Standards Implementation

a) Pathology Laboratories (ISO 15189 & ISO 15190)

Competence in any field is crucial, but it’s even more pertinent in the medical sphere where the patient’s system is compromised by disease or injury. ISO 15189 is a mark of confidence awarded to medical laboratories – an accreditation that proves you are dedicated to delivering a proficient and quality service across all aspects of your operation.

b) Calibration & Testing Laboratories (ISO 17025)

ISO 17025 is an internationally recognized standard that specifies the general requirements for the competence of testing and calibration laboratories. Developed by the International Organization for Standardization (ISO), ISO 17025 sets forth criteria for laboratories to demonstrate their ability to produce accurate, reliable, and consistent results.

The primary objective of ISO 17025 is to ensure that laboratories operate competently and consistently, thereby enhancing confidence in the accuracy and reliability of their test and calibration results. This standard encompasses various elements, including management requirements, technical requirements, and requirements for the competence of personnel.

Key Components of ISO 17025:

Scope: ISO 17025 applies to all laboratories, regardless of the size or nature of their activities, involved in testing, calibration, or sampling. It covers a wide range of disciplines, including chemical, biological, mechanical, electrical, and environmental testing.

Management System Requirements: ISO 17025 emphasizes the establishment and maintenance of a quality management system (QMS) tailored to the specific needs of the laboratory. This includes defining organizational responsibilities, documenting procedures, and implementing measures to continually improve processes.

Resource Management: The standard requires laboratories to have adequate resources, including personnel, equipment, facilities, and support services, to carry out their testing and calibration activities effectively.

Technical Requirements: ISO 17025 outlines specific technical criteria related to testing and calibration methods, equipment calibration and maintenance, measurement traceability, and handling of test and calibration items.

Quality Control and Assurance: Laboratories must implement robust quality control measures to ensure the accuracy, precision, and reliability of their test and calibration results. This involves regular calibration of equipment, participation in proficiency testing programs, and validation of methods.

Personnel Competence: ISO 17025 mandates that laboratory personnel possess the necessary competence, training, and experience to perform their duties effectively. This includes ongoing training and professional development to stay abreast of advancements in their respective fields.

Benefits of ISO 17025 Certification:

Enhances credibility and trustworthiness of laboratory results.
Facilitates acceptance of test and calibration data internationally.
Improves operational efficiency and effectiveness.
Enhances customer confidence and satisfaction.
Ensures compliance with regulatory requirements and industry standards.
In summary, ISO 17025 certification is a testament to a laboratory’s commitment to quality, competence, and continual improvement. By adhering to the requirements of this standard, laboratories can strengthen their reputation, expand their capabilities, and contribute to the advancement of science and technology on a global scale.

c) Proficiency Testing Providers (ISO 17043)

ISO/IEC 17043 Conformity assessment—general requirements for proficiency testing is used to assess the competence of proficiency testing (PT) providers. It expands on the requirements of previous guides and is intended to accommodate PT providers of calibration laboratories and testing laboratories handling both qualitative and quantitative data.

d) Clinical Trials (GLP & GCLP)

Good Clinical Laboratory Practice (GCLP) is a set of standards that provide guidance on implementing Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) principles to the analysis of samples from a clinical trial. GLP is a quality system that covers the organisational process and the conditions under which non-clinical laboratory studies are planned, performed, monitored, recorded, archived and reported. On the other hand, GCP is an international ethical and scientific quality standard for designing, conducting, performing, monitoring, auditing, recording, analysing and reporting clinical trials that involve the participation of human subjects. By combining the GLP and GCP sets of guidelines, GCLP ensures the quality and reliability of the clinical trial data generated by laboratories.

e) Veterinary Laboratories (ISO 17025)

Compliance with ISO/IEC 17025 can enhance credibility, facilitate international recognition, and improve the quality of diagnostic services by veterinary laboratories. By following the standard’s requirements, veterinary laboratories can demonstrate their commitment to delivering accurate and reliable test results, which is essential for safeguarding animal health and supporting various stakeholders in the veterinary and animal agriculture sectors.

f) Food Laboratories (HACCP)

HACCP is a systematic approach to food safety that helps food businesses identify, evaluate, and control food safety hazards. HACCP is internationally recognized and widely used in the food industry to ensure the safety of food products.

The key concepts of HACCP are:

Hazard Analysis: This involves identifying any biological, chemical, or physical hazards that may be present in the food production process. Hazards can include bacteria, toxins, foreign objects, and more.

Critical Control Points (CCPs): CCPs are specific points in the food production process where control measures can be applied to prevent, eliminate, or reduce identified hazards to acceptable levels. These points are crucial for ensuring food safety.

Critical Limits: Critical limits are the maximum or minimum values that must be met at each CCP to ensure food safety. These are established based on regulatory requirements, scientific evidence, and industry standards.

Monitoring: Continuous monitoring of CCPs is essential to ensure that critical limits are consistently met. This involves regular observation, measurement, or testing of parameters relevant to food safety.

Corrective Actions: If monitoring indicates that critical limits are not met, corrective actions must be taken to address the deviation and prevent unsafe food from reaching consumers. These actions should be predetermined and documented in the HACCP plan.

Verification: Verification involves confirming that the HACCP system is working effectively. This includes reviewing records, conducting audits, and testing samples to validate the adequacy of control measures.

Documentation: All aspects of the HACCP plan, including hazard analysis, CCPs, critical limits, monitoring procedures, corrective actions, and verification activities, must be thoroughly documented. Proper documentation is essential for demonstrating compliance with food safety regulations and standards.

By implementing a HACCP system, food businesses can proactively identify and control food safety hazards, minimize the risk of foodborne illness, and ensure the production of safe and wholesome food products.

g) Agricultural Laboratories (GlobalG.A.P) GlobalG.A.P. stands for Global Good Agricultural Practice. It is an internationally recognized set of standards for agricultural production, covering aspects such as food safety, sustainability, and social responsibility. GlobalG.A.P. certification ensures that agricultural products are produced using environmentally and socially responsible methods while meeting stringent quality and safety requirements.
The GlobalG.A.P. standards were developed by the Global Partnership for Good Agricultural Practice, a nonprofit organization founded in 1997. These standards provide a framework for farmers and producers to implement best practices in their agricultural operations, ultimately ensuring the safety of food products, protecting the environment, and promoting the welfare of workers and local communities.
GlobalG.A.P. certification is voluntary but increasingly demanded by retailers, consumers, and food service companies worldwide as a guarantee of quality, safety, and sustainability in agricultural production. It covers a wide range of agricultural sectors, including crops, livestock, aquaculture, and integrated farm assurance.
The certification process involves an assessment of farms or agricultural operations against the GlobalG.A.P. standards by accredited certification bodies. Compliance with the standards demonstrates that the producer follows good agricultural practices throughout the production process, from farm management and crop cultivation to harvesting, handling, and distribution.
Overall, GlobalG.A.P. plays a crucial role in promoting responsible agricultural practices globally, contributing to food safety, environmental protection, and social welfare in the agricultural sector.