ISO 13485 Certification Journey - Synthecon Sutures Manufacturing SA

Founded in 2006, Synthecon Sutures Manufacturing SA cc  is a leading manufacturer of quality surgical sutures supplied to public and private healthcare providers in Southern, Central, East and West Africa. Synthecon has a centralised administrative, manufacturing and distribution plant in Isando, Johannesburg South Africa and employs nearly 100 technical and administrative staff who are predominantly women from previously disadvantaged backgrounds.

Synthecon has a license to manufacture, distribute and export medical devices from the South African Health Products Regulatory Authority (SAHPRA) and also holds a SANS 494-1:2011 Permit from the South African Bureau of Standards (SABS) for suture manufacturing. Furthermore, all sutures manufactured by Synthecon are Certified SABS Approved and Synthecon is a member of both the South African Medical Technology Industry Association (SAMED) and Medical Device Manufacturers of South Africa (MDMSA).

In 2017, SAHPRA published regulations which mandated Medical Device manufacturers to have a certified ISO 13485:2016 quality management system in order to renew manufacturer’s licenses in 2022. In addition, some private healthcare providers and government healthcare products procurement bodies also required suppliers to have a certified ISO 13485:2016 quality management system in place.

Synthecon Sutures therefore took a strategic decision in June 2019 to pursue  ISO 13485:2016 certification. After a lot of research and engagements, Synthecon decided to engage DQS South Africa as the preferred certification body through whom ISO 13485 certification would be achieved.

In the words of Wellington Mudenha , Synthecon’s SHEQ Manager:  

“Synthecon embarked on the project without engaging the services of an ISO 13485 consultant. As the Management Representative and an experienced Quality Management professional, I studied the ISO 13485:2016 standard and identified the gaps between ISO 13485:2016 requirements and the ISO 9001:2015 standard that was in place within the organisation. After documenting the gaps, I documented an implementation plan to regularise all ISO policies, procedures, work instructions and shift some organisational processes in place to conform to ISO 13485 requirements.

This internal project was conducted over a period of one year. It also included making minor changes to the factory floor plan, changing the layout of cleanrooms, procurement of new equipment and cleanroom furniture. Throughout the process, there was constant engagement with key process owners who are the heads of departments and managers within the organisation to ensure their buy-in and collective ownership of the ISO 13485 certification project.

Once all processes, procedures and other changes had been successfully implemented, all ISO QMS internal audits were henceforth conducted using an ISO 13485 checklist to prepare for the certification audits. From 01 to 04 December 2020, DQS conducted a GAP audit to determine if there was sufficient evidence that the Synthecon QMS met ISO 13485 requirements. All gaps identified in the GAP audit were thereafter addressed in the first quarter (Jan-Mar) of 2022. The rest of the year was spent conducting internal audits to internally verify compliance to the standard.”

On 05 November 2021, DQS conducted the Synthecon ISO13485 Stage 1 audit. This audit mainly focussed on the System documentation and recommended that the company proceeds to a stage 2 audit. From 10-12 November 2021, DQS conducted an intensive ISO 13485 stage 2 audit.

After the successful resolution of all deviations raised in the stage 2 audit, on 13 September 2022, Synthecon officially obtained ISO 13485:2016 certification. This was followed up by a handover ceremony conducted by DQS at Synthecon on 07 October 2022 in the presence of Synthecon top management.

The Synthecon ISO 13485:2016 certification was achieved through the following:

• The Synthecon QMS team ensured that they first of all understood the requirements of the ISO 13485 standard before starting the project
• The Synthecon QMS team intentionally developed a unity of purpose among all managers to ensure there was collective ownership of the ISO 13485 project.
• The Synthecon QMS team developed a plan of small consistent incremental steps to implement ISO 13485 and transition from ISO 9001.
• The Synthecon QMS team engaged DQS from the onset of the ISO 13485 implementation project to understand the audit process before working towards the GAP, stage 1 and stage 2 audits.
• The Synthecon QMS team implemented the ISO 13485 standard without fear and were confident in their internal abilities to implement ISO 13485 on their own without the services of a consultant.