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What are standards?
A document approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory; and which may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.
Source: Standards of Malaysia Act 1996 [Act 549]
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What is the Malaysian Standard?
Malaysian Standard (MS) is a consensus document developed by Standards Development Committee (SDCs) within the Malaysian Standards Development System and approved by the Minister of International Trade and Industry in accordance with Standards of Malaysia Act 1996 [Act 549].
An MS is a technical document that specifies the minimum requirements of quality and safety for voluntary use by the public. The MS becomes mandatory when a regulatory agency enforces its use through the relevant Act and Regulations.
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What are the guiding principles in Malaysian Standards development?
The ISO/IEC Guide 59, Code of Good Practice for Standardization and Annex 3 to the WTO/TBT Agreement are the guiding principles in the development of Malaysian Standards.
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Types of Malaysian Standards
- Specification
- Test Method
- Code of practice
- Terminology/glossary/vocabulary/symbol/nomenclature
- Classification/grading
- Guideline
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Why Malaysian Standards are important?
Reference to Malaysian Standards brings immense benefits to all stakeholders in achieving:
- Consumer protection and public welfare
- Standards provide a basis for legislation for controlling quality, protecting consumers, and ensuring health and safety
- Standards ensure the fitness for the intended purpose of products and services
- Standards specify the minimum requirements of quality, health and safety including areas involving the environment and occupational safety, reliability, and quality to consumers
- Standards ensure compatibility, interchangeability, and interoperability to benefit consumers. As consensus documents, standards reflect the requirements at national and international levels.
- Industrial efficiency and development
- Terminology and symbol standards help in better understanding
- Product standards help ensuring good design and improvement in quality of product
- Product standards encourage economic efficiency through variety rationalization and interchangeability of components, materials, and practices
- Process standards provide the means for improving manufacturing processes
- Codes of practice establish good practices in all fields of installation, construction, etc.
- Testing standards set recognized level of repeatability and reproducibility
- Standards being a rich source of current technologies can act as vehicles for technology transfer
- Standards promote better understanding between the purchaser and seller and provide solutions to recurring problems
- Standards facilitate communications
- Use of standards provide the essential key to organize industrial development
- Use of standards lead to direct and indirect economic benefits
- Standards help in import substitution and export promotion
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What is an Standards Development Committeee (SDC)?
Standards Development Committeee (SDC) is a committee established under Malaysian Standards Development System for the purpose of development of Malaysian Standard and participation in international standardisation activities. This may include all National Standards Committees (NSCs), Technical Committees (TCs) and Working Groups (WGs).
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What is the National Standards Committee (NSC)?
National Standards Committee (NSC) is a balanced representation established by the Malaysian Standards and Accreditation Council (MSDAM) with its specified terms of reference to oversee national and international standardisation activities within the scope defined by the MSDAM.
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What is a Technical Committee (TC)?
Technical Committee (TC) established by the NSC with its specified terms of reference to oversee national and international standardisation activities within the scope defined by the NSC.
The TC may establish Working Group (WG) for the purpose of undertaking specific tasks.
Among the roles of the TC is to develop, prepare and review MS documents which cover the general scope and as well responsible for approving the draft MS for the public comment stage as well as reviewing the feedback received from the public comment.
The TC is also responsible by supporting its parent, the NSC by reviewing draft international standards and related matters to provide feedback through ballots as well as with participation in the international meetings. A TC shall consist of balanced representatives.
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What is a Working Group (WG)?
Working Group (WG) is a committee consisting of appointed experts brought together to deal with specific task allocated to this committee. It shall be balanced if it reports directly to the NSC or it is a National Mirror Committee (NMC).
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What is a National Mirror Committee (NMC)?
Standards Development Committee (SDC) that mirrors the structure of the international committee in which Malaysia is participating and observing and is tasked with the responsibility of ensuring that national positions are obtained with regard to the development of international standards and related issues.
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Why does public comment stage take 60 days?
It is an obligation by the WTO-TBT agreement to ensure that all stakeholders are consulted. As stipulated in Annex 3, para L of the WTO-TBT Agreement, public comment shall be conducted for 60 days.
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What is the ISO?
International Organization for Standardization (ISO) is an independent, non-governmental international organization with the membership of national standards bodies from all over the world.
Through its members, ISO brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.
[Source: ISO Website]
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What is IEC?
International Electrotechnical Commission (IEC) is a global, not-for-profit membership organization that brings together countries all over the world and coordinates the work of 20 000 experts globally. IEC International Standards and conformity assessment work underpins international trade in electrical and electronic goods. It facilitates electricity access, and verifies the safety, performance and interoperability of electric and electronic devices and systems, including for example consumer devices such as mobile phones or refrigerators, office and medical equipment, information technology, electricity generation, and much more.
[Source: IEC Website]
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What is SMIIC?
Standards and Metrology Institute for the Islamic Countries (SMIIC) is an intergovernmental regional standardization organization aims at realizing common standards, achieving uniformity in metrology, laboratory testing and establishing conformity assessment schemes for the purpose of expediting exchange of materials, manufactured goods and products in the Muslim World under the umbrella of Organisation of Islamic Cooperation (OIC).
[Source: SMIIC Website]
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How do we benefit by being a member to ISO, IEC and SMIIC?
- Enable national experts and stakeholders to participate and have a say, representing the country in standards development policy or technical activities
- Member body can adopt ISO/IEC/SMIIC standards/deliverables as national adoptions
- Able to participate in international standards development
- Able to bring forth Malaysia's interest and priority areas in standards development discussions
- Sell ISO standards and publications, and use copyright and the ISO name and logo
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What are the 6 principles of Malaysian Standards development?
- Openness
- Development dimension
- Transparency
- Impartiality and consensus
- Coherence
- Effectiveness and relevance
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Why is an Malaysian Standard credible?
An Malaysian Standard is credible as it is:
- Approved by the Minister
- Follows good standardisation practice in its development process
- Undergoes public comment process for 60 days
- Represented by a wide range of stakeholders in its development process
- A consensus document developed by experts with the aim to facilitate stakeholders
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What are the differences between Malaysian Standard and other standards in Malaysia?
Malaysian Standard (MS) is a key reference for stakeholders covering all areas, involving products and services. Here's how an MS is different from other standards:
- Approved by the Minister
- Undergoes public comment for 60 days
- Prescribes to good standardisation practices throughout its development process
- Subjected to review every 5 years
- Can be used by regulators, end users, associations, companies and other stakeholders
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How can I participate in Malaysian Standards development?
If an expert is interested in getting involved in Malaysian Standards development, please send an application with CV / resume to:
Jabatan Standard Malaysia (Standards Malaysia),
Level 4, 5, 6 & 7, Tower 2, Menara Cyber Axis,
Jalan Impact, Cyber 6,
63000 Cyberjaya, Selangor Darul Ehsan, MALAYSIA
Tel : +603-8008 2900
Fax : +603-8008 2901
Email:This email address is being protected from spambots. You need JavaScript enabled to view it. -
What is balanced representation?
A representation of interest groups in a Standards Development Committee such that no single category of interest can dominate the voting procedures. The interest groups are categorised as:
- General
- Producer
- Regulatory/Authority/Government
- User
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How can I propose for a development or revision/amendment of an Malaysian Standard?
Any proposal for a new development or revision/amendment of an Malaysian Standard requires a formal request through New Work Item Proposal (NP) form. The NP form can be acessed here
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Am I allowed to give comment or feedback on a Draft Malaysian Standard?
Anyone can comment on a Draft Malaysian Standard during the public comment stage. The list of drafts available for public comment can be viewed here
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What are the types of Malaysian Standards maintenance available?
Amendment
Modification, addition or deletion of specific parts of the content of an existing Malaysian Standard. Types of amendment include editorial and technical.Revision
A process that involves major amendment and preparation of a new version of Malaysian Standard.Confirmation
An Malaysian Standard where it has been verified, that it is being used and no technical changes to the content is required.Withdrawal with replacement
A process to remove the Malaysian Standard which is superseded with a new version.Withdrawal without replacement
A process to remove the Malaysian Standard which is out of use or practice. -
Can Malaysian Standard be translated?
Yes. This requires a New Work Item Proposal (NP) form to be filled and is subject to approval by the parent committee/DSM. The NP form can be accessed here
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Can I use excerpts from an Malaysian Standard in my thesis/presentation/publication?
Contents of a Malaysian Standard (MS) is copyrighted and belong to Department of Standards Malaysia. Therefore, any references/quotes from an MS shall obtain a written consent from the Director General.
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Can I reproduce or copy all or parts of the Malaysian Standard I have purchased?
Contents of a Malaysian Standard (MS) is copyrighted and belong to Department of Standards Malaysia. Therefore, any references/quotes from an MS shall obtain a written consent from the Director General.
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Why is the full draft adoption of an ISO standard cannot be viewed in public comment?
Contents of an adoption (identical/modification) from ISO standard cannot be given away freely as it is copyrighted by ISO and the NSB. Please refer to the ISO POCOSA and DSM POMS documents for further explanation on this.
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Where can I purchase Malaysian Standards (MS)?
Malaysian Standard can be purchased as follows:
- Soft copy: https://mysol.jsm.gov.my/
- Hard copy can be obtained from our sales counter at:
DEPARTMENT OF STANDARDS MALAYSIA
LEVEL 4, TOWER 2,
MENARA CYBER AXIS,
JALAN IMPACT, CYBER 6,
63000 CYBERJAYA,
SELANGOR.For further information, please email us at
This email address is being protected from spambots. You need JavaScript enabled to view it. -
Liaison officer
Officer : Encik Muhammad Ashraf Mahmood Dean
E-mail : asyrafdean[@]jsm[dot]gov[dot]my
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What are standards?
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What is a CAB?
A CAB (Conformity Assessment Body) is a body that performs conformity assessment activities and that can be the object of accreditation
Source : ISO/IEC 17011:2017
Example : Certification body, inspection body and testing & calibration laboratory.
- Standards of Malaysia Act 1996 (Act 549) -
What's the difference between Accreditation and Certification?
Accreditation and Certification have very specific meanings although it is commonly used interchangeably. In layman's terms accreditation can be described as "certifying the certifiers".
Conformity assessment bodies (CABs), such as Certification Bodies, are accredited after they successfully undergo a process of assessment by an accreditation body like JSM, to ensure they meet international standards. Among other things, the assessment covers the certification bodies impartiality and competence to run its activity.
Certification is undertaken by the CAB and is a process by which an independent and competent third party certifies that a product, system or person, conforms to specific requirements.
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How do I obtain accreditation?
Application forms for various accreditation programmes are available in the JSM website.
Assessments for accreditation will be pursued once completed application forms and application fees are received.
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Which Report Gives You More Confidence In Its Validity?
Confidence - the assurance that your expectations will be met. Using the services of a SAMM accredited laboratory gives you that confidence in the test data it provides you.
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What do I get from a SAMM - endorsed test report?
- The validity of test or measurement date
- The laboratory has been independently audited for technical competence
- The test was done in accordance with the stated specifications, test or calibration method and correct test environment
- The test item was handled and stored properly
- The equipment used in the test was calibrated correctly and maintained according to schedule
- The correct sampling procedure was used
- The test report accurately describes the test results
- The appropriate quality control was performed
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What is a SAMM Accredited Laboratory?
- The laboratory must be able to demonstrate
- Competence to perform specific tests, measurements or calibrations
- Sound laboratory management
- Suitable qualified and trained staff
- Proper equipment management, and adherence to calibration and maintenance programs
- Accurate and complete record keeping
- Adequate quality control and quality assurance procedures
- Adherence to internal audit program
- Appropriate facilities for the handling, storage and testing of samples
- Assurance on essential consumable and outside support services
- Not just an interest, but a commitment to doing things right
Only after all these criteria are met does a laboratory become SAMM accredited. But this is not the end of the process. To remain SAMM accredited, the laboratory must be able to demonstrate continued compliance with the above criteria every time SAMM assesses its testing operation. It is this initial and on-going evaluation of laboratory by SAMM that gives you confidence in its quality of service and in the validity of test data.
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Definition of Good Laboratory Practice?
Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived. Having GLP recognition does not affirm the technical validity of these studies. The studies are undertaken to generate data by which hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals, pesticides, and cosmetics, veterinary drugs, feed additives, food additives and industrial chemicals. GLP helps assure regulatory authorities that the data submitted are true reflection of the results obtained during the study and can therefore be relied upon when making safety assessments.
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What is the difference between GLP recognition and ISO/IEC 17025 accreditation?
GLP is about recognition of a quality system that has organisational processes and conditions that in accordance with OECD criteria. 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 is anon-routine work covers under the non-clinical safety studies. Examples of non-routine work may include dosing animals or spraying fields. Only OECD GLP compliance 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.
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What are the OECD Principles?
OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, 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 (www.oecd.org)
The basis for the development of GLP was to provide assurance of data safety regarding test item data from non-clinical studies related to the hazard assessment of chemicals (pharmaceuticals, veterinary and agricultural chemicals, pesticides etc) when manufacturers are seeking to register products for use.
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Where do I apply the GLP Studies?
The Principles of GLP are applied to studies conducted for non-clinical health and environmental safety studies of test items contained in various chemical products. A study covers work done in a laboratory, animal house, greenhouses and in the field. Non-clinical studies may cover physical-chemical testing, toxicity studies, mutagenicity studies, environmental toxicity on aquatic and terrestrial organisms, studies on behaviour in water, soil and air; bioaccumulation, residue studies, studies on effects of mesocosms and natural ecosystems and the analytical chemistry associated with such studies.
GLP is a quality system concerned with the organisation process and conditions under which the non-clinical studies are planned, recorded, archived and reported. The Principles are prescriptive and also covered the roles of the Study Director, Quality Assurance Unit, Documentation of Standard Operating Procedures, the content of study plans and reports and the way in which all data related to each study is archived.
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Is this program mandatory?
In Malaysia, GLP CP is a voluntary program open to test facilities conducting studies for non-clinical health and environmental safety studies and for purpose of registering and/or licensing on test item.
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.
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What is Mutual Acceptance of Data (MAD)?
MAD is an OECD Council Act 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. Although Malaysia is not an OECD country, it has in 2006 announced that it will unilaterally accept data from OECD countries and other non-member countries of MAD. It intends to work towards MAD acceptance in 2007 for acceptance as a non-member OECD country.
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What is the difference between a deviation and an amendment?
Deviations are unplanned deviations from the study plan e.g. problems that occurred during the executing of certain experiments. Deviations are noted and acknowledged in a timely manner to the study director and signed by him/her. Planned deviations should be made under the form of an amendment of the study plan.
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Who can benefit from GLP recognition?
Companies that can benefit from GLP registration include:
- Research laboratories in the pharmaceutical, pesticides, veterinary drug products and industrial chemicals industries
- Contract research organizations
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Liaison officer
1. Officer 1 : Cik Siti Norehan Binti Ishak
emel : norehan[@]jsm[dot]gov[dot]my
2. Officer 2 : Encik Mark Mariba Anak Rantai
emel : markmariba[@]jsm[dot]gov[dot]my
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What is a CAB?
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How to find JSM Staff Directory?
Please click Contact Us > Directory
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How to find JSM Staff Directory?