πŸ“– Articles

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πŸ“„ 139 articles in total πŸ“… Continuously updated πŸ”₯ Pinned first, then sorted by rating, views and publish date
Quality Management System Β· System Framework & Standards Β· IATF 16949 / AS9100 Industry System Highlights

Reconditioning with a New Label and Shipping? β€”β€” The Compliance Boundaries and Five-Step Control Method for Rework and Repair under the IATF 16949 Framework

A certain automotive parts company was undergoing a second party audit by a customer. The first two days went smoothly. …

Quality Management System Β· System Framework & Standards Β· ISO 9001 Core Clauses Interpretation

In-depth Interpretation of ISO9001 Clauses (26) | 9.1 Monitoring, Measurement, Analysis, and Evaluation: Customer Satisfaction and Data-Driven Analysis

1. Key Points of the Clause 9.1 forms the foundation of Chapter 9, "Performance Evaluation," and consists of three sub c…

Quality Management System Β· Documentation, Records & Knowledge Β· Documented Information Structure

ISO9001 System Document Package (46) | Storage and Material Protection Work Instruction

Document Description : This document is a third level document work instruction that serves ISO 9001:2015 clause 8.5.4 "…

Quality Management System Β· Documentation, Records & Knowledge Β· Documented Information Structure

When the Auditor Asks "Who Changed This Record?" β€”β€” Five Steps to Ensure Compliance of Electronic Records

1. After Going Paperless, Where Does the Evidence Chain Break? A year after the MES Manufacturing Execution System went …

Quality Management System Β· System Framework & Standards Β· ISO 9001 Core Clauses Interpretation

Deep Interpretation of ISO9001 Clause (25) | 8.7 Control of Nonconforming Output: Disposal Methods and the Boundaries of Concession Acceptance

1. Key Points of the Clause ISO 9001:2015 Clause 8.7 is divided into two parts. The core requirements of 8.7.1 can be su…

Quality Management System Β· Documentation, Records & Knowledge Β· Documented Information Structure

ISO9001 System Document Package (45) | Work Instruction for Implementation and Verification of Corrective Actions

Document Description : This document is a third level document work instruction that serves ISO 9001:2015 Clause 10.2 "N…

Quality Management System Β· Documentation, Records & Knowledge Β· Documented Information Structure

Customer Surprise Audit: Unable to Retrieve Last Year's Batch Records in Half an Hour? β€”β€” Five Steps for Record Retrieval and Response

A certain automotive parts company once received a customer audit without prior notice. The customer SQE entered the fac…

Quality Management System Β· System Framework & Standards Β· ISO 9001 Core Clauses Interpretation

Deep Interpretation of ISO9001 Clause (24) | 8.6 Release of Products and Services: Release Criteria and Record Requirements

1. Key Points of the Clause The core requirements of Clause 8.6 "Release of Products and Services" in ISO9001:2015 can b…

Quality Management System Β· System Framework & Standards Β· ISO 9001 Core Clauses Interpretation

ISO9001 Clause In-Depth Interpretation (23) | 8.5.5 Post-Delivery Activities + 8.5.6 Change Control

1. Key Points of the Clause 8.5.5 Post Delivery Activities : The organization shall meet the requirements for post deliv…

Quality Management System Β· Documentation, Records & Knowledge Β· Documented Information Structure

ISO9001 System Document Package (43) | Management Review Input Preparation Work Instruction

Document Number : WI QA 43 Document Level : Level 3 Document Work Instruction Corresponding Clause : ISO 9001:2015 9.3 M…

Quality Management System Β· System Framework & Standards Β· ISO 9001 Core Clauses Interpretation

Deep Interpretation of ISO9001 Clauses (22) | 8.5.3 Customer or External Supplier Property + 8.5.4 Protection

1. Key Points of the Clauses 8.5.3 Customer or External Supplier Property : The organization should take care of custome…

Quality Management System Β· Documentation, Records & Knowledge Β· Documented Information Structure

ISO9001 System Document Package (42) | Internal Audit Implementation Work Instruction (Internal Auditor Manual)

Document Number : WI QA 42 Document Level : Level 3 Document Work Instruction/Internal Auditor Manual Corresponding Clau…