ISO 13485 Providers in
South Africa
Find verified ISO 13485 Medical Devices Quality Management consultants, certification bodies, and training providers in South Africa. Compare profiles, read reviews, and get free quotes — no obligation.
PM Quality helps businesses confidently navigate the world of ISO 13485 and 9001. We assist start ups and established business create and maintain an effective QMS
ISO Quest has been an established consultancy provider of international standards (ISO) services for the past 20 years. We specialise in the design of management systems as well as their implementation, and maintenance. and entrenchment of these systems to ensure continuous improvement and compliance. For the past 20 years, we have harnessed a team of experienced and qualified personnel who have assisted with over 150 management system implementations and well over 1000 compliance audits and gap analysis audits.All our management systems have centred around document and record control as well as the control and communication of information throughout an organization. Our ISO 9001 quality management system and ISO 27001 information security management system background gave us the required foundations to design, develop and implement management systems built around the POPI Act.For the past 2 years, we have been fine-tuning our skills by running our POPI management systems alongside our ISO 9001 quality management and ISO 27001 information security management systems.Our services have also been extended to assist inspection bodies set up their management systems and building in POPIA requirements that tie in with their procedures and policies.In March 2020 ISO Quest became the first ISO 30401 certified company in South Africa with an internationally recognized Knowledge management system. We also work closely with SAHPRA-approved certification bodies who audit our ISO 13485 medical device management systems. Our drive is compliance, whether it be to an ISO or POPI requirements and we aim to achieve this compliance in an effective and practical way.
World Wide Industrial & Systems Engineers? (WWISE) core function is assisting organisations in ISO management systems Implementation, Maintenance of ISO management systems, Auditing, and Training. We also assist in developing SharePoint portals linked to ISO management standards, with various plugins, customised software, and mobile application solutions aligned to ISO management systems standards.Our goal is to ensure that each organisation has an effective ISO Management System that integrates business processes and real-time working activities so that employees can embed the principles of ISO Standards, legal and other requirements in preparation for ISO conformance.? WWISE enables organisations to compete favourably in modern competitive business environments, both locally and internationally.WWISE offers industry experts to answer our clients? questions. Our team consists of engineers, business analysts, lawyers, accountants, psychologists, scientists, and auditors with over 100 years of combined experience in ISO conformance. Our 100% certification record includes over 590 clients in 16 different countrie
With over 20 years of experience in a diverse array of industry sectors that include medical devices, our team at 360 QMS has an impeccable track record in assisting our clients to implement Quality Management Systems and achieve ISO certification and significant business performance improvement. For us, it?s not just about ticking boxes; we?re driven by genuine passion for facilitating tangible improvements within businesses.We want you to achieve more than just certification. Our consultants spends time with you to understand the business and to find easy to implement solutions to ensure compliance and at the same time boost performance and customer satisfaction.Our team doesn?t just speak the language of ISO standards; we have actual industry backgrounds and years of experience of providing Quality Management Solutions. We?re passionate about creating efficiencies and adding value within your business.We are proud to have built management systems for over 120 clients, enabling them to achieve ISO 9001 or ISO 13485 certification. Our solution is future and growth based. We understand the importance of working with you to find solutions that will work for you.Pre-compiled manuals can never adequately reflect the intricacies of your organisation and rarely add the required value to drive growth and performance. Opting for an off the shelf solution is like saying your organisation is no different from your competitor.With 360QMS, you get a tailored Quality management Solution that speaks to your business?s specific needs and fosters long-term improvement.
Verified Providers
Consultants, certification bodies, and training providers based in or serving South Africa
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About iso 13485 providers in south africa.
CertBetter lists verified ISO 13485 Medical Devices Quality Management providers based in or serving South Africa. Filter by service type (consultant, certification body, training), compare profiles and verified reviews, and submit a single free quote request to hear from multiple specialists simultaneously.
Not necessarily. Many ISO 13485 Medical Devices Quality Management consultants work remotely with clients worldwide and can deliver gap analysis, documentation, and training entirely online. However, a locally based consultant in South Africa may have an advantage for on-site work, regulatory familiarity, and surveillance audit support.
Total ISO 13485 Medical Devices Quality Management certification costs in South Africa typically range from $5,000 for a micro business to $60,000+ for a complex medium-sized organisation. This covers consultant fees (gap analysis, implementation, documentation, training) plus certification body audit fees (Stage 1 and Stage 2). Getting multiple quotes through CertBetter is the fastest way to benchmark pricing.
Most South Africa businesses complete first-time ISO 13485 Medical Devices Quality Management certification within 4–12 months. Organisations with existing documented processes and a dedicated internal lead move significantly faster — sometimes within 3 months. A gap analysis at the start is the best way to set a realistic and accurate timeline.
A ISO 13485 Medical Devices Quality Management consultant helps you prepare — conducting gap analysis, building documentation, training staff, and getting audit-ready. A certification body (CB) is an accredited organisation that independently audits your management system and issues the certificate. They are separate roles, and you typically work with both. CertBetter lists both types in South Africa.
Technically yes, but it is significantly harder and slower without expert guidance — especially for first-time certification. Most South Africa businesses that attempt self-certification take longer, face more audit non-conformances, and end up spending more overall. A consultant typically pays for themselves in time savings and reduced re-audit risk.