Hi all, providing some context on our company: We are a super small nonprofit (3 engineers/ quality people on technical side, about 5 doctors/researchers on the implementation side). 1 Quality person establishing QMS, and delegating to engineers. We hold IP on our designs and do all design work, we outsource manufacturing/production/distribution. We develop electricity-free, high-quality, ultra-low-cost respiratory devices for babies in developing countries (primarily funded/ supported by Gates foundation, UNITAID, WHO, UNICEF, etc.). Our market is mostly Latin America and Sub-Saharran Africa. Usually, ISO 13485 certificate is required for these in-country regulatory approvals (necessary for sustained presence in-country). As we are a public benefit company, our budget is extremely small. Thus, traversing the ISO 13485 land has been a challenge. This forum and some ad-hoc support from consultants have been really helpful. I have several questions:
- We established document and control procedures, e-signature procedures, and several other SOPs, and some records (i.e. created a purchasing SOP and generated all supplier evals). What should the sequence of events be? We have not developed a quality manual yet. Any advice here would be great
- Do documents NEED an effective date? This is complicated because we are developing records in parallel with developing SOPs/ qual man. Can we replace the effective date by creating a revision history table and saying when the 1st one was created? Confused on what is required.
- Small problem here. We already developed some records (supplier evaluations) that have different effective dates, and signed these. Is it wrong to have effective dates finalized on these evals, if we haven't established a quality manual yet? Should we hold off on ALL signatures until ALL sops have been generated? What can I do about the records that already have signatures?