Standard operating procedures (SOPs) apply to every business in every industry. They ensure that procedures within the business follow strict requirements for optimal service delivery and high-quality products.
For ISO or FDA standards, how you manage and implement your SOPs can mean the difference between compliance and non-compliance.
Standard operating procedures meaning
SOPs detail established and uniform instructions for company procedures. They ensure everyone follows the same steps to get consistent and repeatable results.
SOPs can describe any type of procedure from something simple like how to pack items for shipping to more complicated procedures like how to manufacture a medical device.
Types of SOPs
The different types of SOPs vary. They can include formats like checklists, flowcharts, hierarchical steps, annotated photos and video instructions.
Neither FDA nor ISO require a specific format. Your SOPs do have to be consistent and traceable with supporting documentation and proof of facilitation and proper management.
Regulations and quality standards that require proper management of SOPs
SOPs are essential for compliance with certain industry standards because they ensure that everyone is following the same measures to get the same end result.
Without SOPs, the results would be varied and compliance would be nearly impossible.
Specific FDA and ISO standards require SOPs to be implemented to achieve compliance. These standards include the following.
FDA’s Current Good Manufacturing Practice for finished pharmaceuticals
These regulations require written procedures for production and process control to prove that products have the identity, strength, quality and purity they claim.
FDA’s Current Good Manufacturing Practice for blood and blood components
Written operating procedures need to be maintained. They should include all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components for transfusion and further manufacturing purposes.
FDA’s Quality System Regulation for medical devices
These regulations also require SOPs and documented instructions to define and control the manner of production.
ISO 9001:2008 and ISO 13485:2003
Both these ISO standards require procedures to be documented with descriptions of how these processes interact. They also require documentation for quality management implementation.
How our document control software can help
Our document control software allows you to manage documentation related to SOPs in a centralized and cloud-based system. Accurate document management for SOPs and quality management is essential for ISO and FDA compliance.
Benefits of our document control software module include:
- secure cloud-based storage of SOP documentation
- accessible by authorized personnel from anywhere in the world
- daily backups and encryption
- full control of SOP approval processes
- 100% reliable document change control and version control
- automated task notifications and document archiving.
At isoTracker, we offer modular, cloud-based quality management software, including our document control software that will help you manage SOPs for ISO and FDA compliance. All our modules can stand alone or integrate with our other quality management software.
Contact us to find out more or to discuss your company’s SOP and document management needs. Alternatively, go ahead and sign up for a free 60-day trial of isoTracker’s quality management software.
