Ace your quality audits.
Documenting the way-of-working in your factory enables you to consistently meet audit criteria and operate processes in a safe and compliant manner.
errors from happening and consistently meet audit criteria.
audit failure with clearly documented procedures, processes, and work instructions.
corrective actions by proactively updating your documentation.
Nailing your ISO9001 quality audits.
Quality audits based on ISO9001 require the following documentation:
An overview of how different processes within the company should be performed, and who is responsible.
Quality policy & objectives.
Deep-dive into product quality and customer satisfaction.
How the various processes are related to each other.
Defines the application and boundaries of the quality management system within the company.
Work instructions are the most detailed and company-specific of all ISO 9001 documentation.
High-quality work instructions should:
→ Describe in detail how particular tasks must be performed.
→ Be easy to maintain and update.
→ Include approvals and version control.
→ Preferably be created by the people who perform the actual work.
→ Be visual and step-by-step.
Rocking your GMP audits.
Good Manufacturing Practice (GMP) audits require detailed written procedures for each process that might affect the product quality:
Are training and hygiene according to the standards?
Buildings and facilities.
Are the premises safe and clean?
Equipment and utensils.
What is the condition of the machinery and equipment?
Is there proof that procedures are followed in a consistent way along the entire process - every single time a product is manufactured?
Packaging and labeling.
Is packaging and labeling material of sufficient quality?
Document control.Is there access to clear work instructions that are easy to follow and up-to-date? Is there proof that these are used?
Process vs. procedure vs. work instruction.
What's the difference?Schedule your demo
What is a process?
A set of related or interacting activities, which transform inputs into outputs = a process.
What is a procedure?
A process that happens in a specific way including specifications on how it happens = a procedure.
What are work instructions?
The best way to complete a specific procedure. Allows any employee on the shop floor to complete a task.
“The top priority in my job is to meet the criteria for audits about document control and pass annual ISO audits. SwipeGuide helps me achieve this.”
Factory Manager at a European F&B CompanyREAD CUSTOMER STORIES