Certified supplier

The industry regulates the certification bodies authorized to certify suppliers. 

The pull system requires that the suppliers to the component fabricator, the component fabricator, and the fabricator s customers work closely together. This is essential as there is little room for error that causes costly line down situations for the fabricators customer. The trend is also for each part of the chain, supplier, fabricator, and customer, to take responsibility for the quality and performance of their own products. This has resulted in a term in general use today, self-certified supplier. ... 

Kletz also provided several cases in which tank trucks have been filled with the wrong material. At the end of this section, he offered this sage-like advice, Suppliers papers tell us what they intend to deliver, not what is in the tank truck or car. We can find that out by analyzing the contents or by seeing what happens. Hopefully, in this day of ISO-certified suppliers, this is no longer a necessity. [10]... 

Contrary to a widespread misconception, the FDA itself does not approve computer systems neither does the FDA certify suppliers or consultants. Pharmaceutical and healthcare companies have... 

Testing schedules may take into account the nature and age of the material, the grading and history of the supplier, and any valid certificate of analysis. A valid certificate of analysis is one from an approved or certified supplier (see Glossary) which relates to a specific batch of material and which is in the proper form, dated and signed. It does not include a certificate of average or typical composition. 

APPROVED SUPPLIER A supplier of starting materials of known origin who is recognised as reliable, based on a history of deliveries which all met specifications and were well packaged and intact on receipt and, where possible, based also on a vendor audit (see also Certified Supplier). 

CERTIFIED SUPPLIER An Approved Supplier who has been formally audited by the purchaser and who meets AS3901 or 3902 requirements and is so certified by Standards Australia (see also Approved Supplier). 

When materials are received to be used in the manufacture of a pharmaceutical product, an inspection (and possible testing) is usually necessary before the materials are accepted. Materials may be stored in a separate quarantined area until they are released and approved for use. The use of certified suppliers has allowed some materials to be received and accepted without additional inspection or testing. The certified supplier may provide a certificate of analysis dociimenting that the material meets the required specifications. Certified suppliers are usually audited to insure that they meet the requirements for certification of the customer. 

Recent newspaper articles focused on lead paint used on Thomas the Tank Engine toys, industrial chemicals in toothpaste, industrial and not pharmaceutical ingredients in children s medicine, chemicals in children s toys that can convert to harmful chemicals when ingested, and contamination of dog food products all indicate that certifying supplier quality in a supply chain is an important component of the purchasing function. However, in the absence of easy-to-perform quality assurance testing, supplier certification and contract incentives play an important role in guaranteeing product quality. 

Certified supplier A supplier that has been approved for providing defined components for manufacturing or distribution. Certification levels may have varying conditions related to cjuahty management, such as needs for quality control. Suppliers are often qualified before financial terms are negotiated. 

If purchased radiopharmaceuticals are used without further processing (e.g. " Tc-radiopharmaceuticals in syringes, F-FDG in syringes or vial, in capsules), their receipt and supply to the nuclear medicine department is an administrative process. On receipt the certificate of analysis is checked under responsibility of the pharmacist and the radiopharmaceuticals are registered. In most situations no physical or chemical quality control is necessary. It is important to purchase only from a certified supplier. However, auditing and qualifying the supplier may be necessary. 

ET is a dominant unit of its supply chain and makes supply chain configuration decisions independently. The supply chain has a small number of fixed units since customers and suppliers are selected dynamically. Nevertheless, there is a portfolio of established customers and a pool of certified suppliers. There is a limited information sharing (the company gives suppliers in advance its own demand... 

Conduet joint quality planning Co-operate with the supplier during eontaet Obtain proof of eonformanee Certify qualified supplier... 

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 ... 

Regulatory requirements may apply to health, safety, environmental emissions, and electromagnetic compatibility and these often require accompanying certification of compliance. In cases where customers require suppliers to be certified to ISO/TS 16949 it imposes a regulatory requirement on the design process. 

The standard requires the supplier to calibrate and adjust all inspection, measuring, and test equipment including measurement devices at prescribed intervals, or prior to use, against certified equipment having a known valid relationship to nationally recognized standards. 

When an employer is unable to obtain an MSDS from a supplier or manufacturer, he/shc should submit a written complaint, witli complete background infoniiation, to the nearest OSHA area office. OSHA will tlien, at the same time, call and send a certified letter to he supplier or manufacturer to obtain the needed information. If the supplier or manufacturer still fails to respond within a reasonable time, OSHA will inspect the supplier or manufacturer and take appropriate enforcement action. 

In contrast to specifying to suppliers what chemicals or materials are restricted, it is useful to specify exactly what chemicals and materials are desired. Once a material or chemical is well characterized, and it is considered benign with respect to human and environmental health, it can be added to a preferred or positive list (i.e., P-list). For example, a textile manufacturer may source certified organic cotton, or polyester made with antimony-free catalysts, to develop a product line based on these fibres. Or a cleaning product formulator may seek bio-based solvents or rapidly biodegradable surfactants consistent with their product development objectives. 

The Promochem Group was the first international specialist supplier of certified reference materials (CRMs) and pharmaceutical reference substances used in environmental, medical and trace element analysis. Their experience provides a viewpoint that echoes, reinforces and expands on many of the trends discussed above (Jenks 1997). From the middle of the 1980 s, sales of CRM by Promochem increased between 10 % and 20 % annually, depending on the market sector and application. Since then National and International Metrology Institutes, such as the now privatized U.K. Laboratory of the Government Chemist (LGC), the European and U.S. Pharmacopoeias, the E.U. IRMM and others have recognized that efficient distribution of RMs, backed by available technical support, is as important as production and certification. Thus, they have moved to spread their influence outside their national origins. The Web and e-commerce will continue to grow as major facilitators of better information dissemination and supply of CRMs. 

Some reference material producers/suppliers use different names to describe their materials. For example, a Standard Reference Material (SRM) is a certified reference material issued by the National Institute of Standards and Technology (NIST), while European Reference Materials (ERMs) are CRMs produced under a joint collaboration between three European reference materials producers, i.e. BAM (Federal Institute for Materials Research and Testing, Germany), IRMM (European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Belgium) and LGC (UK). 

Similarly, organic liquids have a variety of applications. For example, hexane, which frequently contains impurities such as aromatic compounds, is used in a variety of applications for extracting non-polar chemicals from samples. The presence of impurities in the hexane may or may not be important for such applications. If, however, the hexane is to be used as a solvent for ultraviolet spectroscopy or for HPLC analysis with UV absorbance or fluorescence detection, the presence of aromatic impurities will render the hexane less transparent in the UV region. It is important to select the appropriate grade for the task you have. As an example, three different specifications for n-hexane ( Distol F , Certified HPLC and Certified AR ), available from Fisher Scientific UK, are shown in Figure 5.5 [10]. You will see that the suppliers provide extra, valuable information in their catalogue. 

Do you require suppliers to provide documentation that all piping and appurtenances are certified "for chlorine service" or "for sulfur dioxide service" by the manufacturer ... 

There was varied success with these inocula, as a number of unscrupulous operators supplied ineffective inoculants. Some states in the United States established laws that required inoculant suppliers to have their inoculants certified annually by a state agency. This generally was successful in discouraging distribution of ineffective inocula. 

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