Quality Management System – ISO 9001:2015

ISO 9001:2015 is the international standard for Quality Management Systems (QMS), published by ISO (the International Organization for Standardization). The standard was most recently updated in 2015, and is referred to as ISO 9001:2015.

ISO 9001:2015 is a collection of policies, processes, documented procedures and records. This collection of documentation defines the rules that your company will use to manufacture or produce your product or service that will meet the requirements of your customer. For ISO 9001:2015 to be effective, it is important that is tailored and customised to the needs of your company and the products that you provide. It is certainly not a ‘one size fits all’ system, but it provides a set of guidelines to help make sure that you do not miss any important elements that a QMS needs to be successful.

What are the benefits of ISO 9001:2015?

The benefits of ISO 9001 cannot be overstated; companies large and small have used this standard to great effect, discovering and securing tremendous cost and efficiency savings. Here are just a few of these benefits:

Improve your image and credibility – When customer see that you are certified by a recognized certification body, they will understand that you have implemented a system that is focused on meeting customer requirements and improvement. This improves their trust that you will deliver what you have promised.

Improve customer satisfaction – One of the key principles of the ISO 9001 QMS is the focus on improving customer satisfaction by identifying and meeting customer requirements and needs. By improving satisfaction, you improve repeat customer business.

Fully integrated processes – By using the process approach of ISO 9001, you not only look at the individual processes in your organization, but also at the interactions of those processes. By doing this, you can more easily find areas for improvement and resource savings within your organization.

Use evidence-based decision making – Ensuring that you are making decisions based on good evidence is a key to the success of an ISO 9001 QMS. By ensuring that your decisions are based on good evidence, you can better target resources to the best effect to correct problems and improve your organizational efficiency and effectiveness.

Create a culture of continual improvement – With continual improvement as the main output of the QMS, you can attain ever-increasing gains in savings of time, money and other resources. By making this the culture of your company, you can focus your workforce on improving the processes they are directly responsible for.

Engage your people – Who better than the people working within a process to help find the best solutions for improving that process? By focusing your workforce on not only managing, but also improving the processes, they will be more engaged in the outcome of the organization.

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Quality Management System – ISO 13485:2016

ISO 13485:2016 is an international standard that outlines the requirements for a Quality Management System in the medical device industry. This standard is specific to medical devices and covers the entire life cycle of a device, from design and development to production, installation, and servicing. It is intended to ensure that medical devices are safe and effective for their intended use. Compliance with ISO 13485 is often required for regulatory approval of medical devices in many countries around the world. The standard is designed to be flexible and scalable, allowing it to be adapted to the needs of organizations of all sizes and types within the medical device industry.

ISO 13485:2016 is important for medical device manufacturers because it provides a framework for ensuring that their products consistently meet regulatory and customer requirements. Compliance with this standard demonstrates a company’s commitment to producing safe and effective medical devices. It also helps companies meet regulatory requirements in many markets around the world. ISO 13485 can help companies identify and mitigate risks associated with the design, development, and production of medical devices. Finally, it can help companies improve their processes and increase efficiency, leading to better products and higher customer satisfaction.

What are the benefits of ISO 13485:2016?

The most important benefit for South Africa is the requirement by SAHPRA (South African Health Product Regulatory Authority):

“As part of the application for a SAHPRA medical device establishment licence, a company must list all the medical devices that it manufactures, distributes, or wholesales. The application includes a declaration regarding the status of the quality management system in place in the company. Upon renewal of the SAHPRA licence, manufacturers and distributors will have to provide evidence of ISO 13485 certification for the company by an accredited conformity assessment body.”

Other benefits include:

Improve your image and credibility – The ISO 13485 certificate is globally recognized as the standard for quality in the medical device industry. This certification is evidence of following high-quality standards and informs customers that there is a standard in place to ensure it.  

Improve customer satisfaction – One of the key principles of the ISO 13485 QMS is the focus on improving customer satisfaction by identifying and meeting customer requirements and needs. Companies that are ISO 13485 certified are considered more reliable by the customers than the company that doesn’t have one. 

Companies that have implemented ISO 13485 are more focused on the customer needs.      

Fully integrated processes – By using the process approach of ISO3485, you not only look at the individual processes in your organization, but also at the interactions of those processes. By doing this, you can more easily find areas for improvement and resource savings within your organization.

Use evidence-based decision making – ISO 13485 certification helps companies to stay focused and work towards quality goals. Up to date data assists companies to make better decisions based on objective evidence which aligns to the strategic goals and objectives. 

Continual improvement – Continuous improvement is one of the core principles of the ISO quality management systems. When a QMS is adopted in any organization, it leads to cultural change, where management and staff will be looking out for improvements. 

Engage your people – With proper documentation and control of processes, employees are able to understand their role in ISO 13485 implementation. The more the employees understand their roles, the more they become engaged. This results in higher operational efficiency and productivity.

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Environmental Management System – ISO 14001:2015

An environmental management system helps organizations identify, manage, monitor and control their environmental issues in a “holistic” manner. Other ISO standards that look at different types of management systems, such as ISO 9001 for quality management and ISO 45001 for occupational health and safety, all use a High-Level Structure. This means that ISO 14001 can be integrated easily into any existing ISO management system. ISO 14001 is suitable for organizations of all types and sizes, be they private, not-for-profit or governmental. It requires that an organization considers all environmental issues relevant to its operations, such as air pollution, water and sewage issues, waste management, soil contamination, climate change mitigation and adaptation, and resource use and efficiency.

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Information Security Management System – ISO 27001:2022

With cyber-crime on the rise and new threats constantly emerging, it can seem difficult or even impossible to manage cyber-risks. ISO 27001 helps organizations become risk-aware and proactively identify and address weaknesses.

ISO 27001 promotes a holistic approach to information security: vetting people, policies and technology. An information security management system implemented according to this standard is a tool for risk management, cyber-resilience and operational excellence.

As per ISO 27001 definition, the basic goal of an Information Security Management System is to protect three aspects of information:

• Confidentiality: Only authorized persons have the right to access information.
• Integrity: Only authorized persons can change the information.
• Availability: The information must be accessible to authorized persons whenever it is needed.

What are the Benefits of ISO 27001:2022?

• Enhanced Information Security: assists companies to identify and address security risks and to ensure  confidentiality, integrity, and availability.  
• Compliance with Legal and Regulatory Requirements: assists companies to identify and comply with applicable legal and regulatory requirements. 

• Improved Business Continuity: establishment of procedures and controls to ensure the availability of information and critical business processes. 

• Enhanced Customer Trust: your commitment to information security  can improve customer trust and confidence by assuring customers that their sensitive information is handled and protected appropriately.

• Competitive Advantage: many customers prefer to work with companies that are able to demonstrate compliance with recognised information security standards.

• Cost Savings: by reducing the probability of security breaches, data losses, and associated financial impacts.

• Risk Management: by identifying and assessing security risks, companies can make informed decisions on how to control or manage those risks effectively.

• Improved Management Processes: by establishing the required policies, procedures, and processes for the management of information security. 

• Continuous Improvement: by regularly monitoring and reviewing security controls and processes, companies are able to identify areas for improvement and adjust to the changing security threats and challenges.

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OH&S Management System – ISO 45001:2018

An Occupational Health & Safety Management System, often called an OH&SMS, defines the framework in which the organization cares for the occupational health and safety of its employees. It represents a set of rules, policies, processes, plans and practices for preventing occupational health and safety hazards and minimizes risks in the workplace. OH&SMS is unique for every organization and it must be adequate to the legal requirements, occupational health and safety hazards and business processes applied in the organization. ISO 45001 represents the best practices in establishing, implementing and maintaining the OH&SMS. Its requirements and guidelines help an organization to establish effective OH&SMS and to avoid missing important elements along this way.

What are the benefits of ISO  45001:2018?

The benefits to a company of an effective OH&S Management System include:

Improve your image and credibility. By assuring customers that you have a commitment to establish and maintain an occupational health and safety management system, you can enhance your image and market share by reducing the number of OH&S incidents on the workplace and sending a clear message that your organization takes care of its employees.

Improve cost control. One improvement that all organizations are looking for is a reduction of costs. The OH&SMS can help with this by increase rating at insurance companies, while reducing occupational health and safety incidents that may lead to lawsuits and deterioration of the organization’s image.

Use evidence-based decision making. By ensuring that you are using accurate data to make your decisions on what to improve, you can greatly increase the chances that your improvements will be successful the first time, rather than having several unsuccessful attempts. By using this data to track your progress, you can correct these improvement initiatives before they go “off the rails,” which can save costs and time.

Create a culture of continual improvement. With continual improvement, you can work toward better processes and reduced occupational health and safety hazards in a systematic way, in order to improve your public image and potentially reduce your costs. When a culture of improvement is created, people are always looking for ways to make their processes better, which makes maintaining the OH&SMS easier.

Engage your people. Given a choice between working for a company that shows care and concern for occupational health and safety and one that does not, most people would prefer the first one. By engaging your employees to reduce your occupational health and safety hazards, you can increase theirs focus and retention.

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RSPO Supply Chain Standard

WATCH THIS VIDEO – How can palm oil be more sustainable? The Roundtable on Sustainable Palm Oil and WWF’s role in it

What is Certified Palm Oil?

We call it palm oil that was certified by the Roundtable on Sustainable Palm Oil (RSPO) according to specific criteria. By respecting those criteria, we can help to reduce the negative impacts of palm oil cultivation on the environment and communities.

Why do we use palm oil?

Palm oil is used in many of the products on supermarket shelves, from margarine and chocolate to ice cream, soaps, cosmetics, and fuel for cars and power plants. The reason why palm oil is so popular is because:

What is the impact of palm oil farming on the environment?

In some regions, oil palm cultivation has caused – and continues to cause – deforestation. This means that land, which was once predominantly covered by primary forest (forest that has never been touched by man) or which housed protected species and biodiversity, was cleared in order to be converted into palm oil plantations.

Likewise, some palm oil plantations were developed without consulting local communities over the use of their land. Some have even been responsible for forcibly displacing people from their land. Violations of workers’ rights to fair payment and safe working conditions and other malpractices have also occurred.

Despite widely-reported malpractices in the industry, a growing number of players in the palm oil industry have committed to adopting more sustainable practices. The result of this gradual transition is an increasing amount of palm oil in our products that has been produced and sourced in a sustainable manner.

Why can’t we simply replace palm oil?

Although using other vegetable oils seems like a practical solution, it would actually create similar – if not even larger – environmental and social problems. Therefore, the best solution is to ensure you buy products that contain sustainable palm oil.

There is a misconception that these concerns can be addressed when companies simply stop using palm oil in their products. However, this is not as easy as it sounds for a number of reasons:

• Replacing palm oil with other types of vegetable oil (such as sunflower, soybean or rapeseed oil) would mean that much larger amounts of land would need to be used, since palm trees produce 4-10 times more oil than other crops per unit of cultivated land. This would result in serious environmental damage, with the risk that more forests would need to be converted into agricultural land.
• In producing countries, millions of farmers and their families work in the palm oil sector. Palm oil plays an important role in the reduction of poverty in these areas. In Indonesia and Malaysia, a total of 4.5 million people earn their living from palm oil production. Stopping the production of palm oil altogether would create significant problems for these people who support their families by working in this industry.
• Replacing palm oil with other types of oil is not always feasible due to palm oil’s unique properties as food ingredient. Using other oils would not give the products the same texture and taste that palm oil offers.

(ref: www.rspo.org)