Case Study: ISO Systems Implementation
ISO 9001 Quality
ISO 13485 Medical Devices
Case Study: ISO Systems Implementation
ISO 9001 Quality | ISO 13485 Medical Devices
Achieve Certification First Time With Simplicity
The amazing team at Lanaco had a problem, they needed to certify to ISO 9001 for Quality Management Systems and ISO 13485 for Medical Devices quickly to be able to supply their world class Waire™ P2 Respirator Mask to the people that needed it.
The challenge was they were running out of time to meet key order dates and the external ISO certification audits were only 10 weeks away, they also weren't sure of exactly what they had to do, so they called us.
How we helped
Understanding the customer Challenges
Our first step was to understand where the team were at with their implementation project for the certification of their Waire™ P2 Respirator Mask. By conducting a short gap analysis we were quickly able to identify the areas that the client didn’t meet the requirements of the critical ISO 13485 Medical Devices standard.
We then set out working with the quality, design, supply chain and operations teams putting in place the elements we would need to close the gaps. This included auditing some suppliers, fully developing an internal auditing program, development of the medical device files along with the associated document control processes.
We helped the team to ensure that they had all the maintenance and calibration data for the manufacturing equipment fully documented and planned into their systems.
Throughout the project we made use of some key remote working tools such as MS Teams for video conferencing, chat and sharing files and Mango QHSE which is a cloud based QHSE compliance solution allowing us to work in the system and view what Lanaco had done real time. This allowed us to interact with the project team at Lanaco as we needed to in order to meet out tight deadline. For both the Stage 1 and Stage 2 audits we joined the client on site with the certification auditor.
All of this ensures that when Many Caps Consulting steps back from the client, they can manage their own system because they understand what was implemented and why it is important.
- We were able to make use of the Assessments Module to send auditing questionnaires to remote suppliers allowing them to complete and upload supporting evidence as required.
- We used the dedicated Audit Module to plan and automatically reschedule all internal audits, dynamically creating the audit schedule.
- The Event Module allowed us to plan various design and management meetings required by the standards within the system and automate reminders and capture evidence.
- The Documents Module allowed us to create the combined ISO 9001 & ISO 13485 quality manual with all revision controls automatically managed by Mango. All of the product specification and design documents were added to the files section of the document module allowing us to link them within the system to create a simple to use Medical Device File(MDF). As an additional bonus for this set up, any time the design files are updated the MDF is automatically updated and always current.
- We also utilised Mango’s Risk Module to build risk registers that covered health & safety risks, business risk as well as product risks as required by the medical device standard. All with automatic reminders to review them to ensure they stay current.
- With the Mango QHSE system we dramtically increased the speed of the implementation process and simplified the process at the same time.
Achieving the right Results
The Stage 1 audit is designed to ensure you are ready to move forward and to help find any last minute issues. The Stage 2 audit is designed to delve deeper into the company and it's systems to ensure that anything the company have claimed they do, they can prove and is multiple days in length.
The auditor was increadibly complimentary about the processes implemented and the ease of use of the system along with the level of inclusiveness it offered to the whole organisation.
As a result Lanaco passed both their stage 1 and stage 2 audits on their very 1st attempt with zero manjor non conformances.
With only 10 weeks and a lot of work we had managed to deliver a full ISO 9001 and ISO 13485 system for Lanaco.