INTEGRATED SOLUTIONS
QUALITY MANUAL
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Prepared By: |
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Lead Author, Integrated Solutions |
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APPROVED BY & EFFECTIVE ON DATE OF SIGNATURE BELOW: |
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Yufen Chang Yu, Integrated Solutions |
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IN ACCORDANCE WITH THE ISO STANDARD, THE QUALITY MANUAL IS REVIEWED every 18 months AND THE DOCUMENT IS CHANgeD AS NECESSARY. ALL CHANGES ARE REVIEWED AND APpROVED BY THE MANAGEMENT TEAM.
Integrated Solutions
2137 Hwy. #35
Holmdel, New Jersey 07733
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REVISIONS SHEET |
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TITLE: Quality Manual |
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DESCRIPTION OF CHANGE |
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ISSUE |
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SECTION |
DESCRIPTION |
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.0 2.0
2.1
3.0
3.1
3.2
4.0
4.1
5
6
7
8
9
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3/5/97 6/17/97 “ “
8/1/97
5/25/00
5/25/00
10/2/00
10/1/01
12/15/01
08/28/02
12/02/02
7/17/03
12/31/03
2/16/04
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All 1.0 2.0 fig. 1&2
fig. 1&2
fig. 1
sec. 4.1.3
sec. 4.1.2.1
sec. 4.1.4
sec. 4.1.8
All
Sec. 4.20
All
Sec 4.14 Sec. 4.16
Sec. 4.14
Entire Quality Manual
Sec. 4.2.3
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· Original issue. · Mission Statement Added · Vision Statement Added · ISI Organization Charts Added
· Added “Footers” to ISI Organization Charts
· Combined figure #1 and figure #2 to create one template on page #9.
· Changed meetings to reflect Bi-annually.
· Indicated that the Job Responsibilities & Objectives sheets are maintained in the Human Resources Folders. · Indicated that the President/CEO issues guidance to the ISO Manager. · Records of training courses maintained in the employees HR folders
· Reviewed and refined each section to correctly correlate.
· Measurement Analysis and Improvement
· Revised QM to incorporate ISO 9001:2000 standards requirements.
· Revision of Corrective/Preventive/Preventive Action. Revision to Quality Records Sect. 4.16.
· Revised Corrective/Preventive Action /Preventive Action Procedure . · Revision to Quality Manual.
· Updated Organization Chart
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10 |
5/24/04 |
Table of Contents
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· Revised Table of Contents to eliminate error message in Table of Contents |
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11 |
6/15/04 |
Revision Sheet |
· Added statement “Both the latest issue number on revision sheet and issue number on document should be identical.” in the footer. |
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6/15/04 |
Sec 4.14 |
· Delineate “Corrective Action Process” and label it as “Corrective Action Procedure” |
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12 |
12/20/04 |
Sec 4.14 |
· Adding ISO manager follow up procedure for non-software related customer complaints. |
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13 |
12/20/04
6/30/05 |
Revision Sheet
Sec. 4.1.8 |
· Removed statement “Both the latest issue number on revision sheet and issue number on document should be identical.” in the footer.
· Specifying management review items · Updating organization chart |
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14 |
2/17/06 |
Sec. 4.21.6 |
· Soliciting customer feedback proactively, as a measurement of customer satisfaction, |
TABLE OF CONTENTS
4.0 Quality System Requirements
4.1.4 Quality Criteria (Success Criteria)
4.1.5 Organization Responsibility and Authority
4.1.7. Management Representative
4.2.2 Quality System Procedures
4.4.2 Design & Development Planning
4.4.3 Organizational and Technical Interfaces
4.5 Document and data Control (Quality and Development)
4.5.1 Document and Data Approval and Issue
4.5.2 Document and Data Changes
4.6.2 Evaluation of Subcontractors
4.6.4 Verification of Purchased Product
4.7 control of customer-supplied product
4.8 product identification and TRACTABILITY
4.10.2 Receiving Inspection and Testing
4.10.3 In-Process Inspection and Testing
4.10.4 Final Inspection and Testing
4.10.5 Inspection and Test Records
4.11 Control of inspection, measuring, and test equipment
4.12 Inspection and Test Status
4.13 Control of Non-conforming Product
4.13.2 Review and Disposition of Non-Conforming Product
4.14 Corrective Action and preventive action
4.14.1 Software related Customer Complaints
4.14.2 Customer Complaints (other than Software Defects)
4.14.3 Internal/External Audit Findings
4.14.4 Preventative Action (Key Learnings)
4.15 Handling, Storage, Packaging, Preservation and Delivery
4.15.5 Product Release (Delivery)
4.20 Measurement, Analysis and Improvement.
4.20.3 Planning of Product Realization
4.21.2 Monitoring and Measurement of Processes
4.21.3 Monitoring and Measurement of Service
C Customer Focused
O Objective Oriented
R Reliability
E Enterprising Advancements
C Close to Client
H High Quality Work
O Open Communications
I Integrity & Initiative
C Connect to Open System
E Excellence in Performance
The Integrated Solutions Quality Manual is the policy document providing the framework for the Quality System at Integrated Solutions, Inc. The Quality Manual is the first tier in a multi-tier documentation system describing the Quality System.
The Quality Manual references the next tier of the process and procedure manuals within the Quality System documentation. These documents will provide the who, what, when, where, and how implementation of the Quality System. Together, these documents provide a common-sense framework that Integrated Solutions can use to design, develop, deliver, install and maintain products and services with a consistent level of quality.
The manual is intended:
For internal planning by management, especially during periodic reviews of the Integrated Solutions Quality System
As a repository of information on Integrated Solutions’ quality practices
As a tool for internal and external audit teams during assessment of the Integrated Solutions Quality System
The Quality Manual is organized along the lines of the ISO 9001:2000 standard.
The Integrated Solutions Quality System is expected to evolve as new technologies emerge and continuous improvements are made. Consequently, this manual is a living, working document and will be updated as necessary under change control.
“Continually Improving Our Processes to Provide Quality Products and Services.”
The Integrated Solutions Senior Quality policy is that all processes and success criteria stated in the customer contract will be followed. If the processes or success criteria are not described in the contract, the Integrated Solutions processes and success criteria will be used.
We define Quality Service as our ability to fulfill our customer's expectations - not only the expectations for our products, but also for all services in connection with doing business with Integrated Solutions, Inc.
The Quality Service Process has many facets:
Product quality is determined by the ability to develop products with the right quality i.e. functionality and reliability within the established budgets and by the ability to produce these products with a high production quality.
Service is determined by the ability to advise the customers in technical and commercial questions. It is also determined by our ability to build, and sustain relationships by assessing, anticipating, and fulfilling stated and implied needs.
The Integrated Solutions Senior Management’s policy is that all processes and success criteria stated in the customer contract will be followed. If the processes or success criteria are not described in the contract, the Integrated Solutions processes and success criteria will be used.
The purpose of this policy is to:
Make sure that the contract is being followed with respect to process usage
Indicate what the default process usage will be
Indicate where the success criteria will be stated if it is not in the contract
First and foremost is the fact that the contract success criteria must be met. If specific criteria are not documented in the contract or the customer’s processes, it will be documented in one or more of the following processes and procedures.
· Design Review Process
· Code Inspection Process
· Testing Process
· Software Support Process
· System Administration Procedure
It is the responsibility of the Integrated Solutions CEO/President and Managers to define and implement processes, controls and measurements that ensure that products and services meet the quality requirements of internal and external customers. To meet this objective, each process owner defines and implements their respective part of the Quality System consistent with Integrated Solutions Mission Statement and Quality Policy.
It is the responsibility of the Integrated Solutions process owners to:
· Identify and satisfy their customers
· Continuously improve processes
· Initiate action to prevent the occurrence of product nonconformity
· Identify and record any product quality problems
· Initiate, recommend or provide solutions through designated channels
· Verify the implementation of solutions
· Control further processing, delivery or installation of non-conforming product until the deficiency has been corrected
Continuous improvement is the responsibility of all personnel at Integrated Solutions. The quality function is distributed to each organization responsible and accountable for meeting or exceeding the expectations of its customers. The individual's success in fulfilling quality responsibilities is dependent upon many factors, such as training, resources and processes.
The ISO Manager has the responsibility for maintenance of the Quality Manual and has been given the organizational freedom to identify quality problems and to initiate Corrective/Preventive action concerning the Quality System.
Everyone plays a role in providing and improving quality. It is part of each person's job to understand their role, and actively look for ways to expand it.
Individuals in the organization, especially those concerned with product quality or customer satisfaction issues, make decisions using the Quality Policy as criteria. There is no inherent conflict between quality, cost and schedule; however, when process failures create a conflict, the customer's continuing experience of quality has priority.
Each Integrated Solutions employee has a Job Responsibility and Objective Sheet maintained in their Human Resources folder. Each Integrated Solutions employee has an organization chart that is periodically updated by the CEO and Executive Administrator and distributed via email. An employee's general responsibility and authority are defined in these two documents.
Finally, individual objective packages, processes, procedures, work instructions and, where applicable, project plans define specific responsibility and authority for a particular project, job or task.
References Organization Charts
It is the responsibility of the product teams to assure that process owners implement product verification requirements, provide adequate resources and assign trained (independent as appropriate) personnel for all activities.
References
Project Plans
Quality Systems Audit Process
Quality System Management Review
The ISO Manager is responsible for assuring that the requirements of the ISO standard are implemented and maintained. This function reports to the Integrated Solutions CEO/President.
References Organizational Charts
To ensure quality management system’s (QMS) continuing suitability, adequacy and effectiveness, top management shall review the QMS, twice a year.
Management review shall include information on following items:
ISO 9001:2000 Coordinator/quality manager
It is the responsibility of the Integrated Solutions Quality Manager through the guidance of the President/CEO or relating Manager to:
· Develop and maintain quality strategies, policies and programs, and to ensure their effective implementation.
· Provide overall quality leadership to process owners relative to Quality System definition and measurement requirements.
· Provide quality awareness and training relative to quality methodologies and tools.
· Assist process owners in identifying world-class process benchmarks.
· Develop methods to measure the effectiveness of prevention-based methodologies to achieving continuous process, product and service improvement.
· To ensure process owners dedicate resources to resolve critical customer issues and to ensure proactive actions are taken to correct product deficiencies discovered in the field.
The Integrated Solutions Quality System has three objectives:
1. To facilitate consistent engineering and delivery of products and services that meet customers' needs and expectations.
2. To assure management that desired product and service quality is being achieved.
3. To provide confidence to customers that products and services will consistently meet their needs and expectation.
The Quality System philosophy strives to maintain a consistent and disciplined approach while allowing flexibility to accommodate innovation and special circumstances. Plans and procedures are put into place to the extent that circumstances are predictable. When deviations occur, the Quality System allows for the deviation to be identified quickly and applies engineering judgment and good business practice to maintain a quality result. The Waiver Policy will be invoked as needed.
The plans, along with their implementation, will become part of the quality record system maintained in the Document Control (DC). The plans are reviewed and approved by all organizations concerned with their implementation.
The Quality Policy is disseminated to employees by their management. There will be a constant emphasis on the need to achieve internal and external customer satisfaction. Planning for ongoing quality awareness is considered a qualitative requirement of the annual planning process.
Each non-development department is responsible for continuously improving its policies, processes and procedures in order to meet the quality requirements of its internal and external customers.
The Quality Plan is developed by the CEO/President.
References: Document Control Policy
Documentation Control Procedure
Quality Manual
Quality Plan
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Integrated Solutions CEO/President develops and maintains horizontal procedures for contract review and coordinates these activities. The CEO/President also owns the process for negotiating and administering contracts.
The development or service supplier will review each contract to ensure that:
Quality and service requirements are adequately defined and documented.
Requirements differing between Integrated Solutions and the customer are resolved.
Changes to the Contract are covered in the Contract Review Process and must be approved by the Integrated Solutions CEO/President.
Product Management will ensure the maintenance of contract review records as part of Quality Records.
References: Contract Review Process/Checklist
Integrated Solutions has developed a Design Review Process that will ensure that the Design is reviewed with the appropriate individuals and the changes are traceable.
The Design Process is split into hardware, firmware and software design and is used in all product development
At a high level, the product development cycle can be broken into phases:
Pre-Development: Design Requirements
Development: Design and Verification
Activities during the Pre-Development stage are loosely defined, and consist of information gathering and setting of strategies. The Development phase begins when a Project Plan is approved for a given product, product group or product family.
The Project Plan is required to document the work entailed in developing the defined product. A Project Plan includes information such as a statement of work, a work breakdown structure, resource requirements, schedule, milestones and deliverables. It identifies the person or department responsible for design and development. Engineering is responsible for documenting the Project Plan with input from all organizations with product delivery activity. Resources and personnel are defined by the Project Plan.
A Baselined Project Plan is required for all programs.
References: Design Review Process
Each Integrated Solutions employee participating in product development is responsible for the definition and implementation of products that meet customer needs. Formal sign-off and review activities designated between groups shall be addressed in the regular meetings of the team with actions assigned as applicable. Deviations shall be described in the Project Plan.
Functional organization charts are issued and maintained by the Executive Administrator.
Each employee has an objectives package, and is identified on an organization chart. Each employee negotiates objectives with their immediate supervisor at least once each year, which further define their responsibility and authority.
References: Project Plan
Design input is documented for each project. The documentation is hierarchical, with each succeeding document containing a greater level of detail.
Each document is reviewed during the baselining process, and once baselined, is put under change control. A change control document may be updated based on input from review meetings, or by entering a Modification Request (MR). Changes may be made to reflect design decisions, address changing market conditions or clarify an incomplete, ambiguous or conflicting requirement.
The definitive reference at any point in time will consist of the latest revision of the baselined document, all review meeting minutes to date, and all accepted MR’s to date. Other changes under consideration (but not yet accepted) may be found in project team e-mail records and the assigned or submitted MR list.
All documents are driven by a variety of formal and informal information sources. The process for collecting information is flexible; however, when an assumption is based on an external information source, this source will be defined in the endnotes of the formal document. Information sources include: business needs, market conditions, customer requests, technological innovation and strategic plans and any regulatory input as applicable.
The full list of design output is defined by the Quality Plan. A minimum set of output would include:
· Technical Specification: The detailed description of how the features and functionality described by the input documents are realized in the product.
· Design Review: The review of the requirements, and interfaces.
· Release Letter: A full description of the product, consolidating engineering documentation into a single document intended for field marketing and support organizations.
· Engineering Design Information, Design Release: The design information needed to manufacture the product; minimally, and golden masters for software.
· Acceptance Criteria: The applicable quality gate.
Reference: Quality Plan
· Scope and schedule for design reviews.
· Records will be kept and followed through to closure.
The test strategy for a product is defined by the Project Plan. The plan will list:
· Applicable testing unique to the design (such as conformance testing by a third party)
The Project Plan is supported by a test plan that defines all qualification tests and demonstrations that will be performed. The test plan is derived from the functional requirements and technical specification.
· Schedule for Alpha & Beta testing as appropriate.
Integrated Solutions maintains disciplined control of the product while allowing customers or Integrated Solutions personnel to suggest changes to released products. A change to released product or documentation is initiated by an MR. The MR is reviewed by appropriate personnel and, if accepted, the formal change is completed through a development release or documentation update.
Reference: Design Review Process
Documentation is maintained by the Integrated Solutions ISO Manager. The ISO Manager obtains document and Index revisions and maintains the on-line system. A hard copy backup of the documents is located in the Integrated Solutions office and the development and support area on site. Printed copies are uncontrolled and are no longer an official copy. Only copies produced and distributed by the ISO Manager are considered the latest copy. The distribution, tracking, change control and approval of these documents are defined by the Document Control Procedure. All source control will be tracked through a source control system.
Reference: Document Control Procedure
The Integrated Solutions Documentation Control (DC) Procedure covers submission, distribution, tracking, change control and approval procedures for all program realization process documentation. This policy promotes an efficient turn-around of development information and DC maintains an accurate historical record of all development documentation.
In daily operations, the control and maintenance of documents and inspection and test data is generally defined in the processes and procedures. Revision levels of processes, procedures and work instructions are controlled by the Document Control Coordinator.
References: