Glossary / Lexicon

Deutsch: Einreichung / Español: Presentación / Português: Submissão / Français: Soumission / Italiano: Sottomissione

Submission in quality management refers to the process of formally delivering documents, reports, data, or product samples to regulatory authorities, clients, or internal stakeholders for review and approval. This process ensures that the organisation's products, services, or processes comply with predefined quality standards, regulations, or contract requirements.

Description

In quality management, submission plays a critical role in ensuring that all required documentation, test results, and quality assurance records are provided to the appropriate parties. The submission process is vital in demonstrating compliance with industry standards, regulatory requirements, or customer specifications. It often involves providing detailed information on how a product or service meets the required quality criteria and how the organisation has controlled and verified its processes.

Submissions can take various forms depending on the context:

• Regulatory submission: Documents provided to regulatory bodies to demonstrate that a product meets the legal and safety standards, often seen in industries like pharmaceuticals, food, and aerospace.
• Client submission: Reports or product samples submitted to customers to verify that the product meets their specifications before shipment or final approval.
• Internal submission: Documents or data delivered within an organisation to different departments or management teams for review, verification, or approval as part of the internal quality assurance process.

Typical submissions include quality control reports, test results, certificates of compliance, and audit reports. In industries like healthcare, pharmaceuticals, and aerospace, regulatory submissions are required to prove that all quality and safety standards have been adhered to, such as in the case of submitting data to the FDA or European Medicines Agency for product approvals.

Submission is a formalised process and is often accompanied by strict documentation, formatting, and review procedures to ensure accuracy and completeness. A poorly executed submission can delay product approvals, result in financial penalties, or lead to product recalls.

Application Areas

• Pharmaceuticals: Submitting clinical trial data and quality control results to regulatory bodies like the FDA or EMA to gain approval for new drugs.
• Manufacturing: Submissions of product samples, test reports, or inspection results to customers before the final acceptance of the goods.
• Construction: Submission of quality assurance documentation and compliance certificates to ensure that construction materials and processes meet safety and quality standards.
• Aerospace: Submissions of safety reports, test data, and compliance documents to regulatory authorities for the certification of aircraft or components.
• Healthcare: Submitting medical device data or quality assurance documentation to ensure that devices meet regulatory requirements.

Well-Known Examples

• New Drug Application (NDA): A submission to the FDA by pharmaceutical companies to request approval to market a new drug. It includes all data from preclinical and clinical trials, manufacturing processes, and quality controls.
• European CE Marking: Companies submit documentation to regulatory bodies in Europe to prove that their products meet EU safety, health, and environmental protection requirements.
• ISO 9001 Certification: Organisations submit detailed quality management documentation to certification bodies to achieve ISO 9001 accreditation, demonstrating adherence to international quality standards.

Treatment and Risks

Submission processes in quality management come with potential risks, particularly if they are not conducted properly:

• Delays: Incomplete or incorrect submissions can delay product approvals, leading to extended timelines for product launches or deliveries.
• Regulatory non-compliance: Failing to meet submission requirements can result in fines, product recalls, or rejection of product approvals, especially in heavily regulated industries like pharmaceuticals or medical devices.
• Financial loss: Delayed approvals or non-compliance can result in significant financial penalties, loss of business opportunities, or damaged customer relationships.
• Reputation damage: Inconsistent or incorrect submissions can harm an organisation's reputation, particularly if the errors lead to regulatory action or recalls.

To mitigate these risks, it is critical to have a robust quality management system in place that ensures all submission documentation is accurate, complete, and timely. Organisations often implement document control systems and internal audits to verify the completeness of submissions before they are sent to external parties.

Similar Terms

• Regulatory approval: The process of gaining official permission from regulatory bodies, which often requires detailed submissions of quality and compliance data.
• Audit submission: The submission of documents and reports as part of an internal or external audit to verify compliance with quality management systems.
• Quality review: The internal process of reviewing documents, products, or services to ensure they meet quality standards before submission to external stakeholders.

Summary

In quality management, submission refers to the formal process of delivering documents, reports, or product samples to regulatory bodies, customers, or internal teams for review and approval. It is a critical step to ensure compliance with quality standards, industry regulations, and client requirements. Effective submission processes help organisations avoid delays, non-compliance, and financial losses while maintaining strong relationships with stakeholders.

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Weblinks

• architektur-lexikon.de: 'Einreichung' in the architektur-lexikon.de (German)

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