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1 n/a Scope This specification establishes the minimum quality management system QSM-01, Rev.02, Section 1 PTBMI Quality
requirements for organizations that manufacture products or provide Management System
manufacturing-related processes under a product specification for use in the
petroleum and natural gas industry.
n/a This specification specifies requirements of a quality management system for an QSM-01, Rev.02, Section 1 PTBMI Quality
organization to demonstrate its ability to consistently provide reliable products Management System
and manufacturing-related processes that meet customer and legal
requirements.
n/a If an organization performs activities addressed by this document, no claims to QSM-01, Rev.02, Section 1 PTBMI Quality
exclusion of those activities are permitted. Where any requirement of this Management System
speicification cannot be applied due to the nature of an organization, the
requirement can be considered for exclusion. Where exclusions are made, the
basis for claiming exclusions are to be identified. Furthermore, such exclusions
cannot affect the organization's ability, or responsibility, to provide products
and related servicing that meet customer and applicable regulatory
requirements. Exclusions are limited to the following clauses:
n/a 5.4 Design and Development; QSM-01, Rev.02, Section 1 PTBMI Quality QSP-540-01, Rev.00, Design & Development
Management System
n/a 5.7.1.2 Servicing; QSM-01, Rev.02, Section 1 PTBMI Quality QSP-5712-01, Rev.00, Service and Repair
Management System
n/a 5.7.1.5 Validation of Processes for Production and Servicing; QSM-01, Rev.02, Section 1 PTBMI Quality QSP-5711-01-01, Rev.00, Production, QSP-
Management System 5712-01, Rev.00, Service and Repair
n/a 5.7.5 Customer-supplied Property; QSM-01, Rev.02, Section 1 PTBMI Quality QSP-575-01, Rev.00, Customer-Supplied Property
Management System Procedure
n/a 5.8 Control of Testing, Measuring, and Monitoring Equipment. QSM-01, Rev.02, Section 1 PTBMI Quality QSP-580-01, Rev.00, Control of Testing, Measuring,
Management System and Monitoring Equipment Procedure
n/a The quality management system requirements specified in this specification are QSM-01, Rev.02, Section 1 PTBMI Quality
in alignment with the section requirements and format of document used for Management System
the provision of services and use of service-related product (API Q2).
Information marked NOTE are not requirements but are provided for
guidance in understanding or clarifying the associated requirement.
4.1.1 4.1; 4.1c; 7.1; General The organization shall establish, document, implement, and maintain at all QSM-01, Rev.02, Section 4.1.1 General
8.5.1 times a quality management system for all products and servicing provided for
use in the petroleum and natural gas industry. The organization shall measure
the effectiveness and improve upon the quality management system in
accordance with the requirements of this specification.
4.1.2 5.1b; 5.3a; 5.3b; Quality Policy The organizations policy for its commitment to quality shall be defined, QSM-01, Rev.02, Section 4.1.2 Quality Policy
5.3c; 5.3d documented, and approved by top management. The organizations top
management shall review the quality policy to ensure that it is appropriate to
the organization, is the basis for the development of quality objectives (see
4.1.3), and is communicated, understood, implemented, and maintained at all
relevant functions and levels within the organization. The policy shall include a
commitment to comply with requirements and continually improve the
effectiveness of the quality management system.
4.1.3 5.1c; 5.4.1; 7.1a Quality Objectives Management, with approval from top management, shall ensure that quality QSM-01, Rev.02, Section 4.1.3 Quality Objectives
objectives, including those needed to meet product and customer
requirements, are established at relevant functions and levels within the
organization. The quality objectives shall be measurable and consistent with the
quality policy.
5.4.2a b) planning of the quality management system is carried out in order to meet QSM-01, Rev.02, Section 4.1.4 Planning QSP-520-01, Rev.00, Quality Planning
the requirements of this specification.
4.1.5 Communication
4.1.5.1 5.5.3 Internal Management shall ensure that appropriate communication processes are QSM-01, Rev.02, Section 4.1.5.1 Internal QSP-415-01, Rev.00, Communication Procedure
established within the organization and the effectiveness of the quality
management system is communicated.
API Spec Q1 9th Edition Conformity Matrix Page 2 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
4.1.5.2 5.2; 7.2.3 External The organization shall determine and implement a process for communicating QSM-01, Rev.02, Section 4.1.5.2 External QSP-415-01, Rev.00, Communication Procedure
with external organizations, including customers, to ensure requirements are
understood throughout contract execution and product realization. The
communication process shall address:
7.2.3b a) execution of inquiries, contracts, or order handling and amendments (see QSM-01, Rev.02, Section 4.1.5.2 External QSP-415-01, Rev.00, Communication Procedure
5.1);
7.2.3a b) provision of product information, including product nonconformities QSM-01, Rev.02, Section 4.1.5.2 External QSP-415-01, Rev.00, Communication Procedure
identified after delivery to the customer (see 5.10.4);
7.2.3c c) feedback and customer complaints (see 6.2.1); and QSM-01, Rev.02, Section 4.1.5.2 External QSP-415-01, Rev.00, Communication Procedure
n/a d) when required by contract, providing information required by product quality QSM-01, Rev.02, Section 4.1.5.2 External QSP-415-01, Rev.00, Communication Procedure
plans and subsequent changes to those plans (see 5.7.2).
NOTE
Resources can include human resources and specialized skills, organizational
infrastructure, financial resources, and technology.
5.1c a) ensuring that quality objectives are established including key performance QSM-01, Rev.02, Section 4.2.1 General QSP-420-01, Rev.00, Management Responsibility
indicators for use in data analysis; and
5.1d b) conducting management reviews (see 6.5). QSM-01, Rev.02, Section 4.2.1 General QSP-420-01, Rev.00, Management Responsibility
4.2.2 5.5.1 Responsibility and Responsibilities, authorities, and accountabilities of personnel within the scope QSM-01, Rev.02, Section 4.2.1 General QSP-420-01, Rev.00, Management Responsibility
Authority of this document shall be defined, documented, and communicated throughout
the organization.
4.23 5.5.2 Management Top management shall appoint and maintain a member of the organizations QSM-01, Rev.02, Section 4.2.1 General QSP-420-01, Rev.00, Management Responsibility
Representative management who, irrespective of other responsibilities, shall have
responsibility and authority that includes:
5.5.2a a) ensuring that processes needed for the quality management system are QSM-01, Rev.02, Section 4.2.1 General QSP-420-01, Rev.00, Management Responsibility
established, implemented, and maintained,
API Spec Q1 9th Edition Conformity Matrix Page 3 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
4.23 Management
Representative Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
5.5.2b b) reporting to top management on the performance of the quality QSM-01, Rev.02, Section 4.2.1 General QSP-420-01, Rev.00, Management Responsibility
management system and any need for improvement;
n/a c) ensuring initiation of action(s) to minimize the likelihood of the occurrence of QSM-01, Rev.02, Section 4.2.1 General QSP-420-01, Rev.00, Management Responsibility
nonconformities (see 6.4.3); and
5.5.2c d) ensuring the promotion of awareness of customer requirements throughout QSM-01, Rev.02, Section 4.2.1 General QSP-420-01, Rev.00, Management Responsibility
the organization.
4.3 Organization Capability
4.3.1 6.1; 7.1b Provision of Resources The organization shall determine and allocate the resources needed to QSM-01, Rev.02, Section 4.3.1 Provision of QSP-622-01, Rev.00, Internal Audit
implement, maintain, and improve the effectiveness of the elements of the Resources QSP-530-01, Rev.00,Risk Management Assessment
quality management system. QSP-550-01, Rev.00, Contigency Plan
QSP-511-01, Rev.00, Management of Change
4.3.2.2 6.2.1 Personnel Competence Personnel shall be competent based on the appropriate education, training, QSM-01, Rev.02, Section 4.3.2.2 Personal QSP-4322-01, Rev.00, Personnel Competency
skills, and experience needed to meet product and customer requirements. Competence
n/a Evidence of the determination of competence of personnel shall be recorded QSM-01, Rev.02, Section 4.3.2.2 Personal QSP-4322-01, Rev.00, Personnel Competency
and maintained (see 4.5). Competence
API Spec Q1 9th Edition Conformity Matrix Page 4 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
4.3.3 6.3; 6.4 Work Environment The organization shall determine, provide, manage, and maintain the work QSM-01, Rev.02, Section 4.3.3 Work Environment QSP-578-01, Rev.00, Preventive Maintenance
environment needed to achieve conformity applicable to the manufacture of
the product. Work environment shall include:
6.3a a) buildings, workspace, and associated utilities; QSM-01, Rev.02, Section 4.3.3 Work Environment QSP-578-01, Rev.00, Preventive Maintenance
6.3b b) process equipment and its maintenance (both hardware and software) (see QSM-01, Rev.02, Section 4.3.3 Work Environment QSP-578-01, Rev.00, Preventive Maintenance
5.7.8);
6.3c c) supporting services (e.g. transport, communication, information systems); QSM-01, Rev.02, Section 4.3.3 Work Environment QSP-578-01, Rev.00, Preventive Maintenance
6.4 and
d) conditions under which work is performed such as physical, environmental or QSM-01, Rev.02, Section 4.3.3 Work Environment QSP-578-01, Rev.00, Preventive Maintenance
other factors.
4.2.2a 1) the scope of the quality management system, including justification for any QSM-01, Rev.02, Section 4.4.1 General
exclusions to specific quality management system elements (see Section 1);
4.1b; 4.2.2c 2) a description of the sequence and interaction between the processes of the QSM-01, Rev.02, Section 4.4.1 General
quality management system;
n/a 3) identification of processes that require validation (see 5.7.1.5); and QSM-01, Rev.02, Section 4.4.1 General
4.2.2b 4) reference to documented procedures that control the quality management QSM-01, Rev.02, Section 4.4.1 General
system processes;
4.2.1c c) documented procedures established for the quality management system; QSM-01, Rev.02, Section 4.4.1 General
4.2.1d; 7.1b d) documents and records, to ensure the effective planning, operation and QSM-01, Rev.02, Section 4.4.1 General
control of its processes, and compliance with specified requirements; and
n/a e) identification of legal, and other applicable requirements to which the QSM-01, Rev.02, Section 4.4.1 General
organization claims compliance which are needed to achieve product
conformity.
API Spec Q1 9th Edition Conformity Matrix Page 5 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
4.4.2 n/a Procedures All procedures referenced within this specification shall be established, QSM-01, Rev.02, Section 4.4.2 Procedures
documented, implemented, and maintained for continued suitability.
NOTE 1 A single
document can address the requirements of one or more procedures.
NOTE 2 A requirement
for documented procedures can be satisfied by more than one document.
4.4.3 4.2.3 Control of Documents The organization shall maintain a documented procedure for the identification, QSM-01, Rev.02, Section 4.4.3 Control of QSP-443-01, Rev.00, Control of Documents
distribution, and control of documents required by the quality management Documents
system and this specification, including required documents of an origin
external to the organization.
4.2.3a; 4.2.3b The procedure shall specify responsibilities for approval and re-approval and QSM-01, Rev.02, Section 4.4.3 Control of QSP-443-01, Rev.00, Control of Documents
shall identify the controls needed to ensure that the documents required by the Documents
quality management system, including revisions, translations and updates:
4.2.3a; 4.2.3b a) are reviewed and approved for adequacy prior to issue and use, QSM-01, Rev.02, Section 4.4.3 Control of QSP-443-01, Rev.00, Control of Documents
Documents
4.2.3c b) identify changes and revision status, QSM-01, Rev.02, Section 4.4.3 Control of QSP-443-01, Rev.00, Control of Documents
Documents
4.2.3e c) remain legible and readily identifiable, and QSM-01, Rev.02, Section 4.4.3 Control of QSP-443-01, Rev.00, Control of Documents
Documents
4.2.3d d) are available where the activity is being performed. QSM-01, Rev.02, Section 4.4.3 Control of QSP-443-01, Rev.00, Control of Documents
4.2.3f Documents of external origin shall be controlled to ensure that the relevant Documents
QSM-01, Rev.02, Section 4.4.3 Control of QSP-443-01, Rev.00, Control of Documents
versions are used and maintained. Documents
4.2.3g Obsolete documents shall be removed from all points of issue or use, or QSM-01, Rev.02, Section 4.4.3 Control of QSP-443-01, Rev.00, Control of Documents
otherwise identified to ensure against unintended use if they are retained for Documents
any purpose.
n/a Procedures, work instructions and forms required by the quality management QSM-01, Rev.02, Section 4.4.3 Control of QSP-443-01, Rev.00, Control of Documents
system shall be controlled. Documents
4.4.4 n/a Use of External When API product or other external specification requirements, including QSM-01, Rev.02, Section 4.4.4 Use of External QSP-443-01, Rev.00, Control of Documents
Documents in Product addenda, errata, and updates, are used in the design or manufacture of the Documents in Product Realization
Realization product, the organization shall maintain a documented procedure for the
integration of these requirements into the product realization process and any
other affected processes.
4.5 4.2.3; 4.2.4 Control of Records The organization shall maintain a documented procedure to identify the QSM-01, Rev.02, Section 4.5 Control of Records QSP-450-01, Rev.00, Control of Records
controls and responsibilities needed for the identification, collection, storage,
protection, retrieval, retention time, and disposition of records.
API Spec Q1 9th Edition Conformity Matrix Page 6 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph
4.5
ISO 9001:2015 Reference
Control of Records
Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
n/a Records, including those originating from outsourced activities (see 5.6.1.6), QSM-01, Rev.02, Section 4.5 Control of Records QSP-450-01, Rev.00, Control of Records
shall be established and controlled to provide evidence of conformity to
requirements and the organization's quality management system.
4.2.4 Records shall remain legible, identifiable, and retrievable. Records shall be QSM-01, Rev.02, Section 4.5 Control of Records QSP-450-01, Rev.00, Control of Records
retained for a minimum of five years or as required by customer, legal, and
other applicable requirements, whichever is longer.
5 Product Realization
5.1 Contract Review
5.1.1 n/a General The organization shall maintain a documented procedure for the review of QSM-01, Rev.02, Section 5.1.1 General QSP-510-01, Rev.02, Contract Review
requirements related to the provision of products and required servicing.
7.2.1b; 7.2.2 c) requirements not stated by the customer but considered necessary by the QSM-01, Rev.02, Section 5.1.1 General QSP-510-01, Rev.00, Contract Review
organization for the provision of the product.
7.2.2 Where the customer provides no documented statement of the requirements, QSM-01, Rev.02, Section 5.1.1 General QSP-510-01, Rev.00, Contract Review
the customer requirements shall be confirmed by the organization and records
maintained (see 4.5).
5.1.3 7.2.2 Review of Requirements The organization shall review the requirements related to provision of products. QSM-01, Rev.02, Section 5.1.1 General QSP-510-01, Rev.00, Contract Review
This review shall be conducted prior to the organizations commitment to
deliver product to the customer and shall ensure that:
7.2.2a a) requirements are identified and documented; QSM-01, Rev.02, Section 5.1.1 General QSP-510-01, Rev.00, Contract Review
7.2.2b b) requirements differing from those previously identified are resolved; and QSM-01, Rev.02, Section 5.1.1 General QSP-510-01, Rev.00, Contract Review
7.2.2c c) the organization has the capability to meet the documented requirements. QSM-01, Rev.02, Section 5.1.1 General QSP-510-01, Rev. 00, Contract Review
7.2.2 Where contract requirements are changed, the organization shall ensure that QSM-01, Rev.02, Section 5.1.1 General QSP-510-01, Rev.00, Contract Review
relevant documents are amended and that relevant personnel are made aware
of the changed requirements.
7.2.2 Records of the results of the review, including resulting actions, shall be QSM-01, Rev.02, Section 5.1.1 General QSP-510-01, Rev.00, Contract Review
maintained (see 4.5).
5.2 7.1 Planning The organization shall identify and plan the processes and documents needed QSM-01, Rev.02, Section 5.1.1 General
for product realization. Planning of product realization shall be consistent with QSP-520-01, Rev.00, Quality Planning
the requirements of the other processes of the quality management system
(see 4.1.4).
API Spec Q1 9th Edition Conformity Matrix Page 7 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
5.2 Planning Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
7.1b a) required resources and work environment management (see 4.3); QSM-01, Rev.02, Section 5.1.1 General
QSP-520-01, Rev.00, Quality Planning
7.1b b) product and customer-specified requirements (see 5.1); QSM-01, Rev.02, Section 5.1.1 General
QSP-520-01, Rev.00, Quality Planning
n/a c) legal and other applicable requirements; QSM-01, Rev.02, Section 5.1.1 General
QSP-520-01, Rev.00, Quality Planning
n/a d) contingencies based on risk assessment (see 5.3 and 5.5); QSM-01, Rev.02, Section 5.1.1 General
QSP-520-01, Rev.00, Quality Planning
7.1a e) design and development requirements (see 5.4); QSM-01, Rev.02, Section 5.1.1 General
QSP-520-01, Rev.00, Quality Planning
7.1c f) required verification, validation, monitoring, measurement, inspection, and QSM-01, Rev.02, Section 5.1.1 General
test activities specific to the product and the criteria for product acceptance; QSP-520-01, Rev.00, Quality Planning
and
n/a g) management of change (MOC) (see 5.11); and QSM-01, Rev.02, Section 5.1.1 General
QSP-520-01, Rev.00, Quality Planning
7.1d h) records needed to provide evidence that the product realization processes QSM-01, Rev.02, Section 5.1.1 General
meet requirements (see 4.5). QSP-520-01, Rev.00, Quality Planning
n/a The output of planning shall be documented and updated as changes occur. QSM-01, Rev.02, Section 5.1.1 General
QSP-520-01, Rev.00, Quality Planning
7.1 The plans shall be maintained in a structure suitable for the organizations QSM-01, Rev.02, Section 5.1.1 General
method of operations. QSP-520-01, Rev.00, Quality Planning
5.3 n/a Risk Assessment and The organization shall maintain a documented procedure to identify and control QSM-01, Rev.02, Section 5.3 Risk Assessment and QSP-530-01, Rev.00, Risk Management Procedure
Management risk associated with impact on delivery and quality of product. The procedure Management
shall identify the techniques, tools and their application for risk identification,
assessment, and mitigation. NOTE Risk assessment can
include consideration of severity, detection methods, and probability of
occurrence.
n/a Risk assessment associated with product delivery shall include:
n/a a) facility / equipment availability and maintenance; and QSM-01, Rev.02, Section 5.3 Risk Assessment and QSP-530-01, Rev.00, Risk Management Procedure
Management
n/a b) supplier performance and material availability/supply. QSM-01, Rev.02, Section 5.3 Risk Assessment and QSP-530-01, Rev.00, Risk Management Procedure
Management
n/a Risk assessment associated with product quality shall include, as applicable:
n/a c) delivery of nonconforming product (see 5.10.1e); QSM-01, Rev.02, Section 5.3 Risk Assessment and QSP-530-01, Rev.00, Risk Management Procedure
Management
n/a d) availability of competent personnel. QSM-01, Rev.02, Section 5.3 Risk Assessment and QSP-530-01, Rev.00, Risk Management Procedure
Management
API Spec Q1 9th Edition Conformity Matrix Page 8 of 29 FM-186 Rev 1 Effective 7/8/2013
5.3 Risk Assessment and
Management
n/a Records of risk assessment and management including actions taken shall be QSM-01, Rev.02, Section 5.3 Risk Assessment and QSP-530-01, Rev.00, Risk Management Procedure
maintained (see 4.5). Management
NOTE 1: The output of risk assessment may be used in the development of
contingency plans (see 5.5). NOTE
2: Risk assessment can be an activity associated with corrective and/or
preventive action.
7.3.1a b) the design and development stages; QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Planning
7.3.1; 7.3.1c c) the resources, responsibilities, authorities, and their interfaces to ensure QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
effective communication; Development Planning
7.3.1b d) the review, verification, and validation activities necessary to complete each QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
design and development stage; and Development Planning
n/a e) the requirements for a final review of the design (see 5.4.5). QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Planning
n/a When design and development activities are performed at different locations QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
within the same organization, the procedure shall identify the controls required Development Planning
to ensure that the designs meet the requirements of 5.4.
n/a When design and development are outsourced, the organization shall ensure QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
the supplier meets the requirements of 5.6.1.6. Development Planning
NOTE Design and development review, verification, and
validation each have distinct purposes but can be conducted and recorded
separately or in any combination, as suitable for the product and the
organization.
5.4.2 7.3.2 Design and Inputs shall be identified and reviewed for adequacy, completeness, and lack of QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Inputs conflict. Development Planning
7.3.2a; 7.3.2d Inputs shall include functional and technical requirements, and the following, as QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
applicable: Development Planning
n/a a) customer-specified requirements (see 5.1); QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Planning
API Spec Q1 9th Edition Conformity Matrix Page 9 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
5.4.2 Design and
Development Inputs Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
7.3.2d b) requirements provided from external sources, including API product QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
specifications; Development Planning
7.3.2d c) environmental and operational conditions; QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Planning
n/a d) methodology, assumptions, and formulae documentation; QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Planning
7.3.2c e) historical performance and other information derived from previous similar QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
designs; Development Planning
7.3.2b f) legal requirements; and QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Planning
n/a g) results from risk assessments (see 5.3). QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Planning
n/a Records of design inputs shall be maintained (see 4.5). QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Planning
5.4.3 7.3.3 Design and Outputs shall be documented to allow verification against the design and QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Outputs development input requirements. Development Planning
7.3.3 Outputs shall:
7.3.3a a) meet the input requirements for design and development; QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Planning
7.3.3b b) provide appropriate information for purchasing, production, and servicing; QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Planning
7.3.3c c) identify or reference design acceptance criteria (DAC); QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Planning
n/a d) include identification of, or reference to, products and/or components QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
deemed critical to the design; Development Planning
n/a e) include results of applicable calculations; and QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Planning
7.3.3d f) specify the characteristics of the product that are essential for its safe and QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
proper use. Development Planning
n/a Records of design outputs shall be maintained (see 4.5). NOTE QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Identification of criticality of products and/or components can be maintained Development Planning
outside of the design and development process.
5.4.4 7.3.4 Design and At suitable stages, review(s) shall be performed: QSP-540-01, Rev.00, Design & Development
7.3.4a Development Review a) to evaluate the suitability, adequacy, and effectiveness of the results of QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
design and development stages to meet specified requirements; and Development Planning
7.3.4b b) to identify any problems and propose necessary actions. QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Planning
API Spec Q1 9th Edition Conformity Matrix Page 10 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
5.4.4 Design and
Paragraph ISO 9001:2015 Development
Reference Review Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
7.3.4 Participants in such review(s) shall include representatives of functions QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
concerned with the design and development stage(s) being reviewed. Development Planning
7.3.4 Records of the results of the review(s) and any necessary actions shall be QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
maintained (see 4.5). Development Planning
5.4.5 7.3.5 Design and To ensure that the design and development outputs have met the design and QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development development input requirements, design and development verification and a Development Planning
Verification and Final final review shall be conducted and documented in accordance with planned
Review arrangements (see 5.4.1).
7.3.4; 7.3.5 Records of design and development verification and the final design review QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
shall be maintained (see 4.5). Development Planning
5.4.6 7.3.6 Design and Design and development validation shall be performed in accordance with QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Validation planned arrangements (see 5.4.1) to ensure that the resulting product is Development Planning
and Approval capable of meeting the specified requirements.
7.3.6 Validation shall be completed prior to the delivery of the product, when QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
possible. Development Planning
n/a The completed design shall be approved after validation. QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Planning
n/a Competent (see 4.3.2.2) individual(s) other than the person or persons who QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
developed the design shall approve the final design. Development Planning
7.3.6 Records of the design and development validation, approval, and any necessary QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
actions shall be maintained (see 4.5). Development Planning
5.4.7 7.3.7 Design and Design and development changes shall be identified. The changes shall be QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
Development Changes reviewed, verified and validated, as appropriate, and approved before Development Planning
implementation.
7.3.7 The review of design and development changes shall include evaluation of the QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
effect of the changes on product and/or their constituent parts already Development Planning
delivered.
n/a Design and development changes including changes to design documents, shall QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
require the same controls as the original design and development. Development Planning
7.3.7 Records of design and development changes, reviews of those changes and any QSM-01, Rev.02, Section 5.4.1 Design and QSP-540-01, Rev.00, Design & Development
necessary actions shall be maintained (see 4.5). Development Planning
API Spec Q1 9th Edition Conformity Matrix Page 11 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
5.5.1
Number Reference General Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
n/a Contingency planning shall be based on assessed risks (see 5.3) and output shall QSM-01, Rev.02, Section 5.5.1 General QSP-550-01, Rev.00, Contingency Planning
be documented and communicated to the relevant personnel, and updated as
required.
5.5.2 n/a Planning Output The contingency plan shall include, at a minimum:
n/a a) actions required in response to significant risk scenarios to mitigate effects of QSM-01, Rev.02, Section 5.5.1 General QSP-550-01, Rev.00, Contingency Planning
disruptive incidents;
n/a b) identification and assignment of responsibilities and authorities; and QSM-01, Rev.02, Section 5.5.1 General QSP-550-01, Rev.00, Contingency Planning
n/a c) internal and external communication controls (see 4.1.5). QSM-01, Rev.02, Section 5.5.1 General QSP-550-01, Rev.00, Contingency Planning
5.6 Purchasing
5.6.1 Purchase Control
5.6.1.1 4.1; 7.4.1 Procedure The organization shall maintain a documented procedure to ensure that QSM-01, Rev.02, Section 5.6.1.1 Procedure QSP-560-01, Rev.00, Purchasing Procedure
purchased products or outsourced activities conform to specified requirements.
The procedure shall address:
n/a a) determination of the criticality of the activities or products as they are QSM-01, Rev.02, Section 5.6.1.1 Procedure QSP-560-01, Rev.00, Purchasing Procedure
applicable to conformance to product or customer specifications;
7.4.1 b) initial evaluation and selection of suppliers based on their ability to supply QSM-01, Rev.02, Section 5.6.1.1 Procedure QSP-560-01, Rev.00, Purchasing Procedure
products or activities in accordance with the organizations requirements (see
5.6.1.2 and 5.6.1.3);
n/a c) type and extent of control applied to the supplier based on the criticality of QSM-01, Rev.02, Section 5.6.1.1 Procedure QSP-560-01, Rev.00, Purchasing Procedure
the product or activity;
7.4.1 d) criteria, scope, frequency, and methods for reassessment of suppliers; QSM-01, Rev.02, Section 5.6.1.1 Procedure QSP-560-01, Rev.00, Purchasing Procedure
n/a e) maintaining a list of approved suppliers and scope of approval; and QSM-01, Rev.02, Section 5.6.1.1 Procedure QSP-560-01, Rev.00, Purchasing Procedure
4.1 f) type and extent of control to be applied to outsourced activities (see 5.6.1.6). QSM-01, Rev.02, Section 5.6.1.1 Procedure QSP-560-01, Rev.00, Purchasing Procedure
5.6.1.2 n/a Initial Supplier For purchase of critical products, components, or activities , the criteria for the QSM-01, Rev.02, Section 5.6.1.2 Initial Supplier QSP-561-01, Rev.00, Selection, Evaluation & Re-
Evaluation--Critical initial evaluation of suppliers by the organization shall be site-specific for each Evaluation - Critical Purchase evaluation
Purchases supplier and shall include the following:
n/a a) verification that the suppliers quality management system conforms to the QSM-01, Rev.02, Section 5.6.1.2 Initial Supplier QSP-561-01, Rev.00, Selection, Evaluation & Re-
quality system requirements specified for suppliers by the organization; and Evaluation - Critical Purchase evaluation
n/a b) assessment of the supplier to ensure its capability to meet the organizations QSM-01, Rev.02, Section 5.6.1.2 Initial Supplier QSP-561-01, Rev.00, Selection, Evaluation & Re-
purchasing requirements by: Evaluation - Critical Purchase evaluation
n/a i. performing an on-site evaluation of relevant activities; or QSM-01, Rev.02, Section 5.6.1.2 Initial Supplier QSP-561-01, Rev.00, Selection, Evaluation & Re-
Evaluation - Critical Purchase evaluation
n/a ii. performing first article inspection to ensure conformance to stated QSM-01, Rev.02, Section 5.6.1.2 Initial Supplier QSP-561-01, Rev.00, Selection, Evaluation & Re-
requirements; or Evaluation - Critical Purchase evaluation
n/a iii. Identifying how the supplied product conforms to stated requirements when QSM-01, Rev.02, Section 5.6.1.2 Initial Supplier QSP-561-01, Rev.00, Selection, Evaluation & Re-
limited by proprietary, legal and/or contractual arrangements. Evaluation - Critical Purchase evaluation
API Spec Q1 9th Edition Conformity Matrix Page 12 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
5.6.1.3 n/a Initial Supplier For purchase of noncritical products, components, or activities that impact QSM-01, Rev.02, Section 5.6.1.2 Initial Supplier QSP-561-01, Rev.00, Selection, Evaluation & Re-
Evaluation--Noncritical product realization or the final product, the criteria for evaluation of suppliers Evaluation - Critical Purchase evaluation
Purchases by the organization shall meet the requirements of 5.6.1.2 or satisfy one or
more of the following:
n/a a) verification that the suppliers quality management system conforms to the QSM-01, Rev.02, Section 5.6.1.2 Initial Supplier QSP-561-01, Rev.00, Selection, Evaluation & Re-
quality system requirements specified for suppliers by the organization; or Evaluation - Critical Purchase evaluation
n/a b) assessment of the supplier to meet the organizations purchasing QSM-01, Rev.02, Section 5.6.1.2 Initial Supplier QSP-561-01, Rev.00, Selection, Evaluation & Re-
requirements; or Evaluation - Critical Purchase evaluation
n/a c) assessment of the product upon delivery or activity upon completion. QSM-01, Rev.02, Section 5.6.1.2 Initial Supplier QSP-561-01, Rev.00, Selection, Evaluation & Re-
Evaluation - Critical Purchase evaluation
5.6.1.4 n/a Supplier Re-evaluation For re-evaluation of all suppliers (critical and noncritical), the requirements of QSM-01, Rev.02, Section 5.6.1.2 Initial Supplier QSP-561-01, Rev.00, Selection, Evaluation & Re-
5.6.1.3 shall apply. Evaluation - Critical Purchase evaluation
5.6.1.5 7.4.1 Supplier Evaluation-- Records of the results of all evaluations and any necessary actions arising from QSM-01, Rev.02, Section 5.6.1.2 Initial Supplier QSP-561-01, Rev.00, Selection, Evaluation & Re-
Records the evaluations shall be maintained (see 4.5). Evaluation - Critical Purchase evaluation
5.6.1.6 4.1 Outsourcing Where an organization chooses to outsource any activity within the scope of its QSM-01, Rev.02, Section 5.6.1.6 Outsourcing QSP-5616-01, Rev.00, Outsourcing Procedure
quality management system, the organization shall ensure that all applicable
elements of its quality management system are satisfied and shall maintain
responsibility for product conformance to specified requirements, including
applicable API product specifications, associated with product realization.
n/a Records of outsourced activities shall be maintained (see 4.5). QSM-01, Rev.02, Section 5.6.1.6 Outsourcing QSP-5616-01, Rev.00, Outsourcing Procedure
5.6.2 7.4.2 Purchasing Information The organization shall ensure the adequacy of specified purchasing information QSM-01, Rev.02, Section 5.6.2 Purchasing QSP-560-01, Rev.00, Purchasing Procedure
prior to their communication to the supplier. Information
7.4.2 Purchasing information provided to the supplier shall be documented and QSM-01, Rev.02, Section 5.6.2 Purchasing QSP-560-01, Rev.00, Purchasing Procedure
adequately describe the product or activity to be purchased, Information
7.4.2a including acceptance criteria, and where appropriate: QSM-01, Rev.02, Section 5.6.2 Purchasing QSP-560-01, Rev.00, Purchasing Procedure
Information
7.4.2a a) requirements for approval of suppliers procedures, processes, and QSM-01, Rev.02, Section 5.6.2 Purchasing QSP-560-01, Rev.00, Purchasing Procedure
equipment; Information
n/a b) applicable version of specifications, drawings, process requirements, QSM-01, Rev.02, Section 5.6.2 Purchasing QSP-560-01, Rev.00, Purchasing Procedure
inspection instructions, traceability, and other relevant technical data; Information
7.4.2b c) requirements for qualification of suppliers personnel; and QSM-01, Rev.02, Section 5.6.2 Purchasing QSP-560-01, Rev.00, Purchasing Procedure
Information
7.4.2c d) quality management system requirements. QSM-01, Rev.02, Section 5.6.2 Purchasing QSP-560-01, Rev.00, Purchasing Procedure
Information
API Spec Q1 9th Edition Conformity Matrix Page 13 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
5.6.3 n/a Verificaion of Purchased The organization shall maintain a documented procedure for the verification or QSM-01, Rev.02, Section 5.6.3 Verification of QSP-563-01, Rev.00, Verification of Purchased
Products or Activities other activities necessary for ensuring that purchased products or activities Purchased Products or Activities Products or Activities
meet specified purchase requirements.
7.4.3 Where the organization or its customer intends to perform verification at the QSM-01, Rev.02, Section 5.6.3 Verification of QSP-563-01, Rev.00, Verification of Purchased
suppliers premises, the organization shall state the intended verification Purchased Products or Activities Products or Activities
arrangements and method of product release in the purchasing information.
7.4.3 The organization shall ensure and provide evidence that purchased products QSM-01, Rev.02, Section 5.6.3 Verification of QSP-563-01, Rev.00, Verification of Purchased
and activities conform to specified requirements. Purchased Products or Activities Products or Activities
n/a The organization shall maintain records of verification activities (see 4.5). QSM-01, Rev.02, Section 5.6.3 Verification of QSP-563-01, Rev.00, Verification of Purchased
Purchased Products or Activities Products or Activities
5.7 Production and Servicing Provision
5.7.1 Control of Production and Servicing
5.7.1.1 n/a Production The organization shall maintain a documented procedure that describes QSM-01, Rev.02, Section 5.7.1.1 Production QSP-5711-01, Rev.00, Production Procedure
controls associated with the production of products. The procedure shall
address the following:
7.5.1a a) the availability of information that describes the characteristics of the QSM-01, Rev.02, Section 5.7.1.1 Production QSP-5711-01, Rev.00, Production Procedure
n/a product;
b) implementation of the product quality plan, when applicable (see 5.7.2); QSM-01, Rev.02, Section 5.7.1.1 Production QSP-5711-01, Rev.00, Production Procedure
n/a c) ensuring design requirements and related changes are satisfied, when QSM-01, Rev.02, Section 5.7.1.1 Production QSP-5711-01, Rev.00, Production Procedure
applicable (see 5.4);
7.5.1c; 7.5.1d d) the availability and use of suitable production, testing, monitoring, and QSM-01, Rev.02, Section 5.7.1.1 Production QSP-5711-01, Rev.00, Production Procedure
measurement equipment;
7.5.1b e)the availability of work instructions,when applicable; QSM-01, Rev.02, Section 5.7.1.1 Production QSP-5711-01, Rev.00, Production Procedure
n/a f) process control documents (see 5.7.1.3); QSM-01, Rev.02, Section 5.7.1.1 Production QSP-5711-01, Rev.00, Production Procedure
7.5.1e g) the implementation of monitoring and measurement activities; and QSM-01, Rev.02, Section 5.7.1.1 Production QSP-5711-01, Rev.00, Production Procedure
7.5.1f h) the implementation of product release (see 5.9), including applicable delivery QSM-01, Rev.02, Section 5.7.1.1 Production QSP-5711-01, Rev.00, Production Procedure
and post-delivery activities.
5.7.1.2 n/a Servicing The organization shall maintain a documented procedure that describes QSM-01, Rev.02, Section 5.7.1.2 Servicing QSP-5712-01, Rev.00, Service and Repair
controls associated with the servicing (see 3.1.21) of products. The procedure
shall address the following:
7.5.1a a) review and implementation of the organizations, customer-specific, product QSM-01, Rev.02, Section 5.7.1.2 Servicing QSP-5712-01, Rev.00, Service and Repair
servicing, and other servicing requirements;
7.5.1c; 7.5.1d b) the availability and use of suitable servicing, testing, monitoring, and QSM-01, Rev.02, Section 5.7.1.2 Servicing QSP-5712-01, Rev.00, Service and Repair
measurement equipment;
7.5.1b c) the availability of work instructions, when applicable; QSM-01, Rev.02, Section 5.7.1.2 Servicing QSP-5712-01, Rev.00, Service and Repair
n/a d) ensuring identification and traceability requirements are maintained QSM-01, Rev.02, Section 5.7.1.2 Servicing QSP-5712-01, Rev.00, Service and Repair
throughout the servicing process;
7.5.1e e) the implementation of monitoring and measurement activities; and QSM-01, Rev.02, Section 5.7.1.2 Servicing QSP-5712-01, Rev.00, Service and Repair
n/a f) process control documents (see 5.7.1.3), and QSM-01, Rev.02, Section 5.7.1.2 Servicing QSP-5712-01, Rev.00, Service and Repair
API Spec Q1 9th Edition Conformity Matrix Page 14 of 29 FM-186 Rev 1 Effective 7/8/2013
5.7.1.2 Servicing
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
7.5.1f g) requirements for release of the product that was serviced (see 5.9). QSM-01, Rev.02, Section 5.7.1.2 Servicing QSP-5712-01, Rev.00, Service and Repair
5.7.1.3 n/a Process Control Process controls shall be documented in routings, travelers, checklists, process QSM-01, Rev.02, Section 5.7.1.3 Process Control QSP-5711-01, Rev.00, Production Procedure
Documents sheets, or equivalent controls required by the organization and shall include Documents
requirements for verifying conformance with applicable product quality plans
(see 5.7.2), API product specifications, customer requirements and/or other
applicable product standards/codes. The process control documents shall
include or reference instructions, workmanship and acceptance criteria for
processes, tests, inspections, and required customers inspection hold or
witness points.
5.7.1.4 n/a Product Realization The organization shall develop and maintain documentation that includes but is QSM-01, Rev.02, Section 5.7.1.4 Product QSP-572-01, Rev.00, Product Quality Planning
Capability not limited to product realization plans (see 5.2) and records of Realization Capability Documentation
Documentation review/verification, validation, monitoring, measurement, inspection and test
activities, including criteria for product acceptance that demonstrates the
capability of the organization to satisfy specified product and/or servicing
requirements. NOTE: Product
realization documentation is evidence of the capability of the organization to
manufacture products or families of products and does not extend to every
work order or individual product manufactured.
5.7.1.5 7.5.2 Validation of Processes The organization shall validate processes for production and servicing where the QSM-01, Rev.02, Section 5.7.1.5 Validation of QSP-577-01, Rev.00, Inspection and Testing
for Production and resulting output cannot be verified by subsequent monitoring or measurement Process for Production and Servicing Procedure, BMI-WI-577-01, Rev.00, Inspection and
Servicing and as a consequence, deficiencies become apparent only after the product is Testing
in use or the servicing has been delivered. Validation shall demonstrate the
ability of these processes to achieve planned results.
n/a Where an organization chooses to outsource a process that requires validation, QSM-01, Rev.02, Section 5.7.1.5 Validation of QSP-577-01, Rev.00, Inspection and Testing
the organization shall require that the supplier conform to these requirements Process for Production and Servicing Procedure
(see 5.6.1.6).
7.5.2 The organization shall maintain a documented procedure to address methods QSM-01, Rev.02, Section 5.7.1.5 Validation of QSP-577-01, Rev.00, Inspection and Testing
for review and approval of the processes including: Process for Production and Servicing Procedure
7.5.2b a) required equipment; QSM-01, Rev.02, Section 5.7.1.5 Validation of QSP-577-01, Rev.00, Inspection and Testing
Process for Production and Servicing Procedure
7.5.2b b) qualification of personnel; QSM-01, Rev.02, Section 5.7.1.5 Validation of QSP-577-01, Rev.00, Inspection and Testing
Process for Production and Servicing Procedure
7.5.2c c) use of specific methods, including identified operating parameters; QSM-01, Rev.02, Section 5.7.1.5 Validation of QSP-577-01, Rev.00, Inspection and Testing
Process for Production and Servicing Procedure
7.5.2a d) identification of acceptance criteria; QSM-01, Rev.02, Section 5.7.1.5 Validation of QSP-577-01, Rev.00, Inspection and Testing
Process for Production and Servicing Procedure
API Spec Q1 9th Edition Conformity Matrix Page 15 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
7.5.2d e) requirements for records (see 4.5); and QSM-01, Rev.02, Section 5.7.1.5 Validation of QSP-577-01, Rev.00, Inspection and Testing
Process for Production and Servicing Procedure
7.5.2e f) revalidation. QSM-01, Rev.02, Section 5.7.1.5 Validation of QSP-577-01, Rev.00, Inspection and Testing
Process for Production and Servicing Procedure
n/a The organization shall validate those processes identified by the applicable QSM-01, Rev.02, Section 5.7.1.5 Validation of QSP-577-01, Rev.00, Inspection and Testing
product specification as requiring validation. If these processes are not Process for Production and Servicing Procedure
identified, or there is no product specification involved, the processes requiring
validation shall include, as a minimum, nondestructive examination, welding,
and heat treating, if applicable to the product.
5.7.2 n/a Product Quality Plans When required by contract, the organization shall develop a product quality QSM-01, Rev.02. Section 5.7.2 Product Quality QSP-572-01, Rev.00,Product Quality Planning
plan that specifies the processes of the quality management system (including Plans
the product realization processes) and the resources to be applied to a product.
n/a The product quality plan required by contract shall address each of the
following as a minimum:
n/a a) description of the product to be manufactured; QSM-01, Rev.02. Section 5.7.2 Product Quality QSP-572-01, Rev.00,Product Quality Planning
n/a b) required processes and documentation, including required inspections, tests, Plans5.7.2 Product Quality
QSM-01, Rev.02. Section QSP-572-01, Rev.00,Product Quality Planning
and records, for conformance with requirements; Plans
n/a c) identification and reference to control of outsourced activities; QSM-01, Rev.02. Section 5.7.2 Product Quality QSP-572-01, Rev.00,Product Quality Planning
n/a d) identification of each procedure, specification or other document referenced Plans5.7.2 Product Quality
QSM-01, Rev.02. Section QSP-572-01, Rev.00,Product Quality Planning
or used in each activity; and Plans
n/a e) identification of the required hold, witness, monitor and document review QSM-01, Rev.02. Section 5.7.2 Product Quality QSP-572-01, Rev.00,Product Quality Planning
n/a points.
These product quality plans and any revisions to them shall be documented and Plans5.7.2 Product Quality
QSM-01, Rev.02. Section QSP-572-01, Rev.00,Product Quality Planning
approved by the organization to ensure customer requirements are met. These Plans
product quality plans and any revisions shall be communicated to the customer.
NOTE 1 A product quality plan may be
comprised of one or several different documents .
NOTE 2 A product quality plan is sometimes referred
by other terms--such as quality plan (QP), inspection and test plan (ITP),
manufacturing process specification (MPS), process control plan (PCP), quality
activity plan (QAP), and often makes references to parts of the quality manual
or to procedure documents.
5.7.3 7.5.3 Identification and The organization shall maintain a documented procedure for identification and
Traceability traceability while the product is under control of the organization as required by
the organization, the customer, and the applicable product specifications,
throughout the product realization process, including applicable delivery and
post-delivery activities. QSM-01, Rev.02, Section 5.7.3 Identification and QSP-573-01, Rev.00, Identification & Traceability
n/a The procedure shall include requirements for maintenance or replacement of Traceability Procedure
identification and/or traceability marks.
API Spec Q1 9th Edition Conformity Matrix Page 16 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
5.7.4 n/a Product Inspection/Test The organization shall maintain a documented procedure for the identification
Status of product inspection and/or test status throughout the product realization
process which indicates the conformity or nonconformity of product with
respect to inspections and/or tests performed.
QSM-01, Rev.02, Section 5.7.4 Production QSP-574-01, Rev.00, Product Inspection and Test
Inspection/Test Status Procedure
n/a The organization shall ensure that only product that meets requirements or
5.7.5 7.5.4 Customer-Supplied The organization shall maintain a documented procedure for the identification,
Property verification, safeguarding, preservation, maintenance, and control of customer-
supplied property, including intellectual property and data, while under control
of the organization.
7.5.4 QSM-01, Rev.02, Section 5.7.5 Customer-supplied QSP-575-01, Rev.00, Customer-Supplied Property
The procedure shall include requirements for reporting to the customer any Property Procedure
loss, damage, or unsuitability for use of customer-supplied property.
7.5.4 Records for the control and disposition of customer-supplied property shall be
maintained (see 4.5).
5.7.6 Preservation of Product
5.7.6.1 n/a General The organization shall maintain a documented procedure describing the
methods used to preserve the product and constituent parts throughout
product realization and delivery to the intended destination in order to maintain
conformity to requirements. As applicable, preservation shall include QSP-576-01, Rev.00, Preservation of Product
identification and traceability marks, transportation, handling, packaging, and QSM-01, Rev.02, Section 5.7.6.1 General
Procedure
protection.
5.7.6.2 n/a Storage and Assessment The procedure shall identify the requirements for storage and assessment.
n/a The organization shall use designated storage areas or stock rooms to prevent
damage or deterioration of product, pending use or delivery.
n/a In order to detect deterioration, the condition of product or constituent parts in QSM-01, Rev.02, Section 5.7.6.2 Storage and QSP-5762-01, Rev.00, Storage and Assessment
stock shall be assessed at specified intervals identified by the procedure. Assessment Procedure
API Spec Q1 9th Edition Conformity Matrix Page 17 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
5.7.6.2 Storage and Assessment
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier
QSM-01, 1 (Quality
Rev.02, Manual)
Section 5.7.6.2 Storage and Tier 2 (Procedure/Work
QSP-5762-01, Instruction)
Rev.00, Storage and Assessment
Number Reference Document Number/ID,
AssessmentRevision Level, Document Number/ID,
ProcedureRevision Level,
Document Description Document Description
n/a The interval shall be appropriate to the products or constituent parts being
assessed.
QSM-01, Rev.02, Section 5.7.7.1 General QSP-577-01, Rev.00, Inspection and Testing
8.2.4 The procedure shall include requirements for in-process and final inspection Procedure
and testing. Records of required inspection and testing shall be maintained per
documented procedures (see 4.5).
5.7.7.2 8.2.4 In-process Inspection The organization shall inspect and test the product at planned stages as QSM-01, Rev.02, Section 5.7.7.1 General QSP-577-01, Rev.00, Inspection and Testing
and Testing required by the product quality plan (see 5.7.2), process control documents Procedure
(see 5.7.1.3), and/or documented procedures. Evidence of conformity with the
acceptance criteria shall be maintained.
5.7.7.3 n/a Final Inspection and The organization shall perform all final inspection and testing in accordance
Testing with the product quality plan (see 5.7.2) and/or documented procedures to
validate and document conformity of the finished product to the specified
requirements.
n/a Personnel other than those who performed or directly supervised the QSP-577-01, Rev.00, Inspection and Testing
QSM-01, Rev.02, Section 5.7.7.1 General
production of the product shall perform final acceptance inspection at planned Procedure
stages of the product realization process. NOTE For single
step manufacturing processes (e.g. threading), in-process and final inspection
and testing can be performed as one activity
5.7.8 n/a Preventative The organization shall maintain a documented procedure for the establishment
Maintenance of preventive maintenance for equipment used in product realization. The
procedure shall identify requirements for:
n/a a) type of equipment to be maintained;
n/a b) frequency; and QSM-01, Rev.02, Section 5.7.8 Preventive QSP-578-01, Rev.00, Preventive Maintenance
n/a c) responsible personnel. Maintenance Procedure
n/a Records of preventive maintenance shall be maintained (see 4.5). NOTE
Preventive maintenance can be based on risk, system reliability, usage history,
experience, industry recommended practices, relevant codes and standards,
original equipment manufacturer's guidelines, or other applicable
requirements.
API Spec Q1 9th Edition Conformity Matrix Page 18 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
5.8 7.6 Control of Testing, The organization shall determine the testing, monitoring, and measurement
Measuring and requirements and the associated equipment needed to provide evidence of
Monitoring Equipment conformity to those requirements.
for Product Conformity
QSM-01, Rev.02, Section 5.8 Control of Testing, QSP-580-01, Rev.00, Control of Testing, Measuring,
n/a The organization shall maintain a documented procedure in order to ensure Measuring, and Monitoring Equipment and Monitoring Equipment Procedure
that testing, measurement, and monitoring equipment is calibrated and
maintained and that the equipment is used in a manner that is consistent with
monitoring and measurement requirements.
7.6 The procedure shall include requirements for the specific equipment type that
addresses:
API Spec Q1 9th Edition Conformity Matrix Page 19 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
n/a 5) be used under environmental conditions that are suitable for the calibrations,
inspections, measurements and tests being carried out.
n/a The organization shall maintain a registry of the required testing, measurement,
and monitoring equipment used to determine product conformity to
requirements that includes a unique identification, specific to each piece of
equipment.
7.6 Records of the results of calibration and verification shall be maintained (see
5.9 n/a Product Release 4.5).
The organization shall maintain a documented procedure to ensure release of
product to the customer shall not proceed until the planned arrangements (see
5.7) have been satisfactorily completed, unless otherwise approved by a
relevant authority and,
QSM-01, Rev.02, Section 5.9 Product Release QSP-590-01, Rev.00, Product Release Procedure
8.2.4 where applicable, by the customer.
8.2.4 Records shall be maintained to enable identification of the individual releasing
the product (see 4.5).
API Spec Q1 9th Edition Conformity Matrix Page 20 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
5.10.1 General where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, DocumentRev.00,
Number/ID,
QSM-01, Rev.02, Section 5.10.1 General QSP-5100-01, ControlRevision Level,
of Nonconforming
Document Description Document Description
Product Procedure
5.10.2 n/a Nonconforming Product The organization shall address nonconforming product by performing one or
more of the following:
n/a a) repair or rework with subsequent inspection to meet specified requirements; QSP-5100-01, Rev.00, Control of Nonconforming
QSM-01, Rev.02, Section 5.10.1 General
n/a b) regrade for alternative applications; Product Procedure
n/a c) release under concession (see 5.10.3); and/or
n/a d) reject or scrap.
5.10.3 n/a Release or Acceptance The evaluation and release under concession of nonconforming product that
of Nonconforming does not satisfy manufacturing acceptance criteria (MAC) shall be permitted
Product under MAC or when the organizations relevant authority and the customer (where applicable)
DAC Concession have authorized the release provided that:
n/a a) products continue to satisfy the applicable DAC and/or customer criteria; or QSP-5100-01, Rev.00, Control of Nonconforming
QSM-01, Rev.02, Section 5.10.1 General
Product Procedure
n/a b) the violated MAC are categorized as unnecessary to satisfy the applicable
DAC and/or customer criteria; or
n/a c) the DAC are changed and the products satisfy the revised DAC and associated
MAC requirements.
5.10.4 n/a Customer Notification The organization shall notify customers of product not conforming to DAC or
contract requirements that has been delivered. The organization shall maintain
records of such notifications (see 4.5). QSM-01, Rev.02, Section 5.10.1 General QSP-5100-01, Rev.00, Control of Nonconforming
Product Procedure
5.10.5 8.3 Records Records of the nature of nonconformities and any subsequent actions taken,
including concessions obtained, shall be maintained (see 4.5). QSM-01, Rev.02, Section 5.10.1 General QSP-5100-01, Rev.00, Control of Nonconforming
Product Procedure
API Spec Q1 9th Edition Conformity Matrix Page 21 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
5.4.2b The organization shall ensure that the integrity of the quality management
system is maintained when changes to the quality management system are
planned and implemented.
QSM-01, Rev.02, Section 5.11 Management of QSP-511-01, Rev.00, Management of Change
Change Procedure
n/a For the management of change, the organization shall identify the potential
risks (see 5.3) associated with the change and any required approvals prior to
the introduction of such changes.
n/a The organization shall maintain records of MOC activities (see 4.5).
5.11.2 n/a MOC Implementation The organization shall use the MOC process for any of the following that may
negatively impact the quality of the product:
n/a a) changes in the organizational structure (see 4.3.2)
n/a b) changes in key or essential personnel (see 4.3.2); QSM-01, Rev.02, Section 5.11 Management of QSP-511-01, Rev.00, Management of Change
Change Procedure
n/a c) changes in critical suppliers (see 5.6.1);
n/a d) changes to the management system procedures, including changes resulting
from corrective and preventive actions (see 6.4);
5.11.3 n/a MOC notification The organization shall notify relevant personnel, including the customer when
required by contract, of the change and residual or new risk due to changes QSM-01, Rev.02, Section 5.11 Management of QSP-511-01, Rev.00, Management of Change
that have either been initiated by the organization or requested by the Change Procedure
customer.
6 Quality Management System Monitoring, Measurement, Analysis, and Improvement
6.1 4.1c; 8.1b; 8.1c; General The organization shall plan and implement the monitoring, measurement, QSM-01, Rev.02, Section 6.1 General
8.5.1 analysis, and improvement processes needed to ensure conformity of the
quality management system to the requirements of this specification and to
continually improve the effectiveness of the quality management system.
API Spec Q1 9th Edition Conformity Matrix Page 22 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date:
6.2.1 24-Mar-14
Customer Satisfaction
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference QSM-01, Rev.02,
Document Section 6.2.1
Number/ID, Customer
Revision Level, QSP-621-01,Number/ID,
Document Rev.00, Customer Satisfaction
Revision Level,
DocumentSatisfaction
Description Procedure
Document Description
8.2.2a; 8.2.2b Audits shall verify that the quality management system is effectively
implemented and maintained, and conforms to the requirements of this
specification.
8.2.2 The planning of internal audits shall take into consideration the results of
previous audits and criticality of the process being audited.
QSM-01, Rev.02, Section 6.2.2.1 General QSP-622-01, Rev.00, Internal Audit Procedure
8.2.2 The organization shall identify the audit criteria, scope, frequency, and methods
n/a to ensure that all processes of the quality management system claiming
conformity to the requirements of this document are audited at least every
twelve months.
n/a Outsourced activities that impact the quality of the product and that are
performed at the organizations facility shall be included as part of the internal
audit of the organization.
6.2.2.2 8.2.2 Performance of Internal Audits shall be performed by competent personnel (see 4.3.2.2) independent of
Audit those who performed or directly supervised the activity being audited to
ensure objectivity and impartiality of the audit process.
8.2.2 Records of the audits shall provide objective evidence that the quality
management system is implemented and maintained (see 4.5).
QSM-01, Rev.02, Section 6.2.2.1 General QSP-622-01, Rev.00, Internal Audit Procedure
n/a All processes of the quality management system required to meet this
specification shall be audited prior to claiming conformance to the
requirements of this specification.
NOTE : Product specification requirements may be
embedded throughout the quality management system processes an audited in
conjunction with one or more quality management system processes.
6.2.2.3 8.2.2 Audit Review and The organization shall identify response times for addressing detected
Closure nonconformities.
API Spec Q1 9th Edition Conformity Matrix Page 23 of 29 FM-186 Rev 1 Effective 7/8/2013
QSM-01, Rev.02, Section 6.2.2.1 General QSP-622-01, Rev.00, Internal Audit Procedure
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
6.2.2.3 Audit Review and Document Description Document Description
Closure
8.2.2 The management responsible for the area being audited shall ensure that any
necessary corrections and corrective actions follow the requirements of 6.4.2.
QSM-01, Rev.02, Section 6.2.2.1 General QSP-622-01, Rev.00, Internal Audit Procedure
5.6.2a The results of internal audits and the status of corrective actions shall be
reported in the management review (see 6.5).
6.2.3 4.1e; 4.1f; 8.2.3 Process Evaluation The organization shall apply suitable evaluation methods to demonstrate the
ability of the quality management system processes to achieve planned results,
including conformity to product requirements.
QSM-01, Rev.02, Section 6.2.2.1 General QSP-622-01, Rev.00, Internal Audit Procedure
8.2.3 When planned results are not achieved, correction and corrective action shall
be taken (see 6.4.2), as appropriate.
NOTE Performance of internal audits and management reviews satisfy
this requirement.
API Spec Q1 9th Edition Conformity Matrix Page 24 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
QSM-01, Rev.02, Section 6.3 Analysis of Data QSP-630-01, Rev.00, Analysis of Data Procedure
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
8.4 The organization shall use data to evaluate where continual improvement of the
effectiveness of the quality management system can be made.
6.4 Improvement
6.4.1 8.5.1 General The organization shall continually improve the effectiveness of the quality
management system through the use of the quality policy, quality objectives,
audit results, analysis of data, corrective and preventive actions, and
management review. NOTE See ISO
9000 for definitions of correction, corrective action and preventive action. QSM-01, Rev.02, Section 6.4.1 General QSP-642-01, Rev.00, Corrective Action Procedure
6.4.2 8.5.2 Corrective Action The organization shall maintain a documented procedure to correct
nonconformities and to take corrective actions, both internally and within the
supply chain, to eliminate the causes of a nonconformity in order to minimize
the likelihood of its recurrence.
QSM-01, Rev.02, Section 6.4.2 Corrective Action QSP-642-01, Rev.00, Corrective Action Procedure
8.5.2 Corrective actions shall be appropriate to the effect(s) of the nonconformity
encountered. NOTE Corrective
action can apply to both quality management system processes and non-
conforming product trends.
n/a Records shall identify the activities performed to verify effectiveness of the
corrective actions taken.
API Spec Q1 9th Edition Conformity Matrix Page 25 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
6.4.3 8.5.3 Preventive Action The organization shall maintain a documented procedure to determine and
implement preventive actions, both internally and within the supply chain, to
eliminate the causes of potential nonconformities in order to minimize the
likelihood of their occurrence.
QSM-01, Rev.02, Section 6.4.3 Preventive Action QSP-643-01, Rev.00, Preventive Maintenance
8.5.3 Preventive actions shall be appropriate to the effect(s) of the potential Procedure
problems.
NOTE Preventive action can apply to both quality management system
processes and product analylsis.
n/a d) identifying the timeframe and responsible person(s) for implementing a QSP-643-01, Rev.00, Preventive Maintenance
preventive action; QSM-01, Rev.02, Section 6.4.3 Preventive Action
Procedure
8.5.3e e) reviewing the effectiveness of the preventive action taken; and
n/a f) MOC (see 5.11) when the preventive action require new or changed controls
within the quality management system.
8.5.3d Records of the activities for control of potential process nonconformities shall
be maintained (see 4.5).
6.5 Management Review
6.5.1 5.6.1; 5.1d General The organizations quality management system shall be reviewed at least every
twelve months by the organizations management to evaluate the quality
management systems continuing suitability, adequacy, and effectiveness.
6.5.2 5.6.2 Input Requirements The input to management review shall include, as a minimum:
5.6.2e a) effectiveness of actions resulting from previous management reviews;
API Spec Q1 9th Edition Conformity Matrix Page 26 of 29 FM-186 Rev 1 Effective 7/8/2013
QSM-01, Rev.02, Section 6.5.2 Input Requirements
Company: PT. Borneo Mandiri Investment Instructions
Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference
where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo Mandiri Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 24-Mar-14
6.5.2 Input Requirements
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
5.6.1 Management reviews shall be documented and records of these reviews shall
be maintained (see 4.5).
n/a b) Each licensee shall develop and maintain an API Monogram marking QSP-A5-01, Rev 00, API Monogram & Marking
procedure that documents the marking/monogramming requirements specified QSM-01, Rev.02, Annex A Section A.5
Requirement
by this annex and any applicable API product specification(s) and/or
standard(s).
API Spec Q1 9th Edition Conformity Matrix Page 27 of 29 FM-186 Rev 1 Effective 7/8/2013
Company: PT. Borneo Mandiri Investment Instructions
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A.5 Control of the where each requirement has been addressed in your Quality Management System Documentation. If you are
Facility Name/ID: PT. Borneo
Application Mandiri
and Removal Investment/8458 applying for exclusions to your QMS, please indicate Excluded in the Tier 1/Tier 2 boxes for each requirement
being excluded. See Section 1 of Q1 for a list of allowable exclusions.
of the API Monogram
Date: 24-Mar-14
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in yellow are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2015 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level,
Document Description Document Description
n/a 1) define the authority responsible for application and removal of the API
n/a Monogram;
2) define the method(s) used to apply the Monogram;
n/a 3) identify the location on the product where the API Monogram is to be
applied;
n/a 4) require the application of the licensee's license number and date of
manufacture of the product in conjunction with the use of the API Monogram;
n/a 5) require that the date of manufacture, at a minimum, be two digits
representing the month and two digits representing the year (e.g. 05-12 for
May 2012) unless otherwise stipulated in the applicable API product
specification(s) or standard(s); and QSP-A5-01, Rev 00, API Monogram & Marking
n/a 6) require application of the additional API product specification(s) and/or QSM-01, Rev.02, Annex A Section A.5
standard(s) marking requirements, as applicable. Requirement
n/a c) Only an API licensee shall apply the API Monogram and its designated license
number to API monogrammable products.
n/a d) The API Monogram license, when issued, is site-specific and subsequently
the API Monogram shall only be applied at that site specific licensed facility
location.
n/a e) The API Monogram may be applied at any time appropriate during the
production process but shall be removed in accordance with the licensees API
Monogram marking procedure if the product is subsequently found to be out of
conformance with any of the requirements of the applicable API product
specification(s) and/or standard(s) and API Monogram Program.
A.6 n/a Design Package Each licensee and/or applicant for licensing shall maintain a current design QSM-01, Rev.02, Annex A Section A.6 QSP-540-01, Rev.00, Design & Development
Requirements package for all of the applicable products that fall under the scope of each
Monogram license. The design package information shall provide objective
evidence that the product design meets the requirements of the applicable and
most current API product specification(s). The design package(s) shall be made
available during API audits of the facility.
In specific instances, the exclusion of design activities is allowed under the
Monogram Program, as detailed in Advisory # 6.
I hereby declare that PT. Borneo Mandiri Investmenthas implemented a quality management system that conforms to all applicable requirements of API Spec Q1, 9 th Edition as described in this document.
Signed by:
Name
Title
Date
API Spec Q1 9th Edition Conformity Matrix Page 28 of 29 FM-186 Rev 1 Effective 7/8/2013