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New Work Item Proposal 113-996 ED1: Nanomanufacturing – Requirements for a quality management system

Source:
IEC
Committee:
NTI/1 - Nanotechnologies
Categories:
Information management | Standardization. General rules
Comment period start date:
Comment period end date:

Comment by:

Scope

This International Standard specifies requirements for a quality management system for an organization which is involved in the value chain of nano-enabled electric or electronic products and

– needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements,

– aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements,

– operates a continuous improvement program to integrate the latest advancements in nanotechnology knowledge into fabrication processes and materials, and

– ensures that the organization proactively addresses nanotechnology EHS risks, leveraging opportunities to enhance product performance using science -based state-of-the-art evaluations of the technology.

It defines nanospecific requirements within the established ISO 9001 QMS framework. It ensures that organizations engaged in the production, handling, and use of nanomaterials meet both, the overarching quality standard ISO 9001 and the specialized demands of nanotechnology applications. The nanospecific stipulations are either added into existing ISO 9001 requirement lists or introduced as supplementary clauses within the appropriate ISO 9001 sections. Consequently, organizations already certified under IS O 9001 can be seamlessly audited according to this standard.

All the requirements of this Technical Specification are intended to be applicable to any organization involved in the value chain for nano-enabled electric or electronic products.

Purpose

This project is developed to address the insufficient specificity of general quality management systems such as ISO 9001 in nanoscale manufacturing scenarios. It establishes specialized requirements focusing on key aspects including the properties of nanomaterials, process quality control, nanomaterial safety, as well as occupational health and labor protection for operators.

Implementation of this work will regulate the full life cycle quality and safety management of nanomanufacturing, improve production efficiency and product consistency for enterprises, reduce compliance and quality costs, and generate direct economic benef its. Meanwhile, it will strictly control the environmental release and exposure risks of nanomaterials to achieve green and low -carbon environmental benefits.

By strengthening occupational health protection, safeguarding personnel safety, and enhancing public trust in the nanomanufacturing industry, it will produce significant social benefits. This project can provide a unified, scientific and implementable management basis for nanomanufacturing enterprises worldwide, and promote the high -quality and sustainable development of the nanomanufacturing industry.

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