- Assures customers of the organisation’s commitment to demonstrate environmental management.
- Maintains good public/community relations.
- Obtains insurance at a reasonable cost.
- Enhances image of the organisation or organisational positioning, and market share.
- Meets vendor certification criteria.
- Improves the organisation’s cost control.
- Reduces incidents that resulted in liability and demonstrates reasonable care.
- Conserves input materials and energy.
- Facilitates the organisation’s attainment of necessary permits and authorisations.
- Foster the development and sharing of environmental solutions.
- Improve the organisation’s relationships with local, state and the federal government.
International Organization of Standardization
ISO Services
ISO 9001
ISO 9001: Quality Management System
The ISO 9001 international standard defines the requirements for a Quality Management System (QMS) and is widely accepted and adopted globally by all types of organisations. ISO 9001 provides an effective framework for organisations to continually improve on their products, processes and system; in order to consistently meet and enhance their customer’s requirements and satisfaction.
The latest version of ISO 9001 is the ISO9001:2015
which defines the way an organisation operates to meet the requirements of its customers and stakeholders.
The ISO 9001 standard is built on 7 Quality Management Principles (QMPs) as the basis of the standard:
Principle 1 – Customer focus
Organisations depend on their customers and therefore should understand current and future customer needs before aligning their objectives, should meet customer’s requirements and endeavour to exceed customer expectations.
Principle 2 – Leadership
Leaders establish a vision and direction for the organisation. They should create and maintain the internal environment in which people can be empowered and can become fully involved in achieving the organisation’s objectives.
Principle 3 – Engagement of people
People at all levels are the essence of an organisation. Allowing their full participation and continuous improvement allows their abilities to be used for the organisation’s benefit.
Principle 4 – Process approach
A desired result is achieved more efficiently when activities are managed as a process, related resources are deployed effectively, and improvement opportunities are prioritised.
Principle 5 – Continual improvement
Continual improvement of the organisation’s overall performance should be a permanent objective of the organisation.
Principle 6 – Evidence based decision making
Effective decisions are based on the analysis of accurate and reliable data and information balanced with practical experience.
Principle 7 – Relationship management
An organisation shall maintain good relationships with all relevant parties such as customers, suppliers, authority, etc. in order to collaborate on improvement and development activities, manage costs, optimise resources and create value.
Benefits of ISO 9001
- Demonstrates organisation’s commitment to customers and stakeholders while strengthening “organisational capability”.
- Improves processes that result in reduction of errors and risk of rework.
- Increases customer satisfaction.
- Enhances image of the organisation or organisational positioning through proactive quality-focused leadership.
- The entire organisation recognizes its responsibility and involvement in the betterment of quality.
- Better defined processes and sub-processes, including their critical links.
- Recognition of deterrents to an operation’s or service’s efficiency and effectiveness.
- Identifies opportunities for continuous improvement.
- Strengthens commitment toward the organisation’s fulfilment of regulatory requirements.
- Improves communication amongst employees.
While it’s not readily apparent, ISO 9001 can also be applied to address areas such as customer concerns, administrative issues, equipment up/downtime, and process efficiencies, etc.
ISO 14001
ISO 14001: Environmental Management System
ISO 14001 is an international standard for Environmental Management Systems (EMS). It sets out the requirements to help the organisation improve its environmental performance through more efficient use of resources and reduction of waste, gaining a competitive advantage and the trust of stakeholders.
The latest version of ISO 14001 is the ISO 14001:2015 which provides key improvements such as the increased prominence of environmental management within the organisation’s strategic planning processes, greater involvement from leadership management and a stronger commitment to proactive initiatives that boost environmental performance.
The ISO 14001:2015 revision also includes the incorporation of a High-Level Structure (HLS) as part of the effort to structure all ISO standards in the same way. ISO 14001 may also be combined with other management systems such as ISO 9001, ISO 13485, ISO 22000, HACCP MS and ISO 45001 (OHSAS 18001) to provide the basis for an Integrated Management System (IMS).
Benefits of ISO 14001
ISO 13485
ISO 13485: Medical Devices Quality Management System
Introduced by the International Organization for Standardization (ISO) in July 2003, ISO 13485 is recognized throughout the world as a quality management system standard for organisations involved in the medical device industry. The current revision of ISO 13485:2016 was published on March 1, 2016, which replaced the previous version of ISO 13485:2003.
Based on the same basic principles and clause structure as ISO 9001:2015, ISO 13485:2016 is a standard that focuses on how an organisation should manage a risk-based approach related to purchasing, design and development, production, storage, distribution, installation and servicing activities and other aspects of the quality management system. The standard specifies requirements for organisations involved in one or more stages of the medical device life cycle. It is often seen as a crucial first step in ensuring manufacturing and design processes consistently produce quality products that meet regulatory requirements.
ISO 13485 can also be used by importers or appointed agencies that import and distribute medical devices who may be required to set up a medical devices quality management system in compliance with local regulation.
The primary objective of ISO 13485:2016 is to expedite harmonised medical device regulatory requirements for quality management systems. As a result, it includes specific requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Due to these exclusions, organisations certified to ISO 13485 would not be able to claim conformity to ISO 9001 unless their quality management systems indeed conform to all the requirements of ISO 9001.
Benefits of ISO 13485
- Assists in maintaining global recognition with the best quality practices from companies within the medical device industry.
- Enables organisations to work within various countries by complying to necessary regulations and obligations.
- Helps to create an organised framework for the organisation to maintain and evaluate its processes and customer handling.
- Provides a framework to ensure ongoing maintenance and improvement of effective processes with applicable requirements.
- Enables improved performance through increased sales, shorter timelines in getting products to the global marketplace, lowered costs, less waste, and higher productivity with quality production.
- Demonstrates compliance to the European Union (EU) Directives through establishment and independent assessment of the quality management system.
Good Distribution Practice for Medical Devices (GDPMD)
The Good Distribution Practice for Medical Devices (GDPMD) specifies the requirements for a quality management system to be established, implemented and maintained by an establishment of medical device importer/distributor/ authorised representative to comply with Malaysian Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012.
The objective of GDPMD is to ensure the quality, safety and performance of medical device which include but are not limited to product sourcing and procurement; transportation and delivery; storage; installation, commissioning, service and maintenance, calibration and after sales service; tracking, documentation and record-keeping practices. Organisations that are involved in wholesaling and/or importing Medical Devices in Malaysia are required to implement and obtain GDPMD certificate to apply for an establishment license.
OHSAS 18001 / ISO 45001
OHSAS 18001: Occupational Health & Safety Management System
OHSAS 18001 is an assessment specification for Occupational Health and Safety Management Systems. Developed in response to the need of an organisation to meet their health and safety obligations in an efficient manner, OHSAS 18001 is based on standards which specify a process of achieving continuously improved Occupational Health & Safety (OH&S) performance and complying with legislation.
With the health and safety best practices implemented in accordance to this global standard, the organisation would be able to manage occupational health and safety risks; and improve onsite safety standards for employees, customers, contractors, suppliers, temporary staff, and other incidental personnel at the workplace. Following the stringent requirements and regulations of OHSAS 18001, employees will be protected from incurring work-related injuries and illnesses. However, the success of implementing an OH&S will require whole-hearted commitment from all levels of the organisation, especially from top management.
Benefits of ISO 14001
- Assures customers of the organisation’s commitment to demonstrate environmental management.
- Maintains good public/community relations.
- Obtains insurance at a reasonable cost.
- Enhances image of the organisation or organisational positioning, and market share.
- Meets vendor certification criteria.
- Improves the organisation’s cost control.
- Reduces incidents that resulted in liability and demonstrates reasonable care.
- Conserves input materials and energy.
- Facilitates the organisation’s attainment of necessary permits and authorisations.
- Foster the development and sharing of environmental solutions.
- Improve the organisation’s relationships with local, state and the federal government.
ISO 45001: Occupational Health & Safety Management System
In March 2018, the International Organization for Standardization (ISO) published ISO 45001:2018 – Occupational Health and Safety Management System Requirements. The international standard will give organisations a framework to improve employee safety, reduce workplace risks and create better, safer working conditions, all over the world.
It follows other management system approaches such as ISO 9001:2015 and ISO 14001:2015 by being built on the same high-level framework, Annex SL which allows for an easy integration with other similar standards. The new ISO 45001 also incorporates other International Standards in this area such as OHSAS 18001, the International Labour Organization’s ILO-OSH Guidelines, various national standards and the ILO’s International Labour Standards and Conventions.
ISO 45001 has replaced OHSAS 18001, the world’s former reference for workplace health and safety. Organisations already certified to OHSAS 18001 will have Three (3) years to comply with the new ISO 45001 standard, although certification of conformity to ISO 45001 is not a requirement of the standard. Migration to the standard will end on March 11, 2021 at which point OHSAS 18001:2007 will be completely withdrawn.
Benefits of ISO 45001
- Stand apart from competitors by implementing the most up-to-date internationally recognised occupational health and safety standard.
- Builds a strong, efficient organisation centered around “best practices”.
- Increases trust in the organisation from public, future employees and prospective clients by facilitating continuous improvement of employee morale, safety and performance as well as transparent corporate social responsibility efforts.
- Attracts lower insurance premiums and proves due diligence to the marketplace.
- Improves mental health and physical safety of all persons affected by the organisation’s activities whether by process or use of machinery.
- Improves managerial oversight through monitoring and measurement of key performance indicators for health and safety.
- Improves preventative assessment of risks and hazards through an internal auditing “early warning system”.
- Increases Return-On-Investment (ROI).
- Occupational focus reduces staff turnover and improves retention rate.
- Deals with risks and opportunities whereas OHSAS 18001 and other similar standards only dealt with risks.
ISO 22000 / FSSC 22000
ISO 22000: Food Safety Management System
Food-borne hazards present in food at the point of consumption raises a food safety issue. Adequate control in place at any stage in the food chain is needed to ensure the handling of food safety hazards. ISO 22000 is the globally recognised standard developed by the International Organization for Standardization (ISO) for ensuring food safety at every point of the food supply chain. The continuous increase in consumer demand for safe food has led to the development of numerous food safety standards such as ISO 22000, CODEX HACCP, Good Manufacturing Practices (GMP), Good Housekeeping Practices (GHP), Good Distribution Practices (GDP), Good Laboratory Practices (GLP) and Good Agriculture Practices (GAP).
Compliance to ISO 22000 requires that all organisations regardless of size, involved in the food chain are to ensure that food safety hazards are controlled, and that the food produced is consistently safe for human consumption. Therefore, food safety is a joint responsibility that is principally assured through the combined efforts of all the parties participating in the food chain. Even the organisations that produce the equipment, cleansers, additives, ingredients and packaging involved in food production are also eligible for certification.
ISO 22000:2018 was published on June 19, 2018, to harmonise the requirements for food safety management worldwide. ISO 22000, “Food safety management systems – Requirements for any organisation in the food chain,” applies the same High-Level Structure (HLS) common to other ISO standards and is intended to be compatible with the current tools for food safety management, ISO 9001:2015 and HACCP, and to extend its reach for greater diligence. Organisations have a Three-year transition period in place for ISO 22000:2018 until June 29, 2021 at which point ISO 22000:2005 would be invalidated.
Benefits of ISO 22000
- Better control over food safety activities.
- Assurance in customer, statutory and regulatory compliance.
- Facilitates market growth.
- Increases effective communication and feedback to relevant parties in the food chain.
- Increases customer satisfaction, stakeholders and consumer confidence.
- Improves risk management.
- Allows integration with other ISO management systems.
FSSC 22000 version 5: Food Safety Management Systems Certification Scheme
FSSC 22000 is a food safety certification scheme that is benchmarked and recognised by the Global Food Safety Initiative (GFSI). The GFSI is a division of the Consumer Goods Forum and a collaboration of retailers, manufacturers and food service companies that work on harmonising food safety standards and benchmarking them against a basic set of criteria. Due to complex challenges in the global food supply chain, many large retailers and manufacturers require their suppliers to register to a GFSI-recognised scheme. However, ISO 22000 is not recognised under the GFSI.
The Foundation for Food Safety Certification developed FSSC 22000 and based it on the internationally recognised Food Safety Management Systems standard ISO 22000, complemented by industry relevant Pre-Requisite Programs (PRP) such as ISO TS 22002-1 for food manufacturing and ISO TS 22002-2 for packaging manufacturing and GFSI-defined additional requirements. FSSC 22000 defines requirements for integrated processes that work together to control and minimise food safety hazards.
The certification scheme specifically targets the food, feed and packaging manufacturing sectors as well as the storage and distribution, catering and retail/wholesale sectors. While the first editions of FSSC 22000 only applied to food manufacturers, the scope for version 5 has been extended to other segments of the supply chain.
Benefits of FSSC 22000
- Provides a powerful management system framework fully integrated with the organisation’s overall management system. FSSC 22000 version 5 is also fully consistent with other standards, such as ISO 9001 and ISO 14001 (including the alignment with the ISO High Level Structure).
- Provides a robust Hazard Analysis and Risk Management methodology based on HACCP principles and assists to improve food safety effectiveness and efficiency.
- Pre-requisite programs with technical specifications, such as ISO TS 22002-1 for food manufacturing provide additional due diligence along the supply chain and allow for adapting to needs of customers.
ISO 27001
ISO 27001: Information Security Management System
ISO 27001 is an international standard published by the International Standardization Organization (ISO) which is recognised globally for managing risks to the security of information held in an organisation. The latest revision of this standard was published in 2013 with its full title as ISO/IEC 27001:2013. The standard provides a set of requirements for an Information Security Management System (ISMS) and adopts a process-based approach for establishing, implementing, operating, monitoring, maintaining, and improving an ISMS.
ISO 27001 is suitable for any size of organisation, in any sector. It is especially suitable for the protection of critical information in sectors such as banking, finance, health, public and IT. The standard also applies to organisations which manage high volumes of data, or information on behalf of other organisations such as data centres and IT outsourcing companies.
Benefits of ISO 27001
- Secures confidential information against constantly evolving threats.
- Provides confidence to customers and stakeholders in terms of risk management.
- Enforces a secure information exchange.
- Gains costs savings from security incidents and inefficient solutions.
- Achieve compliance with regulations such as the European Union General Data Protection Regulation (EU GPDR).
- Provides competitive advantage over competitors.
- Enhances customer satisfaction and customer retention.
- Manages and minimises risk exposure through fraud, information loss, disclosure and cyber-attacks.
- Builds a culture of security, high employee ethics and efficient processes.
- Improves consistency in service or product delivery.
- Protects the company, assets, shareholders and directors.
ISO 22301
ISO 22301: Business Continuity Management System
All types of organisations, regardless of their size or nature of business, whether in the private or public sector are vulnerable to many forms of disruptions. Natural disasters, political upheavals, terrorism, epidemics and technology failure may occur at any time and lead to business disruptions such as interruptions in service delivery, supply chain, displacement/harm to personnel, or damage to company inventory and property which ultimately hurts the bottom line.
ISO 22301:2012 was developed as the World’s First International Standard for Business Continuity Management (BCM) to help organisations prepare and ensure their businesses can continue in the face of external threats. Built upon the ISO High Level Structure, ISO 22301 provides a framework in which an organisation shall plan, establish, implement, operate, monitor, review, maintain and continually improve a Business Continuity Management System (BCMS).
The standard emphasises the need for a well-defined incident response structure, thus ensuring that when incidents occur, timely responses are escalated, and people are empowered into taking effective necessary actions. Focus is placed upon safety of lives and the organisation must communicate with external parties who may be affected, for example, an incident that poses a noxious or explosive risk to the surrounding public area.
Benefits of ISO 22301
- Helps in identifying and managing current and future threats to an organisation.
- Minimises the impact of incidents and losses.
- Minimises downtime during incidents and improves recovery time.
- Ensures critical function are kept online during times of crises.
- Assists in meeting legal and regulatory requirements.
- Demonstrates resilience to customers, suppliers and other stakeholders.
ISO 37001
ISO 37001 Anti-Bribery Management Systems
Transparency and trust are the building blocks of any organization’s credibility. Nothing undermines effective institutions and equitable business more than bribery, which is why there’s ISO 37001.
It’s the International Standard that allows organizations of all types to prevent, detect and address bribery by adopting an anti-bribery policy, appointing a person to oversee anti-bribery compliance, training, risk assessments and due diligence on projects and business associates, implementing financial and commercial controls, and instituting reporting and investigation procedures.
Providing a globally recognized way to address a destructive criminal activity that turns over a trillion dollars of dirty money each year, ISO 37001 addresses one of the world’s most destructive and challenging issues head-on, and demonstrates a committed approach to stamping out corruption.