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Date: DGM-QA/QC
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(60%min required)
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4,
4.4
4.1, Quality management system and its
5 4.4.1
4.1.1, processes
4.4.2
A4
Section 5 - Leadership
(Check the following requirements of ISO 9001:2015 and API Spec Q1 9th Edition, Addendum 2 are established, implemented and maintained by the Supplier QMS)
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Section 6 - Planning
(Check the following requirements of ISO 9001:2015 and API Spec Q1 9th Edition, Addendum 2 are established, implemented and maintained by the Supplier QMS)
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1 6.0 - Planning
6.1
Actions to address risks and
2 6.1.1 -
opportunities
6.1.2
6.2
Quality objectives and planning to
4 6.2.1 4.1.3,4.1.4
achieve them
6.2.2
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Section 7 - Support
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9 7.1.5.1 - General
4.3.1,4.3.2,
12 7.2 Competence
4.3.2.2
4.3.2.3,
13 7.3 Awareness
4.3.2.2
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7.5.3
22 7.5.3.1 4.4.3 Control of documented information
7.5.3.2
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Section 8 - Operation
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1 8.0 5 Operation
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8.2.3
Review of the requirements for products
6 8.2.3.1 5.1.3
and services
8.2.3.2
9 8.3.1 - General
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8.4.3
27 5.6.2 Information for external providers
8.4.3.1
8.4.3.2
28 5.6.3 Verification of purchased product
8.4.3.3
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F-392-0-R02 Page 14 of 19
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9.2.2
9 6.2.2.2 Performance of Internal Audit
9.2.2.1
9.3.1
12 6.5.1 General
9.3.1.1
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Section 10 - Improvement
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10.2
10.2.1
3 6.4.2 Nonconformity and corrective action
10.2.1.1
10.2.2
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(Note: For each question marked N/A deduct 4 points from 496 to determine total available points).
N/A Not Applicable (Used only if element not applicable to business or service provided)
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