ISO 9000 accreditation

To receive ISO 9000 accreditation, a certification body must meet the requirements of ISO Guide 62 and EN 45012, which invokes ISO 10011. There is normally a mark of accreditation (a Grown and Tick in the case of UKAS accreditation) that certification bodies use to signify their credibility. Once accredited, a certification body may perform audits on suppliers offering products and services within the scope of accreditation. In theory, accreditation is granted only if the certification body has expertise (i.e. competent auditors) for the particular industry sectors (EAG codes) requested. 

Commonly Found Errors According to an American Chemical Society short course in which the concepts of GLP regulations and ISO 9000 accreditation are discussed, errors that the QAU commonly finds in the course of its work are mostly errors of record-keeping. The list provided at the short course is reproduced in Box 8.1. 

ISO 9000 accreditation for quality management fully satisfies the requirements of validation for GxP. This is not true in relation to the 1994 standards, althongh ISO 9001 1994 (supply of goods or services) and ISO 9000-3 1997(snpply of software) and their replacements, ISO 9001 2000 and ISO 9004 2000, do provide a good basis for validation. 

The supplier s Project and Qnality Plans specify project responsibilities, procedures, and deliverable documentation. The supplier s scope of work usually revolves around Design and Development, Coding, Configuration and Bnild, and Development Testing. The URS and User Qualification may also be specified in the plans as reqnested by a pharmacentical or healthcare company. The supplier firm should be encouraged to include a statement of its development capability for the service or equipment they are providing. This statement conld be based on a firm s ISO 9000 accreditation. Resumes of key staff should be available to support the capability statement. 

Presentation of an ISO 9000-accredited quality system, adherence to established company and industry practices, and use of competent personnel. 

It has been shown many times that just because the LIMS supplier is ISO 9000 accredited does not mean the supplier is a quality supplier of software products. This is because the LIMS supplier is often accredited for the implementation and integration of LIMS, rather than the development of software. In these cases, the only way of gaining confidence in the approach to be taken in the software development, testing and change control processes is to visit the LIMS supplier s premises. Where a supplier is accredited to ISO 9000-3 (TickIT), this will give the manufacturer greater confidence that a defined life cycle is followed because it is specifically aligned with the production of software. 

ISO 9000 To gain ISO 9000 accreditation an organization has to demonstrate to an accredited auditor that they have a well-documented standard and consistent process in place which achieves a defined level of quality or performance. ISO accreditation win give a customer confidence that the product or service provided will meet certain specified standards of performance and that the product or service will always he consistent with the documented standards. 

Order qualifiers are factors that are regarded by the market as an entry ticket. Unless the product or service meets basic performance standards, it will not be taken seriously. An example is quality accreditation a possible supplier to major utilities such as PowerGen in Britain and EOF in France would not be considered seriously without ISO 9000 certification. And delivery reliability is a must for newspapers - yesterday s news is worthless. Note that, in both examples, order qualifiers are order-losing sensitive loss of ISO 9000 accreditation would make it impossible to supply to major utilities, and late delivery of newspapers would miss the market. 

ISO 9000 is not a statutory requirement and neither is certification, hence certification is voluntary. However, suppliers may be under pressure to obtain registration to ISO 9001, ISO 9002, or ISO 9003 in order to tender for contracts. Within the ISO 9000 certification scheme, the certification industry is regulated by accreditation bodies. An International Accreditation Forum (lAF) attempts to harmonize accreditation practices world-wide through ISO Guide 61. The accreditation bodies authorize certification bodies to conduct certification to prescribed standards - a process that is called accreditation. The accreditation body performs witness audits and desk audits of the certification body to ensure compliance with the conditions of accreditation. 

The certification business has grown enormously in the last ten years. The International Accreditation Forum (lAF) recorded 616 accredited certification bodies in January 1999. The experience of the vehicle manufacturers with ISO 9000 certification led them to question the wisdom of so many certification bodies chasing the same business in a competitive market. The results seemed to indicate that cost reductions by the certification bodies led to a decline in the quality of auditing and that was the opposite of what the vehicle manufacturers wanted. The vehicle manufacturers had not seen a significant rise in product quality as a result of ISO 9000 and they believed this was partially due to the quality of the accreditation and certification schemes being operated as well as inadequacies in the quality system standard. When the four national automotive schemes were launched, great emphasis was placed on regulating more closely the accreditation and certification schemes. From a customer perspective, the ISO 10011 scheme had some particular problems ... 

This would check the certification status of the quality system, verifying that any certification was properly accredited. For non-ISO 9000 registered subcontractors, a quality system assessment may be carried out at this stage either to ISO 9000 or the customer s standards. 

The main issue that should be taken into accoimt is that certification and accreditation serve different tasks. The standards used in each case illustrate this difference. The ISO 9000 standards were originally developed to enable manufacturers to demonstrate to all interested parties that they are exercising control over the whole procedme they cany out and over its quality. 

A specification agreed with a supplier is not a guarantee that all deliveries will fully comply with it and arrive in full and on time. A Certificate of Analysis adds confidence and if the supplier is accredited to the ISO 9000 series or a national equivalent it shows that the quality systems have been independently audited and found to be acceptable. However, there is no substitute for regular performance reviews, backed up as appropriate by audits of the manufacturing facilities and quality systems (including incoming raw materials). This is a very onerous and time-consuming exercise, well beyond the resources of most soft drink manufacturers. 

For laboratory accreditation, based on ISO guide 25 [27] and the EN 45001 standard, as well as for certification, based on the ISO 9000 series of standards [1], it is required that measurement and test results be traceable to international, defined, and accepted physical and physicochemical standards [28], This requirement includes the use of conventionally expressed quantities and units in conformity with the SI [29], It also includes the proper use of the concept of measurement uncertainty. All these are necessary conditions for reliance on the measurement results of another laboratory. Accreditation is granted when a laboratory has demonstrated that it is competent and capable of working in the above-mentioned sense. Technical trade barriers then fall away, and the needs and requests from industrialists, traders, and the general public can be met in the interest of open and fair trade, health, safety, and the environment. 

In the near future quality assurance elements as recommended by the quality guidelines ISO 9000-9004 will certainly also be applied to pharmaceutical developers, manufacturers and to sales organizations. A formal accreditation of compliance with these standards requires the implementation of quality assurance schemes, covering for example the following aspects of a business ... 

For ISO 9000 approval there are several certification bodies who register and certify companies meeting the requirements. In the UK such certification bodies must themselves be accredited by UKAS as competent to carry out certifications. For GLP. the GLP Monitoring Authority of the Medicines Control Agency issues a letter of compliance to an approved laboratory. This is restricted to laboratories carrying out safety studies as described above. However, any laboratory may state they work within the GLP guidelines. In the case of accreditation by UKAS, a Certificate of Accreditation is issued which relates to specific tests or calibrations. Laboratories will be included in UKAS s list of accredited laboratories, i.c. UKAS Directory of Accredited Labora-... 

Audits are usually conducted by an audit team and led by a qualified, accredited auditor. Accredited auditors should have completed a certified development program, be accredited under an appropriate standard (ISO 9000 2000 TicklT in this context), and should have conducted a number of qualifying audits. Pharmaceutical and healthcare companies that do not have their own accredited auditors can engage an independent auditor, as we have seen. Names and addresses of accredited auditors can be found in national registers of certified auditors. The International Register of Certificated Auditors is one such register, associated with the Institute of Quality Assurance (IQA). 

Has accreditation/registration been achieved (ISO 9000, specify other)... 

ISO certification is carried out by accredited organizations known as registrars. Registrars review the organization s quality manual and audit the process to ensure that the system documented in the manual is in place and effective. When an organization receives ISO 9000 certification,... 

These themes of the ISO standards in no way contradict the themes that have been emphasized in the earlier and parallel pharmaceutical and medical devices GMP Regulations and Guides. Indeed many pharmaceutical companies are already putting pressure on their suppliers to gain accreditation with the ISO 9000 series of standards. It is possible that the way forward for GMPs in the sterile products manufacturing industry as a whole may eventually defer to these standards in the way of the Blue Guide. 

Laboratory accreditation in the U.S. is handled by more than ISO accrediting private and quasi-govemment bodies. Thus, there is a bewildering array to choose from as to which is the best accreditation for a laboratory. This will depend to some extent on the industry and the customers with which a laboratory does business. The most well known program is ISO 9000... 

A national Accreditation Body, such as the United Kingdom Accreditation Service (UKAS), accredits a certification body (e.g. Lloyds, BSI, etc.) who in turn certifies individual companies that make a voluntary application to them. This certification is based on successful audits by trained ISO 9000 auditors. The company maintains its ISO standards by means of internal auditors and by annual or biannual audits and regular follow-up audits from the certification body. 

NAMAS accreditation is similar to the ISO 9000 certification process, in that it requires a thorough assessment by independently appointed industry experts. Six months following accreditation, a full follow-up visit is made by UKAS, and aimual audits are made thereafter. Four years after accreditation a full re-accreditation assessment is made, although UKAS can make unannounced visits at any time. Laboratories found to be unsatisfactory on inspection will lose NAMAS accreditation until such time as that laboratory again meets the required standard. 

A aitical part of the successful introduction of an ERP system is in the early stages where Supplier Audits are vital to ensure confidence in the design of the software and control of software changes. It has been shown that acceptance of a software vendor simply on the basis of a quality accreditation, e.g., ISO 9000, is inadequate. The customer should carry out an audit of the supplier to review written proof of use of the claimed quality system. It is also essential to verify the quality system was used for the particular version of software to be implemented. 

---