Quality system responsibilities

A quality management system is established, maintained, and documented as a means to ensure that products and services conform to specilied requirements. This quality system is designed to comply with the ISO 9001 2000 standard. The quality systems responsibilities are tabulated in Table 1 (amend the table as relevant to your company). 

The quality system responsibilities are tabulated in Table 1. Amend the table as relevant your company. 

B.2. Method of assuring quality in product/service (quality system, responsibilities for quality)... 

A signed statement by management without its approval to the quality system documented policies and procedures will indicate that it is not committed to honoring the policies and procedures. Managers need to approve the documents within the quality system that prescribe activities for which they themselves are responsible. This serves to demonstrate that they agree with the manner in which the policy has been interpreted and are prepared to provide the resources needed to implement the documented practices. 

The key to this requirement is determining what work affects quality i.e. if you can identify any work that does not affect quality, you are not obliged to define in your quality system the responsibilities and authority of those who manage, perform, or verify it. 

If there are personnel involved with the identification, interpretation, promulgation, and verification of such regulations then their responsibilities and authority will need to be defined in the quality system. 

Job descriptions or job profiles are useful in describing what a person is responsible for however, it rather depends upon the reason for having them as to whether they will be of any use in managing quality. Those produced for job evaluation, recruitment, salary grading, etc. may be of use in the quality system if they specify the objectives people are responsible for achieving and the decisions they are authorized to take. 

An organization may respond to these requirements in several ways, so in managing the quality system a list of the documents is needed which contains the definition of people s responsibilities and authority. The difficulty arises in keeping all such documents compatible and so it is often better to limit the documents to the three types above, if possible. 

The standard requires that the supplier s management with executive responsibility appoints a member of its own management with responsibility for ensuring that quality system requirements are established, implemented, and maintained in accordance with ISO 9001, and for reporting on the performance of the quality system to management for review and as a basis for improvement of the quality system. 

There is a note in clause 4.1.2.3 of ISO 9001 which states The responsibility of a management representative mag also include liaison with external parties on matters relating to the supplier s quality system. 

Appoint a management representative to manage the quality system and define, agree, and publish the responsibilities and authority. 

Why should all this be necessary to maintain the quality system The answer can be found in ISO 8402 which defines a quality system as the organizational structure, responsibilities, procedures, processes, and resources needed to implement quality man-... 

Quality plans are needed when the work you intend to carry out requires detailed planning beyond that already planned for by the quality system. The system will not specify everything you need to do for every job. It will usually specify only general provisions which apply in the majority of situations. You will need to define the specific documentation to be produced, tests, inspections, and reviews to be performed, and resources to be employed. The contract may specify particular standards or requirements that you must meet and these may require additional provisions to those in the quality system. Although ISO/TS 16949 requires the plan to include customers requirements, the intention is not that these requirements are reproduced if provided in a documented form by the customer, but that a cross reference is made in the plan together with any other relevant specifications referred to in the contract. However, when constructing the plan, it would make sense to refer to specific customer requirements and provide a response that indicates your intentions regarding those requirements. 

Subcontractor/supplier performance will be evident from audit reports, surveillance visit reports, and receipt inspections carried out by you or the third party if one has been employed. You need to examine these documents for evidence that the subcontractor s quality system is controlling the quality of the products and services supplied. You can determine the effectiveness of these controls by periodic review of the subcontractor s performance what some firms call vendor rating . By collecting data on the performance of subcontractors/suppliers over a long period you can measure their effectiveness and rate them on a scale from excellent to poor. In such cases you should measure at least three characteristics quality, delivery, and service. Quality would be measured by the ratio of defective conforming products received delivery would be measured by the number of days early or late and service would be measured by the responsiveness to actions requested by you on scale of excellent to poor. The output of these reviews should be in the form of updates to the list of assessed subcontractors/suppliers. 

All activities of the overall management function that determine the quality policy, objectives, and responsibilities and implement them by means such as quality planning, quality control, and quality improvement within the quality system (ISO 8402). 

Quality Management system priorities to consider are management responsibility, quality system principles, auditing, contract review, design control, corrective action, document control, quality records, training, product safety and liability, and statistical techniques, because these are critical aspects of the Quality Management system where Xmple Inc. already has some systems in place. 

Basic requirements applicable to all management systems Management responsibility Quality system principles... 

Management Responsibility [Quality System Principles These two requirements are fundamental to any quality-based management system and must be the first to be installed. 

The QSR major new requirements are in the areas of design, management responsibility, purchasing, and servicing. It encompasses quality system requirements that apply to the entire life cycle of a device. 

In a survey [68] of the use of 93 neural computing applications in 75 UK companies covering all business sectors, the major benefits identified were improved quality, improved response times, and increased productivity. Eighty-four percent of users were satisfied or very satisfied with their systems, with only three percent expressing dissatisfaction. Business benefits specifically for the domain of product formulation (albeit for nonpharmaceuticals) have been given as [15]... 

The different types or classes of phytochemicals can have multiple influences on the GIT (Kitts, 1994). For example, caffeine stimulates the motor, hormonal and secretory functions (Boekmaefa/., 1999). Although many phytochemicals reduce nutrient quality or availability, traditional herbal medicines have exploited some of these characteristics to improve health. Moreover, some of the systemic responses attributed to certain phytochemicals (beneficial or detrimental) can be explained by their influences on the GIT (Carbonaro et al., 2001). To date, the most of the information about phytochemicals is focused on the reductions in the functional capacities of the GIT (the bad), or the toxic properties (the ugly). There are also numerous examples of phytochemicals that can be used to obtain desirable GIT characteristics (the... 

After five years as an analyst, Vicki moved within LGC to work on the DTI-funded Valid Analytical Measurement (VAM) programme. In this role, she was responsible for providing advice and developing guidance on method validation, measurement uncertainty and statistics. One of her key projects involved the development of approaches for evaluating the uncertainty in results obtained from chemical test methods. During this time, Vicki also became involved with the development and delivery of training courses on topics such as method validation, measurement uncertainty, quality systems and statistics for analytical chemists. 

The owner s Inspector is responsible to the owner to verify that all required examinations, inspections, and testing are complete. The owner s Inspector verifies that all required certifications and records have been completed. Also, the owner s Inspector is responsible for verification of the construction organization s quality systems program implementation. 

Each construction organization shall be responsible for developing a QSP. The Quality System shall include a quality manual, quality policy and objective, structure of organization, documented procedures, work instructions, a quality plan, and document and data control. 

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