About Accreditation & Conformity Assessment
International Organization for Standardization
International Standards
"Voluntary Standards" become mandatory only when they are incorporated into contracts; or they are referenced or adopted by government agencies as part of a regulation to protect public health, safety, and the environment;
The difference between a standard and a technical regulation lies in compliance. While conformity with standards is voluntary, technical regulations are by nature mandatory.
Conformity Assesment
- Ensure the conformance of products/services with relevant standards (ISO, IEC/BIS etc);
- Encourage international trade (tries to check trade malpractices);
- Prevent sale of substandard/unsafe product;
- Prevent importation of substandard products;
- Save lives and property;
- Prevent pollution of air and water;
- Conserve hard-earned foreign exchange.
Accreditation
- Webster defines accreditation as to give trust or confidence to: to vouch for; to recommend; to furnish with credentials, as an envoy or ambassador.
- According to ISO/IEC 17011:2017 Accreditation means: Third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific assessment tasks.
- It is a formal recognition by an independent body, generally known as an accreditation body, certifies Conformity Assessment Body to be capable and competent. Accreditation is not obligatory but it adds another level of confidence, as accredited means the Conformity Assessment Body has been independently checked to make sure it operates according to international standards.
- As per International Organization For Standardization (ISO) Accreditation is not compulsory, and non-accreditation does not necessarily mean it is not reputable, but it does provide independent confirmation of competence.
- PAC accreditation of the Conformity Assessment Bodies (CABs) conveys formal demonstration to carry out specific certification, inspection, registration verification/validation, assessment, testing and calibration. This independent assessment and recognition of Conformity Assessment Bodies (CABs) may allow the accredited organizations tests, inspection reports and certificates to be recognized as equivalent to organizations in other countries.
Benefits of Accreditation
- Accreditation is a trade support tool for recognition of a level of organizational competence as per the requirements of internationally agreed standards and other benchmarks that is comparable to other conformity assessment bodies accredited by the same accrediting body.
- Accreditation of a conformity assessment body signifies that its systems and processes are under regular oversight to be competent, effective, efficient, accountable, improvement oriented and has adequate resources while providing services.
- Accredited service quality implies meeting or exceeding the international standards.
PAC Accreditation Schemes
Management System Certification Bodies
- Demonstrates compliance with ISO/IEC 17021
- Provides the credentials that ensure certification marks will have acceptance in the marketplace and by governmental agencies that regulate service or product acceptance
- PAC accreditation is accepted by regulators and the marketplace
- Assurance of competence and best practices
- Reduce duplication of audits by other third-party providers
PAC Accreditation Scheme for the Management Systems Certification Bodies Programmes
Inspection Bodies
"ISO/IEC 17020:2012 - General Criteria for the Operation of Various Types of Bodies Performing Inspection" is an internationally recognized standard for the competence of the inspection bodies. Many people confuse ISO 17020 with ISO 9001, which is a generic quality management system. ISO 17020 requires evaluation of the technical competence of an inspection body.
PAC Accreditation requires that Inspection Bodies must conform to the most recent version of the following standards:
- ISO/IEC 17020:2012 - General Criteria for the Operation of Various Types of Bodies Performing Inspection;
- Demonstrated Technical Competence specific to the field in which inspection is done;
- The PAC Accreditation Scheme Manual.
Testing & Calibration Laboratories
Available For Classifications
- ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories.
- Demonstrated Technical Competence specific to the field in which Testing is performed.
- Relevant PAC Accreditation Requirements.
Product Certification Bodies
ISO/IEC 17065:2012 Conformity Assessment-requirements for bodies certifying products, process & services (or EN 45011 as it is known in its European version) is for those certification bodies that require demonstrating their competence to certain regulatory authorities. /IEC 17065:2012 accreditation is to be performed against a reference standard or standards. The reference standard may be the production and processing standards of a national regulation (often a national standard) but may also be your own or another organization's private standard.
Product Certification Bodies must conform to the most recent version of the following standards
- ISO/IEC 17065:2012 Conformity Assessment - requirements for bodies certifying products, process & services
- Demonstrated Technical Competence specific to the field in which product certification is done.
- Relevant PAC Accreditation Requirements.
Person Certification Bodies
ISO/IEC 17024:2012 Conformity assessment - General requirements for bodies operating certification of persons. This standard provides a benchmark for certification bodies offering certification of individuals applicable to any occupation.
- ISO/IEC 17024:2012 Conformity assessment - General requirements for bodies operating certification of persons.
- Relevant PAC Accreditation Requirements.
Medical Laboratories
ISO 15189:2012 which defines particular requirements for the quality and competence of medical laboratories. It may be noted that the medical laboratories accredited to ISO 15189:2012 (a sector-specific technical competence and management system standard) are recognized as meeting the management system principles of ISO 9001:2008. Medical laboratories services are essential to patient care and include arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent validation, interpretation, reporting and advice, in additions to the considerations of safety and ethics in the laboratory.
PAC Accreditation Is Available Primarily For The Following Classifications
Pathology, Chemistry , Cytogenetics, Hematology, Histocompatibility, Immunology, Microbiology, Point of Care Testing, Immunohaematology and Imaging.
PAC Accreditation must conform to the most recent version of the following standards
- ISO 15189:2012 - Medical laboratories - Particular requirements for quality and competence.
- Demonstrated Technical Competence specific to the field in which Testing is performed.
- Relevant PAC Accreditation Requirements.
Proficiency Testing Providers
ISO/IEC 17043 Standard is mainly used for Proficiency Testing.ISO/IEC 17043 is used for inter-Laboratory comparison of Determining the Performance of individual laboratories for specific tests. The primary objective of Proficiency testing is to provide the Laboratories with an information and support to demonstrate and improve the quality of their analytical measurement.
Accreditation requires that the Proficiency Testing Providers to the most recent version of the following standards
- ISO/IEC 17043:2010 - Guidelines for the requirements for the competence of providers of proficiency testing schemes.
- Demonstrated Technical Competence specific to the field in which Testing is performed.
- The PAC Accreditation Scheme Manual.
Apply for Accreditation now
Accreditation Process & Time Frame
About Accreditation Process & Time Frame
How to Apply for Accreditation
Cost of Accreditation
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