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.
Nailing your ISO9001 quality audits.
Quality audits based on ISO9001 require the following documentation:
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Procedures.
An overview of how different processes within the company should be performed, and who is responsible.
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Quality policy & objectives.
Deep-dive into product quality and customer satisfaction.
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Process flowchart.
How the various processes are related to each other.
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Scope statement.
Defines the application and boundaries of the quality management system within the company.
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Work instructions.
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:
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Frontline teams.
Are training and hygiene according to the standards?
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Buildings and facilities.
Are the premises safe and clean?
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Equipment and utensils.
What is the condition of the machinery and equipment?
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Process controls.
Is there proof that procedures are followed in a consistent way along the entire process - every single time a product is manufactured?
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Packaging and labeling.
Is packaging and labeling material of sufficient quality?
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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?
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 Company
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