ISO 9001:2000 Quality Manual (Section 5)
5 Management responsibility
5.1 Management commitment
The company?s top management has established a quality policy, quality objectives and a quality management system by which our company performs its operations to ensure customer satisfaction. The quality policy and effectiveness of the quality management system is evaluated at least annually during Management Review Meetings, where quality measurements are analyzed against their established objectives and suggestions for improvement of the system are considered. Further quality planning is also conducted during Management Review Meetings to ensure the continuing availability of the resources necessary to meet the expectations of our customers.
5.2 Customer focus
The company?s training requirements dictate that each employee understands the importance of fulfilling customer requirements for both internal and external customers. Customer needs and expectations are processed in such a manner to satisfy customer requirements, in an effort to gain and retain their confidence. To that end, customer requirements are identified, reviewed, and translated into work orders under controlled conditions to ensure that the requirements are fully understood and met.
Management ensures that any legal requirements applying to our operations and to the quality of our products are identified and met. Where such requirements exist, management has built the requirements into our processes to ensure that they are met. New legal requirements will be considered during Management Review Meetings or more frequently as deemed appropriate by management.
5.3 Quality policy
Top management has established a quality policy as a framework for establishing and reviewing quality Objectives. The quality objectives are controlled according to the Document and Data Control procedure. Top management ensures that the quality policy is communicated and understood by all employees and that the policy is implemented throughout the company.
To exceed the customers expectation of quality, service and value.
Management will maintain an environment of continuous improvement and empower our employees to achieve success in both individual performance and teamwork.
5.4 Planning
5.4.1 Quality objectives
Quality objectives are derived from the Quality Policy. Quality objectives have been established to continually improve the quality management system as a whole as well as each management process, extending to processes involved with meeting product requirements. Quality objectives are measurable, so that they can be analyzed during Management Review to determine the degree to which they are met.
5.4.2 Quality management system planning
In general, our quality plans are consistent with our normal methods of operation covered by existing procedures. These plans ensure that quality objectives set forth in our quality policy and those identified during Management Review Meetings are met. Where customer-specified requirements identify activities that are outside of our standard methods and practices, a separate quality plan will be prepared and issued.
As part of the regular maintenance of our quality system, proposed modifications to processes and procedures are reviewed during Management Review Meetings to ensure that the requirements of the quality system have been addressed prior to the implementation of any modifications. This review ensures that no new process is implemented without first considering the actions that must be taken to ensure that the company remains in compliance with the system as it is documented. Items evaluated and planned actions are documented in the Management Review Meeting minutes.
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
The lines of responsibility and reporting for all personnel are documented on the company organization chart, which appears in Appendix A of this document. In order to ensure that personnel understand their authorities and responsibilities associated with the quality system, authorities and responsibilities are further documented in specific procedures.
General authorities and responsibilities are described below:
General
All authorities and responsibilities reside with top management and are delegated to functions and/or individual members of staff within their control as appropriate. All personnel who manage, perform and/or verify work are responsible for the quality of products produced by the company. All such personnel are authorized to identify and record problems relating to products, processes, and the quality system as a whole. All staff and personnel have the responsibility to comply with documented procedures and the direction of management. All personnel have the responsibility to assure that processes in which they are working are in a state of control and that the tasks are completed in a responsible manner. All personnel are also responsible for identifying nonconforming product, marking such product as being nonconforming, notifying management, and controlling further processing until the problem has been corrected. To prevent non-conformities, they may also initiate, recommend, or provide solutions through designated channels, such as the Corrective and Preventive Action system.
President
The President is responsible for the engineering/quality assurance, research and development, sales and marketing, production and financial administration of the Company. The President is responsible for determining the long-term direction and goals of the company; guaranteeing compliance with industry, state, local, and federal regulatory requirements; and ensuring that the company has allocated the necessary resources to be in compliance with the quality system. The President allocates resources to assure that employees are trained and that the system is followed as designed and assigned in Management Review Meetings.
Research Manager
The Research Manager is responsible for developing new products for ACME. The goals are to develop simple and cost effective products.
Engineering/Quality Manager
The Engineering/Quality Manager is responsible for the Company?s product development team, quality assurance, and documentation control. Other duties include the development and implementation of Quality Control policies, procedures, and verification, as well as supervision of incoming parts and final inspection of completed product. In addition, he coordinates all customer and approval agency audits.
General Services Manager
The General Manager is responsible for materials management, accounting, budgeting, banking relationships, human resources, and is involved in the production process. This position is also responsible for the design and implementation of all phases of business management software and computer network solutions currently in use by all production, engineering and accounting departments.
Production Manager
The Production Manager is responsible for all production activities, including overseeing production personnel, planning and scheduling production for stock levels and sales. This position also includes payroll and some general accounting functions.
Operators
Operators perform product assembly, inspection, packaging, shipping, staging, and inventory activities.
Internal Auditors
Internal Auditors are responsible for performing independent audits of the quality system to verify that operations are in compliance with documented procedures, and specified quality standards. These individuals are trained and qualified to perform the audits to which they are assigned. They are responsible for preparing for the audits and documenting them in accordance with the Internal Auditing procedure. These individuals also identify and record problems related to products, processes, and the quality system and recommend solutions.
5.5.2 Management Representative
Irrespective of other duties, the Management Representative (shown on the organizational chart) has the main responsibility and authority for establishing, implementing, and maintaining the quality system and ensuring that it continues to be compliant with the requirements of ISO 9001. The Management Representative is responsible for evaluating the effectiveness of the quality system and reporting on it to executive management and other attendees at scheduled Management Review Meetings, and for making suggestions to improve the system.
In addition, as part of the continued maintenance of the quality system, the Management Representative is responsible for the approval, coordination, and control of the Corrective and Preventive Action system and the Internal Audit system, including the verification of implemented Corrective and Preventive Actions to ensure that they are effective.
The Management Representative serves as the primary liaison to external parties on matters concerning the quality system. The Management Representative also ensures that employees are aware of the importance of meeting customer requirements and how those requirements relate to their work activities. In the absence of the Management Representative, the President will assume these responsibilities.
5.5.3 Internal Communication
Although informal communication is an effective method of transmitting information relating to products and processes, formal mechanisms are in place to document and facilitate such communication. The effectiveness of internal communications and any further formalization of such communications are considered during Management Review Meetings.
The effectiveness of the quality management system processes are communicated to the various levels and functions through use of quality system documentation, training, Internal Audits and subsequent reporting, Document and Data Control, Corrective and Preventive Action systems, and Management Review Meetings. Further communication regarding such production processes and their effectiveness is achieved via staff meetings, memos, etc.
5.6 Management Review
5.6.1 General
Management Review Meetings are held to assess and evaluate the quality system to ensure its continued effectiveness and suitability in satisfying the requirements of ISO 9001 and our stated quality policy and objectives. Reviews are carried out according to the Management Review procedure as frequently as necessary, but at least annually. Topics discussed during the meeting and resulting action plans are recorded in Management Review Agenda and Minutes, which are maintained as quality records in accordance with the Document and Data Control procedure.
5.6.2 Review input
During Management Review Meetings, top management reviews current performance and improvement opportunities arising from the results of internal audits, customer feedback, process performance/trends, product conformance, the status of corrective and preventive actions, and follow-up actions from previous meetings. Other inputs the customer satisfaction survey data.
The quality policy and quality objectives are also reviewed for their continuing suitability. Data gathered through measurement and monitoring activities is analyzed to determine the effectiveness of the quality management system. Analysis is also applied to data relating to customer satisfaction, conformance to customer requirements, suppliers, and any other relevant sources. Also, communications methodology is reviewed. The Company plans to continually improve the quality management system. This improvement is facilitated not only by management review, but also by establishing and reviewing the quality policy and objectives, internal audit results, the analysis of data and corrective and preventive actions, as well as any other recommendations for improvement. All such processes are managed to achieve improvement.
Management Review also includes quality system planning to ensure that changes in our processes are evaluated and that quality system requirements are addressed prior to their implementation. In addition, the Management Review Meetings serve as a vehicle whereby we may evaluate potential problems and take actions to prevent their occurrences.
5.6.3 Review output
Outputs from Management Review Meetings include action items regarding the improvement of the quality management system, improvement of the product in relation to customer requirements, and the identification of any needed resources to ensure the continuing satisfaction of our customers.
Associated documents/records for section 5:
Quality Objectives, SQ00xx
Management Review Meetings procedure, SQ00xx
Management Meeting Minutes, Notebook in Document Control
Document and Data Control procedure, SQ00xx