Frequently Asked Questions on SAC Accreditation Programmes
Below are some questions and answers that would help you understand what accreditation is and how to attain accreditation.
Accreditation is the endorsement by an authoritative body (such as SAC) of an organisation’s competence, credibility, independence and integrity in carrying out its conformity assessment activities, such as testing, calibration, inspection and certification.
Accreditation: Accreditation is the formal recognition by an accreditation authority of the technical and organisational competence of a conformity assessment body to carry out a specific service in accordance to the standards and technical regulations as described in their scope of accreditation.
Certification: Certification is the procedure by which a third party gives written assurance that a product, process, system or person conforms to specified requirements.
ILAC and IAF have published an informative article titled “Standards, Conformity Assessment and Accreditation: the Pillars of Assurance in the Global Marketplace” in Standards Engineering, a bimonthly journal from the Society of Standards Professionals (SES). It explains the differences between standards, certification and accreditation, and how they form the framework to deliver confidence to regulators, industry and end-users.
These are some of the key benefits of being accredited.
Building Trust: In the global industry, customers are becoming more demanding and seeking assurances on the products and services that you provide them. By getting accreditation, your customers will have the confidence in the quality of products and services that you provide. This will enable you to build trust between you and your customer.
International Recognition: Through the various mutual recognition arrangements between accreditation bodies, overseas markets will accept your company more readily if they know that you have been certified by an SAC-accredited certification body or accept your test results/inspections if you are an accredited laboratory or inspection body.
Minimises Risk: Accredited organisations reduce the risk of providing unreliable test results, services and products, and are able to meet the customers’ expectations.
Reduce Costs: Although accreditation comes at a cost, the cost savings that result from being accredited will outweigh the cost of accreditation. Cost savings may result from improved productivity, reduced downtime, less re-testing, etc.
Demonstrate Credibility: No organisation will want to spend money on getting a report or certificate that has not been accredited by a competent body. An SAC-accredited organisation is able to demonstrate competence for the report or certificate through its sound management system and the use of trained and competent personnel.
Currently SAC operates the following accreditation schemes:
Accreditation Scheme for Laboratories (SAC-SINGLAS) This scheme evaluates the technical competence of testing and calibration laboratories based on the general requirements of ISO/IEC 17025 and specific technical requirements of each field. For medical testing and medical imaging laboratory, the standard is ISO 15189.
Accreditation Scheme for Inspection Bodies This scheme evaluates the technical competence of inspection bodies based on the general requirements of ISO/IEC 17020 and specific technical requirements of each field.
Accreditation Scheme for Management Systems Certification Bodies Quality Management System (QMS): This scheme evaluates the technical competence, integrity and independence of certification bodies providing ISO 9001certification, based on the general requirements of ISO/IEC 17021 and IAF Mandatory Documents. The scheme also covers the certification of bunker suppliers (SS 524) and the certification of good distribution practice of medical devices (GDPMDS).
Business Continuity Management System (BCM): This scheme evaluates the technical competence, integrity and independence of certification bodies providing SS 540 or ISO 22301 certification, based on the general requirements of ISO/IEC 17021 and CT 08 - SAC Criteria for Certification Bodies (BCM).
Energy Management System (ENMS): This scheme evaluates the technical competence, integrity and independence of certification bodies providing ISO 50001 certification, based on the general requirements of ISO/IEC 17021 and CT 10 - SAC Criteria for Certification Bodies (ENMS).
Environmental Management System (EMS): This scheme evaluates the technical competence, integrity and independence of certification bodies providing ISO 14001 certification, based on the general requirements of ISO/IEC 17021 and IAF Mandatory Documents.
Occupational Safety and Health Management System (OSHMS): This scheme evaluates the technical competence, integrity and independence of certification bodies providing SS 506 Part 1 and SS 506 Part 3 certification, based on the general requirements of ISO/IEC 17021 and CT 02 - SAC Criteria for Certification Bodies (OSHMS).
HACCP based Food Management System: This scheme evaluates the technical competence, integrity and independence of certification bodies providing SAC HACCP Doc 2 certification, based on the general requirements of ISO/IEC 17021 and SAC HACCP Doc 01.
Food Safety Management System: This scheme evaluates the technical competence, integrity and independence of certification bodies providing ISO 22000 certification, based on the general requirements of ISO/TS 22003 and CT 07 - SAC Criteria for Certification Bodies (FSMS).
Accreditation Scheme for Product Certification: This scheme evaluates the technical competence, integrity and independence of product certification bodies, based on the general requirements of ISO/IEC 17065 and IAF Guidance.
More information for each accreditation scheme, can be obtained at Accreditation Schemes section.
The general procedure to obtain accreditation is as below:
Enquiry and Formal Application: Applicants will submit an application form to SAC with the necessary documents and a non-refundable application fee. An SAC Officer will contact the applicant and make the necessary arrangements.
Preliminary Assessment (Optional): An SAC assessor will conduct a preliminary assessment to check if the applicant is ready to be accredited.
Initial Assessment: A team consisting of SAC assessor and/or technical experts will conduct the initial assessment.
Recommendation by Assessment Team: The team will make a recommendation to the Review Committee for accreditation decision if the applicant has rectified any non-conformity satisfactorily.
Award of Accreditation: If the Review Committee is agreeable with the recommendation of the assessment team, the applicant will be granted accreditation and issued with a certificate of accreditation.
This would depend on a number of factors, such as the degree of an organisation’s compliance with requirements, complexity of scope of the accreditation, availability of witnessing and clearance of incidences of non-conformance highlighted during the assessment. A reasonable time frame is between three to six months.
If you are accredited, you will be able to use the SAC Accreditation Mark and offer your products or services with confidence both nationally and worldwide. You can also make use of the ILAC or IAF MRA mark. In addition, your company and the scope of accreditation will be listed in the SAC Directory and website, where companies and regulators visit to source for reliable providers.
There will also be periodic surveillance assessments to ensure your continued compliance with the scope of accreditation. The accreditation certificate will also require renewal periodically and the renewal period will depend on the terms and conditions of the accreditation scheme.
If you have any questions or doubts, you can drop us an email or call us directly through the Contact Us section.
Frequently Asked Questions on Singapore GLP Compliance Programme
GLP is a quality system concerned with the organisational process and the conditions under which the non-clinical studies are planned, recorded, archived and reported. ISO/IEC 17025 accreditation is a formal recognition for technical competence to undertake specific tests or calibrations. In general GLP is used for non-clinical health & safety studies that are often called for in regulations while ISO/IEC 17025 accreditation is used normally voluntary. Laboratory accreditation to ISO/IEC 17025 is for routine testing and measurement while GLP covers often a series of experiments. Only GLP recognition can provide an effective quality system that gives regulators the necessary confidence in relation to how non-clinical health and safety studies are planned, performed, monitored, recorded, reported and archived.
Any facility claiming to be in compliance with the Principles of Good Laboratory Practice of the Organisation for Economic Cooperation and Development (OECD) under the Singapore compliance-monitoring programme must be recognised by SAC for that compliance.
In 1981, a decision was made by the OECD Council that data generated in an OECD member country under its national compliance monitoring programme is accepted in other OECD member countries for the purposes of product registration (Mutual Acceptance of Data). Since January 2010, Singapore has been accepted as a non-OECD member country to be a member of the OECD Mutual Acceptance of Data framework. With this adherence, GLP studies conducted in Singapore will be accepted in more than 30 OECD and non-OECD member countries.
Product registration in overseas markets are typically referred to the US FDA for pharmaceuticals and the European authority (EMEA). In Singapore, the relevant registration authorities are Health Sciences Authority (HSA for pharmaceuticals), Agri-Food & Veterinary Authority (AVA for biologics and agricultural chemicals) and National Environment Agency (NEA for pesticides and industrial chemicals). With the MAD adherence, the Singapore GLP Compliance programme will provide greater assurance of test data for non-clinical studies. These regulators will be able to accept the test data with confidence in the assessment of health and safety for product approvals.
The basic document dealing with the GLP is the OECD Principles of Good Laboratory Practice, published by OECD’s Environment Directorate, and most recently revised in 1998. This document is produced by the OECD GLP Working Group and is available at OECD website.
The Principles of GLP are applied to the conduct of non-clinical health and environmental safety studies of test items contained in various chemical products. A study covers work done in a laboratory, in an animal house, in greenhouses, and in the field. Non-clinical studies may cover physical-chemical testing, toxicity studies, mutagenicity studies, environmental toxicity, bioaccumulation, residue studies, studies on effects of mesocosms and ecosystems and the analytical chemistry associated with such studies.
A facility seeking recognition for compliance with the OECD GLP Principles should apply to SAC, stating its proposed scope of recognition and type of studies. It will have to provide key information such as :
a. Management structure
b. Key responsibilities of the personnel and units
c. Information on names of Study Director, Study Sponsor
d. Persons in charge of Quality Assurance and the Archive
e. Quality Manual and Standard Operating Procedures Structure, Master Schedule etc.
The facility must first comply with the OECD Series on Principles of Good Laboratory Practice. Other compliance documents include:
a. Quality Assurance and GLP
b. Compliance with Laboratory Suppliers with GLP Principles
c. The Application of the GLP Principles to Field Studies
d. The Application of GLP Principles to Short Term Studies
e. The Role and Responsibilities of the Study Director in GLP Studies
f. The Application of Principles of GLP to Computer Systems
g. The Application of the OECD Principles of GLP to the Organisation and Management of Multi-site Studies
h. The Application of the Principles of GLP to In Vitro Studied
i. Establishment and Control of Archives that Operate in Compliance with the Principles of GLP
The process for registration generally includes the following stages: Enquiry, Application, Document Review, On-site Inspection, follow-ups and Award of Registration.
Once a research facility indicates an interest to be GLP compliant, SAC will visit the facility and provide information on the criteria, fees and process. Upon application, a review of documentation submitted and a site visit will follow. The site visit will include interviews with key staff, review of equipment, calibration, process, test materials management, dosing, records, study audits, archive etc to ensure that the OECD Principles are complied with.
After registration, there will be an annual visit for study audits and inspection to ensure continued compliance.
A time frame of 3-6 months is estimated as the time frame for the process. It may however vary from the type and nature of studies.
Programme is voluntary. However, in some countries, particularly those within European Union, it is required by law that any non-clinical studies are to be conducted in compliance with the OECD Principles of GLP.
MAD is a framework OECD Council established in 1981 stating that data generated in an OECD Member country in accordance with OECD Test Guidelines and Principles of Good Laboratory Practice (GLP) will be accepted in other Member countries for assessment purposes and other uses relating to the protection of human health and the environment.
Companies that can benefit from GLP registration include:
- Research laboratories in the pharmaceutical, pesticides, veterinary drug products and industrial chemicals industries
- Contract research organisations
There is a misconception that GLP is required for conducting clinical studies. That is not correct. The introduction to the OECD Principles of GLP makes it clear that they only apply to non-clinical (pre-clinical) studies. Clinical studies, such as pharmaco-kinetic and efficacy studies, are excluded. The relevant documents for clinical studies are the various codes, such as International Conference on Harmonisation (ICH). The USFDA and other registration authorities do require a demonstration of the quality of test data from clinical studies. In the US, this may be by means of conformance with CLIA (Clinical Laboratories Improvement Act). In Singapore, this is best demonstrated by the testing laboratory’s SAC-SINGLAS accreditation (in Medical Testing, Chemical & Biological Testing etc).
A facility seeking recognition for compliance with OECD Principles of GLP should apply to SAC, stating the proposed scope of recognition, type of studies etc. An on-site assessment is done to determine compliance with the Principles. At least one GLP compliant study must be completed prior to the initial assessment. Re-assessments are done every two years and a study audit is done annually.
Copies of the OECD Principles of GLP, Consensus Documents and useful guidance documents can be downloaded from the OECD website.
Further information on the Singapore compliance monitoring programme should be sent to firstname.lastname@example.org.
If you have any questions or doubts, you can drop us an email or call us directly through the Contact Us section.