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ISO 13485 certification in Durban
About Durban
Durban, or eThekwini in Zulu, roughly translates to “bay, lagoon”. This coastal city holds the third spot for population size in South Africa. As the main city in the province of KwaZulu-Natal, it’s nestled along South Africa’s east coast in the Indian Ocean’s Natal Bay. Known as South Africa’s hustle and bustle port, Durban was once called Port Natal.Â
To the north, there’s the city and harbour’s entrance Umgeni River. On the western side, the city’s flat centre then elevates to Berea hills and to the south, the Bluff stretches along the coastline.Â
In 2021, around 595,061 people were living within Durban city limits. The city climate is a humid subtropical mix with sweltering, damp summers and mild, dry winters.Â
So, what sets Durban apart? This city is famous for lifeguard-guarded beaches, depth-defying aquarium world’s 5th largest, Moses Mabhida stadium, walk-friendly beaches, and fantastic surf.
Types Of ISO Certification In Durban
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How Durban city boosts South Africa’s Economy?
South Africa, positioned at the southernmost part of the African continent, includes a minor sub-Atlantic archipelago named the Prince Edward Islands. It’s bordered by nations like Botswana, LeÂsotho, Mozambique, Namibia, Swaziland, and Zimbabwe.Â
It functions as a republic, headed by a president. This country hosts a mixed economy, second to Nigeria’s in Africa. Its GDP per capita is decent compared to its sub-Saharan neighbors.Â
South Africa is a part of the South and African Development Community and is globally recognized for its export of gold, platinum, and other resources. Developed sectors include finance, legal, communication, energy, transportation, and a large stock exchange.
Agriculture in South Africa is remarkably diverse, with various farming types like corporate, private, intensive, and extensive crop farming. They produce vegetables, fruit, nuts, and grain. A successful commercial farming sector is vital to their agricultural economy.Â
They’ve seen the best growth rate among other sectors and earned great export revenue. Their major exports include citrus, wine, table grapes, corn, and apples, alongside smaller exports of wool, nuts, sugar, mohair, and pears.
South Africa’s climate and biodiversity allow them to produce and export top-quality goods. There’s room for improvement in subsistence or small-scale farming, which is exciting to note. Thousands of commercial farms exist here, with only a small portion producing most of their agricultural output.
Previously the economy’s growth engine, the South African manufacturing industry is struggling. The government has focused on this sector due to its job creation potential. Initiatives like the Black Industrialist Scheme were created, which have supported numerous industrialists.Â
Major areas in manufacturing include food processing and textile, metal, and chemical production. These sectors rely heavily on agriculture and fisheries. Despite recent challenges, manufacturing output increased earlier this year, contributing to the sector’s revival.
South Africa’s transport options are vast and varied. Their extensive network of roads and railways serve as the primary mode of transport, supplemented by air travel. Transnet, a public corporation, owns and operates most of the railway system, transporting goods like coal and iron ore.
They also offer internationally bound flights. South African ports are controlled by subsidiaries of Transnet. The major port is Durban, handling traffic for several nearby regions. Other ports include Port Elizabeth, Cape Town, and East London.
What is ISO 13485?
13485 as a global standard, made by the International Standards Organization. It’s like ISO 9001. But, it’s specifically for medical equipment’s quality control.
It lists everything needed by those who make, supply, distribute or are connected to the medical device business.
This assures everyone that they have strong procedures and controls for selling these devices worldwide. Many places make sure medical device creators have a quality management system running.
The FDA [Food and Drug Administration] declared recently they plan to implement ISO 13485 for medical device compliance quality standards. This is aimed at simplifying regulatory demands globally and easing manufacturers’ workload.
ISO 13485’s Quality Management System allows for adherence to varied jurisdictional necessities at once. Having an ISO 13485 Quality Management System certified by an external certification body demonstrates this compliance.
Clauses ISO 13485
Let’s break down ISO 13485. It has eight parts. The first three parts provide essential information such as references and word meanings used in the standard here.
Then, from part 4 to 8, it explains how to start and keep up an ISO 13485 quality management system. Part 4 lists out the basic and documentation needs for the quality management system, like a need for a quality manual, medical devices file, document control, and record control.Â
Part 5 is about what the top management of a company using ISO 13485 Quality Management System needs to do, it stresses the management’s dedication to the system and a focus on the customer. It emphasizes a quality policy and planning for a quality management system.
Also, it mentions who holds responsibility and power for the system, represents the top management, and communicates quality management system details internally.
The final segment of Part 5 is about its management review. It explains what input and output are required for the management review.
Part 6 centers around resource management. It presents the needs for resource provision, human resources, infrastructure, workspace, and contamination control.
Part 7 is all about turning the plan into a product. It involves planning, customer-based processes, design and development, purchasing, production, service provision, and finally, how to keep track of monitoring and measuring equipment.
Lastly, Part 8 is totally about measurement, analysis and enhancement. It outlines the need for feedback, managing complaints, reporting to authorities, internal audits, watching and measuring processes, overseeing and measuring product, controlling non-compliant product, data analysis and improvement from corrective and preventative action.
Why ISO 13485 is essential for medical device manufacturing project?
Getting ISO 13485 certified means meeting higher standards than just ISO 9001, specifically for the medical field. It comes with six notable upgrades.
Better risk management ensures all risks in the process are identified. Management roles are clearly set so all involved know their duties. Staff get regular skill upgrades and help others learn too, under the enhanced training.
Keeping the facility clean and organized is important, and so is labeling and separating products. The way designs are created is improved, with clear and efficient methods for specific product types.
 Suppliers are held accountable at each step in the journey, ensuring traceability. An ISO 13485 manufacturer guarantees clear leadership, hygiene, efficient methods, and responsibility.Â
For instance, a CT scanner for inspecting 3D printed metal parts. You need specialized machines used only for a particular material, not for other clients. Hence, the quality system highly values the isolation of all production risks. A better explanation of management duties is necessary. This means every stakeholder has well-outlined roles and responsibilities.Â
There’s improved training too. It implies that all quality-related staff continuously improve their skills and guide others.Â
ISO 13485:2016 Certification comes with some benefits-
- It promises a steady and efficient way of running a business.
- It brings down the dangers by using good old management tricks.
- You'll gain a competitive advantage and attract top executives
- Plus, you can rely on it to keep your product quality stable.
Internal Auditing in ISO 13485
Internal audits and ISO in the medical device industry, Internal audits are key for checking if a company’s processes meet ISO standards. These audits help improve and maintain rules.
Why conducting internal audits in ISO terms is beneficial?
They’re more than just a compliance tool. It’s an opportunity to asses quality management system, find places for improvement, and make sure we’re following ISO 13485 rules. They also help improve understanding of quality processes in the company.
ISO Clause 9.2 deals with internal audits. ISO 9.2 asks companies to conduct internal audits that are systematic, independent and documented. This means gathering and assessing audit evidence objectively to check the quality management system against the plans keeping ready for your internal audits under ISO. You’ll need to work out how often to audit, the scope, and the methods, pick the right people, and set clear criteria for the audit.
When you conduct the audit, start with a meeting laying out goals and expectations, gather information and evidence during the audit, engage with staff to understand processes and gather insights, check documents, records and procedures to ensure everything is in compliance. Scrutinizing ISO-specific documentation is a crucial part of internal audits.
This includes checking the documented information against the real practices, ensuring documented procedures stick to ISO standards and making sure records are correct, complete and maintained. You might find some issues, where processes do not meet ISO standards while auditing.
When that happens, note down and document these issues, find out the root causes and develop and implement ways to correct these issues effectively. After all the activities of the audit are concluded, hold a closing meeting summarizing finding, discuss corrective actions and provide recommendations for improvement, and after the meeting, report your findings, conclusions, and recommendations in a thorough audit report.
Internal audits aren’t just about compliance. They’re also a way to continually improve. Companies should use audit outcomes to make positive changes, improve processes and increase QMS effectiveness in accordance with ISO.
Some best practices for internal audits under ISO 13485
- Make sure auditors are impartial and objective
- Train auditors to make them better at their jobs
- Customize your audit program based on risk and priorities specific to the medical device industry.
- Engage employees at all levels in the audit process to improve understanding and collaboration.
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