Guidelines for the Development of Standards

There are guidelines for the recovery and recycling of plastics waste (78). The standard ISO 15270 2008 provides a guideline for the development of standards and specifications covering plastics waste recovery, including recycling. 

This standard establishes the different options for the recovery of plastics waste arising from pre-consumer and post-consumer sources. It also establishes the quality requirements that should be considered in all steps of the recovery process, and provides general recommendations for inclusion in material standards, test standards and product specifications. Consequently, the process stages, requirements, recommendations and terminology presented in the standard are intended to be of general applicability. 

Proper methods for the preparation of test samples that can be used for the determination of the ultimate aerobic and anaerobic biodegradability of plastic materials in an aqueous medium, soil, controlled compost or anaerobic digesting sludge have been standardized. These should result in an improved reproducibility of the test results during the assessment of the biodegradability (79). 

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W. D. Pocklington, Guidelines for the Development of Standard Methods by Collaborative Study (V Edition), Laboratory of the Government Chemist, Teddington, ISBN 0 94892606 6,1990, ix -I- 258 pp. 

National Committee for Clinical Laboratory Standards, NRSCL 3-T (National Reference System for the Clinical Laboratory) Guidelines for the Development of Certified Reference Materials for Use in Clinical Chemistry, National Committee for Clinical Laboratory Standards, Villanova, 1984. 

For this reason, more and more standards and guidelines for the development of safety-relevant systems demand safety analyses for the system and the software as part of a rigorous development process. Examples of this are lEC 61508 [1], lEC/TR 80002 [2], MISRA safety analysis guidelines [3], and ISO 26262 [4]. ISO 26262 is a committee draft for the development of road vehicles. It defines requirements on the development of electrical and electronic systems and particularly requirements on the development of software, which include qualitative safety analysis for software architecture as well as for software unit design. However performing a qualitative safety analysis technique such as failure mode and effect analysis (FMEA) or fault tree analysis (FTA) on software architectmal design is a complex task. One reason for this is that safety analyses do not fit well with software architectural design and do not... 

ISO 9000-3 1997, Quality Management and Quality Assurance Standards — Part 3 Guidelines for the Application of ISO 9001 1994 to the Development, Supply, Installation, and Maintenance of Computer Software. 

The FDA is announcing the Agency s policy on the development and use of standards with respect to international harmonization of regulatory requirements and guidelines. Specifically, the policy is intended to address the conditions under which the FDA plans to participate with standards bodies outside of the FDA, domestic or international, in the development of standards applicable to products regulated by the FDA. The policy also covers the conditions under which the FDA intends to use the resultant standards, or other available domestic or international standards, in fulfilling its statutory mandates for safeguarding the public health. 

ISO 9004. This standard, like ISO 9000, is advisory providing guidelines for the development and application of an internal quality management system. 

Syndromic surveillance is a work in progress. There is a need for continued development of standardized signal detection methods and signal response protocols (Henning, 2004). Also, whereas reporting of patient information as part of traditional public health surveillance has been deemed exempt from the confidentiality guidelines in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), how those guidelines may be applicable to syndromic surveillance systems remains unclear (Buehler, 2004). 

ISO 9000-3 1997 Quality management and quality assurance standards Part 3. Guidelines for the application of ISO 9001 1994 to the development, supply, installation and maintenance of computer software. BSI 1998. 

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