Did you wait until the last minute to update your quality system procedures to the new ISO 13485:2016 standard?

My team is helping 3 companies with this problem. One company is very large, with thousands of employees and multiple sites. Another company is small and was recently acquired by a larger company, but their quality system has not yet been merged. The third company has less than 10 employees. Despite the differences, all 3 companies can simplify their quality systems using 3 strategies.

Strategy 1
Consolidate your procedures. 28 procedures are required in ISO 13485:2016 and 25 procedures are required in 21 CFR 820. However, 2 companies have more than 70 procedures and the largest has more than 500. You don’t need a corrective action procedure and a preventive action procedure, when a CAPA procedure will do. You also don’t need a nonconforming materials procedure and a rework procedure. Those 2 procedures can be combined. Design controls requires 3 procedures, but you could easily consolidate that into 1 or 2.

Strategy 2
Be and editor–not a writer. Every time a company receives a nonconformity or an FDA 483, the first approach is to add a reminder to a procedure. This seldom is effective. Better training and monitoring quality objectives are more effective. Therefore, delete the ineffective reminders and cut the procedure down to the minimum requirements so every procedure is as simple as it can be. Then implement quality objectives for tasks that are sometimes neglected. Your new lean procedures will be easier to remember too.

Strategy 3
Don’t duplicate procedure content in your quality manual. Your manual explains how you meet requirements of each subsection in the standard, but if you have a procedure that meets the requirement–just reference the procedure. This strategy cuts down 28 subsections to a short sentence for each (e.g., This requirement is met by SOP 8.5.2).

source: https://www.linkedin.com/groups/2070960/2070960-6395273031622672388