Glad to inform that we got through successfully the ISO 13485; ISO 9001:2008; and the MDD assessment with the scope expansion of adding a site and a new product assembly process. Wish to share some of the learning had in this project .
1. The GHTF proposed document , Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 4: Multiple Site Auditing was very useful in the modifications to the Quality manual
2. Establishing a quality agreement between the two sites with regard to process ownership and interaction, communication between the lead site and site 1 was a strong point.
3. Key areas that were recognized as strong points were process re-validation plan and activity, Internal audit program and management, Relook at customer property management after direct link to customer documents server access and download was established, Progressive management reviews at shorter intervals during the establishment of the new site, Proper and timely notified body communication about significant changes in the QMS, Mapping of ISO 13485 clauses to the two site activities within the Quality management document, Linkage of the two organization charts within the quality manual, Bringing shop floor lighting activity within the work environment monitoring.
A tough but good audit and a sense of satisfaction having made this scope expansion audit along with the annual recertification assessment.
1. The GHTF proposed document , Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 4: Multiple Site Auditing was very useful in the modifications to the Quality manual
2. Establishing a quality agreement between the two sites with regard to process ownership and interaction, communication between the lead site and site 1 was a strong point.
3. Key areas that were recognized as strong points were process re-validation plan and activity, Internal audit program and management, Relook at customer property management after direct link to customer documents server access and download was established, Progressive management reviews at shorter intervals during the establishment of the new site, Proper and timely notified body communication about significant changes in the QMS, Mapping of ISO 13485 clauses to the two site activities within the Quality management document, Linkage of the two organization charts within the quality manual, Bringing shop floor lighting activity within the work environment monitoring.
A tough but good audit and a sense of satisfaction having made this scope expansion audit along with the annual recertification assessment.