When companies begin their quest for an ISO 9001 or ISO 13485 certification, they often wonder how many procedures do they need to satisfy certification requirements? It seems that there is a perception that if the number is too big, then the quality system will be too burdensome. If the number is too small, then the system may be too weak and not meet all of the certification requirements.
The certification auditor will likely want to see a quality manual and a procedure for each main element of the standard. This will make it easy for him to audit. If certification is the goal, easily auditable processes and procedures is likely more important than the quantity of documentation or the number of procedures.
Let Conformity Tech help you create your auditable processes and procedures.