• Organisations that are involved in one or more stages of product design, development, production, storage, distribution, installation, or servicing of a medical device, as well as the design, development, or provisioning of associated activities (e.g. technical support) are required to conform to an International Standard that regulates medical devices.
• This global Standard is mandatory in some countries.
• Certification verifies your organisations ability to provide medical devices and related services that meet customer and applicable regulatory requirements consistently.
• The Standard assists organisations to ensure maintained customer satisfaction and continuous improvement.
• The Standard allows you to align seamlessly with Unites States Food and Drug Administration (FDA) and South African Health Products Regulatory Authority (SAPHRA).

• Improved customer satisfaction. The ISO 13485:2016 Standard is founded on a set of quality management principles. Customer satisfaction can be achieved by assessing customer needs and expectations and striving to achieve them.
• Improve your processes. Using the process approach as defined in the Standard highlight’s opportunities for improvement. Confidently identify and eliminate waste within and between processes , reduce errors, and avoid rework—facilitating greater efficiency and savings.
• Create a culture of continual improvement. With the support of an embedded culture, management and employees are motivated to improve current activities.
• Increased employee engagement. Through this process, employees will identify improvements in their own processes/activities, resulting in increased investment in the growth and success of the organisation.
• Global recognition. Many countries and customers require manufacturers that medical products to be certified.
• Reduced costs of sales. This certification improves the organisations credibility, earning prospective customer’s trust and confidence.
• Statutory, regulatory, and marketing requirements are met.

ISO Consulting & Implementation:

We have a range of professional consultants, engineers, and registered auditors to assist in implementing and maintaining any ISO management system. Our industry expertise includes services, telecommunication, manufacturing, construction, engineering services, fast-moving consumer goods, mining, power generation, state owned companies, and government-run organisations. A good consultant takes the time to truly understand the processes of your company.

Therefore, they can approach the implementation of ISO requirements accordingly. The cost of hiring a consultant and the time spent to implement your ISO management system will definitely pay off in the long run.

WWISE has a 4-Phase Approach:

• Phase 1: Gap Analysis Audit and Information Gathering
• Phase 2: ISO Documentation, Risk Assessment, and Process Mapping
• Phase 3: Implementation and Coaching
• Phase 4: Certification

WWISE provides a turnkey solution which includes templates, 1-on-1 coaching, on-the-job training, and mentorship. As a consulting firm, we do not provide certification services. However, we will guide you through the certification process and ensure that your business becomes certified.

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An organisation can get certified to a requirement standard. You can implement the standard and get certified by a third party.

Click here to view certification process