ISO/IEC 17021 was designed for all types of management systems, along with this standard, several other versions of 17021 have been published to meet the needs of specific management systems.

Including:

• ISO/IEC TS 17021-2 for environmental management systems
• ISO/IEC TS 17021-3 for quality management systems
• ISO/IEC TS 17021-4 for event sustainability management systems
• ISO/IEC TS 17021-5 for asset management systems
• ISO/IEC TS 17021-6 for business continuity management systems
• ISO/IEC TS 17021-7 for road traffic safety management systems
• ISO/IEC TS 17021-8 (under construction) for sustainable development in communities management systems
• ISO/IEC TS 17021-9 for anti-bribery management systems 
• ISO/IEC TS 17021-10 for occupational health and safety management systems

Accreditation to ISO/IEC 17020, Conformity assessment - Requirements for the operation of various types of bodies performing inspection, is gaining momentum in industries around the globe. The broad definition of inspection in the standard allows great flexibility in application from systems to services and raw material to finished products.

ISO/IEC 17020 incorporates same level of requirements for the organizational quality management system as ISO 9001 and ISO/IEC 17000 series standards such as ISO/IEC 17021-1, Conformity assessment - Requirements for bodies providing audit and certification of management systems, and ISO/IEC 17065, Conformity assessment - Requirements for bodies certifying products, processes and services. ISO/IEC 17020, however, puts greater emphasis on organizational ability to manage impartiality and conflicts of interest as well as the technical competence of people, inspection processes, and equipment.

Accredited inspection provides assurance of technically competent service and consistently reliable results, reducing costs and lowering risks. It is key in demonstrating that products, equipment, structures, and systems meet required specifications. Governments and industries around the world are increasingly requiring use of accredited inspection services.

Thorough examining a product (design & quality), service, process or plant is called "Inspection", which is also used to determine the conformity of the object against given requirements. ISO/IEC 17020:2012 is used to improve quality and accuracy of examination for Inspection Bodies.

The Professionals doing the inspection work are called inspectors and in wider term "Inspection Bodies". The Accreditation Scheme for these Bodies provides official recognition of the integrity and reliability of an inspection body’s services. Proper implementation of ISO 17020 is very important for overall maintenance of machinery, plant, tools, infrastructure, processes and system itself.

Inspection Bodies Accreditation, monitors technical competence of quality management system and provides guidelines to achieve consistent and accurate inspection processes.

Accreditation to ISO/IEC 17020, Conformity assessment - Requirements for the operation of various types of bodies performing inspection, is gaining momentum in industries around the globe. The broad definition of inspection in the standard allows great flexibility in application from systems to services and raw material to finished products.

ISO/IEC 17020 incorporates same level of requirements for the organizational quality management system as ISO 9001 and ISO/IEC 17000 series standards such as ISO/IEC 17021-1, Conformity assessment - Requirements for bodies providing audit and certification of management systems, and ISO/IEC 17065, Conformity assessment - Requirements for bodies certifying products, processes and services. ISO/IEC 17020, however, puts greater emphasis on organizational ability to manage impartiality and conflicts of interest as well as the technical competence of people, inspection processes, and equipment.

Accredited inspection provides assurance of technically competent service and consistently reliable results, reducing costs and lowering risks. It is key in demonstrating that products, equipment, structures, and systems meet required specifications. Governments and industries around the world are increasingly requiring use of accredited inspection services.

Thorough examining a product (design & quality), service, process or plant is called "Inspection", which is also used to determine the conformity of the object against given requirements. ISO/IEC 17020:2012 is used to improve quality and accuracy of examination for Inspection Bodies.

The Professionals doing the inspection work are called inspectors and in wider term "Inspection Bodies". The Accreditation Scheme for these Bodies provides official recognition of the integrity and reliability of an inspection body’s services. Proper implementation of ISO 17020 is very important for overall maintenance of machinery, plant, tools, infrastructure, processes and system itself.

Inspection Bodies Accreditation, monitors technical competence of quality management system and provides guidelines to achieve consistent and accurate inspection processes.

Accreditation to this standard is patient-focused, impartial, objective, and operates within a good system. It provides many benefits such as those detailed below:

1. For Healthcare Regulators
   • provides an independent assurance of quality and safety,
   • provides a mechanism for measuring quality improvement,
   • supports consistency in the quality of care,
   • encourages innovation
2. For Patients
   • consistency in the quality of care,
   • up-to-date technologies and its procedures and techniques reflect current best practice,
   • Staff providing the service is competent to undertake the tasks they perform.
3. For Medical Laboratories
   • provides an opportunity for external perspectives on the laboratory�s practice,
   • can prevent the unnecessary duplication of information gathering on performance often required by regulatory bodies,
   • encourages the sharing of best practice,
   • reduces risk, and
   • Provides international recognition.

ISO 15189 standard for Medical Laboratories - Particular requirements for quality and competence - covers the essential elements for medical laboratories to demonstrate the quality and competence of their services, as well as to consistently deliver technically valid test or "examination" results as they are known in the standard. The standard, which has been developed with strong involvement from the medical, scientific and clinical community, is for the use of medical laboratories in developing their management systems and maintaining their own competence; and for accreditation bodies to confirm or recognize the competence of these laboratories through accreditation. Medical laboratory services are essential in the diagnosis and assessment of the health of patients. Their services encompass arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent result validation, interpretation, reporting and advice. Medical laboratory services should therefore meet the needs of all patients, clinical personnel responsible for patient care and any other interested parties. The laboratory's aim is not only to provide accurate results, but to do so for the right patient within a meaningful timeframe as regards clinical management, using appropriate laboratory procedures and with a respect for ethics, confidentiality and the safety of the patient. At present, the 2012 version is in the implementation. The standard mainly focuses on quality system requirements and technical requirements covering the quality assurance practices. This standard is applicable to mainly following types of laboratories:

1. Clinical Biochemistry
2. Clinical Pathology
3. Haematology and Immunohaematology
4. Microbiology and Serology
5. Histopathology
6. Cytopathology
7. Genetics
8. Nuclear medicine (in-vitro tests only)

ISO 15189 Medical Laboratory Accreditation in India

ISO 15189 standard for Medical Laboratories - Particular requirements for quality and competence - covers the essential elements for medical laboratories to demonstrate the quality and competence of their services, as well as to consistently deliver technically valid test or "examination" results as they are known in the standard. The standard, which has been developed with strong involvement from the medical, scientific and clinical community, is for the use of medical laboratories in developing their management systems and maintaining their own competence; and for accreditation bodies to confirm or recognize the competence of these laboratories through accreditation. Medical laboratory services are essential in the diagnosis and assessment of the health of patients. Their services encompass arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent result validation, interpretation, reporting and advice. Medical laboratory services should therefore meet the needs of all patients, clinical personnel responsible for patient care and any other interested parties. The laboratory's aim is not only to provide accurate results, but to do so for the right patient within a meaningful timeframe as regards clinical management, using appropriate laboratory procedures and with a respect for ethics, confidentiality and the safety of the patient. At present, the 2012 version is in the implementation. The standard mainly focuses on quality system requirements and technical requirements covering the quality assurance practices. This standard is applicable to mainly following types of laboratories:

1. Clinical Biochemistry
2. Clinical Pathology
3. Haematology and Immunohaematology
4. Microbiology and Serology
5. Histopathology
6. Cytopathology
7. Genetics
8. Nuclear medicine (in-vitro tests only)

ISO 15189:2012 Certification Consultancy

Punyam.com, a leading ISO and accreditation consultant in India, provides consultancy for ISO 15189:2012 Certification. The ISO 15189 certificate for accreditation is issued by accreditation bodies, such as NABL for India. and others. The ISO 15189:2012 certificate is issued for the period of 2 years after successful completion of pre-assessment and registration (final) assessment. Surveillance audit is conducted by the accreditation body after 1 year. Upon completion of 2 years, renewal audit for ISO 15189 systems is done and certificate is issued for 2 more years. After that, at every 2 years the renewal audit for ISO15189 accreditation is conducted without any surveillance.

Steps of ISO 15189 Accreditation Consultancy by Punyam.com

Punyam.com, a leading ISO 15189 Consultancy in India, is having vast industrial experience in the implementation of ISO 15189:2012 for all types of medical laboratories, such as clinical, pathology, microbiology, etc. Punyam implements the ISO 15189 system for its customers in the following manners:

1. Micro�level survey for each and every test parameter of the laboratory and preparation of detailed Gap Analysis report,
2. Preparation of applicable documents required by ISO 15189:2012 based on detailed study of all activities of the laboratory, such as;
   • ISO15189 Quality Manual,
   • Quality Procedures (Mandatory procedures required by the ISO 15189 standard),
   • Standard Operating Procedures (SOPs) to control identified activities having risk potential to the test parameter,
   • Formats to establish the objective evidence of implementation and to ensure control over all the activities,
3. ISO 15189 awareness training to all levels of employees within the laboratory,
4. Help in effective implementation of system by periodic visit till accreditation,
5. Conduct internal audit to check readiness for the accreditation,
6. Conduct management review meeting in presence of Top Management to guide the laboratory for effective implementation on all the issues related to management requirements and technical requirements.

Benefits of ISO 15189 Accreditation

Accreditation to this standard is patient-focused, impartial, objective, and operates within a good system. It provides many benefits such as those detailed below:

1. For Healthcare Regulators
   • provides an independent assurance of quality and safety,
   • provides a mechanism for measuring quality improvement,
   • supports consistency in the quality of care,
   • encourages innovation
2. For Patients
   • consistency in the quality of care,
   • up-to-date technologies and its procedures and techniques reflect current best practice,
   • Staff providing the service is competent to undertake the tasks they perform.
3. For Medical Laboratories
   • provides an opportunity for external perspectives on the laboratory�s practice,
   • can prevent the unnecessary duplication of information gathering on performance often required by regulatory bodies,
   • encourages the sharing of best practice,
   • reduces risk, and
   • Provides international recognition.

Technical Requirements for ISO 15189 System

Laboratories have to identify the following technical requirements during ISO 15189 system implementation:

1. Nominate one person as Quality Manager for establishing, implementation and monitoring of effective implementation of the management requirements, and one person as Technical Manager for control, supervision and monitoring of the technical requirements,
2. Define the test parameters, range of detection, and limit of detection, % C.V. or MU,
3. Establishing quality assurance procedures and examination procedures, etc.