0. Table of Contents
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4.1 |
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4.2.1 |
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4.2.2 |
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4.2.3 |
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4.2.4 |
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5.1 |
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5.2 |
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5.3 |
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5.4 |
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5.5 |
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5.6 |
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6.1 |
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6.2 |
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6.3 |
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6.4 |
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7.1 |
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7.2.1 |
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7.2.2 |
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7.2.3 |
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7.3 |
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7.4.1 |
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7.4.2 |
21 |
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7.4.3 |
22 |
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7.5.1 |
22 |
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7.5.2 |
24 |
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7.5.3 |
24 |
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7.5.4 |
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7.5.5 |
25 |
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7.6 |
25 |
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8.1 |
26 |
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8.2.1 |
27 |
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8.2.2 |
28 |
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8.2.3 |
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8.2.4 |
30 |
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8.3 |
31 |
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8.4 |
32 |
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8.5.1 |
32 |
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8.5.2 |
33 |
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8.5.3 |
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Appendix A |
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Appendix B |
35 |
1. Scope
1.1 General
IsoQual, Inc. developed and implemented the Quality Management System (QMS) described in this manual to help our organization demonstrate its ability to consistently provide products/services that meet customer and applicable regulatory requirements, and operate with increased effectiveness and efficiency with the overall aim of enhancing customer satisfaction.
Our QMS utilizes the process approach and quality management principles contained in the international standards ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000 to enhance our ability to continually improve.
1.2 Application
Our QMS complies with all applicable requirements contained in ISO 9001:2000, covers the design and provision of all company products, and encompasses all operations at our facility located at 10903 Hobbs Station Road, Louisville, Kentucky, USA 40243 (?). The following table identifies ISO 9001:2000 requirements not applicable to our organization and provides a brief narrative justifying their exclusion from the scope of our QMS (this is just a sample, include your unique exclusions and related justifications if/as applicable; exclusions limited to clause 7):
ISO 9001:2000 Requirements EXCLUSION TABLE |
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Clause or Sub-clause |
Exclusion |
Justification |
7.4.3 (part) |
Verification of Purchased Product (at source)
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IsoQual does not verify purchased product at source. |
7.5.1.f (part) |
Product Realization Processes (post delivery services) |
IsoQual does not offer any warranty service on its products nor does it perform any after sales servicing. |
7.6 (part) |
Monitoring and Measuring Devices (software) |
IsoQual does not use computer software to monitor and measure product conformance. |
2. Reference Documents. (list all documents actually referenced in your manual).
The following external documents contain provisions which, through reference in this manual, constitute provisions of our QMS:
ISO 9000:2000, Quality management systems - Fundamentals and vocabulary
ISO 9001:2000, Quality management systems - Requirements
ISO 9004:2000, Quality management systems - Guidelines for performance improvements
Appendix A, contains the Master List of Standard Operating Procedures (SOPs) referenced in this manual and defines the key top level processes for implementing our quality policy.
The latest edition of each referenced document applies. Section 4.2.3 defines our policy and procedures governing the control of these and other QMS documents. Note: documents are referenced throughout this manual only by document number; see Appendix A for complete titles.
3. Terms and Definitions.
Our QMS uses the same internationally recognized terms, vocabulary and definitions given in ISO 9000:2000. Acronyms, terms, vocabulary and definitions unique to our organization, customers, industry and region and referenced throughout our QMS are contained in Appendix B, Terms and Definitions (define your unique terms/definitions, if any, in Appendix B).
4. Quality Management System
4.1 General requirements
Our QMS is that part of our overall management system which establishes, documents and implements our quality policy, and related processes for providing products and services which meet or exceed customer requirements, and satisfy QMS requirements of ISO 9001:2000.
We have adopted the process and system approaches advocated by ISO 9001:2000, which simply means we define and manage:
process inputs, controls, and outputs to ensure desired results are achieved, and
interfaces between interrelated processes to ensure system effectiveness is achieved.
Overall responsibilities for and the sequence and interaction of our key QMS processes (including management activities, the provision of resources, production realization and measurement, as well as outsourced processes) are documented in the Deployment Flow Chart (DFC) depicted in DFC 4.1.
Specific responsibilities for and the sequence and interaction of these key QMS processes are detailed in Standard Operating Procedures (SOPs); Appendix A contains a Master List of SOPs.
In accordance with the increased customer emphasis advocated by ISO 9001:2000, we pay particular attention to QMS processes with direct inputs from our customers to ensure that desired results are achieved; these include all customer-related processes; see Section 7.2.
We also recognize the significant role that subcontractors play in achieving desired results; accordingly, we also manage all outsourced processes; see Section 7.4.
Finally, we closely manage those `production processes' unique to our business. Detailed responsibilities for and the sequence and interaction of these production processes are defined in job travelers, process flow charts and related information contained in job packs developed and issued for each job; see Section 7.5.1.
4.2 Documentation requirements
4.2.1 General
This quality manual contains documented statements of our quality policy and quality objectives and references documented procedures required by ISO 9001:2000 and other documents needed to ensure effective planning, operation and control of our key QMS processes; see DFC 4.1.
The level and type of QMS documentation established for our business is continually reviewed to ensure it remains appropriate for the complexity and interaction of our processes and the competence of our employees. QMS documents and data may be in hard copy or electronic media. QMS documentation includes this quality manual, SOPs, DFCs, and other internal and external documents and data needed to manage, perform or verify work affecting product quality.
We use SOPs to document and define the key QMS processes depicted in DFC 4.1; we use DFCs and associated Process Assessment Worksheets (PAWs) to aid in the development and/or improvement of processes defined in SOPs; see Section 8.2.3 and Section 8.5. We also issue and control work instructions, job descriptions, and other internal and external documents and data as appropriate and needed to effectively manage our QMS; see Section 4.2.3.
4.2.2 Quality manual
This manual is that part of our QMS that defines the scope of our QMS and documents the policy, procedures and processes needed to implement our quality policy and achieve our quality objectives. This manual also documents justifications for exclusions from ISO 9001:2000 requirements (see Section 1.2) and defines the overall sequence of and interaction between our key QMS processes; see DFC 4.1.
5.3 Quality policy
(insert your quality policy statement here):
We will achieve customer satisfaction
by continually improving processes, products and services
to ensure they consistently meet or exceed requirements.
Our quality policy statement indicates our commitment and focuses on what is important to us as an organization: achieving customer satisfaction; and it prescribes the method by which we accomplish this: by continually improving processes, products, and services to ensure they consistently meet or exceed requirements. Moreover, our quality policy statement acts as a compass in providing the direction and a framework for establishing key corporate level performance measures and related improvement objectives (see Section 5.4.1).
We ensure that our quality policy is communicated and understood at all levels of the organization through documented training, regular communication, and reinforcement during annual employee performance reviews (see Section 6.2.2).
Our quality policy statement is controlled by inclusion in this manual, and along with all policies contained in this manual, is reviewed for continuing suitability during management review meetings (see Section 5.6).
5.4 Planning
5.4.1 Quality objectives
Our overall quality goal is to achieve our quality policy, and maintain the integrity of and continually improve a QMS compliant with ISO 9001:2000. We establish both corporate level and operational level improvement objectives that are measurable and achievable within a defined time period. Corporate and operational level improvement objectives are determined from process monitoring activities in each of the following areas: (list here those areas where you will establish measurable quality objectives), e.g.:
Corporate level improvement objectives are documented in management review meeting minutes (and/or in our Business Plan) and reviewed for achievement and continuing suitability during management reviews; see Section 5.6.
All officers, managers and supervisors (?) monitor and measure performance of processes within their area(s) of responsibility and, where appropriate, establish measurable operation level improvement objectives consistent with our quality policy and corporate level improvement objectives. These operational level improvement objectives are documented, deployed to individuals or individual work areas, and reviewed for achievement and continuing suitability during employee performance reviews; see Section 6.2.2.
5.4.2 Quality management system planning
The QMS planning process involves the establishment and communication of our quality policy and objectives through issuance of this manual and its associated procedures, and through the provision of resources needed for its effective implementation; see Section 5.3, Section 5.4.1, and Section 6.1. Accordingly, this manual constitutes our overall plan for establishing, maintaining and improving an effective QMS. Our management review process (see Section 5.6) and internal audit process (see Section 8.2.2) ensure the integrity of our QMS is maintained when significant changes are planned and implemented that affect our key QMS processes depicted in DFC 4.1.
The Quality Manager (?) develops appropriate quality planning documents for specific products, projects or contracts whenever customer requirements exceed the capability or intent of the product/service realization and support processes described in our QMS; see Section 7.1.
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
The Chief Executive Officer (CEO) sets direction and ensures the success of our business through the clear definition and communication of QMS responsibilities and authorities. Other members of Top Management include: (?) the Chief Operations Officer (COO), the Chief Financial Officer (CFO) and the Human Resources Officer (HRO). The interrelationship of Top Management and other key personnel is depicted in IsoQual's Organization Chat, Form 5.5.1.
7.4.3 Verification of purchased product
The Quality Manager (?) ensures that purchased product is verified prior to use or release in accordance with provision of this section; receiving inspection is performed per Section 8.2.4. In some cases, criteria for approval of incoming product is specified in a product quality plan (see Section 7.1) and may include part evaluation by a designated laboratory, data submitted by the supplier, including statistical data, certificates of conformance, etc., and/or another method agreed with the customer.
The Quality Manager (?), plans and implements appropriate sampling plans and/or other statistical techniques to verify purchased product; see Section 8.1.
All requirements for approval of purchased product and/or supplier procedures, processes, equipment, personnel, and/or quality systems are reviewed for adequacy prior to communication to the supplier; see SOP 7.4.2.
Neither we nor our customers currently perform verification activities at our suppliers' premises. Should we or our customers choose to do so in the future, the Quality Manager (?) will document and communicate the intended verification arrangements and method of product release.
7.5 Production and service provision
7.5.1 Control of production and service provision
We utilize a process-focused approach to control operations and support services related to production and service provision. Our initial focus is to assure the quality of process inputs - that is, employees, material, facilities and equipment, and methods. Employees must be equipped to perform the process properly through appropriate education, training, and certification. Material must meet specified requirements and be properly identified, stored, and issued. Equipment and facilities must be adequate, accurate, available and properly utilized. Work instructions and other important data must be current and correct. Methods must be appropriate and proven capable of accomplishing the desired results. The appropriateness of all these process inputs must be assured, and processes must be measured, monitored and controlled to assure effectiveness and identify opportunities for improvement.
Section 6.2 addresses our strategy for ensuring the competency, awareness and training of our employees. Section 7.4 addresses our strategy for ensuring that correct materials and services are planned, procured and verified. Section 6.3 addresses our strategy for planning, providing and maintaining appropriate and suitable facilities, equipment and related support services. Section 7.3 addresses our strategy for developing effective production processes capable of meeting all applicable requirements. Section 7.1 addresses our strategy for verifying the output of our product realization processes at all stages of processing. Section 7.5.2 addresses our strategy for validating production processes that cannot be readily verified through subsequent inspection and test are capable of performing as intended. The Production Manager (?) has overall responsibility for ensuring production processes are planned, scheduled and carried out in a timely and effective manner (see SOP 7.5.1).
8.2 Monitoring and measurement
8.2.1 Customer Satisfaction
Customers are the reason we exist and drive our quality policy “to meet or exceed customer requirements”. The Sales Manager (?) has overall responsibility for identifying and reviewing customer requirements (see Section 7.2.1 and Section 7.2.2) and for monitoring and measuring customer satisfaction (see SOP 8.2.1) as follows:
Data collected by customer contact personnel during routine communications (see Section 7.2.3) provide our primary basis for assessing customer satisfaction. Sales personnel and Customer Service staff (?) utilize a very simple customer satisfaction survey form (hard copy or electronic) to ascertain the customer's overall perception of how well we are meeting their requirements and to document any recommendations for improvement. At a minimum, related performance indicators, include: (define your key customer satisfaction indicators here - e.g.: delivered part quality performance, customer disruptions / field returns; delivery schedule performance / incidents of premium freight; customer notifications related to quality and delivery issues, or?). Further, product realization processes are monitored (per Section 8.2.3) to demonstrate compliance with customer requirements (for product quality and/or efficiency, as applicable).
Customer complaints (whether received in writing, verbally or electronically through our web site customer contact form) are immediately forwarded to appropriate Sales or Customer Service personnel (?) for action. If these personnel cannot resolve the issue to the customer's satisfaction, then the complaint is transferred to the Sales Manager (?) for assignment to another appropriate manager or function for resolution. Customer complaints are documented and monitored through resolution through our corrective/preventive action process; see Section 8.5.
Customer survey data along with other customer feedback (including written or verbal complaints and information collected from our web site's customer feedback form) is reviewed daily by Sales personnel and Customer Service staff (?) to initiate any corrective/preventive actions needed; see Section 8.5.
The Sales Manager (?) periodically reviews customer satisfaction survey data and other customer feedback (including complaints), as well as progress towards achievement of corporate level customer satisfaction improvement objectives (see Section 5.4.1) and provides related recommendations for review by Top Management; see Section 5.6.
8.2.3 Monitoring and measurement of processes
We apply suitable methods for monitoring and measuring all QMS processes. QMS processes depicted in DFC 4.1 are documented measured, controlled and evaluated to ensure they are effective (i.e. achieve desired results) and to identify opportunities for improvement. The manager with overall responsibility for the process develops key process measures used to quantify process effectiveness and/or efficiency. Responsible managers are trained in the development and use of appropriate process management and control tools and techniques (see Section 8.5.1):
A process is effective if desired results are achieved. Effectiveness can be measured in terms of product quality, process accuracy, delivery/schedule performance, cost/budget performance, employee/function performance against established objectives, and/or customer satisfaction.
A process is efficient when resource utilization is optimal. Efficiency can be measured in terms of total resource utilization, productivity indicators, and or waste/rework costs or hours.
Since effectiveness is of primary importance to our customers and efficiency is of primary importance to management and our shareholders, achieving and improving effectiveness and efficiency of all our key QMS processes (as depicted in DFC 4.1) is critical to our success.
We conduct process audits to verify QMS process conformance or performance and we conduct product audits to verify product conformance to specified requirements; see Section 8.2.2.
Where required by the customer or otherwise deemed appropriate, process studies are performed on all new product realization processes to verify process capability and provide additional input for process control. Process capability study results, where applicable, and specifications (including methods of production, measurement and test, maintenance) are documented and acceptance criteria (as well as objectives for process capability, reliability, maintainability and availability?) and appropriate reaction plans are included in control plans (see Section 7.1) and/or job packs (see Section 7.5.1).
Job set ups are verified prior to commencing each new production run and/or when process changes are made; see Section 8.2.4. Production personnel monitor and report on the quality of their own work to ensure process capability or performance is maintained in accordance with the applicable control plan (see Section 7.1) and/or associated instructions included in the job pack or other work instructions located in the work area (see Section 7.5.1) per procedures detailed in SOP 8.2.3. Production personnel monitoring activities may include visual checks or formal inspections using specified measurement techniques / sampling plans (see Section 8.1). Significant process events, such as tool change or machine repair, are recorded. As appropriate, production personnel follow documented reaction plans when processes become unstable or are no longer capable.
Further, the Quality Manager (?), is responsible for planning and implementing formal in-process inspection activities (see Section 8.2.4), including those using statistical techniques (see Section 8.1) to ensure process control at the product, project or contract level in accordance with the applicable control plan; see Section 7.1.
Appendix A
Master List of Key QMS Documents
(list all internal documents referenced in this manual)
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