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MANAGEMENT SYSTEMS CERTIFICATION BODIES

Accredi accredits management system certification bodies on the basis of the ISO/IEC 17021 standard. Certification bodies are assessed based on their independence, integrity and technical competence. They have to demonstrate a level of competence, within their area of operation and the audit organization management systems that fulfils the requirements of ISO 9001, ISO 14001, ISO 22000 or other international standards.

 

Scope of Accreditation

 

A certification body’s scope of accreditation indicates which management systems it is accredited to assess and certify:

 

  • Quality Management Systems
  • Energy Management Systems
  • Environmental Management Systems
  • Food Safety Management Systems
  • Occupational Health And Safety Management Systems
  • Information Security Management Systems
  • Service Management Systems
  • Business Continuity Management Systems
  • Management Systems For Manufacturers of Medical Devices

 

All certification bodies are eligible to apply for the above accreditation schemes.

CALIBRATION AND TESTING LABORATORIES

Accredi accredits laboratories on the basis of the ISO/IEC 17025 standard. Accredi accreditation is only granted for specific tests and calibrations in specific fields. Laboratories are only allowed to issue endorsed reports for accredited tests and calibrations.

 

Scope of Accreditation

 

Accredi offers specialty programs in the following areas:

 

  • Agriculture, food, animal health, and plant protection
  • Calibration
  • Environmental
  • Fasteners
  • Forensic
  • IT security evaluation and testing
  • Mineral analysis
  • Test method development and non-routine testing
  • Medical laboratories
  • Proficiency testing

 

All certification bodies are eligible to apply for the above accreditation schemes.

PRODUCT CERTIFICATION BODIES

Accredi accredits product certification bodies on the basis of the ISO/IEC 17065 standard. Product certification bodies determine whether products, services or manufacturing processes meet requirement. A major difference is that they do not just inspect a single sample or a single batch but they also inspect the company. They also assess subsequent products to verify if a batch of products meets the specified requirements for example? And verify the consistency if the next batch is produced in the same way. Complying manufacturers can use the relevant mark. A product certifying body continues to provide ongoing supervision.

INSPECTION BODIES

Accredi accredits inspection bodies on the basis of the ISO/IEC 17020 standard.Inspection covers a wide array of activities/services. It is the examination of a product design, product service or process/plant. It also involves determining its conformity, either against specific requirements or on the basis of professional judgment. Achieving effective inspection is important in maintaining the safety of plant machinery, equipment, structures and systems in operation.

PROFICIENCY TESTING PROVIDERS

Accredi accredits proficiency testing providers on the basis of the ISO/IEC 17043 standard.Proficiency testing involves the use of inter-laboratory comparisons for the determination of laboratory performance. PTP’s ensure that all samples have precisely the same composition and that the results obtained are processed in the correct way. Calibration laboratories, test laboratories and medical laboratories regularly have to take part in proficiency testing. For a proficiency test various laboratories are sent the same sample, which could be blood, sludge or drinking water for example. The composition of the sample is known to the organiser. The laboratories test the sample and send their results to the organising party who then checks whether the results are mutually comparable and reports on this to the participants. This guarantees that a laboratory produces reliable results. The need for ongoing confidence in laboratory performance is not only essential for laboratories and their customers but also for other interested parties such as regulators and accreditation bodies.

PERSONNEL CERTIFICATION BODIES

Accredi accredits personnel certification bodies on the basis of the ISO/IEC 17024 standard. Accreditation of a personnel certification body is the process of assessing and publicly recognizing the credibility, impartiality and technical competence of an organization’s personnel certification services. Personnel certification bodies provide services for many professional and trade persons, such as auditors, welders and doctors. The role of certification bodies involves assessing the individuals’ necessary competencies, and ensuring that these are appropriate to the work being performed. The major difference between this and a diploma is the certification involves ongoing supervision. A certificate therefore has a specific period of validity.

GOOD MANUFACTURING PRACTICE

Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public. Good manufacturing practices, along with good agricultural practices, good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United Kingdom, United States, Canada, Europe, China, and other countries.

GOOD LABORATORY PRACTICE

The Organization for Economic Cooperation and Development (OECD) Principles of Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. Nonclinical health and environmental safety studies covered by the principles of GLP include work conducted in the laboratory, in greenhouses, and in the field. GLP principles are applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives and industrial chemicals.

GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES

The Good Distribution Practice for Medical Devices (GDPMD) specifies that a quality management system shall be established, implemented and maintained by an establishment carrying out activities in the medical devices act. It requires an establishment to demonstrate its ability to maintain the quality, safety and performance of medical while its custody. It is applicable to all parties involved in the supply-chain of medical devices covering authorized representatives of foreign manufacturers, importers and distributors of medical devices. Good Distribution Practice (GDP) is that part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation or product specification. In order to provide such assurance, companies will require more than just a set of quality manuals, it requires a comprehensive system to “give assurance”. This may include appropriate procedures, suitably trained and qualified personnel, correct processes / facilities / equipment as well as clear and timely records and documentation, to credibly demonstrate the consistency of quality assurance.

GOOD CLINICAL PRACTICES

International Conference on Harmonization (ICH)’s Good Clinical Practices (GCP) is an ethical and scientific quality standard for designing, conducting and recording trials that involve the participation of human subjects. Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. Compliance with this standard provides assurance to public that the rights, safety and well being of trial subjects are protected and ensures that clinical trial data are credible. It also provides assurance of the safety and efficacy of the newly developed compounds.

GREEN HOUSE GAS VALIDATION & VERIFICATION BODIES

ISO 14065, Green House Gases – requirements for Green House Gas validation & verification bodies for using accreditation or other forms of recognition. The ACCAB offers accreditation of Green House Gas (GHG) Validation & Verification bodies to ISO 14065 standard. ISO 14065:2007 Green House Gases requirements for Green House Gas validation & verification bodies for using accreditation or other forms of recognition.

BESPOKE ACCREDITATION

Traditionally industry, trade, business, and professional associations as well as chambers of commerce have played and will continue to play a significant role as a critical link between entrepreneurs and the government. The contributions of these various associations thought to be immense in terms of securing the general acceptance of industry standards, encouraging and enforcing codes of ethics, , and increasing the economic welfare of members and individuals. Same is the case with the Conformity Assessment Bodies who wish to offer conformity assessment services where an established Standard/ Guide is not available. In order to satisfy these requirements, in consultation with the Technical Advisory Committee will decide on the suitable accreditation criteria keeping the relevant stakeholders interest in mind.

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