ISO 9001:2015 Clause 8.5.4, titled "Preservation," focuses on the requirements for preserving the conformity of products and services from production through to delivery. This clause ensures that the quality of products and services is maintained until they reach the customer, preventing damage, deterioration, or loss. Preservation encompasses various stages including identification, handling, packaging, storage, and protection of the products. Here's a detailed look at the components of this clause:
Purpose of Preservation
The primary purpose of preservation is to maintain product quality and ensure that products remain suitable for their intended use. This is critical for customer satisfaction and compliance with regulatory requirements.
Key Elements of Clause 8.5.4
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General Requirements for Preservation:
- Organizations must take appropriate measures to preserve the conformity of products and services throughout the process, including delivery to the intended destination. This applies to products and services in production, in storage, and in transit.
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Identification:
- Proper identification methods must be used to ensure that the product is preserved in a manner that is traceable and retrievable. Identification helps in managing the preservation process effectively.
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Handling:
- Appropriate handling procedures must be established and followed to prevent damage or deterioration during processing, storage, and transportation. This includes the safe handling of sensitive or fragile items.
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Packaging:
- Packaging methods must be selected and applied in a way that protects the products from deterioration or damage during transport and storage. Packaging should ensure that the product reaches its destination in the intended condition.
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Storage:
- Suitable storage conditions must be maintained to protect the products from damage or deterioration. This may involve controlling environmental conditions such as temperature, humidity, and cleanliness, especially for products that are sensitive to such conditions.
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Protection:
- Measures must be taken to protect the products from any adverse conditions that could affect their conformity to requirements. This includes protection against corrosion, electrostatic discharge, and contamination.
Implementing Preservation Measures
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Assessment of Risks: Organizations should assess the risks to product quality during handling, storage, and transportation and implement appropriate preservation strategies.
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Documentation: Documented procedures or instructions for preservation should be established, communicated, and maintained. This includes specific requirements for handling, packaging, storage, and protection of products.
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Training: Personnel involved in the handling, packaging, and storage of products should be trained to understand and implement the preservation procedures effectively.
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Monitoring: The effectiveness of preservation methods should be monitored, and corrective actions should be taken if products are found to be damaged or deteriorated.
Importance
Proper preservation is essential for ensuring that the product quality is maintained until it reaches the customer, thereby directly impacting customer satisfaction and compliance with regulatory requirements. It helps in minimizing waste, reducing costs associated with rework or replacement, and maintaining the organization's reputation for quality.
In summary, ISO 9001:2015 Clause 8.5.4 emphasizes the importance of preserving product and service conformity throughout the entire process from production to delivery. By implementing effective preservation practices, organizations can ensure that their products and services meet both customer and regulatory requirements consistently.