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API Spec Q1 9th Edition - Mandatory Documented Procedures: No. Clause No. Description

This document outlines 30 mandatory procedures for an API quality management system as outlined in ISO 9001:2015. The procedures cover topics such as human resources, documentation control, design and development, purchasing, production and service provision, inspection, testing, monitoring, control of nonconforming products, customer satisfaction, internal audits, corrective and preventive actions, and analysis of quality data. Adherence to these procedures is necessary to meet the ISO 9001 standard for quality management systems.

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589 views1 page

API Spec Q1 9th Edition - Mandatory Documented Procedures: No. Clause No. Description

This document outlines 30 mandatory procedures for an API quality management system as outlined in ISO 9001:2015. The procedures cover topics such as human resources, documentation control, design and development, purchasing, production and service provision, inspection, testing, monitoring, control of nonconforming products, customer satisfaction, internal audits, corrective and preventive actions, and analysis of quality data. Adherence to these procedures is necessary to meet the ISO 9001 standard for quality management systems.

Uploaded by

zae nuddin
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLS, PDF, TXT or read online on Scribd
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API Spec Q1 9th Edition - Mandatory Documented Procedures

No. Clause No. Description


1 4.3.2.1 Human Resource General
2 4.4.1 Documentation Requirements General
3 4.4.3 Control of Documents
4 4.4.4 Use of External Documents in Product Realization
5 4.5 Control of Records
6 5.1.1 Contract Review General
7 5.3 Risk Assessment & management
8 5.4.1 Design & Development Planning
9 5.5.1 Contingency Planning General
10 5.6.1.1 Purchasing Control - Procedure
11 5.6.3 Verification Of Purchased Products or activities
12 5.7.1.1 Control of Production & Servicing - Production
13 5.7.1.2 Servicing
14 5.7.1.5 Validation of Process for Production & Servicing
15 5.7.3 Identification & traceability
16 5.7.4 Product Inspection/Test Status
17 5.7.5 Customer-supplied Property
18 5.7.6.1 Preservation of Product - General
19 5.7.7.1 Inspection & Testing - General
20 5.7.7.2 In-process Inspection and Testing
21 5.7.7.3 Final Inspection and Testing
22 5.7.8 Preventive Maintenance
23 5.8 Control of Testing, Measuring & Monitoring Equipment
24 5.9 Product Release
25 5.10.1 Control of Nonconforming Product - General
26 6.2.1 Customer Satisfaction
27 6.2.2.1 Internal Audit - General
28 6.3 Analysis of Data
29 6.4.2 Corrective Action
30 6.4.3 Preventive Action

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