October 08, 2016

CBD-P-004
Rev.01

LIST OF PROCEDURES & RECORDS AS REQUIRED

BY API SPEC Q1: 9th EDITION
Minimum Required Procedures & Records

NILESH MISTRY
ISO 9001 (2015) QMS Lead Auditor, QA-QC Engineer, B.E (Mechanical)
Ahmedabad, Gujarat, India
E-Mail: er.nileshmistry@gmail.com, nileshmistry@icloud.com
Web: conformityblog.wordpress.com
Mobile : +91-8469616406, +91-9429022762
CBD-P-004 Page 1 of 4

Mandatory Documented Procedures as required by API Spec Q1: 9th Edition

API Spec Q1 (9th Edition) requires documented procedures in different 28 clauses of it. There shall be at least 28 documented
procedures as per API Q1 (9th Edition). These procedures are enlisted under with the reference clause number of API Q1.

Sr API Q1 (9th
Subject Description
# Edition) Clause #
Procedure for defining personnel competency and identifying
training requirements or other actions to achieve the necessary
1 4.3.2.1 Human Resources
competency of personnel whose responsibilities fall within the
scope of the quality management system.
Procedure for the identification, distribution, and control of
documents required by the quality management system and
2 4.4.3 Control of Documents
this specification, including required documents of an origin
external to the organization.
Use of External Documents in Procedure for the integration of these requirements into the
3 4.4.4
Product Realization product realization process and any other affected processes.
Procedure to identify the controls and responsibilities needed
4 4.5 Control of Records for the identification, collection, storage, protection, retrieval,
retention time, and disposition of records.
Procedure for the review of requirements related to the
5 5.1.1 Contract Review
provision of products and required servicing.
Risk Assessment and Procedure to identify and control risk associated with impact
6 5.3
Management on delivery and quality of product.
Design and Development Procedure to plan and control the design and development of
7 5.4.1
Planning the product.
Procedure for contingency planning needed to address risk
8 5.5.1 Contingency Planning
associated with impact on delivery and quality of product.
Procedure to ensure that purchased products or outsourced
9 5.6.1.1 Purchasing Control
activities conform to specified requirements.
Procedure for the verification or other activities necessary for
Verification of Purchased
10 5.6.3 ensuring that purchased products or activities meet specified
Products or Activities
purchase requirements.
A documented procedure that describes controls associated
11 5.7.1.1 Control of Production
with the production of products.
Procedure that describes controls associated with the servicing
12 5.7.1.2 Controls of Servicing
(see 3.1.21) of products.
Validation of Processes for Procedure to address methods for review and approval of the
13 5.7.1.5
Production and Servicing processes.
Procedure for identification and traceability while the product is
under control of the organization as required by the
14 5.7.3 Identification and Traceability organization, the customer, and/or the applicable product
specifications throughout the product realization process,
including applicable delivery and post-delivery activities.
Procedure for the identification of product inspection and/or
test status throughout the product realization process that
15 5.7.4 Product Inspection/Test Status
indicates the conformity or nonconformity of product with
respect to inspections and/or tests performed.
Procedure for the identification, verification, safeguarding,
preservation, maintenance, and control of customer-supplied
16 5.7.5 Customer-supplied Property
property, including intellectual property and data, while under
control of the organization.
Procedure describing the methods used to preserve the
product and constituent parts throughout product realization
17 5.7.6.1 Preservation of Product
and delivery to the intended destination in order to maintain
conformity to requirements.

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CBD-P-004 Page 2 of 4

Sr API Q1 (9th
Subject Description
# Edition) Clause #
5.7.7.1 Inspection and Testing
Procedure for inspection and testing to verify that product
18 5.7.7.2 In-Process Inspection & Testing
requirements have been met.
5.7.7.3 Final Inspection and Testing
Procedure for the establishment of preventive maintenance for
19 5.7.8 Preventive Maintenance
equipment used in product realization.
Procedure in order to ensure that testing, measurement, and
Control of Testing, Measuring, monitoring equipment is calibrated and maintained and that the
20 5.8
and Monitoring Equipment equipment is used in a manner that is consistent with
monitoring and measurement requirements.
Procedure to ensure release of product to the customer shall
not proceed until the planned arrangements (see 5.7) have
21 5.9 Product Release
been satisfactorily completed, unless otherwise approved by a
relevant authority and, where applicable, by the customer.
Procedure(s) to identify the controls and related responsibilities
22 5.10.1 Control of Nonconforming Product
and authorities for addressing nonconforming product.
23 6.2.1 Customer Satisfaction Procedure to measure customer satisfaction.
Procedure to define responsibilities for planning, conducting,
24 6.2.2.1 Internal Audit
and documenting internal audits.
Procedure for the identification, collection, and analysis of data
25 6.3 Analysis of Data to demonstrate the suitability and effectiveness of the quality
management system.
Procedure to correct nonconformities and to take corrective
actions, both internally and within the supply chain, to eliminate
26 6.4.2 Corrective Action the causes of nonconformities in order to minimize the
likelihood of its recurrence. Corrective actions shall be
appropriate to the effect(s) of the nonconformity encountered.
Procedure to determine and implement preventive actions,
both internally and within the supply chain, to eliminate the
27 6.4.3 Preventive Action
causes of potential nonconformities in order to minimize the
likelihood of their occurrence.
Control of the Application and
28 A.5 -
Removal of the API Monogram

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CBD-P-004 Page 3 of 4

Mandatory Records as required by API Spec Q1: 9th Edition

API Spec Q1 (9th Edition) requires records to be maintained by an organization in different 31 clauses of it. The records for the
following activities/processes shall be maintained.

Sr API Q1 (9th
Subject Description
# Edition) Clause #
1 4.3.2 Personnel Competence -
2 4.3.2.3 Training and Awareness Records of education, training, skills, and experience.
Where the customer provides no documented statement of the
3 5.1.2 Determination of Requirements requirements, the customer requirements shall be confirmed
by the organization and records maintained.
Records of the results of the review of requirements related to
4 5.1.3 Review of Requirements
provision of products, including resulting actions.
Records needed to provide evidence that the product
5 5.2 Planning
realization processes meet requirements.
Records of risk assessment and management including
6 5.3 Risk Assessment & Management
actions
7 5.4.2 Design and Development Inputs -
8 5.4.3 Design and Development Outputs -
9 5.4.4 Design and Development Review -
Design and Development
10 5.4.5 -
Verification and Final Review
Design and Development
11 5.4.6 -
Validation and Approval
Design and Development
12 5.4.7 -
Changes
13 5.6.1.5 Supplier Evaluation -
14 5.6.1.6 Outsourcing -
Verification of Purchased
15 5.6.3 -
Products or Activities
Validation of Processes for
16 5.7.1.5 -
Production and Servicing
17 5.7.3 Identification and Traceability -
18 5.7.5 Customer-supplied Property -
19 5.7.6.2 Storage and Assessment -
20 5.7.7.1 Inspection and Testing -
21 5.7.8 Preventive Maintenance -
Equipment traceability to international or national
Control of Testing, Measuring,
22 5.8 measurement standards; where no such standards exist, the
and Monitoring Equipment
basis used for calibration or verification shall be recorded.
Records to enable identification of the individual releasing the
23 5.9 Product Release
product.
Records of notifications of product not conforming to DAC or
24 5.10.4 Customer Notification
contract requirements, that has been delivered.
Records of the nature of nonconformities and any subsequent
25 5.10.5 Nonconformities actions taken, including concessions obtained, shall be
maintained (see 4.5).
26 5.11.1 Management of Change (MOC) -
27 6.2.1 Customer Satisfaction -
28 6.2.2.3 Internal Audit -

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CBD-P-004 Page 4 of 4

Sr API Q1 (9th
Subject Description
# Edition) Clause #
Records shall identify the activities performed to verify
29 6.4.2 Corrective Action
effectiveness of the corrective actions taken.
Records of the activities for control of potential process
30 6.4.3 Preventive Action
nonconformities.
31 6.5.3 Management Review -

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