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SANAS: Services, Processes, and Benefits

SANAS Services Processes and Benefits
ISO 17025

SANAS: Services, Processes, and Benefits

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What is the South African National Accreditation System SANAS?

 

The South African National Accreditation System SANAS is the nation’s sole body responsible for carrying out conformity assessment of:

 

  • testing, calibration, and verification laboratories
  • certification bodies
  • inspection bodies
  • B-BBEE verification agencies

 

SANAS is mandated through the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act (Act 19 of 2006).

 

Furthermore, SANAS is a signatory to the International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF).

 

Every four years, SANAS undergoes a rigorous peer evaluation process by ILAC and IAF. This process proves that SANAS continues to follow the international requirements of an accreditation body, and can provide a competent accreditation service.

 

Lastly, SANAS aims to establish a transparent and impartial mechanism for organizations to independently show their com­petence. This will lead to facilities in a beneficial exchange of goods, services, and knowledge.

 

 

What Services Can the South African National Accreditation System Provide?

 

Accreditation services from SANAS are widely recognized. The services promote the international acceptance of South African products and services.

 

Such accredited programs help open global markets and reduce trade barriers for services and certified products through the use of mutual and multi-lateral recognition of accreditation.

 

Furthermore, the knowledge center of SANAS is located in Brooklyn, Pretoria. Aside from training, SANAS provides workshops and courses.

 

            All applications can be done online. To get started, simply follow these steps:

 

  1. Log onto the SANAS website at sanas.co.za.
  2. On the Home page, click ‘Apply for Accreditation’.
  3. If you have not yet registered, follow the prompts to register, otherwise select the type of facility you wish to apply for accreditation for.
  4. Follow the prompts to complete the application in full.
  5. Make sure to attach all the required documents and information for your application to be accepted.
  6. Contact the SANAS office should you need further assistance.

 

Accreditation Services Offered by SANAS

 

Blood Transfusion Facilities

 

Blood transfusion facilities provide the transfusion of safe units of blood. Accreditation ensures that competent personnel conduct activities such as blood collection, testing, processing, and storage.

 

Broad-Based Black Economic Empowerment Verification Agencies

 

B-BBEE verification agencies support the government’s national objective to enable broader participation of previously disadvantaged individuals in the mainstream economy.

 

Calibration Laboratories

 

Calibration laboratories provide metrological traceability in South Africa as stipulated in the Measurement Units and Measurement Standards Act. SANAS accredited laboratories perform physical measurements for manufacturing and exports, safety or scientific purposes, and law enforcement purposes.

 

Certified Reference Materials

 

Producers of Certified Reference Materials attain certification from SANAS by adhering to ISO 17034. This standard outlines the general requirements for the producers of reference materials and Certified Reference Materials.

 

Forensic Laboratories

 

SANAS accreditation guarantees forensic laboratories use a scientific examination of physical evidence to give valuable data that aids in crime investigation and prosecution.

 

GLP Compliant Facilities

 

GLP Compliant Facilities perform non-clinical health and environmental studies to be submitted to regulatory authorities. Such studies assess the health and environmental safety of chemicals and chemical products.

 

GCP Compliant Facilities

 

GCP Compliant Facilities conduct clinical studies to be submitted to regulatory authorities to evaluate the safety and efficacy of drugs.

 

Inspection Bodies

 

Regulators, the industry, and citizens must be confident that inspection bodies are competent to perform their duties. This applies to:

 

  • bodies inspecting workplace health and safety requirements as per the Occupational Health and Safety Act;
  • those inspecting diagnostic imaging equipment such as medical and dental diagnostic X-ray equipment under the Hazardous Substances Act;
  • those inspecting compulsory standards following the National Regulator for Compulsory Specifications Act;
  • the Green Industry Initiative through the measurement and verification of energy efficiency and the energy performance of buildings.

 

Medical Pathology Laboratories

 

Accreditation from SANAS means patients can rely on medical pathology laboratories to produce accurate and reliable laboratory tests.

 

Pharmaceutical Laboratories

 

Pharmaceutical laboratories with accreditation from SANAS guarantee quality chemical and microbiological testing. This means they are capable of contributing to the fight against many diseases.

 

Proficiency Testing (PT) Schemes

 

Providers of Proficiency Testing (PT) Schemes may seek accreditation from SANAS according to the requirements of the international standard ISO/IEC 17043. PT schemes with accreditation assure that they can evaluate the performance of laboratories for:

 

  • specific tests or measurements
  • monitoring laboratories’ on-going performance
  • the validation of uncertainty claims
  • the evaluation of the performance characteristics of a calibration
  • test or measurement method

 

Testing Laboratories

 

Testing laboratories with accreditation from SANAS play a substantial role in supporting the South African manufacturing, exports, and Industrial Policy Action Plan (IPAP) priority sectors. This means testing laboratories can provide objective evidence that a product or service conforms to certain customer requirements or specifications.

 

Verification Laboratories (Legal Metrology)

 

Verification Laboratories protect consumers from unfair trade practices. Accredited organizations verify that volume, mass, and length measuring instruments meet the requirements of the Legal Metrology Act and other related technical regulations to ensure reliable results.

 

Veterinary Laboratories

 

Accredited veterinary laboratories are crucial in the diagnosis of diseases. They are also important in testing the safety of meat and other animal products.

 

 

What are the Available Courses and Workshops?

 

            SANAS has developed a 10-day timeframe for facilities to gain valuable knowledge for accreditation.

Management Systems 3 Days
Documenting the Systems 3 Days
Internal Auditing 2 Days
Nominated Representative and Technical Signatory 1 Day
Technical Assessing Techniques 1 Day
Internal Auditing 2 Days

 

Knowledge Transfer Services

 

The SANAS Knowledge Transfer Services (KTS) has been providing training services for over 13 years.

Course facilitators, who are also qualified assessors, will share the first-hand experience on accreditation activities and best practices during the presentation of courses.
Besides, SANAS has experts and accreditation field managers who are capable of providing courses in all current accreditation and emerging fields.

Countries such as Egypt, Zimbabwe, Mozambique, Botswana, Uganda, Swaziland, Kenya, Tanzania, Seychelles, and Mauritius have benefited from SANAS services including:

 

  • Scheduled courses at SANAS premises
  • Provincial-regional courses
  • In-house courses nationally and internationally

 

SANAS ensures that all course attendees will gain knowledge and skills that could add value to their accreditation and business sustainability.

 

The course design and delivery approach are focused on:

 

  • Attaining impact in knowledge transfer and skills development as per organizational objectives;
  • The ability to address current and future desired results;
  • Promoting personal responsibility for knowledge discovery and skills development;
  • Customization of courses to the level of candidates to ensure value;
  • Interactive and participative training methods to safeguard the outcomes-based approach and enable practical implementation of learning points;
  • Guaranteed partnership and future guidance on problem-solving and knowledge transfer for all candidates.

 

Is Accreditation Mandatory?

 

Accreditation is the official recognition, by an authoritative third party, that a facility is competent to conduct certain tasks. It also acknowledges that a Conformity Assessment Body (CAB) has a documented Management System to guarantee the consistent implementation of its processes.

 

An accredited CAB will have demonstrated, through formal assessment, that it is competent to execute the specific tasks for which accreditation is sought. Likewise, it must satisfy both national and international requirements for accreditation.

 

In general, accreditation is voluntary for all calibration and testing laboratories. This includes medical, pharmaceutical, forensic, blood transfusion, and veterinary.

 

Accreditation also applies to certification bodies and inspection bodies falling within a non-regulatory scope.

 

In the case of Verification Laboratories, B-BBEE Verification Agencies, and all other Inspection Bodies, the South African regulation requires accreditation before these facilities are authorized to operate.

 

Note that regulators, as well as public and private companies, may use the accreditation mechanism in their business processes to ensure the conformity of products or services.

 

Hence, it’s possible to encounter organizations that require accreditation before they work with other companies or organizations.

 

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The Relevance of ISO 9001 and ISO/IEC 17025

 

In a nutshell, ISO 9001 establishes compliance with quality management systems requirements. Meanwhile, ISO/IEC 17025 covers technical requirements for laboratory personnel and operations.

 

Being ISO 9001 certified should not be interpreted to imply compliance to ISO/IEC 17025.

 

Although, a laboratory’s fulfillment of the requirements of ISO/IEC 17025 means the laboratory meets both the vital management system requirements and technical competence requirements.

 

Therefore, ISO/IEC 17025 certification also means that a laboratory can consistently provide technically valid test results and calibrations.

 

What are the Rewards and Benefits?

 

  • Improve your laboratory’s products and services.
  • Improve the system’s quality and safety.
  • Show market accountability.
  • International recognition.
  • Marketing and competitive advantage.
  • A decrease in risks.
  • Increased in overall operational efficiency.
  • Reduced long-term costs.

 

Where Should My Organization Begin with the Accreditation?

 

The first step is to gain a thorough understanding of which standard your laboratory needs to implement.

Once your laboratory has sufficient knowledge about the standard, only then can you begin developing a management system.

Afterward, you can document and implement the management system.

When your laboratory can accomplish these, it is time to apply to SANAS for accreditation.

The relevant team assistant will explain the entire process. It will also provide the SANAS information pack that contains all essential information such as:

 

  • application process
  • applicable fees
  • accreditation process
  • accreditation requirements
  • technical guidance documents

 

Facilities can apply for accreditation via the SANAS website. Do not forget to submit your laboratory’s quality manual, policies and procedures, specific methods, and work instructions. Moreover, your laboratory must clearly define the scope of activities you are seeking accreditation.

 

What are the OECD Principles of Good Laboratory Practice (GLP)?

 

The Principles of Good Laboratory Practice (GLP) are a managerial quality control system. They cover the organizational process and the conditions under which non-clinical health and environmental studies are planned, conducted, monitored, recorded, and reported.

 

Furthermore, the GLP Principles define the responsibilities of test facility management, study personnel, and quality assurance personnel that are operating within a GLP system.

 

Likewise, the Principles identify the minimum standards about the suitability of equipment and facilities to carry out studies, the need for standard operating procedures, raw data documentation, study reports, and records archiving.

 

More than that, the GLP OECD Principles are followed by test facilities conducting studies to be submitted to national authorities. This phase aims to assess the health and environmental safety of chemicals and chemical products. Such products may be of natural or biological origin and, in some cases, living organisms.

 

Depending on the jurisdiction, the GLP Principles can also be used for non-clinical safety testing of other regulated products, such as medical devices.

 

Importance of the OECD Principles of Good Laboratory Practice

 

Before the introduction of GLP in 1961, some governments found testing laboratories submitted deceitful studies to regulatory authorities. This led to OECD governments deciding to develop a set of principles about the production of quality test data across all OECD nations.

 

This would ensure that before making regulatory decisions about the safety of chemicals that will enter the market, governments would have confidence that the data upon which they make their decisions is of high quality.

 

Furthermore, the standards enable traceability of studies, wherein CMP inspectors who visit test facilities can audit the results of a study. This delivers confidence to regulators about the integrity and validity of the data they are reviewing.

 

Lastly, the application of GLP is harmonized across OECD countries. Thus, governments can accept data from other nations with the guarantee that it will be valid.

 

What are the Phases of the Application Process?

 

  1. Application and Document Review.
  2. Pre-assessment (voluntary for all programs including Inspection Bodies to ISO/IEC 17020, compulsory for Verification Laboratories, the rest of Inspection Bodies and B-BBEE Verification Agencies).
  3. Initial assessment.
  4. Decision-making about whether accreditation can be granted.
  5. Continued monitoring of accreditation status via surveillance assessments and re-assessments over a fixed accreditation cycle.

            These documents are available in the application information pack and on the SANAS website.

To see a brief explanation of the accreditation process phases, please see SANAS document A 03 ‘General Information on the Accreditation Process’ briefly explains the phases of the accreditation process. For the detailed process, check the program-specific P documents.

 


What About the Accreditation Cost?

 

There are designated fees for the application, pre-assessment fee, and initial assessment. Note that there are annual fees, too.

 

The pre-assessment fee is mandatory for facilities where accreditation is obligatory.

 

SANAS recommends contacting the relevant Accreditation Manager with a completed application form. The Accreditation Manager can prepare a cost estimate for the activities that your facility wants to be accredited.

 

The costs for each phase of accreditation are reflected in the P14 ‘SANAS Fees’ document available on the SANAS website (www.sanas.co.za).

 

Duration of the Application Process

 

            The application process depends on how well your facility has implemented the management system as per the appropriate standard and accreditation requirements.

 

Similarly, the timeline would depend on your facility’s state of readiness. Another factor is the time you take to address any findings identified by SANAS.

 

Additionally, SANAS is accrediting your facility as a third party. We must see objective evidence that your facility is releasing reliable data or results consistently.

 

The usual timeline is at a minimum of three to six months for the whole accreditation process. The longest it could take is 12 months.

 

To prevent any delays in the initial assessment, make sure to:

 

  • Submit a fully accomplished application.
  • Present a quality manual that addresses all the relevant standard’s requirements.
  • Pass all policies and procedures, specific methods, work instructions, and BEE Codes.

 

Your facility will have ample time to address gaps found by SANAS in the quality manual during the document review stage. You must finish this before SANAS can arrange an initial assessment.

 

The accreditation timeline will be quicker if the on-site assessment finds that your facility has:

 

  • well-implemented management system
  • trained and competent staff
  • relevant documentation and records
  • zero non-conformances

 

In the case where non-conformances are raised at the initial assessment, your facility will be given six months to address the non-conformances.

 

Can My Facility Use a Standard’s Previous Version Instead of the Latest Version?

 

Every new version of a standard has a transition period. By the end of the transition period, SANAS would no longer provide accreditation to the standard old version.

 

The transition period lets facilities review their management system in line with the current version. Likewise, it gives SANAS time to assess the facilities to the standard’s new version.

 

Facilities that have not shifted to the latest version of the standard by the end of the transition period will lose their accreditation. Transition periods are normally two years unless otherwise specified.

 

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