documents
Documents required by the QMS shall be controlled.
Records are a special type of document and shall be controlled according to the
requirements detailed in the next section of this document.
iBiz QMS Document Control Procedures have been established to define the controls
needed for the following:
•
To approve documents for adequacy prior to issue
•
To review and update as necessary and reapprove documents
•
To ensure that changes, as well as the current revision status of documents, are
identified
•
To ensure that relevant versions of applicable documents are available at points of use
•
To ensure that documents remain legible and readily identifiable
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•
To ensure that any documents of external origin determined by the organization to be
necessary for the planning and operation of the QMS are identified and their
distribution controlled
•
To prevent the unintended use of obsolete documents, and to apply suitable
identification to them if they are retained for any purpose
iBiz QMS Document Control Procedures:
1. These Procedures are owned by the Vice President of Quality Assurance (VP of
QA).
2. The VP of QA reviews and approves all documents, procedures, forms, and
templates included on the ISO SharePoint site of the iBiz Employee Portal to
ensure the document is adequate for use.
3. QMS Documents will be stored on the ISO SharePoint site of the iBiz Employee
Portal, and will be accessible to all iBiz staff. The URL for this site is:
4. https://digitalibiz.sharesrvr.com/iso/default.aspxThe iBiz VP of QA will have
‘create/read/write/update’ access to all folders on the ISO site.
5. All iBiz staff will be allowed access to read files on the Employee Portal and the
iBiz SharePoint ISO Site.
6. Document Owners Site will have ‘create/read/write/update’ access to the
documents they own.
7. Draft, or un-reviewed and approved, revisions of QMS Documents will be labeled
as draft by including “DRAFT” in the artifact file name.
8. The Employee Portal structure will include:
a. The ISO Site which is organized into the following folders:
i. ISO Repository
ii. ISO Pages
iii. iBiz ISO Calendar
iv. ISO Quality Training List
v. QMS Action Item Log
vi. Lessons Learned Log
vii. Customer Ratings
viii. External Audit Tracking – no longer used
ix. Internal Audit Tracking
x. In Progress Reviews
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xi. Proposal Reviews
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xii. Audit Process Checklists
xiii. Quality Management Reviews
xiv. Supplier Evaluations
9. All iBiz-created QMS documents will use the following standard for file naming:
a. Title_YYYY_MM_DD_STATUS, where:
b. Title is the name of the document
c. YYYY_MM_DD represents the date of last update
d. STATUS is either DRAFT, APPROVED or ARCHIVED
10. iBiz-created QMS documents, including this QM, the Proposal Process, and the
Project Management Handbook, must include a Revision History that tracks the
document version date, a description of the change to the document, the date of
modification, and the status of the document’s approval for use.
Templates, forms, PowerPoint presentations, drawings, or other QMS documents
that are not created in a standard word processing format are excluded from the
requirement for a revision history.
11. QMS documents are reviewed at the quarterly Quality Management Reviews
(QMRs) to ensure that QMS documentation continues to be suitable.
12. If a QMS document is updated, the draft version will live in the Draft folder on
the iBiz ISO Site during revision, review, and approval. Once approved for use,
the VP of Quality Assurance or the Document Owner will move the previously
approved version into the Archive folder on the ISO Site, and move the newly
approved version from the Draft folder to the appropriate staff-accessible folder.
The VP of Quality Assurance is responsible for maintaining the current version of
all QMS documents on the ISO Site.
13. Project Managers will receive training and usage updates and notification of
changes to approved QMS documents as part of quarterly In-Progress Reviews
(IPRs).
14. iBiz recognizes the dangers of maintaining a copy of an external document such
as version control or a document management record, as well as the danger of
potential distribution of sensitive client or Government information. iBiz does not
make a practice of maintaining documents of external origin. If an external
document is required for contractual purposes, the Project Manager of that
contract will ensure that a control and distribution procedure for the external
document is documented in the Project Binder.
15. If any document of external origin is maintained by iBiz, it may only be stored on
the iBiz ISO Site if sufficient detail or description is provided to ensure that users
of the iBiz Network ISO drive are aware the document is not of iBiz creation.
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External documents should be labeled in such a way as to clearly identify the title
and source of the document.
16. The only document of external origin maintained by iBiz relating to this QMS is
the ISO 9001:2008 Standard itself. This document is kept in hard copy form by
the VP of Quality Assurance. The ISO Standard is not to be distributed but is
available as reference if needed.
4.2.4 Control of Records
Records established to provide evidence of conformity to requirements and of the
effective operation of the QMS shall be controlled.
The organization shall establish a documented procedure to define the controls needed for
the identification, storage, protection, retrieval, retention, and disposition of records.
iBiz records are maintained in three locations depending on the type of record.
Responsibility for control of records is summarized by the following guidance:
1. QMS records maintained on the iBiz ISO Siteare controlled by the VP of Quality
Assurance.
2. QMS records maintained in the Project Binder are controlled by the Project
Manager.
3. QMS records maintained in personnel files are controlled by the VP of Human
Resources.
A Matrix of Records required by ISO 9001:2008 is provided below as the planned
procedure for control of records, Table 4.2.3.
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