ISO/IEC 80079-34
ISO/IEC 80079-34 quality management for manufacturing Ex products
ISO/IEC 80079-34 consulting supports manufacturers and suppliers of explosion-protected products introducing products, changing certificates or improving quality systems. Vosurein reviews scope, existing processes and evidence to assign responsibilities, implement controls and check manufacturing consistency against certificate requirements.
For Your Business
Who this service is for and when to start
For manufacturers and suppliers of explosion-protected products working on new products, certificate changes or quality system improvements. Start by identifying gaps where certificates and manufacturing documents differ, component changes lack review, or outsourcing controls and traceability are incomplete.
The Challenge
Common challenges faced by businesses
Changes to components, drawings or processes need to be checked against the applicable certificate. An unchanged appearance does not establish manufacturing consistency. Procurement and quality assurance need the same controlled versions, rather than discovering discrepancies only at final inspection.
Our Approach
Methods and applicable requirements
The adopted version is ISO/IEC 80079-34:2018. Version history: ISO/IEC 80079-34:2011.
This standard for quality management of explosion-proof products manufactured according to certification should be read together with ISO 9001:2015. The focus is on consistency in controlled documents, components, and manufacturing; Product design testing and explosion-proof certification are separate procedures.
The following consulting tasks can be arranged to suit your needs.
Certificates and documents
Organize applicable certificates, drawing versions, and production requirements.
Change control
Plan the approval processes for design, production, and part changes.
Supply and manufacturing processes
Review key procurement, outsourcing, production control, and traceability.
Inspection and nonconformities
Organize inspections, equipment management, and evidence for handling nonconformities.
Process
Consulting scope and process
Review certificate scope and documentation
Compare product certificates, controlled drawings, and production scope to confirm on-site usage versions, and identify discrepancies between documents and manufacturing requirements.
Parts manufacturing process and change control
Attach part substitutions, design, and process changes to the approval process, clearly specifying what kind of confirmation procurement and production must receive before execution.
Production inspection and traceability trials
Inspect key materials, manufacturing, and inspection records by batch, ensuring products can be traced back to applicable documents and relevant evidence.
Nonconformity and consistency review
Review the handling and impact scope of nonconformities, confirm corrected manufacturing consistency, and then organize the data needed for external evaluation.
Preparation
What documents do companies need to prepare?
- Certificate documents: Product range, controlled drawings, and versions.
- Manufacturing process: Key processes, equipment, and operation instructions.
- Supplier information: parts, outsourcing, modifications, and acceptance.
- Quality Records: Inspection, traceability, nonconformity, and improvement.
For the initial discussion, you can provide a summary. Handle customer, personal and confidential business information within the necessary scope and agreed access permissions.
Project Planning
Estimating time and cost
Workload depends on protection types and the number of certificates and processes. Before tracing components or past changes, check whether the necessary documents and supplier records are available.
Consulting covers the manufacturing quality system. Explosion-protection design tests, product certification and technical change approvals follow the applicable scheme, with costs agreed separately.
FAQ
Frequently asked questions
Is manufacturing quality management the same as explosion-proof product certification?
No. The management system addresses manufacturing consistency. Product design, testing, certificates and certification scheme procedures have separate requirements; these do not replace one another.
Can existing systems and records be reused?
You can first review existing products and a summary of certificate scope, manufacturing processes, controlled documents, parts and suppliers, and inspection records to confirm applicable periods, scope, and the quality of evidence, then fill the gaps; rewriting all documents is not a prerequisite for implementation.
What if old drawings are used on the production floor?
First, confirm the affected products and batches, handle them according to nonconformity and change procedures, and identify version transmission problems so that subsequent production uses the applicable controlled documents.
How are consulting and third-party certification responsibilities divided?
Vosurein supports system implementation and preparation but does not issue third-party certificates. Confirm the applicable certification scheme, accreditation scope, fees and schedule separately. A certificate does not constitute product approval or proof of compliance with every regulation.
Can we substitute components with similar specifications?
Changes should be confirmed according to controlled documents, certificates, and applicable programs; replacement cannot be done just because the specifications appear similar.
Which version should be confirmed before implementation?
This service uses ISO/IEC 80079-34:2018, which replaced the 2011 edition. For implementation or transition, check the editions and transition arrangements required by customers and assessment schemes. Publication of a standard is not the same as the deadline for an organisation to transition.
Related
Related services and enquiries
Please provide the industry, activities, locations, main requirements, and expected completion time.Contact Vosurein
Content checked: . Applicable versions and requirements depend on the company’s circumstances.
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