Quality systems defined

Any activity that affects the ability of a product or service to satisfy stated or implied needs or the organization s ability to satisfy those needs. If the quality system defines the activities that need to be executed to achieve quality then any activity specified in the documented quality system is also a quality activity. 

To obtain a realistic assessment, the method and detail of the purchaser s evaluation of a new supplier must be formalised, and the results documented. The opportunity must be taken to view the supplier under normal operating conditions, with the involvement of the relevant technical staff. Systems of working routines must be made available and the operation of quality systems defined. The supplier company should explain its organisation (line/functional disposition), its personnel training policy, and its philosophy and commitment to quality. 

These responsibdities are further elaborated on in QIO by stating that Senior management has the ultimate responsibility to achieve the quality objectives. Management should participate in the design, implementation, monitoring and maintenance of an effective pharmaceutical quality system, define individual and collective roles, responsibilities, authorities and inter-relationships of all organisational units related to the pharmaceutical quality system. 

All these standards have since been adopted by the member countries as their national standards, fully or in slightly modified forms, to suit their own requirements and working conditions. These standards define and clarify the quality norms and aim at in-house quality disciplines, to automatically and continually produce a product, provide a service or programme to the stipulated specifications, quality norms and customer needs. They guarantee a product or service with a minimum quality. The envisaged quality systems thus aim at a work culture that pervades all those involved in different key activities or processes, to achieve the desired goal through carefully evolved systems. 

Modern management systems stress the need for continuous monitoring of defined systems and procedures for enforcement and improvement of quality systems. These should minimize immediately and eliminate ultimately the recurrence of simihir problems through preventive measures. 

Often in plant operations condensate at high pressures are let down to lower pressures. In such situations some low-pressure flash steam is produced, and the low-pressure condensate is either sent to a power plant or is cascaded to a lower pressure level. The following analysis solves the mass and heat balances that describe such a system, and can be used as an approximate calculation procedure. Refer to Figure 2 for a simplified view of the system and the basis for developing the mass and energy balances. We consider the condensate to be at pressure Pj and temperature tj, from whence it is let down to pressure 2. The saturation temperature at pressure Pj is tj. The vapor flow is defined as V Ibs/hr, and the condensate quality is defined as L Ibs/hr. The mass balance derived from Figure 2 is ... 

These are the characteristics which need to be specified and their achievement controlled, assured, improved, managed, and demonstrated. These are the characteristics which form the subject matter of the specified requirements referred to in ISO 9000. When the value of these characteristics is quantified or qualified they are termed quality requirements or requirements for quality. ISO 8402 1994 defines requirements for quality as an expression of the needs or their translation into a set of quantitatively or qualitatively stated requirements for the characteristics of an entity to enable its realization and examination. While rather verbose, this definition removes the confusion over quality requirements and technical requirements. (An additional definition is provided in Appendix A.) Technical requirements for a product or service are quality requirements. The requirements of ISO 9000 are quality system requirements. 

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. 

Does ISO 9001 require the other types of policies to be defined and documented There is no requirement in clause 4.1.1 but in clause 4.2.2 there is a requirement to prepare a quality manual covering the requirements of the standard and this is where you should document your operational policies. While the quality manual could simply contain the quality system procedures, the guidelines given in ISO 10013 clearly indicate that whether or not this is the case, the manual should describe the organization s policies for meeting the requirements of the standard. These aspects are addressed in Part 2 Chapter 2. 

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. 

A problem is the difference between the way things are and the way things ought to be, as perceived by the one identifying it. A problem relating to the product, process, or quality system (or quality problem) is therefore a difference between what has been achieved and what is required. There is no requirement in this clause for you to actually identify and record such problems (see below). You are only required to define the... 

The standard requires that the quality system be reviewed at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of ISO 9001 and the supplier s stated quality policy and objectives. There is also a supplementary requirement in clause 4.2.8 for the performance of the system to be evaluated to verify the effectiveness of its operation. 

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

This requirement clearly defines the purpose of a quality system, that of ensuring that products conform to specified requirements. One of the principal differences between ISO 9000 and ISO/TS 16949 is the emphasis placed on internal efficiency and effectiveness. Implementing the requirements of ISO/TS 16949 will cause the waste, errors, and internal costs to be minimized. Unlike ISO 9001, ISO/TS 16949 requires the system to enable the organization to implement its quality policy and achieve its quality objectives, which after all is its purpose. This fundamental shift in concept is also behind the changes being made to ISO 9000 in the year 2000 edition. 

One of the first decisions to take should be to define the purpose of the quality system, what you want it to do, why you want to create it. Your reasons for creating a documented quality system may be to ... 

These are only some of the reasons for creating a quality system. Whatever your reasons are, define and document them and review them frequently. When you evaluate the system these reasons will help determine whether your system is effective (see Part 2 Chapter 17). 

The standard only requires the documentation covering the requirements of the standard to be defined in a quality manual. If your quality system covers areas outside the scope of ISO/TS 16949, as it may if you have used ISO 9004 as the basis for designing the system, or if you have included more functions of the business than addressed in ISO/TS 16949, this raises several questions ... 

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-... 

The standard only refers to procedures as the category of quality system documentation. If we use the term documented practices we have a wider choice as to the types of documents we put into the quality system. Many documents are not procedures. They do not tell us how to proceed or specify a way to perform an activity. They specify criteria we must meet or provide guidance in conducting a task. They may, however, give examples or define rules to follow. 

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. 

This requirement should have been unnecessary since clause 4.2.1 requires the quality system to be maintained. However, what it does do is overcome any ambiguity by defining the occasions when the control plan has to be updated. 

Define what you want your quality system to do - define its purpose. 

Determine the hierarchy of documentation which you intend to produce to define your quality system (the number and content of the volumes of procedures etc.)... 

Define what types of document constitute your quality system. 

What is the purpose of the quality system and where is it defined ... 

Documents and data that relate to the requirements of the standard could be interpreted as including all the documents and data you produce, or be limited to those documents that are essential to the achievement and demonstration of quality. The requirement can be quite onerous because it requires that every document has an associated governing procedure. So if you include memoranda in your system, you will need a procedure to control them. The way out of this maze is to use the quality system to define the documents that need to be controlled. 

The standard provides a choice as to whether you define the inspections and tests required in a quality plan or in documented procedures. You may of course need to do both. As the quality system is often designed to accommodate all products and services you supply, it may not specify inspections and tests which are needed for particular products. This is one of the roles of the quality plan. Within such a plan you should identify the verification stages during product development, production, installation, and servicing as applicable. These stages will vary depending on the product, so your quality plan will be product, contract, or project specific (see Part 2 Chapter 2). There may... 

Whichever method applies you should define it within your quality system. You should maintain lists of all the devices that require calibration and indicate in these lists ... 

The documents that define the calibration process themselves are derived documents and therefore will be governed by your control procedure. They do not need to be listed along with all your other control and operating procedures in the index of quality system documents. A separate index of calibration methods should be maintained. Calibration methods are like test and inspection procedures, they are product specific. 

If a quality record was intended to be any document generated or used by the quality system, the definition would surely have indicated this. If we decompose the definition further, requirements for quality are defined in ISO 8402 as the expression of the needs or their translation into a set of quantitatively stated requirements for the characteristics of an entity to enable its realization and examination. Clearly, such a requirement would be a contract, product specification, design requirement, etc. This implies that any product verification records are quality records, but it rules out any recorded information as being a quality record. 

Planned arrangements is another unusual term, especially when throughout the standard the terms documented quality system and documented procedures have been used. However, so that audits are not restricted to documented procedures and policies, the term planned arrangement has been used. It encompasses contracts, specifications, plans, objectives, strategies - in fact any arrangement made by the organization to satisfy customer needs. You therefore need to define what constitutes your planned arrangements. 

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