Quality system definition

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. 

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. 

Many suppliers will already have methods in place that cover many of the requirements of ISO/TS 16949. What they may not have done, however, is to integrate these methods into a system that will cause conformity and prevent nonconformity. The ISO 8402 definition of a quality system makes it clear that a quality system is not just a set of procedures. It is the organization structure, processes, and resources to manage the achievement, control, and improvement of quality. 

If we look at ISO 10013, which is referenced for guidance in preparing a quality manual, we will see that it shows that the quality manual is a top-level document containing the stated quality policy, the quality objectives, and a description of the quality system (see Figure 2.2). The definition in ISO 8402 supports this concept and the requirement aligns with this definition. However, ISO 8402, ISO 10013, and the above requirement from ISO 9001 provide a choice as to whether the manual contains or refers to procedures. 

The definition of nonconformity in ISO 8402 states that it is the nonfulfillment of specified requirements therefore a nonconforming product is one that does not conform to the specified requirements. Specified requirements are either requirements prescribed by the customer and agreed by the supplier in a contract for products or services, or are requirements prescribed by the supplier which are perceived as satisfying a market need. This limits the term nonconformity to situations where you have failed to meet customer requirements. However, ISO 8402 1987 suggests that nonconformity also applies to the absence of one or more quality system elements, but clearly the requirements of clause 4.13 cannot be applied to nonconformity with quality s /stem requirements. Both ISO 9001 and ISO 9004 only address nonconformity in the context of products, processes, and services and when addressing quality system elements the term deficiencies is used. Some auditors use the term nonconformity to describe a departure from the requirements of ISO 9001 but it would be preferable if they chose the term noncompliance to avoid any confusion. The requirements of clause 4.13 therefore only apply to products, processes, and services and not to activities, quality system elements, or procedures. 

Some auditors believe that any document generated or used by the quality system is a quality record and will attempt to apply the requirements of clause 4.16. Whilst it can be argued that any documented output is a record of an activity, the reader is referred to ISO 8402 for a definition of records in the context of the quality system. ISO 8402 states that a record is a document which furnishes objective evidence of activities performed or results achieved. A quality record provides objective evidence of the fulfillment of the requirements for quality (e.g. product quality record) or the effectiveness of the operation of a quality system element (e.g. quality system record). 

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. 

The impact of this requirement depends upon what constitutes the specified requirements. The standard does not require you to demonstrate conformance with every requirement of ISO 9001. However, if your customer has invoked ISO 9001 in the contract, this clause requires that you maintain sufficient records to demonstrate compliance. As stated elsewhere in this book, there is no definition clarifying what specified requirements are. If specified requirements are a//the requirements that you have specified in your quality system, your plans, procedures, specifications, etc., this requirement may well be viewed as the most onerous in the standard. A pragmatic approach to take is to declare in your quality manual that the specified requirements are specified customer requirements . 

Overview of Definitions from ISO 9004 Quality Management and Quality Systems Elements—... 

Although a united compost quality system of the European Union does not exist, the European Compost Network (ECN), as an initiative of the ORBIT Association developed a Quality Assurance System providing the necessary background information and documentation to build up a European Quality Assurance System (ECN-QAS). Product definitions and characterizations of this system are shown in Table 12.7. 

Recent initiatives by global organizations such as ISO (International Organization for Standardization, www.iso.org) and ICH (International Conference on Harmonization, www.ich.org) are attempting to bring consistency in concept and standardization in definition to the QMS. In 2004, the Pharmaceutical Inspection Co-Operation Scheme (PIC/S, www.picscheme.org) issued its recommendation on Quality System Requirements for Pharmaceutical Inspectorates. The U.S. Food and Drug Administration (FDA) initiated inspection surveillance approaches based upon QMS organization and is another source of definition and interpretation. 

While the object of this chapter is to introduce readers to the science of polyurethane design, it is best to begin with definitions of terms. When physical requirements are to be addressed, quality system disciplines dictate that a system of analysis be established to monitor compliance with the design. For instance, if a device is to allow the flow of water through a foam, a system that can be validated to indicate flow rate or pressure drop must be established. 

Because the NELAC standards are general, they require interpretation or clarification in certain areas of application. That is why the US DOD undertook a task of specifying some of these broad areas in definite terms in a manual that unifies laboratory requirements of the Navy, Air Force, and United States Army Corps of Engineers (DOD, 2000). This manual, titled Department of Defense Quality Systems Manual for Environmental Laboratories, is offered to the DOD representatives and contractors who design, implement, and oversee contracts with environmental laboratories. Currently, the three DOD branches implement their own laboratory accreditation programs with some reciprocity between the three a task force has been created to combine these programs into a single DOD accreditation process. 

A quality audit has been defined as A systematic, independent examination of a manufacturer s quality system that is performed at defined intervals and sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives 21 CFR 820.2 (t). Another definition is Quality Audit A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives (International Organization for Standardization/American Society for Quality Control). 

As of this writing, there are a number of outstanding issues that remain unresolved and that could threaten the viability of the MRA. One of FDA s biggest concerns is the unharmonized definition of GMP and the EU member states interpretation and enforcement of quality system standards. Another potential problem is the EU s reluctance to conduct inspections of APIs, despite their inclusion in the pharmaceutical GMP annex. 

There are several reasons why a quality system must be fully documented. Firstly it is a pre-requisite of most quality standards. Secondly, in most laboratories it would be impossible to accurately remember and hence communicate all of the analytical methodology and quality management procedure to staff. This would lead to the quality system becoming compromised due to slalT turnover. Thirdly the process of audit (see Section 5.1) requires a precise definition of the planned quality system. This is provided by the documentation. 

The Quality unit has failed to ensure that procedures are in place, which define all system definition documentation, which must be maintained for the WAN. 

The Quality unit has failed to ensure that complete WAN system definition documentation is included in WAN documentation. For example, the Quality unit has failed to ensure that the WAN validation documentation includes WAN site diagrams. 

In order to attain its purpose, any quality system needs to define very clearly the different levels of responsibility. The definition of the test facility management serves to delineate these responsibility borderlines, and it invests test facility management with the ultimate power for ensuring GLP compliance. 

Definition of the main directions for the improvement of the air quality system. 

Before discussing the various quality systems encountered by the pharmaceutical analyst, I would like to more clearly define some of the quality terms that are used to ensure some consistency, as these definitions may vary depending on the quality system. These definitions are taken from the GMP guide for API, ICH Q7A [3] as there is a good chance that more than one interested group has input into the definition. 

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