Quality system requirements - meaning

Quality system—Requires that a quality system meeting the requirements of the ISO 9002 standard be established, maintained, and documented as a means of ensuring that product conforms to requirements. 

Most ISO 9000 registered organizations claim to provide quality products and services, so why should there be so many dissatisfied customers when there are over 270,000 organizations in the world certified to ISO 9001, 9002, or 9003 One of the principal requirements in the standard is for the supplier to establish a quality system as a means of ensuring that product or service meet specified requirements. If an organization s products or services do not meet specified requirements then clearly the system has failed, but the failure is no fault of the standard - it is a fault of the way the standard has been applied and interpreted both by the organizations themselves and by the auditors who determine conformity. If the specified requirements are less than those of the customers, it is inevitable that products will bring dissatisfaction. This realization has, in the case of the automotive industry, led to two distinct needs ... 

Quality products are products that meet customer needs and expectations but, as has already been said, quality does not happen by chance. A quality system is the means by which organizations produce products that meet customer needs and expectations. Even if that system is not formalized, it is the combination of processes, resources, and organization that will deliver quality products. All ISO/TS 16949 does is define a minimum set of requirements which if met will enable an organization to satisfy its customers. It is a kind of framework for achieving product quality. 

Are the means used to ensure that product conforms to specified requirements documented in the form of a quality manual and quality system procedures ... 

Next is a questionnaire which only covers the specific requirements of the standard. This breaks down the requirements into their individual components where it is likely that the solutions for each part will be different. It can be used as a basic checklist for verifying that the quality system you have designed addresses all the requirements, or as a means of creating policy or of assessing conformity. 

The term resource is often used to imply only human resources when there are in fact other types of resources. The standard is not specific although resources would normally include time, manpower, machines, materials, finance, plant, facilities in fact, any means available to the supplier for implementing the quality system. So when ISO 9001 requires that you provide adequate resources it requires that you provide all the human, finance, and material resources necessary to implement your quality system, including the allocation of sufficient time. 

To establish means to set up on a permanent basis, and the requirement therefore emphasizes that the quality system should form part of the infrastructure of the organization. 

The standard doesn t require a procedure for Management Review and while it does require procedures for Design Control it does not specify that a Design Review Procedure is required. The phrases consistent with and in accordance with have the same meaning as both imply compatibility and agreement. If you restrict yourself to a literal interpretation of the standard, you need produce no more than 43 documented procedures - possibly less if some aspects do not apply to your business. You can combine several procedures in one document, the size of which depends on the complexity of your business. The more complex the business the greater the number of quality system documents. The more variations in the ways that work is executed, the larger the quality system will need to be. If you have a small business and only one way of carry-... 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

Very special quality demands and quality systems are those for the production and certification of kosher and halal products, which at the time are gaining in importance all over the world. Kashrut is the body of Jewish law dealing with what foods Jews can and cannot eat and how those foods must be prepared. Kashrut originates from the ffebrew and means fit , proper or correct . The more commonly known word kosher comes from the same roots and refers to foodstuffs that meet these dietary requirements of Jewish law. Halal is an... 

In the control of outsourced operations, the cGMP regulations require that the QU approve or reject products or services provided under a contract. Under current quality system models, the organization must follow a formal vendor qualification process to qualify outsource providers and verify through inspection or other appropriate means that the provider is capable of meeting the requirements of the organization. To comply with the regulation, these operations should be conducted by the QU. 

Company name) has established and maintained a documented quality system as a means of ensuring that the product conforms to specified requirements. This includes ... 

ISO/DIS 13485 The supplier shall establish, document, and maintain a quality system as a means of ensuring that product conforms to specified requirement. The supplier shall prepare a quality manual covering the requirements of ISO 9001. The quality manual shall include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system. 

The purpose of validation is to demonstrate the capability of the water treatment and air handling system to continuously supply the required quantity of water and air with the specified quality attributes. Documented means to provide documented evidence. Validation provides the system owner with the means of assessing when a water treatment and/or air handling system is operating outside established control parameter limits and provides a means for bringing the system back into a state of control. It results in written operating and maintenance procedures for personnel to follow, which in turn helps ensure consistent system performance. 

Data quality has a meaning only in relation to the intended use of the data and when defined by a certain standard. The standard comprises a system of applicable general and project-specific requirements for sampling and analysis, and when stated in the SAP, forms the qualitative and quantitative acceptance criteria for the PARCC parameters. 

Laboratories worldwide have different facilities, instrumentation, personnel, and perhaps differing procedures, which means that each laboratory actually requires its own work instructions. These work instructions have to be included in the quality system documentation of the laboratory. In constructing work instructions, the ROPs can offer consultancy (7). In addition, there are other useful literature available discussing the methods for analysis of CWC-related chemicals and giving examples on how the laboratories have performed in round-robin tests or PTs (8 l4). 

This thus requires a sampling plan that reflects the data quality objectives and analytical measurement subjected to the laboratory quality system (Swyngedouw and Lessard, 2007). The measurement uncertainty can be controlled and evaluated (Eurachem, 2000). The sampling variance may contain systematic and random components of error from population representation and sampling protocol. Note that the errors are separate and additive. This means that the laboratory cannot compensate for sampling errors. 

There can be no rule for how often pump oil should be changed. It cannot be done on an every two to three thousand mile basis, or even after 20 to 30 hours of operation. It may be necessary to change the oil as often as every day or as seldom as once every several years. It all depends on how often you use your system, what types of chemicals your system is being exposed to, how effective your trapping systems are, and how effectively you are using your gas ballast (if any) (see Sec. 7.3.5). If your system requires an oil change every six months, it does not mean that you only have to check it every six months. Monthly, or even weekly, oil quality checks are advised for any system. A log book, kept in the lab, with sections that note important data (as shown in Fig. 7.16) will help in lab maintenance. (This log book will also be of value when looking for leaks.)... 

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