Seamus Orr Lead Consultant, offered the first ISO 13485:2016 training in Australia and New Zealand, now we are offering ISO 13485:2016 Templates for sale, our customers describe the templates as follow – “Your templates are the most high-level (as well as attractive and professional looking) of all the templates I am finding online. They are nearly double the price of the others I am finding, but they look to be worth it from the previews.” And later….. “Now that I’m dealing with your company I’m convinced I made the right decision.”
Anyone buying and downloading the old ISO 13485:2003 version this year, i.e. since 1st January 2016, can contact us for a free gap analysis and tracking spreadsheet on the gap between 2003 and 2016 and get the 2016 version free.
Why we focus on documentation?
Our experience and data from the US FDA on all 483 citations in 2015, by FDA investigator shows that the top issues relate to documentation, that is why we are so careful in the development of our template pack.
|CFR Reference||ISO 13485:2016 Reference*1||Short Description||Long Description|
|21 CFR 820.100(a)||8.5.2 and 8.5.3||Lack of or inadequate procedures||Procedures for corrective and preventive action have not been [adequately] established. Specifically, ***|
|21 CFR 820.198(a)||8.2.2||Lack of or inadequate complaint procedures||Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established. Specifically,***|
|21 CFR 820.50||7.4.1||Purchasing controls, Lack of or inadequate procedures||Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established. Specifically, ***|
|21 CFR 820.75(a)||7.5.6||Lack of or inadequate process validation||A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures. Specifically, ***|
|21 CFR 803.17||8.2.3||Lack of Written MDR Procedures||Written MDR procedures have not been [developed] [maintained] [implemented]. Specifically, ***|
|21 CFR 820.90(a)||8.3.1||Nonconforming product, Lack of or inadequate procedures||Procedures have not been [adequately] established to control product that does not conform to specified requirements. Specifically, ***|
|21 CFR 820.100(b)||8.5.2 and 8.5.3||Documentation||Corrective and preventive action activities and/or results have not been [adequately] documented. Specifically, ***|
|21 CFR 820.22||8.2.4||Quality audits - Lack of or inadequate procedures||Procedures for quality audits have not been [adequately] established. Specifically, ***|
|21 CFR 820.30(i)||7.3.9||Design changes - Lack of or inadequate procedures||Procedures for design change have not been [adequately] established. Specifically,***|
|21 CFR 820.181||4.2.3*2||DMR - not or inadequately maintained||A device master record has not been [adequately] maintained. Specifically, ***|
|21 CFR 820.25(b)||6.2||Training - Lack of or inadequate procedures||Procedures for training and identifying training needs have not been [adequately] established. Specifically, ***|
*2 ISO 13485:2016 is not as explicit as CFRs in terms of maintaining device master record and device history file. The ISO equivalent of DMR = Medical Device File*1As a guide we have added what we feel is the comparable ISO 13485:2016 clause
What’s included in the Medical Device QMS template pack?
The ISO 13485:2016 templates includes quality management system templates for developing Policies, Standard Operating Procedures (SOPs) and Work Instructions for the following areas of your business:
- product information, quotations and orders
- product development
- production and quality planning
- purchasing and receiving
- labelling, packaging, shipping and distribution
- monitoring and measurement of products
- monitoring and measurement of the Quality Management System
- monitoring customer feedback and satisfaction management policies, planning and commitments
- management review
- human resources
- plant, facility and equipment
- information resources
- measuring and monitoring devices
- continual improvement
- risk management
- corrective and preventative actions (CAPA)
These areas are specified as being essential components of a medical device quality management system by the various regulatory bodies e.g. TGA, EU and US FDA.
Buy the templates here
PharmOut is described by our clients as the leading QMS consultants having worked on most large Pharmaceutical and Medical Device Quality Management System (QMS), from the dental chair assembler working out of a “garage” to blue chip multinationals company’s.
Book your next ISO 13485:2016 training here