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ISO 45001 Occupational Health & Safety

Occupational Health and Safety

ISO 45001 | Compliance with Health and Safety legislation and regulations is a critical requirement for all businesses. Implementing a structured Occupational Health and Safety Management System (OHSMS) based on recognized standards can provide significant benefits, including improved compliance, reductions in illness and injury statistics, and cost savings. The OHSAS 18001 standard is the most widely recognized Occupational Health &Safety Management System standard globally. This structured management systems approach enables organizations to identify hazards and assess and prioritize risks. OHSAS 18001 is compatible with the ISO 14001 and ISO 9001 international standards, and more organizations are recognizing the efficiencies and other benefits of an integrated business management systems approach to implement appropriate protective and preventive control measures to reduce the potential for occupational injuries, illnesses, and fatalities. Companies with the above systems have the necessary marketing edge and it helps them to stay in front when it comes to Employee Protection. OHSAS programs deliver Significant benefits, better awareness and control of workplace hazards and risks can reduce the number and severity of lost time incidents and injuries and improve employee health and safety and delivery.

Key Benefits

Implementing ISO 45001 Helps Your Company In The Following Way.

Commitment to the protection of employees and safeguarding of property
Compliance with Health and Safety Legislation
Improve efficiency and consequently reduce Loss of time
Improving cost control through reduced Incidents
Reduce insurance premium
Improve safety culture
Improve Image with Authorities
Improve Employee ethics
Improve awareness in society

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ISO 14001|EMS

Environment Management System

With the alarm of global warming and its consequences, human society has become serious about ecology and its preservation. ISO 14001 is an international standard developed by the International Organization for Standardization (ISO) through dedicated technical committees representing approximately 173 countries around the world. Its purpose is to enable an organization of any type or size to develop and implement a policy committing it to the prevention of pollution, compliance with legal and other requirements, and continual improvement. Companies adopting ISO 14001 EMS are well placed against their competitors and are duly recognized at the global level. Environmental regulations are getting stricter, and so is law enforcement. Customers and shareholders increasingly demand that businesses diminish the environmental impact of their business, demonstrate what they do, and how they improve. An Environmental Management System helps your organization to be in control of and successfully manage the most significant environmental aspects, e.g. emissions, waste handling, utilization of natural resources, and energy efficiency. An ISO 14001 implementation and certification proves that your Environmental Management System has been measured against a best practice standard and found compliant.

Key Benefits

Implementing ISO 14001 helps your company in the following way
Compliance to Environmental Legislation
Improving cost control through materials and Energy
Reducing Environmental Incidents
Improve Image with Authorities
Improve Employee ethics
Improve awareness in society

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ISO 50001 | Energy Management

Energy Management systems | EMS

Requirements with guidance for use, is a voluntary International Standard developed by ISO (International Organization for Standardization). ISO 50001 gives organizations the requirements for energy management systems (EnMS). ISO 50001 benefits organizations large and small, in both public and private sectors, in manufacturing and services, in all regions of the world. ISO 50001 will establish a framework for industrial plants, commercial, institutional, and governmental facilities, and entire organizations to manage energy. Targeting broad applicability across national economic sectors, it is estimated that the standard could influence up to 60 % of the world's energy use. ISO 50001 energy management standards identify requirements for an organization to establish, implement, sustain, and improve an Energy Management System (EnMS), this enables the organization to take a deliberate approach to continually improve energy performance. This new standard will establish an international structure to help manage the energy supply, uses, and intake of industrial, commercial, or institutional organizations, which includes measurement, documentation, reporting, design, and procurement practices for energy-using equipment, systems, and processes. ISO 50001 energy management standard applies to all aspects impacting energy use, and this can be monitored and influenced by an organization.

Implementing ISO 50001 Helps Your Company In The Following Way:

Enables the organization to establish the system and processes required to improve energy commandment, which includes energy efficiency use consumption, and intensity
Reductions in energy cost. GHG emissions and other environmental impacts, through the systematic management of energy
Demonstrate that the organization implemented sustainable energy management systems, completed a baseline of energy use, and focused on continuously improving their energy vividness

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Good Manufacturing Practice (GMP)

WHAT IS GMP?

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any production that cannot be eliminated through testing the final product.

GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.

Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a food or drug product is safe for human consumption. Many countries have legislated that food; pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.

All guidelines follow a few basic principles:

Hygiene: A pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area.
Controlled environmental conditions in order to prevent cross-contamination of food or drug product from adulterants that may render the product unsafe for human consumption.
Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
Instructions and procedures are written in clear and unambiguous
Operators are trained to carry out and document procedures.
Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug were as expected. Deviations are investigated and documented.
Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
The distribution of the food or drugs minimizes any risk to their quality.
A system is available for recalling any batch from sale or supply.
Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent a recurrence.

Practices are recommended with the goal of safeguarding the health of consumers and patients as well as producing good quality food, medicine, medical devices, or active pharmaceutical products. In the United States, a food or drug may be deemed “adulterated” if it has passed all of the specifications tests, but is found to be manufactured in a facility or condition which violates or does not comply with current good manufacturing guideline. Therefore, complying with GMP is mandatory in all pharmaceutical manufacturing and most food processing

GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company’s responsibility to determine the most effective and efficient quality process.

The key benefits to GMP certification:

Prove organization’s management capabilities in product quality, safety assurance
Enable employees to develop good production/operations habits
Reduce safety risk in product quality and safety
Timely detect production and management problems, reduce cost
Better understand and comply with the relevant laws and regulations
Enhance the international credibility and public image
Increase customer’s long-term confidence in the enterprise

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GSP

WHAT IS GSP?

Good Storage Practice (GSP) is a system for ensuring that products are consistently produced and being stored ccording to national & international guideliness or standards. It is designed to minimize the risks involved in any food and pharmaceutical production that cannot be eliminated through testing the final product.

GSP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process — every time a product is made.

Good Storage Practices (GSPs) play an integral role in various Pharmaceutical and Pharmacovigilance oriented companies, organizations and institutions. Each one of them is required to demonstrate not only efficient management but also efficient storage of pharmaceutical products. Such efficient storage of drugs is essential because it will that the potency and the physical integrity of medicaments are preserved and kept. What is more, GSPs are activities which generally prevent deterioration and ensure that the quality and safety of drugs are also maintained. All storage conditions for medical materials and products are expected to be compliant with products' labelling.

Good Pharmaceutical Storage Practices is often accompanied by the concept of Good Distribution Practice (GDP) because both of them are included in the medical products' management chain. In this regard just like GDPs, GSPs is also part of the Quality Management System. Precisely, GSPs represent this part which makes sure that the quality of drugs is well-preserved. This is done through monitoring and controlling a number of procedures which are closely linked to storage processes. To present this differently, GSPs could be envisioned as a compilation of measures that should be taken into consideration when it comes to the safe-keeping of pharma and medical products.

GSP is also sometimes referred to as "cGSP". The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been "top-of-the-line" 20 years ago, may be less than adequate by today's standards.

GSP Covers and Requires:

Record Keeping
Personnel Qualifications
Equipment Verifications
Storage Maping and Identified Controls
Sanitation
Cleanliness
Process Validation
Complaint Handling

BENEFITS OF GSP

Cost Factor: The cost factor is vital in terms of the operational costs, profits and the overall cost of production. Handling materials is very expensive in terms of equipment, plant, time and labour. Therefore the more efficiently and quickly materials can be moved, the less the cost per unit. Efficient use of space reduces waste of space hence reducing cost of each unit.

Reduce Or Eliminate Damages: Efficient warehouses reduce the amount of movement to a minimum, and make the necessary movements as efficient as possible. The less items are handled or moved, the less likely they will be damaged, stolen or otherwise mislaid and the less cost will be incurred when item moving internally.

Reduce Movement: Materials flow has to be maintained if output and distribution have to be effective. Transportation starts from the point of offloading to the storage to the point of production moved through process back to the storage and then to distribution. Good storage system plan layout and handling simultaneously for example by planning layout to ensure that fast moving items have the least length of travel reduces overall handling costs.

Safety Of Personnel: Health and safety of many members of staff depend a great deal upon the type of materials handling and storage systems employed, the equipment operated and the level of training among operators.

Production Interruptions: Where manufacturing is involved, proper MHS reduces interruptions in the production. Delays in delivering materials in the production system result to machines and labour idle time resulting in inefficiencies. A good storage system ensures that materials are delivered as and when required in the most efficient manner.

Customer Satisfaction: A good storage system ensures that goods are located in the shortest time possible in the store. It takes a long time to locate an item in a poor storage system. With changing dynamics and stiff competition in the market, most customers would not wait for long before they move to the competitors. A good storage system ensures that goods are readily available.

Stock Records: Stock records should be available for any good storage system. The storekeeper can tell how much is held in stock at any one time. This reduces holding of too much or too little inventory. Stock forms a large part of working capital and should be well managed to reduce tying a lot of resources in inventory. This can only be managed when stock records are available.

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CGMP ISO 22716

What is cGMP for Cosmetics? (ISO 22716:2007)

Current Good Manufacturing Practices (cGMP) for cosmetics, as defined by ISO 22716:2007, provide guidelines for the production, control, storage, and distribution of cosmetic products to ensure quality, safety, and regulatory compliance.

Unlike pharmaceutical cGMP, which is regulated by the FDA, ISO 22716 is an international standard recognized globally for ensuring consistent and safe manufacturing practices in the cosmetics industry.

ISO 22716 and cGMP Compliance

ISO 22716 integrates quality and risk management principles into every stage of the cosmetic manufacturing process, ensuring:

✅ Hygienic Production Environment – Preventing contamination and ensuring cleanliness
✅ Raw Material & Ingredient Control – Verifying quality, safety, and traceability
✅ Manufacturing Process Consistency – Standardizing production to avoid variations
✅ Packaging & Labeling Compliance – Ensuring correct product identification and safety information
✅ Storage & Distribution Management – Maintaining product integrity throughout the supply chain

ISO 22716 certification is essential for companies looking to export cosmetics to regions such as Europe, the USA, and other regulated markets that require proof of compliance with GMP standards.

Products Covered Under ISO 22716 cGMP Certification

ISO 22716 applies to all cosmetic and personal care products, including:

✅ Skincare Products (creams, lotions, serums)
✅ Haircare Products (shampoos, conditioners, hair treatments)
✅ Makeup & Cosmetics (foundations, lipsticks, powders)
✅ Fragrances & Perfumes
✅ Oral Care Products (toothpaste, mouthwash)
✅ Personal Hygiene Products (soaps, deodorants)

Who Needs ISO 22716 Certification?

Companies involved in the manufacturing, packaging, storage, or distribution of cosmetic products should obtain ISO 22716 certification to ensure regulatory compliance and consumer safety. This includes:

Cosmetic Manufacturers & Private Label Producers
Contract Manufacturers & Third-Party Manufacturers
Raw Material & Ingredient Suppliers
Cosmetic Packaging & Distribution Companies

Benefits of ISO 22716 Certification

✔ Ensures compliance with international regulatory requirements (EU, FDA, ASEAN, etc.)
✔ Enhances product safety and quality control
✔ Reduces risks of contamination, defects, and recalls
✔ Builds consumer confidence and brand reputation
✔ Expands global market access and export opportunities

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GDPMD for Medical Devices

WHAT IS GDPMD?

GDPMD specifies the requirements for a quality management system to be established, implemented, and maintained by an established of medical device importer/distributor/ authorized representative to comply with the 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 the medical device which includes but is 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.

The aim of GDPMD is to ensure that companies dealing with medical devices have a quality distribution system in place. This ensures that the quality of the medical devices is maintained throughout the storage and distribution process. The certification to GDPMDS is a mandatory requirement in the application of an Importer's or Wholesaler's License.

Why do you need to implement and certify GDPMD?

1) A license to trade in the logistics and shipping of medical devices

2) Develop a consistent product or service quality, efficiency, and cost benefits

BENEFITS:

Medical devices are appropriately managed and controlled throughout the supply chain thus ensuring their safety and performance at the point of use.
Provides assurance to stakeholders through certification that the organization is able to maintain the quality, safety, and performance of medical devices while under its custody.
Fulfillment of establishment licensing requirements.

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ISO 28000

WHAT IS ISO 28000?

This standard identifies the requirements for a supply chain security management system, relating security management to many other aspects of business management. These include all activities controlled or influenced by organizations that impact supply chain security, which includes the transportation of these goods along the supply chain.

ISO 28000 uses an additional pragmatic approach where the risk levels of your supply chain operations are identified. It enables your organization to execute a risk assessment with supporting management tools (I.e., document controls, key performance indicators, internal audits, and training) and implement the controls in accordance with the risk involved.

The framework of ISO 28000 is structurally very similar to the ISO 14001 Environmental Management Systems (EMS) standard. The environmental aspects identification and evaluation process in EMS is similar to security risk assessment in security management.

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ISO 15189

WHY ISO 15189?

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.

With 300,000 tests performed every working day of the year and around 95% of clinical pathways relying on patients having access to pathology services, it’s clear that medical laboratories sit at the heart of a fully-functional modern society. Becoming ISO 15189 accredited will verify three key components of a laboratory: your integrity, impartiality and capabilities. Here’s a little bit more about this crucial ISO standard.

What is ISO 15189?
ISO 15189:2012 is an international standard for medical laboratories. Laboratory accreditation helps labs develop quality management systems, assesses their competence and ensures they are functioning in line with industry and legal standards.

As part of your ISO 15189 accreditation process, you will create a document that explains how your laboratory can work to conform to each requirement to a high standard of quality. This handy document will provide each member of your team with instructions for performing the tasks to an ISO-accredited standard.

Who needs ISO 15189?
Laboratory testing is incredibly important in the delivery of information-based healthcare outcomes – this is incredibly important in a world where decisions need to be driven by facts, science and data. Any medical laboratory that wants to deliver clinically relevant results that meet the highest ethical standards should become ISO 15189 accredited.

Is ISO 15189 mandatory?
ISO 15189 accreditation is not mandatory in every jurisdiction, but it’s worth checking your local regulations. Nevertheless, the importance of laboratory accreditation should never be overlooked, especially when you are dealing with public health.

As part of your accreditation process, you will get your organisation up-to-date with all the complex legal requirements that a medical laboratory must adhere to. With the ISO’s culture of continuous improvement, any changes to law or regulation will be implemented as part of your ongoing commitment to best practice.

What are the benefits of ISO 15189 accreditation?
There are many reasons why ISO 15189 is important – here are some of the numerous benefits it offers to medical laboratories.

Risk reduction
When you structure your operation around best practise, your systems will be more rigorous. Planning for and identifying any potential risks will help massively reduce them – especially in laboratories that deal with sensitive information, complicated equipment and matters pertaining to people’s health.

Cost-saving
By assuring results are technically valid, your laboratory will save costs associated with retesting. There will also be other cost-saving measures implemented across the standard as your efficiency increases.

Improved team morale
The standard works to reduce staff mistakes and other preventable errors. Your staff motivation won’t only be improved by their demonstration of better performance, but also by you recognising and promoting your staff’s technical competence.

Legally compliant
By implementing legislation and industry standards into your medical laboratory, ISO 15189 assures that your clinical services are safe, reliable and of good value. This conveys trust to stakeholders and decision-makers who recognise and appreciate the commitment. Legal challenges will be less likely and, if they do occur, you can ensure the framework will support you.

Continual improvement
Best practices won’t start and end with your ISO 15189 certification: through integrating this framework into the core of what you do, you will develop additional programmes over time. The framework acts as a tool for measuring quality improvements and continually supporting consistency.

Globally recognised
Being a globally recognised standard not only has reputational benefits. For ISO 15189, global recognition is particularly pertinent. A series of Multilateral Mutual Recognition Arrangements within the International Laboratory Accreditation Cooperation (ILAC) means that laboratories accredited to ISO 15189 will have their certificates and test reports accepted in over 80 countries around the world. This way, your work can benefit medical health not just in your country, but all over the globe.

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