Quality Policy & Standards
Bakare® are an ISO 13485:2016 accredited company. Bakare® is committed to delivering the best possible service and products to our customers, and our ISO 13485:2016 accreditation shows our commitment ensuring their satisfaction.
Bakare®’s ISO 13485:2016 accreditation means that our customers can be confident that the products we supply are safe and and of the highest-quality. It also means that we have the systems in place to catch and correct any issues before they become problems.
What Does It Mean for Our Customers?
Bakare® is excited to announce that we have achieved ISO 13485:2016 accreditation. This certification is a testament to our commitment to providing the best products and services to our customers. It is an internationally recognised standard that ensures that we maintain the highest quality products and services. Our customers can rest assured knowing that their safety and satisfaction are our top priorities. ISO 13485:2016 sets the benchmark for quality and safety, and we are proud to meet and exceed these standards. This accreditation proves our dedication to delivering the best possible service and products to our customers, and our commitment to their satisfaction.
What is ISO 13485:2016?
ISO 13485:2016 is a standard that establishes the requirements for a quality management system for the supply of medical devices. ISO 13485:2016 ensures that medical device companies have the proper infrastructure in place to design, supply, and distribute high-quality medical devices and is intended to reduce the risk of harm caused by faulty devices.
Benefits of ISO 13485:2016 accreditation
ISO 13485:2016 accreditation proves to customers that Bakare®’s systems and processes meet the highest standards of quality and safety. ISO 13485:2016 shows customers that Bakare® has the systems in place to supply high-quality products that are safe for patients.
How does ISO 13485:2016 benefit our customers?
ISO 13485:2016 certification ensures that all of our products are safe and effective and also ensures that Bakare®’s operational processes are efficient and streamlined. ISO 13485:2016 certification shows that we have systems in place to prevent faulty products from being shipped to customers.
How does Bakare® ensure compliance with ISO 13485:2016?
Bakare® is committed to meeting and exceeding ISO 13485:2016 standards. To do so, we have established a Quality Management System (QMS). Our QMS is focused on continuous improvement. We use the PDCA (Plan, Do, Check, Act) model to catch and correct any issues before they become problems. Bakare® has a quality assurance team who are tasked with monitoring and auditing processes and facilities. The quality assurance team use a variety of tools and techniques to ensure that Bakare® meets and exceeds ISO 13485:2016 standards. These tools include document reviews, audits, risk assessments, process assessments, and more. Quality assurance team also use the findings from these audits and assessments to create action plans. These plans outline the steps that need to be taken to correct any issues and bring Bakare® into compliance with ISO 13485:2016.
What processes does Bakare® Beds have to ensure customer satisfaction?
Bakare® Beds has a robust customer feedback process in place to ensure that customers are happy with the products they receive. Bakare® Beds also has internal procedures in place to make sure that products that have been reported as faulty or defective are quickly recalled in conjunction with the MHRA, UKs healthcare regulator. Bakare®Beds also has a robust product field safety notice & recall procedure in place. This procedure is used to quickly notify customers of faulty products.