FM-186 Q1 9th Conformity Matrix Obsolete

Company: M/S.United Industrial services Co LLC,Plot No.
142-144, Sohar Industrial Estate,

Sohar, Sultanate of Oman.
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 applying for exclusions to your QMS, please indicate “Excluded” in the Tier 1/Tier 2 boxes for each
Facility Name/ID: Description/License Number : 5CT/1274, 6A/1193, 6D/1103, 7-1/0846 requirement being excluded. See Section 1 of Q1 for a list of allowable exclusions.
Date: 25.10.2015
Reference: API Spec Q1 9th Ed NOTE: Areas shaded in blue are new API Spec Q1 9th Edition requirements.
Paragraph ISO 9001:2008 Reference Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction) Tier 3 (Procedure/Work Instruction)
Number Reference Document Number/ID, Revision Level, Document Number/ID, Revision Level, Document Document Number/ID, Revision
Document Description Description Level, Document Description
4 Quality Management System Requirements

4.1 Quality Management System
4.1.1 4.1; 4.1c; 7.1; General The organization shall establish, document, implement, and Quality Manual Operating Procedures Work Instructions
8.5.1 maintain at all times a quality management system for all UNISCO[M]MS 001 Rev-05 UNISCO[M]MS 013 Rev-05 UNISCO[M]MS 014 Rev-02
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; Quality Policy The organization’s policy for its commitment to quality shall be Quality Assurance Policy
5.3b; 5.3c; defined, documented, and approved by top management. The UNISCO[M]MS 004 Rev-01
5.3d organization’s 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; Quality Management, with approval from top management, shall ensure Management Responsibility
7.1a Objectives that quality objectives, including those needed to meet product UNISCO[M]MS 008 Rev-04 Section 1.4.1
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.
4.1.4 4.1a; 7.1 Planning Management shall ensure that:

a) criteria and methods needed for the operation and control of Management Responsibility
all quality management system processes are determined, UNISCO[M]MS 008 Rev-04 Section 1.4
managed, and effective; and
5.4.2a b) planning of the quality management system is carried out in Management Responsibility
order to meet the requirements of this specification. UNISCO[M]MS 008 Rev-04 Section 1.4.2
4.1.5 Communication
4.1.5.1 5.5.3 Internal Management shall ensure that appropriate communication Management Responsibility
processes are established within the organization and the UNISCO[M]MS 008 Rev-04 Section 1.5
effectiveness of the quality management system is and 1.6.4
communicated.
5.1a The organization shall establish processes to ensure that:

API Spec Q1 9th Edition Conformity Matrix Page 1 of 32 FM-186 Rev 2 Effective 7/16/2013
Company: M/S.United Industrial services Co LLC,Plot No.142-144, Sohar Industrial Estate,
Instructions
Date: 25.10.2015
4.1.5.1 Reference
Number Internal Document Number/ID, Revision Level, Document Number/ID, Revision Level, Document Document Number/ID, Revision
5.1a
a) importance of meeting customer, legal, and other applicable Management Responsibility
requirements is communicated at relevant functions within the UNISCO[M]MS 008 Rev-04 Section 1.4.2
organization; and
NR in 9001* b) results of analysis of data (see 6.3) are communicated at Measurement, Analysis and Improvement Analysis of Data UNISCO[P]MS
relevant levels and functions within the organization. UNISCO[M]MS 011 Rev-02 017 Rev-03
Section 1.4
4.1.5.2 5.2; 7.2.3 External The organization shall determine and implement a process for
communicating 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 Product Realization UNISCO[M]MS 010 Rev-04 Tendering and Contract Review
amendments (see 5.1); Section 1.2 UNISCO[P]MS 002 Rev-05
7.2.3a b) provision of product information, including product Measurement, Analysis & Improvement Control of Nonconformance
nonconformities identified after delivery to the customer (see UNISCO[M]MS 011 Rev-02 Section 1.2 & 1.3 UNISCO[P]MS 010 Rev-03 6.16
5.10.4);
7.2.3c c) feedback and customer complaints (see 6.2.1); and Measurement, Analysis and Improvement Customer compliant, Corrective and Preventive Actions
UNISCO[M]MS 011 Rev-02 UNISCO[P]MS 011 Rev-04
Section 1.2.1
NR in 9001* d) when required by contract, providing information required by Product Realization UNISCO[M]MS 010 Rev-04 Control of Production and service provision
product quality plans and subsequent changes to those plans (see Section 1.5.1.2 UNISCO[P]MS 007 Rev-03 Section 6
5.7.2).
4.2 Management Responsibility

4.2.1 4.1d; 5.1; 5.1e General Top management shall ensure the availability of resources Resource Management
essential to establish, implement, maintain, and improve the UNISCO[M]MS 009 Rev-03
quality management system.
Management shall provide evidence of its commitment to the

development and implementation of the quality management
system and continually improve its effectiveness by:
5.1c a) ensuring that quality objectives are established including key Management Responsibility Analysis of Data UNISCO[P]MS
performance indicators for use in data analysis; and UNISCO[M]MS 008 Rev-04 Section 1.4 017 Rev-03
5.1d b) conducting management reviews (see 6.5). Management Responsibility

UNISCO[M]MS 008 Rev-04 Section 1.6
Instructions
Date: 25.10.2015
4.2.2 5.5.1 Responsibility Responsibilities, authorities, and accountabilities of personnel Management Responsibility List of Job Description
and Authority within the scope of this document shall be defined, documented, UNISCO[M]MS 008 Rev-04 Section 1.5 UNISCO[M]MS 016 Rev-04
and communicated throughout the organization.
4.2.3 5.5.2 Management Top management shall appoint and maintain a member of the
Representative organization’s 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 Management Responsibility Operating Procedures Work Instructions
system are established, implemented, and maintained, UNISCO[M]MS 008 Rev-04 Section 1.5 UNISCO[P]MS 001 to UNISCO[P]MS 024 UNISCO[W]ME 001 to
UNISCO[W]ME 021, HSE 101 - 130
5.5.2b b) reporting to top management on the performance of the Management Responsibility Management Review
quality management system and any need for improvement; UNISCO[M]MS 008 Rev-04 Section 1.5 UNISCO[P]MS 001 Rev-03 & Internal Audit
UNISCO[P]MS 014 Rev-04 Section 6.4
NR in 9001* c) ensuring initiation of action(s) to minimize the likelihood of the Management Responsibility Customer Compliants, Corrective & Preventive Actions
occurrence of nonconformities (see 6.4.3); and UNISCO[M]MS 008 Rev-04 Section 1.5 UNISCO[P]MS 011 Rev- 03 Section 6.3, 6.3.3, 6.3.4
5.5.2c d) ensuring the promotion of awareness of customer Management Responsibility Training and Qualification
requirements throughout the organization. UNISCO[M]MS 008 Rev-04 Section 1.5 UNISCO[P]MS 015 Rev-04 6.3.3
4.3 Organization Capability
4.3.1 6.1; 7.1b Provision of The organization shall determine and allocate the resources Resource Management
Resources needed to implement, maintain, and improve the effectiveness of UNISCO[M]MS 009 Rev-03 Section 1.1
the elements of the quality management system.
4.3.2 Human Resources

4.3.2.1 6.2.2a; 6.2.2b; General The organization shall maintain a documented procedure for Resource Management Copetency, Training & Awareness UNISCO[P]MS 14 Rev-
6.2.2c defining personnel competency and identifying training UNISCO[M]MS 009 Rev-03 04
requirements or other actions to achieve the necessary
competency of personnel whose responsibilities fall within the
scope of the quality management system. The procedure shall
include provisions for determining and documenting the
effectiveness of the training or other actions taken toward the
achievement of required competency.
4.3.2.2 6.2.1 Personnel Personnel shall be competent based on the appropriate Resource Management
Competence education, training, skills, and experience needed to meet UNISCO[M]MS 009 Rev-03
product and customer requirements.
Instructions
Date: 25.10.2015
4.3.2.2 Personnel
Competence
NR in 9001* Evidence of the determination of competence of personnel shall Resource Management

be recorded and maintained (see 4.5). UNISCO[M]MS 009 Rev-03
4.3.2.3 6.2.2 Training and The organization shall:

Awareness
NR in 9001* a) provide for quality management system training and job Resource Management Training and Qualification
training; UNISCO[M]MS 009 Rev-03 UNISCO[P]MS 015 Rev-04
NR in 9001* b) ensure that customer-specified training and/or customer- Resource Management Training and Qualification
provided training, when required, is included in the training UNISCO[M]MS 009 Rev-03 UNISCO[P]MS 015 Rev-04
program;
NR in 9001* c) ensure that the frequency and content of training is identified; Resource Management Training and Qualification
6.2.2d d) ensure that its personnel are aware of the relevance and Resource Management Training and Qualification
importance of their activities and how they contribute to the UNISCO[M]MS 009 Rev-03 UNISCO[P]MS 015 Rev-04
achievement of the quality objectives; and
6.2.2e e) maintain appropriate records of education, training, skills, and Resource Management
experience (see 4.5). UNISCO[M]MS 009 Rev-03
4.3.3 6.3; 6.4 Work The organization shall determine, provide, manage, and maintain
Environment the work environment needed to achieve conformity applicable
to the manufacture of the product. Work environment shall
include:
6.3a a) buildings, workspace, and associated utilities; UNISCO's Introduction UNISCO[M]MS 003 Rev-
03 Resource Management
UNISCO[M]MS 009 Rev-03
6.3b b) process equipment and its maintenance (both hardware and Resource Management Control of Production and service provision
software) (see 5.7.8); UNISCO[M]MS 009 Rev-03 UNISCO[P]MS 007 Rev-03
6.3c c) supporting services (e.g. transport, communication, Resource Management
information systems); and UNISCO[M]MS 009 Rev-03
6.4 d) conditions under which work is performed such as physical, Resource Management Procedure for Aspect/Impact & Hazard/Risk Identification
environmental or other factors. UNISCO[M]MS 009 Rev-03 UNISCO[P]MS
021 Rev-01
4.4 Document Requirements

4.4.1 4.2.1 General The quality management system documentation shall include:
4.2.1a a) statements of quality policy and quality objectives; Quality Assurance Policy
UNISCO[M]MS 004 Rev-01 & Management
Responsibility UNISCO[M]MS 008 Rev-04
[Quality Objectives]
Instructions
Date: 25.10.2015
4.4.1 General
4.2.1b b) a quality manual that addresses each requirement of this Quality Manual UNISCO[M]MS001 to 017
specification and includes:
4.2.2a 1) the scope of the quality management system, including Purpose and Scope
justification for any exclusions to specific quality management UNISCO[M]MS 005 Rev-02
system elements (see Section 1);
4.1b; 4.2.2c 2) a description of the sequence and interaction between the Preservation of Product
processes of the quality management system; UNISCO[M]MS 012 Rev-02
NR in 9001* 3) identification of processes that require validation (see 5.7.1.5); Product Realization Identification & Validation of Processes
and UNISCO[M]MS 010 Rev-04 1.3.6 UNISCO[P]MS 023 Rev-01
4.2.2b 4) reference to documented procedures that control the quality List Of Procedures
management system processes; UNISCO[M]MS 013 Rev-05
4.2.1c c) documented procedures established for the quality List Of Procedures

management system; UNISCO[M]MS 013 Rev-05
4.2.1d; 7.1b d) documents and records, to ensure the effective planning, Document and Data Contol
operation and control of its processes, and compliance with UNISCO[P]MS 003 Rev-03
specified requirements; and
NR in 9001* e) identification of legal, and other applicable requirements to Product Realization Procedure for Review/ Reevaluation of applicable
which the organization claims compliance which are needed to UNISCO[M]MS 010 Rev-04 legislation and Other Requirements
achieve product conformity. UNISCO[P]MS 022 Rev-00
4.4.2 NR in 9001* Procedures All procedures referenced within this specification shall be List of Procedures
established, documented, implemented, and maintained for UNISCO[M]MS 013 Rev-05
continued suitability.
4.4.3 4.2.3 Control of The organization shall maintain a documented procedure for the Document and Data Control
Documents identification, distribution, and control of documents required by UNISCO[P]MS 003 Rev-03 6.3
the quality management 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- Document and Data Control
approval and shall identify the controls needed to ensure that the UNISCO[P]MS 003 Rev-03 Section 6.0
documents required by the 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 Document and Data Control
use, UNISCO[P]MS 003 Rev-03 Section 6.1.1, 6.3.3.
4.2.3c b) identify changes and revision status, Document and Data Control
UNISCO[P]MS 003 Rev-03 Section
6.1.4 and 6.1.5, 6.3.3
4.4.3 Control of
Documents

Instructions
Date: 25.10.2015
4.2.3e c) remain legible and readily identifiable, and Document and Data Control
UNISCO[P]MS 003 Rev-03
4.2.3d d) are available where the activity is being performed. Document and Data Control
4.2.3f Documents of external origin shall be controlled to ensure that Document and Data Control
the relevant versions are used and maintained. UNISCO[P]MS 003 Rev-03 Section 6.3
4.2.3g Obsolete documents shall be removed from all points of issue or Document and Data Control
use, or otherwise identified to ensure against unintended use if UNISCO[P]MS 003 Rev-03 Section 6.2.5 and 6.3.7
they are retained for any purpose.
NR in 9001* Procedures, work instructions and forms required by the quality List of Procedures List of Work Instructions List of Forms
management system shall be controlled. UNISCO[M]MS 013 Rev-05 UNISCO[M]MS 014 Rev-02 UNISCO[M]MS 015 Rev-05
4.4.4 NR in 9001* Use of External When API product or other external specification requirements, Design and Development Control
Documents in including addenda, errata, and updates, are used in the design or UNISCO[P]MS 018 Rev-02 , Control of Documents
Product manufacture of the product, the organization shall maintain a UNISCO[P]MS 003 Rev-03
Realization 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 The organization shall maintain a documented procedure to Control of Records UNISCO[P]MS
Records identify the controls and responsibilities needed for the 013 Rev-03
identification, collection, storage, protection, retrieval, retention
time, and disposition of records.
NR in 9001* Records, including those originating from outsourced activities Product Realization Control of Records UNISCO[P]MS
(see 5.6.1.6), shall be established and controlled to provide UNISCO[M]MS 010 Rev-04 Section 1.4.1.3 013 Rev-03 Section 6.1
evidence of conformity to requirements and the organization's
quality management system.
4.2.4 Records shall remain legible, identifiable, and retrievable. Control of Records UNISCO[P]MS
Records shall be retained for a minimum of five years or as 013 Rev-03 Section 6.2
required by customer, legal, and other applicable requirements,
whichever is longer.
5 Product Realization
5.1 Contract Review
5.1.1 NR in 9001* General The organization shall maintain a documented procedure for the Tender & Contract Review
review of requirements related to the provision of products and UNISCO[P]MS 002 Rev-05
required servicing.
5.1.2 7.2.1 Determination of The organization shall determine:

7.2.1a Requirements a) requirements specified by the customer; Tender & Contract Review
UNISCO[P]MS 002 Rev-05 Section 6.1.2
Instructions
Date: 25.10.2015
5.1.2 Determination of
Requirements
7.2.1c; 7.2.1d b) legal and other applicable requirements; and Tender & Contract Review
7.2.1b; 7.2.2 c) requirements not stated by the customer but considered Tender & Contract Review
necessary by the organization for the provision of the product. UNISCO[P]MS 002 Rev-05 Section 6.1.2
7.2.2 Where the customer provides no documented statement of the Control of Quality Records
requirements, the customer requirements shall be confirmed by UNISCO[P]MS 013 Rev-03
the organization and records maintained (see 4.5).
5.1.3 7.2.2 Review of The organization shall review the requirements related to
Requirements provision of products. This review shall be conducted prior to the
organization‘s commitment to deliver product to the customer
and shall ensure that:
7.2.2a a) requirements are identified and documented; Product Realization Tender & Contract Review
UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 002 Rev-05 Section 6.1.2 and 6.2.2
7.2.2b b) requirements differing from those previously identified are Product Realization Tender & Contract Review
resolved; and UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 002 Rev-05 Section 6.2.3 and 6.2.4
7.2.2c c) the organization has the capability to meet the documented Product Realization Tender & Contract Review
requirements. UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 002 Rev-05 Section 6.1.2
7.2.2 Where contract requirements are changed, the organization shall Product Realization Tender & Contract Review
ensure that relevant documents are amended and that relevant UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 002 Rev-05 Section 6.2.3 and 6.2.4
personnel are made aware of the changed requirements.
7.2.2 Records of the results of the review, including resulting actions, Product Realization Tender & Contract Review
shall be maintained (see 4.5). UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 002 Rev-05 Section 6.1.2 and 6.2.2
5.2 7.1 Planning The organization shall identify and plan the processes and Product Realization
documents needed for product realization. Planning of product UNISCO[M]MS 010 Rev-04
realization shall be consistent with the requirements of the other
processes of the quality management system (see 4.1.4).
7.1 In planning, the organization shall address the following:

7.1b a) required resources and work environment management (see Resourse Management Comptence, awareness and Training UNISCO[M]MS
4.3); UNISCO[M]MS 009 Rev-03 1.1 010 Rev-04 Section-6.1
7.1b b) product and customer-specified requirements (see 5.1); Product Realization
NR in 9001* c) legal and other applicable requirements; Product Realization
UNISCO[M]MS 010 Rev-04 1.1
Company:
5.2
M/S.United Industrial services Co LLC,Plot No.142-144, Sohar Industrial Estate,
Planning
Instructions
Date: 25.10.2015
NR in 9001* d) contingencies based on risk assessment (see 5.3 and 5.5); Product Realization Risk assessment and management UNISCO[M]MS 020
UNISCO[M]MS 010 Rev-04 Rev-01
7.1a e) design and development requirements (see 5.4); Product Realization
7.1c f) required verification, validation, monitoring, measurement, Product Realization
inspection, and test activities specific to the product and the UNISCO[M]MS 010 Rev-04 Section 1.3
criteria for product acceptance; and
NR in 9001* g) management of change (MOC) (see 5.11); and Management Responsibility
UNISCO[M]MS 008 Rev-04 Section 1.4.2
7.1d h) records needed to provide evidence that the product Product Realization
realization processes meet requirements (see 4.5). UNISCO[M]MS 010 Rev-04
NR in 9001* The output of planning shall be documented and updated as Product Realization
changes occur. UNISCO[M]MS 010 Rev-04
7.1 The plans shall be maintained in a structure suitable for the Product Realization
organization‘s method of operations. UNISCO[M]MS 010 Rev-04
5.3 NR in 9001* Risk Assessment The organization shall maintain a documented procedure to Risk Assessment and Management
and identify and control risk associated with impact on delivery and UNISCO[P]MS 020 Rev-01
Management quality of product. The procedure shall identify the techniques,
tools and their application for risk identification, assessment, and
mitigation.
NR in 9001* Risk assessment associated with product delivery shall include:
NR in 9001* a) facility / equipment availability and maintenance; and Risk Assessment and Management
NR in 9001* b) supplier performance and material availability/supply. Risk Assessment and Management
NR in 9001* Risk assessment associated with product quality shall include, as
applicable:
NR in 9001* c) delivery of nonconforming product (see 5.10.1e); Risk Assessment and Management
NR in 9001* d) availability of competent personnel. Risk Assessment and Management
NR in 9001* Records of risk assessment and management including actions Risk Assessment and Management
taken shall be maintained (see 4.5). UNISCO[P]MS 020 Rev-01
5.4 Design and Development

5.4.1 NR in 9001* Design and The organization shall maintain a documented procedure to plan Product Realization Design & Development Control
Development and control the design and development of the product. UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
Planning
7.3.1 The procedure shall identify:
Instructions
Date: 25.10.2015
5.4.1 Design and
Development
Planning
7.3.1 a) the plan(s), including plan updates, used for design Product Realization Design & Development Control
development; UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
7.3.1a b) the design and development stages; Product Realization Design & Development Control
7.3.1; 7.3.1c c) the resources, responsibilities, authorities, and their interfaces Product Realization Design & Development Control
to ensure effective communication; UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
7.3.1b d) the review, verification, and validation activities necessary to Product Realization Design & Development Control
complete each design and development stage; and UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
NR in 9001* e) the requirements for a final review of the design (see 5.4.5). Product Realization Design & Development Control
NR in 9001* When design and development activities are performed at Product Realization Design & Development Control
different locations within the same organization, the procedure UNISCO[M]MS 010 Rev-04 1.3.1 UNISCO[P]MS 018 Rev-02 6.4
shall identify the controls required to ensure that the designs
meet the requirements of 5.4.
NR in 9001* When design and development are outsourced, the organization Product Realization Design & Development Control
shall ensure the supplier meets the requirements of 5.6.1.6. UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
5.4.2 7.3.2 Design and Inputs shall be identified and reviewed for adequacy, Product Realization Design & Development Control
Development completeness, and lack of conflict. UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
Inputs
7.3.2a; 7.3.2d Inputs shall include functional and technical requirements, and Design & Development Control
the following, as applicable: UNISCO[P]MS 018 Rev-02
NR in 9001* a) customer-specified requirements (see 5.1); Product Realization Design & Development Control
7.3.2d b) requirements provided from external sources, including API Product Realization Design & Development Control
product specifications; UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
7.3.2d c) environmental and operational conditions; Product Realization Design & Development Control
NR in 9001* d) methodology, assumptions, and formulae documentation; Product Realization Design & Development Control
7.3.2c e) historical performance and other information derived from Product Realization Design & Development Control
previous similar designs; UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
7.3.2b f) legal requirements; and Product Realization Design & Development Control
NR in 9001* g) results from risk assessments (see 5.3). Risk Assessment and Management
NR in 9001* Records of design inputs shall be maintained (see 4.5). Product Realization Design & Development Control
5.4.3 7.3.3 Design and Outputs shall be documented to allow verification against the Product Realization Design & Development Control
Development design and development input requirements. UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
Outputs
Instructions
Date: 25.10.2015
5.4.3 Design and

Development
Outputs
7.3.3 Outputs shall:
7.3.3a a) meet the input requirements for design and development; Product Realization Design & Development Control
7.3.3b b) provide appropriate information for purchasing, production, Product Realization Design & Development Control
and servicing; UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
7.3.3c c) identify or reference design acceptance criteria (DAC); Product Realization Design & Development Control
NR in 9001* d) include identification of, or reference to, products and/or Design & Development Control
components deemed critical to the design; UNISCO[P]MS 018 Rev-02
NR in 9001* e) include results of applicable calculations; and Product Realization Design & Development Control
7.3.3d f) specify the characteristics of the product that are essential for Product Realization Design & Development Control
its safe and proper use. UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
NR in 9001* Records of design outputs shall be maintained (see 4.5). Product Realization Design & Development Control
5.4.4 7.3.4 Design and At suitable stages, review(s) shall be performed:
7.3.4a Development a) to evaluate the suitability, adequacy, and effectiveness of the Product Realization Design & Development Control
Review results of design and development stages to meet specified UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
requirements; and
7.3.4b b) to identify any problems and propose necessary actions. Product Realization Design & Development Control
7.3.4 Participants in such review(s) shall include representatives of Product Realization Design & Development Control
functions concerned with the design and development stage(s) UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
being reviewed.
7.3.4 Records of the results of the review(s) and any necessary actions Product Realization Design & Development Control
shall be maintained (see 4.5). UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
5.4.5 7.3.5 Design and To ensure that the design and development outputs have met Product Realization Design & Development Control
Development the design and development input requirements, design and UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
Verification and development verification and a final review shall be conducted
Final Review and documented in accordance with planned arrangements (see
5.4.1).
7.3.4; 7.3.5 Records of design and development verification and the final Product Realization Design & Development Control
design review shall be maintained (see 4.5). UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
5.4.6 7.3.6 Design and Design and development validation shall be performed in Product Realization Design & Development Control
Development accordance with planned arrangements (see 5.4.1) to ensure that UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
Validation and the resulting product is capable of meeting the specified
Approval requirements.
7.3.6 Validation shall be completed prior to the delivery of the product, Product Realization Design & Development Control
when possible. UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
Instructions
Date: 25.10.2015
5.4.6 Design and
Paragraph ISO 9001:2008 Reference
Development Requirement Tier 1 (Quality Manual) Tier 2 (Procedure/Work Instruction) Tier 3 (Procedure/Work Instruction)
Number Reference Validation and Document Number/ID, Revision Level, Document Number/ID, Revision Level, Document Document Number/ID, Revision
Approval Document Description Description Level, Document Description
NR in 9001* The completed design shall be approved after validation. Product Realization Design & Development Control
NR in 9001* Competent (see 4.3.2.2) individual(s) other than the person or Product Realization Design & Development Control
persons who developed the design shall approve the final design. UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
7.3.6 Records of the design and development validation, approval, and Product Realization Design & Development Control
any necessary actions shall be maintained (see 4.5). UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
5.4.7 7.3.7 Design and Design and development changes shall be identified. The changes Product Realization Design & Development Control
Development shall be reviewed, verified and validated, as appropriate, and UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
Changes approved before implementation.
7.3.7 The review of design and development changes shall include Product Realization Design & Development Control
evaluation of the effect of the changes on product and/or their UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
constituent parts already delivered.
NR in 9001* Design and development changes including changes to design Product Realization Design & Development Control
documents, shall require the same controls as the original design UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
and development.
7.3.7 Records of design and development changes, reviews of those Product Realization Design & Development Control
changes and any necessary actions shall be maintained (see 4.5). UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 018 Rev-02
5.5 Contingency planning

5.5.1 NR in 9001* General The organization shall maintain a documented procedure for Risk Assessment and Management
contingency planning needed to address risk associated with UNISCO[P]MS 020 Rev-01
impact on delivery and quality of product.
NR in 9001* Contingency planning shall be based on assessed risks (see 5.3) Risk Assessment and Management
and output shall be documented and communicated to the UNISCO[P]MS 020 Rev-01
relevant personnel, and updated as required.
5.5.2 NR in 9001* Planning Output The contingency plan shall include, at a minimum:
NR in 9001* a) actions required in response to significant risk scenarios to Risk Assessment and Management
mitigate effects of disruptive incidents; UNISCO[P]MS 020 Rev-01
NR in 9001* b) identification and assignment of responsibilities and Management Responsibility
authorities; and UNISCO[M]MS 008 Rev-03 Section 1.5
NR in 9001* c) internal and external communication controls (see 4.1.5). Management Responsibility Product Realization UNISCO[M]MS
UNISCO[M]MS 008 Rev-03 Section 1.6.4 010 Rev-04 Section 1.2.3
5.6 Purchasing
5.6.1 Purchase Control
Instructions
Date: 25.10.2015
5.6.1.1 4.1; 7.4.1 Procedure The organization shall maintain a documented procedure to Purchase Control UNISCO[P]MS
ensure that purchased products or outsourced activities conform 004 Rev-05
to specified requirements.
The procedure shall address:
NR in 9001* a) determination of the criticality of the activities or products as Purchase Control UNISCO[P]MS
they are applicable to conformance to product or customer 004 Rev-05 Section 6
specifications;
7.4.1 b) initial evaluation and selection of suppliers based on their Purchase Control UNISCO[P]MS
ability to supply products or activities in accordance with the 004 Rev-05 Section 61.2,6.1.3
organization‘s requirements (see 5.6.1.2 and 5.6.1.3);
NR in 9001* c) type and extent of control applied to the supplier based on the Purchase Control UNISCO[P]MS
criticality of the product or activity; 004 Rev-05 Section 61.2,6.1.3
7.4.1 d) criteria, scope, frequency, and methods for reassessment of Purchase Control UNISCO[P]MS
suppliers; 004 Rev-05 Section 6.1.4
NR in 9001* e) maintaining a list of approved suppliers and scope of approval; Purchase Control UNISCO[P]MS
and 004 Rev-05 Section 6.1.2
4.1 f) type and extent of control to be applied to outsourced Purchase Control UNISCO[P]MS
activities (see 5.6.1.6). 004 Rev-05 Section 6.1.2
5.6.1.2 NR in 9001* Initial Supplier For purchase of critical products, components, or activities , the
Evaluation-- criteria for the initial evaluation of suppliers by the organization
Critical Purchases shall be site-specific for each supplier and shall include the
following:
NR in 9001* a) verification that the supplier’s quality management system Purchase Control UNISCO[P]MS
conforms to the quality system requirements specified for 004 Rev-05 Section 6.1.2
suppliers by the organization; and
NR in 9001* b) assessment of the supplier to ensure its capability to meet the Purchase Control UNISCO[P]MS
organization’s purchasing requirements by: 004 Rev-05 Section 6.1.2
NR in 9001* i. performing an on-site evaluation of relevant activities; or Purchase Control UNISCO[P]MS
004 Rev-05 Section 6.1.2
NR in 9001* ii. performing first article inspection to ensure conformance to Purchase Control UNISCO[P]MS Method-B
stated requirements; or 004 Rev-05 Section 6.1.2
NR in 9001* iii. Identifying how the supplied product conforms to stated Purchase Control UNISCO[P]MS
requirements when limited by proprietary, legal and/or 004 Rev-05 Section 6.3.6
contractual arrangements.
Instructions
Date: 25.10.2015
5.6.1.3 NR in 9001* Initial Supplier For purchase of noncritical products, components, or activities
Evaluation-- that impact product realization or the final product, the criteria
Noncritical for evaluation of suppliers by the organization shall meet the
Purchases requirements of 5.6.1.2 or satisfy one or more of the following:
NR in 9001* a) verification that the supplier’s quality management system Purchase Control UNISCO[P]MS
conforms to the quality system requirements specified for 004 Rev-05 Section 6
suppliers by the organization; or
NR in 9001* b) assessment of the supplier to meet the organization’s Purchase Control UNISCO[P]MS
purchasing requirements; or 004 Rev-05 Section 6
NR in 9001* c) assessment of the product upon delivery or activity upon Purchase Control UNISCO[P]MS
completion. 004 Rev-05 Section 6
5.6.1.4 NR in 9001* Supplier Re- For re-evaluation of all suppliers (critical and noncritical), the Purchase Control UNISCO[P]MS
evaluation requirements of 5.6.1.3 shall apply. 004 Rev-05 Section 6
5.6.1.5 7.4.1 Supplier Records of the results of all evaluations and any necessary Purchase Control UNISCO[P]MS
Evaluation-- actions arising from the evaluations shall be maintained (see 4.5). 004 Rev-05 Section 6
Records
5.6.1.6 4.1 Outsourcing Where an organization chooses to outsource any activity within Purchase Control UNISCO[P]MS
the scope of its quality management system, the organization 004 Rev-05 Section 6
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.
NR in 9001* Records of outsourced activities shall be maintained (see 4.5). Control of Quality Records Purchase Control UNISCO[P}MS 004
UNISCO[P]MS 013 Rev-03 Section 6.1, Section-6.5, Indentification and Validation
of Process UNISCO[P]MS 023 Section-6.4
5.6.2 7.4.2 Purchasing The organization shall ensure the adequacy of specified Purchase Control UNISCO[P]MS
Information purchasing information prior to their communication to the 004 Rev-05 Section 6.2.1
supplier.
7.4.2 Purchasing information provided to the supplier shall be Purchase Control UNISCO[P]MS
documented and adequately describe the product or activity to 004 Rev-05 Section 6.2
be purchased,
7.4.2a including acceptance criteria, and where appropriate:

7.4.2a a) requirements for approval of supplier’s procedures, processes, Purchase Control UNISCO[P]MS
and equipment; 004 Rev-05
Instructions
5.6.2 Purchasing
Information
25.10.2015
Date:
NR in 9001* b) applicable version of specifications, drawings, process Purchase Control UNISCO[P]MS

requirements, inspection instructions, traceability, and other 004 Rev-05
relevant technical data;
7.4.2b c) requirements for qualification of supplier’s personnel; and Purchase Control UNISCO[P]MS
004 Rev-05
7.4.2c d) quality management system requirements. Purchase Control UNISCO[P]MS
004 Rev-05
5.6.3 NR in 9001* Verificaion of The organization shall maintain a documented procedure for the Monitoring and measuring of Product
Purchased verification or other activities necessary for ensuring that UNISCO[P]MS 008 Rev-03
Products or purchased products or activities meet specified purchase
Activities requirements.
7.4.3 Where the organization or its customer intends to perform Monitoring and measuring of Product
verification at the supplier‘s premises, the organization shall state UNISCO[P]MS 008 Rev-03 section 6.1.5
the intended verification arrangements and method of product
release in the purchasing information.
7.4.3 The organization shall ensure and provide evidence that Monitoring and measuring of Product
purchased products and activities conform to specified UNISCO[P]MS 008 Rev-03 section 6.1
requirements.
NR in 9001* The organization shall maintain records of verification activities Monitoring and measuring of Product
(see 4.5). UNISCO[P]MS 008 Rev-03 section 6.1.4
5.7 Production and Servicing Provision
5.7.1 Control of Production and Servicing
5.7.1.1 NR in 9001* Production The organization shall maintain a documented procedure that Process Control UNISCO[P]MS 007 Rev-03 - Monitoring
describes controls associated with the production of products. and measuring of Product UNISCO[P]MS 008 Rev-03
The procedure shall address the following:
7.5.1a a) the availability of information that describes the characteristics Process Control UNISCO[P]MS 007 Rev-03 Section 6.3 &
of the product; 6.4, Monitoring and measuring of Product UNISCO[P]MS
008 Rev-03 section 6.2.1
NR in 9001* b) implementation of the product quality plan, when applicable Process Control UNISCO[P]MS 007 Rev-03 Section 6.1.4,
(see 5.7.2); 6.1.5, Monitoring and measuring of Product
UNISCO[P]MS 008 Rev-03 section 6.2.1
NR in 9001* c) ensuring design requirements and related changes are Monitoring and measuring of product UNISCO[P]MS 008
satisfied, when applicable (see 5.4); Rev-03 section-6.4.1
7.5.1c; 7.5.1d d) the availability and use of suitable production, testing, Control of Inspection, Measuring and Testing Equipment
monitoring, and measurement equipment; UNISCO[P]MS
009 Rev-03
5.7.1.1 Production

Instructions
Date: 25.10.2015
7.5.1b e)the availability of work instructions,when applicable; Process Control UNISCO[P]MS 007 Rev-03 Section 6.3 &
6.4, Monitoring and measuring of Product UNISCO[P]MS
008 Rev-03 section 6.2.1
NR in 9001* f) process control documents (see 5.7.1.3); Process Control Procedures;- Gate valve UNISCO[P]MS007-1, Check Valve UNISCO[P]MS007-2, Ball Valve UNISCO[P]MS007-3, Plug Valve
UNISCO[P]MS007-4, Globe Valve UNISCO[P]MS007-5, Control Valve UNISCO[P]MS007-6, Butterfly Valve UNISCO[P]MS007-7, Relief Valve
UNISCO[P]MS007-8, Actuators UNISCO[P]MS007-9, Manacture, Reapir and remanufacture of API 6A components UNISCO[P]MS007-10, Manacture,
Reapir and remanufacture of API 6D components UNISCO[P]MS007-11, Assembly of valves UNISCO[P]MS007-12
7.5.1e g) the implementation of monitoring and measurement activities; Control of Inspection, Measuring and Testing Equipment
and UNISCO[P]MS
009 Rev-03
7.5.1f h) the implementation of product release (see 5.9), including Monitoring and measuring of Product
applicable delivery and post-delivery activities. UNISCO[P]MS 008 Rev-03 section 6.4.3, 6.4.4
5.7.1.2 NR in 9001* Servicing The organization shall maintain a documented procedure that
describes 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 organization’s, customer- Product Realization Operating Procedures UNISCO[P]MS 001 to Work Instructions UNISCO[W]ME 001 to
specific, product servicing, and other servicing requirements; UNISCO[M]MS 010 Rev-04 Section 1.5 UNISCO[P]MS 024 UNISCO[W]ME 021
7.5.1c; 7.5.1d b) the availability and use of suitable servicing, testing, Product Realization Operating Procedures UNISCO[P]MS 001 to Work Instructions UNISCO[W]ME 001 to
monitoring, and measurement equipment; UNISCO[M]MS 010 Rev-04 Section 1.6 UNISCO[P]MS 024 UNISCO[W]ME 021
7.5.1b c) the availability of work instructions, when applicable; Product Realization Operating Procedures UNISCO[P]MS 001 to Work Instructions UNISCO[W]ME 001 to
UNISCO[M]MS 010 Rev-04 Section 1.5.1.1 UNISCO[P]MS 024 UNISCO[W]ME 021
NR in 9001* d) ensuring identification and traceability requirements are Product Realization Operating Procedures UNISCO[P]MS 001 to Work Instructions UNISCO[W]ME 001 to
maintained throughout the servicing process; UNISCO[M]MS 010 Rev-04 Section 1.5.3 UNISCO[P]MS 024 UNISCO[W]ME 021
7.5.1e e) the implementation of monitoring and measurement activities; Product Realization Operating Procedures UNISCO[P]MS 001 to Work Instructions UNISCO[W]ME 001 to
and UNISCO[M]MS 010 Rev-04 Section 1.6 UNISCO[P]MS 024 UNISCO[W]ME 021
NR in 9001* f) process control documents (see 5.7.1.3), and Product Realization Operating Procedures UNISCO[P]MS 001 to Work Instructions UNISCO[W]ME 001 to
UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 024 UNISCO[W]ME 021
7.5.1f g) requirements for release of the product that was serviced (see Product Realization Operating Procedures UNISCO[P]MS 001 to Work Instructions UNISCO[W]ME 001 to
5.9). UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 024 UNISCO[W]ME 021
Instructions
Date: 25.10.2015
5.7.1.3 NR in 9001* Process Control Process controls shall be documented in routings, travelers, Monitoring and measuring of Product UNISCO[P]MS 008 Rev-02 and Process Control Procedures;- Gate valve UNISCO[P]MS007-1, Check Valve
Documents checklists, process sheets, or equivalent controls required by the UNISCO[P]MS007-2, Ball Valve UNISCO[P]MS007-3, Plug Valve UNISCO[P]MS007-4, Globe Valve UNISCO[P]MS007-5, Control Valve UNISCO[P]MS007-
organization and shall include requirements for verifying 6, Butterfly Valve UNISCO[P]MS007-7, Relief Valve UNISCO[P]MS007-8, Actuators UNISCO[P]MS007-9, Manacture, Reapir and remanufacture of API 6A
conformance with applicable product quality plans (see 5.7.2), components UNISCO[P]MS007-10, Manacture, Reapir and remanufacture of API 6D components UNISCO[P]MS007-11, Assembly of valves
API product specifications, customer requirements and/or other UNISCO[P]MS007-12
applicable product standards/codes. The process control
documents shall include or reference instructions, workmanship
and acceptance criteria for processes, tests, inspections, and
required customer’s inspection hold or witness points.
5.7.1.4 NR in 9001* Product The organization shall develop and maintain documentation that Design and Develpoment Control
Realization includes but is not limited to product realization plans (see 5.2) UNISCO[P]MS 018 Rev-01
Capability and records of review/verification, validation, monitoring,
Documentation 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.
5.7.1.5 7.5.2 Validation of The organization shall validate processes for production and Process Control UNISCO[P]MS 007 Rev-03 Section 6.4.7,
Processes for servicing where the resulting output cannot be verified by Identification and Validation of Process UNISCO[P]MS
Production and subsequent monitoring or measurement and as a consequence, 023 Rev-01
Servicing deficiencies become apparent only after the product is in use or
the servicing has been delivered. Validation shall demonstrate
the ability of these processes to achieve planned results.
NR in 9001* Where an organization chooses to outsource a process that Quality Management System Identification and Validation of Process UNISCO[P]MS
requires validation, the organization shall require that the UNISCO[M]MS 007 Rev-03 Section 1.1 023 Rev-01
supplier conform to these requirements (see 5.6.1.6).
7.5.2 The organization shall maintain a documented procedure to

address methods for review and approval of the processes
including:
7.5.2b a) required equipment; Monitoring and measuring of Product

UNISCO[P]MS 008 Rev-03 section 6.3
7.5.2b b) qualification of personnel; Monitoring and measuring of Product
7.5.2c c) use of specific methods, including identified operating Monitoring and measuring of Product
parameters; UNISCO[P]MS 008 Rev-03 section 6.3
Instructions
Date: 25.10.2015
7.5.2a d) identification of acceptance criteria; Monitoring and measuring of Product

7.5.2d e) requirements for records (see 4.5); and Monitoring and measuring of Product
7.5.2e f) revalidation. Monitoring and measuring of Product
NR in 9001* The organization shall validate those processes identified by the Process Control Procedures;- Gate valve UNISCO[P]MS007-1, Check Valve UNISCO[P]MS007-2, Ball Valve UNISCO[P]MS007-3, Plug Valve
applicable product specification as requiring validation. If these UNISCO[P]MS007-4, Globe Valve UNISCO[P]MS007-5, Control Valve UNISCO[P]MS007-6, Butterfly Valve UNISCO[P]MS007-7, Relief Valve
processes are not identified, or there is no product specification UNISCO[P]MS007-8, Actuators UNISCO[P]MS007-9, Manacture, Reapir and remanufacture of API 6A components UNISCO[P]MS007-10, Manacture,
involved, the processes requiring validation shall include, as a Reapir and remanufacture of API 6D components UNISCO[P]MS007-11, Assembly of valves UNISCO[P]MS007-12
minimum, nondestructive examination, welding, and heat
treating, if applicable to the product.
5.7.2 NR in 9001* Product Quality When required by contract, the organization shall develop a Process Control Procedures;- Gate valve UNISCO[P]MS007-1, Check Valve UNISCO[P]MS007-2, Ball Valve UNISCO[P]MS007-3, Plug Valve
Plans product quality plan that specifies the processes of the quality UNISCO[P]MS007-4, Globe Valve UNISCO[P]MS007-5, Control Valve UNISCO[P]MS007-6, Butterfly Valve UNISCO[P]MS007-7, Relief Valve
management system (including the product realization processes) UNISCO[P]MS007-8, Actuators UNISCO[P]MS007-9, Manacture, Reapir and remanufacture of API 6A components UNISCO[P]MS007-10, Manacture,
and the resources to be applied to a product. Reapir and remanufacture of API 6D components UNISCO[P]MS007-11, Assembly of valves UNISCO[P]MS007-12
NR in 9001* The product quality plan required by contract shall address each
of the following as a minimum:
NR in 9001* a) description of the product to be manufactured; Process Control Procedures; Reapir and remanufacture of API 6A components UNISCO[P]MS007-10, Control of Production and service
Manacture, Reapir and remanufacture of API 6D components UNISCO[P]MS007-11 provision
NR in 9001* b) required processes and documentation, including required Control of Production and service provision
inspections, tests, and records, for conformance with UNISCO[P]MS 007 Rev-03
requirements;
NR in 9001* c) identification and reference to control of outsourced activities; Quality Management System Identification and Validation of Process UNISCO[P]MS
UNISCO[M]MS 007 Rev-03 023 Rev-01 6.4
NR in 9001* d) identification of each procedure, specification or other Control of Production and service provision
document referenced or used in each activity; and UNISCO[P]MS 007 Rev-03
NR in 9001* e) identification of the required hold, witness, monitor and Control of Production and service provision
document review points. UNISCO[P]MS 007 Rev-03 6.1.4
NR in 9001* These product quality plans and any revisions to them shall be Control of Production and service provision
documented and approved by the organization to ensure UNISCO[P]MS 007 Rev-03 6.1.4
customer requirements are met. These product quality plans and
any revisions shall be communicated to the customer.
Instructions
Date: 25.10.2015
5.7.3 7.5.3 Identification The organization shall maintain a documented procedure for Product Identification and Tracability
and Traceability identification and traceability while the product is under control UNISCO[P]MS 006 Rev-02
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.
NR in 9001* The procedure shall include requirements for maintenance or Product Identification and Tracability
replacement of identification and/or traceability marks. UNISCO[P]MS 006 Rev-02 Section 6.3 to 6.5
7.5.3 Records (see 4.5) of identification and traceability shall be Product Identification and Tracability
maintained. UNISCO[P]MS 006 Rev-02 Section 6.8
5.7.4 NR in 9001* Product The organization shall maintain a documented procedure for the Monitoring and measuring of Product
Inspection/Test identification of product inspection and/or test status throughout UNISCO[P]MS 008 Rev-03
Status the product realization process which indicates the conformity or
nonconformity of product with respect to inspections and/or
tests performed.
NR in 9001* The organization shall ensure that only product that meets Monitoring and measuring of Product
requirements or UNISCO[P]MS 008 Rev-03 Section 6.2 and 6.3, 6.4
8.3b is authorized under concession (see 5.10.3), is released. Monitoring and measuring of Product Control of Non conformances
UNISCO[P]MS 008 Rev-03 Section 6.2 and 6.3 UNISCO[P]MS 010 Rev-03 6.3, 6.4
5.7.5 7.5.4 Customer- The organization shall maintain a documented procedure for the Control on customer Property
Supplied identification, verification, safeguarding, preservation, UNISCO[P]MS 005 Rev-04
Property maintenance, and control of customer-supplied property,
including intellectual property and data, while under control of
the organization.
7.5.4 The procedure shall include requirements for reporting to the Control on customer Property
customer any loss, damage, or unsuitability for use of customer- UNISCO[P]MS 005 Rev-04 Section 6.2
supplied property.
7.5.4 Records for the control and disposition of customer-supplied Control on customer Property
property shall be maintained (see 4.5). UNISCO[P]MS 005 Rev-04 6.3
5.7.6 Preservation of Product
5.7.6.1 NR in 9001* General The organization shall maintain a documented procedure Preservation of Product UNISCO[P]MS
describing the methods used to preserve the product and 012 Rev-04
constituent parts throughout product realization and delivery to
the intended destination in order to maintain conformity to
requirements. As applicable, preservation shall include
identification and traceability marks, transportation, handling,
packaging, and protection.
Instructions
Date: 25.10.2015
5.7.6.2 NR in 9001* Storage and The procedure shall identify the requirements for storage and Preservation of Product UNISCO[P]MS
Assessment assessment. 012 Rev-04
NR in 9001* The organization shall use designated storage areas or stock Preservation of Product UNISCO[P]MS
rooms to prevent damage or deterioration of product, pending 012 Rev-04
use or delivery.
NR in 9001* In order to detect deterioration, the condition of product or Preservation of Product UNISCO[P]MS
constituent parts in stock shall be assessed at specified intervals 012 Rev-04 Section 6.3
identified by the procedure.
NR in 9001* The interval shall be appropriate to the products or constituent Preservation of Product UNISCO[P]MS
parts being assessed. 012 Rev-04 Section 6.3
NR in 9001* Records of the results of assessments shall be maintained (see Preservation of Product UNISCO[P]MS
4.5). 012 Rev-04 Section 6.3
5.7.7 Inspection and Testing
5.7.7.1 NR in 9001* General The organization shall maintain a documented procedure for Monitoring and measuring of Product
inspection and testing to verify that product requirements have UNISCO[P]MS 008 Rev-03
been met.
8.2.4 The procedure shall include requirements for in-process and final Monitoring and measuring of Product
inspection and testing. Records of required inspection and testing UNISCO[P]MS 008 Rev-03 Section 6.2, 6.4
shall be maintained per documented procedures (see 4.5).
5.7.7.2 8.2.4 In-process The organization shall inspect and test the product at planned Monitoring and measuring of Product
Inspection and stages as required by the product quality plan (see 5.7.2), process UNISCO[P]MS 008 Rev-03 Section 6.2, 6.4
Testing control documents (see 5.7.1.3), and/or documented procedures.
Evidence of conformity with the acceptance criteria shall be
maintained.
5.7.7.3 NR in 9001* Final Inspection The organization shall perform all final inspection and testing in Monitoring and measuring of Product
and Testing accordance with the product quality plan (see 5.7.2) and/or UNISCO[P]MS 008 Rev-03 Section 6.4, 6.2.1
documented procedures to validate and document conformity of
the finished product to the specified requirements.
NR in 9001* Personnel other than those who performed or directly supervised Monitoring and measuring of Product
the production of the product shall perform final acceptance UNISCO[P]MS 008 Rev-03 Section 6.6
inspection at planned stages of the product realization process.
Instructions
Date: 25.10.2015
5.7.8 NR in 9001* Preventative The organization shall maintain a documented procedure for the Control of Inspection, Measuring and Testing Equipments Preventive and periodical maintenance
Maintenance establishment of preventive maintenance for equipment used in UNISCO[P]MS UNISCO[P}MS 024 Rev-01
product realization. The procedure shall identify requirements 009 Rev-03
for:
NR in 9001* a) type of equipment to be maintained; Control of Inspection, Measuring and Testing Equipments Preventive and periodical maintenance
UNISCO[P}MS 024 Rev-01
NR in 9001* b) frequency; and Control of Inspection, Measuring and Testing Equipments Preventive and periodical maintenance
NR in 9001* c) responsible personnel. Control of Inspection, Measuring and Testing Equipments Preventive and periodical maintenance
UNISCO[P]MS 009 Rev-03 Section 5 and 6.5
NR in 9001* Records of preventive maintenance shall be maintained (see UNISCO's measuring and Testing Preventive and periodical maintenance
4.5). Instruments/Equipments are periodically calbrated. The UNISCO[P}MS 024 Rev-01
unfit Instruments/Equipments are discarded.
5.8 7.6 Control of The organization shall determine the testing, monitoring, and Product Realization Control of Inspection, Measuring and Testing Equipments
Testing, measurement requirements and the associated equipment UNISCO[M]MS 010 Rev-04 UNISCO[P]MS
Measuring and needed to provide evidence of conformity to those requirements. 1.6.1 009 Rev-03
Monitoring
Equipment for
Product
NR in 9001* Conformity The organization shall maintain a documented procedure in order Product Realization Control of Inspection, Measuring and Testing Equipments
to ensure that testing, measurement, and monitoring equipment UNISCO[M]MS 010 Rev-04
is calibrated and maintained and that the equipment is used in a UNISCO[P]MS 009 Rev-03
manner that is consistent with monitoring and measurement
requirements.
7.6 The procedure shall include requirements for the specific Product Realization
equipment type that addresses: UNISCO[M]MS 010 Rev-04
7.6c a) unique identifier; Product Realization Control of Inspection, Measuring and Testing Equipments
Section 6.7, 6.8 and 7.2
7.6a b) calibration status; Product Realization Control of Inspection, Measuring and Testing Equipments
7.6a;7.6b c) equipment traceability to international or national Product Realization Control of Inspection, Measuring and Testing Equipments
measurement standards; where no such standards exist, the UNISCO[M]MS 010 Rev-04
basis used for calibration or verification shall be recorded (see UNISCO[P]MS 009 Rev-03 Section 6.10
4.5);
Instructions
Date: 25.10.2015
NR in 9001* d) frequency of calibration, at specific intervals or prior to use Product Realization Control of Inspection, Measuring and Testing Equipments
NR in 9001* e) calibration or verification method, including adjustments and Product Realization Control of Inspection, Measuring and Testing Equipments
re-adjustments, as necessary; UNISCO[M]MS 010 Rev-04
7.6 f) acceptance criteria; Product Realization Control of Inspection, Measuring and Testing Equipments
7.6 g) control of equipment identified as out-of-calibration in order Product Realization Control of Inspection, Measuring and Testing Equipments
to prevent unintended use; and UNISCO[M]MS 010 Rev-04
7.6 h) when the equipment is found to be out of calibration, an Product Realization Control of Inspection, Measuring and Testing Equipments
assessment of the validity of previous measurements and actions UNISCO[M]MS 010 Rev-04
to be taken on the equipment and product, including maintaining UNISCO[P]MS 009 Rev-03
records and evidence of notification to the customer (see 4.1.5.2) Section 6.6 and 7.2
if suspect product has been shipped.
7.6 Testing, measuring, monitoring equipment shall: Product Realization

NR in 9001* 1) be calibrated or verified, or both, against measurement Product Realization Control of Inspection, Measuring and Testing Equipments
standards, UNISCO[M]MS 010 Rev-04
NR in 9001* 2) have the calibration status identifiable by the user for the Product Realization Control of Inspection, Measuring and Testing Equipments
activities being performed at all times; UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 009 Rev-03 Section
6.7
7.6d 3) be safeguarded from adjustments that would invalidate the Product Realization Control of Inspection, Measuring and Testing Equipments
measurement result or the calibration status; UNISCO[M]MS 010 Rev-04
7.6e 4) be protected from damage and deterioration during handling, Product Realization Control of Inspection, Measuring and Testing Equipments
maintenance and storage; and UNISCO[M]MS 010 Rev-04
UNISCO[P]MS 009 Rev-03 Section 6.12, 6.6
NR in 9001* 5) be used under environmental conditions that are suitable for Product Realization Control of Inspection, Measuring and Testing Equipments
the calibrations, inspections, measurements and tests being UNISCO[M]MS 010 Rev-04
carried out. UNISCO[P]MS 009 Rev-03 Section 6.10, 6.16
7.6 When used in the testing, monitoring, or measurement of Product Realization

specified requirements, the ability of computer software to UNISCO[M]MS 010 Rev-04
satisfy the intended application shall be confirmed prior to initial
use and reconfirmed as necessary.
Instructions
Date: 25.10.2015
NR in 9001* When the equipment is provided from a source external to the Product Realization Control of Inspection, Measuring and Testing Equipments
organization, including third party, proprietary, employee- and UNISCO[M]MS 010 Rev-04
customer-owned equipment, the organization shall verify that UNISCO[P]MS 009 Rev-03 Section 6.17
the equipment is suitable and provide evidence of conformity to
the requirements of this section.
NR in 9001* The organization shall maintain a registry of the required testing, Product Realization Control of Inspection, Measuring and Testing Equipments
measurement, and monitoring equipment used to determine UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 009 Rev-03 6.5
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 Product Realization Control of Inspection, Measuring and Testing Equipments
maintained (see 4.5). UNISCO[M]MS 010 Rev-04 UNISCO[P]MS 009 Rev-03 Section
7
5.9 NR in 9001* Product Release The organization shall maintain a documented procedure to Monitoring and measuring of Product
ensure release of product to the customer shall not proceed until UNISCO[P]MS 008 Rev-03
the planned arrangements (see 5.7) have been satisfactorily
completed, unless otherwise approved by a relevant authority
and,
8.2.4 where applicable, by the customer. Monitoring and measuring of Product

UNISCO[P]MS 008
Rev-03 6.4.3
8.2.4 Records shall be maintained to enable identification of the Monitoring and measuring of Product
individual releasing the product (see 4.5). UNISCO[P]MS 008 Rev-03 Section 6.4 .3, 6.4.4
5.10 Control of Nonconforming Product

5.10.1 8.3 General The organization shall maintain (a) documented procedure(s) to Control of Non Conformance
identify the controls and related responsibilities and authorities UNISCO[P]MS 010 Rev-03
for addressing nonconforming product.
8.3 The procedure for addressing nonconforming product identified

during product realization shall include controls for:
8.3 a) product identification to prevent unintended use or delivery; Control of Non Conformance
UNISCO[P]MS 010 Rev-03 6.1
8.3a b) addressing the detected nonconformity (see 5.10.2); Control of Non Conformance
8.3c c) taking action to preclude its original intended use or delivery; Control of Non Conformance
and UNISCO[P]MS 010 Rev-03 6.3
5.10.1 General
Instructions
Date: 25.10.2015
8.3b d) authorizing its use, release or acceptance under concession by Control of Non Conformance
relevant authority and, where applicable, by the customer (see UNISCO[P]MS 010 Rev-03 Section 6.15, 6.4
5.10.3).
8.3 The procedure for addressing nonconforming product identified
after delivery shall include controls for:
NR in 9001* 1) identifying, documenting and reporting nonconformances or Control of Non Conformance
product failure identified after delivery; UNISCO[P]MS 010 Rev-03
NR in 9001* 2) ensuring the analysis of product nonconformance or failure, Control of Non Conformance
provided the product or documented evidence supporting the UNISCO[P]MS 010 Rev-03
nonconformity is available to facilitate the determination of the
cause (see 6.4.2);
8.3d 3) taking action appropriate to the effects, or potential effects, of Control of Non Conformance
the nonconformance when nonconforming product is detected UNISCO[P]MS 010 Rev-03 6.16
after delivery.
5.10.2 NR in 9001* Nonconforming The organization shall address nonconforming product by

Product performing one or more of the following:
NR in 9001* a) repair or rework with subsequent inspection to meet specified Control of Non Conformance
requirements; UNISCO[P]MS 010 Rev-02 Section 6.3
NR in 9001* b) regrade for alternative applications; Control of Non Conformance
NR in 9001* c) release under concession (see 5.10.3); and/or Control of Non Conformance
NR in 9001* d) reject or scrap. Control of Non Conformance
5.10.3 NR in 9001* Release or The evaluation and release under concession of nonconforming
Acceptance of product that does not satisfy manufacturing acceptance criteria
Nonconforming (MAC) shall be permitted when the organization’s relevant
Product under authority and the customer (where applicable) have authorized
MAC or DAC the release provided that:
Concession
NR in 9001* a) products continue to satisfy the applicable DAC and/or Control of Non Conformance
customer criteria; or UNISCO[P]MS 010 Rev-03 Section 6.15
NR in 9001* b) the violated MAC are categorized as unnecessary to satisfy the Control of Non Conformance
applicable DAC and/or customer criteria; or UNISCO[P]MS 010 Rev-03 Section 6.15
NR in 9001* c) the DAC are changed and the products satisfy the revised DAC Control of Non Conformance
and associated MAC requirements. UNISCO[P]MS 010 Rev-03 Section 6.15
5.10.4 NR in 9001* Customer The organization shall notify customers of product not Control of Non Conformance
Notification conforming to DAC or contract requirements that has been UNISCO[P]MS 010 Rev-03 Section 6.17
delivered. The organization shall maintain records of such
notifications (see 4.5).
Instructions
Date: 25.10.2015
5.10.5 8.3 Records Records of the nature of nonconformities and any subsequent Control of Non Conformance
actions taken, including concessions obtained, shall be UNISCO[P]MS 010 Rev-03
maintained (see 4.5).
5.11 Management of Change (MOC)

5.11.1 NR in 9001* General The organization shall maintain a process for management of Management Responsibility
change (MOC). UNISCO[M]MS 008 Rev-03
5.4.2b The organization shall ensure that the integrity of the quality Management Responsibility
management system is maintained when changes to the quality UNISCO[M]MS 008 Rev-03 Section 1.4.2
management system are planned and implemented.
NR in 9001* For the management of change, the organization shall identify Management Responsibility
the potential risks (see 5.3) associated with the change and any UNISCO[M]MS 008 Rev-03 Section 1.4.2
required approvals prior to the introduction of such changes.
NR in 9001* The organization shall maintain records of MOC activities (see Management Responsibility
4.5). UNISCO[M]MS 008 Rev-03 Section 1.4.2
5.11.2 NR in 9001* MOC The organization shall use the MOC process for any of the Management Responsibility
Implementation following that may negatively impact the quality of the product: UNISCO[M]MS 008 Rev-03 Section 1.4.2
NR in 9001* a) changes in the organizational structure (see 4.3.2) Management Responsibility

NR in 9001* b) changes in key or essential personnel (see 4.3.2); Management Responsibility
NR in 9001* c) changes in critical suppliers (see 5.6.1); Management Responsibility
NR in 9001* d) changes to the management system procedures, including Management Responsibility
changes resulting from corrective and preventive actions (see UNISCO[M]MS 008 Rev-03 Section 1.4.2
6.4);
5.11.3 NR in 9001* MOC notification The organization shall notify relevant personnel, including the Management Responsibility
customer when required by contract, of the change and residual UNISCO[M]MS 008 Rev-03 Section 1.4.2
or new risk due to changes that have either been initiated by the
organization or requested by the customer.
6 Quality Management System Monitoring, Measurement, Analysis, and Improvement
Instructions
Date: 25.10.2015
6.1 4.1c; 8.1b; General The organization shall plan and implement the monitoring, Measurement, Analysis and Improvement Analysis of Data UNISCO[P]MS017 Rev-03
8.1c; 8.5.1 measurement, analysis, and improvement processes needed to UNISCO[M]MS 011 Rev-02
ensure conformity of the quality management system to the
requirements of this specification and to continually improve the
effectiveness of the quality management system.
8.1 Quality management system monitoring, measurement, analysis, Measurement, Analysis and Improvement Analysis of Data UNISCO[P]MS017 Rev-03
and improvement shall include determination of applicable UNISCO[M]MS 011 Rev-02 Section 1.4
methods, including techniques for the analysis of data, and the
extent of their use.
6.2 Monitoring, Measuring, and Improving

6.2.1 6.1b; 8.2.1 Customer The organization shall maintain a documented procedure to Measurement, Analysis and Improvement
Satisfaction measure customer satisfaction. UNISCO[M]MS 011 Rev-02 Section 1.2.1
8.2.1 The procedure shall address the frequency of measurement, Measurement, Analysis and Improvement
obtaining customer feedback, key performance indicators (KPIs), UNISCO[M]MS 011 Rev-02 Section 1.2.1
and other information that the organization uses to determine
whether the organization has satisfied customers in meeting
identified requirements.
NR in 9001* Records of the results of customer satisfaction information shall Measurement, Analysis and Improvement
be maintained (see 4.5). UNISCO[M]MS 011 Rev-02 Section 1.2.1
6.2.2 Internal Audit

6.2.2.1 8.2.2 General The organization shall maintain a documented procedure to Internal Audit
define responsibilities for planning, conducting, and documenting UNISCO[P]MS 014 Rev-02
internal audits.
8.2.2a; 8.2.2b Audits shall verify that the quality management system is Internal Audit
effectively implemented and maintained, and conforms to the UNISCO[P]MS 014 Rev-04
requirements of this specification.
8.2.2 The planning of internal audits shall take into consideration the Internal Audit
results of previous audits and criticality of the process being UNISCO[P]MS 014 Rev-04
audited.
8.2.2 The organization shall identify the audit criteria, scope, Internal Audit
frequency, and methods UNISCO[P]MS 014 Rev-03
NR in 9001* to ensure that all processes of the quality management system Internal Audit
claiming conformity to the requirements of this document are UNISCO[P]MS 014 Rev-04
audited at least every twelve months.
NR in 9001* Outsourced activities that impact the quality of the product and Internal Audit
that are performed at the organization’s facility shall be included UNISCO[P]MS 014 Rev-04 Section 6.1.3
as part of the internal audit of the organization.
Instructions
Date: 25.10.2015
6.2.2.2 8.2.2 Performance of Audits shall be performed by competent personnel (see 4.3.2.2) Internal Audit
Internal Audit independent of those who performed or directly supervised the UNISCO[P]MS 014 Rev-04 Section 6.2.3
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 Internal Audit
quality management system is implemented and maintained (see UNISCO[P]MS 014 Rev-04 Section 7
4.5).
NR in 9001* All processes of the quality management system required to Internal Audit
meet this specification shall be audited prior to claiming UNISCO[P]MS 014 Rev-04 Section 6.1.1
conformance to the requirements of this specification.
6.2.2.3 8.2.2 Audit Review and The organization shall identify response times for addressing Internal Audit
Closure detected nonconformities. UNISCO[P]MS 014 Rev-04 Section 6.2.7
8.2.2 The management responsible for the area being audited shall Internal Audit
ensure that any necessary corrections and corrective actions UNISCO[P]MS 014 Rev-04 Section 6.2.7
follow the requirements of 6.4.2.
5.6.2a The results of internal audits and the status of corrective actions Internal Audit
shall be reported in the management review (see 6.5). UNISCO[P]MS 014 Rev-04 Section 6.4.1
8.2.2 Records of internal audits shall be maintained (see 4.5). Internal Audit
UNISCO[P]MS 014 Rev-04 Section 7
6.2.3 4.1e; 4.1f; Process The organization shall apply suitable evaluation methods to Product Realizatiom
8.2.3 Evaluation demonstrate the ability of the quality management system UNISCO[M]MS 010 Rev-04
processes to achieve planned results, including conformity to
product requirements.
8.2.3 When planned results are not achieved, correction and corrective Customer Compliants, Corrective & Preventive
action shall be taken (see 6.4.2), as appropriate. action
6.3 Analysis of Data

6.3 4.1c The organization shall maintain a documented procedure for the Analysis of Data UNISCO[P]MS017 Rev-03
identification, collection, and analysis of data to demonstrate the
suitability and effectiveness of the quality management system.
8.4 The analysis shall include data generated from monitoring and Analysis of Data UNISCO[P]MS017 Rev-03
measurement, internal audits (see 6.2.2), management reviews
(see 6.5), and other relevant sources.
The data analysis output shall provide information relating to:
Instructions
6.3
Date: 25.10.2015
8.4a a) customer satisfaction (see 6.2.1); Analysis of Data UNISCO[P]MS017 Rev-03 Section
6.1.1
8.4b b) conformity to product requirements; Analysis of Data UNISCO[P]MS017 Rev-03 Section
6.1.1
NR in 9001* c) nonconformities and product failures identified after delivery Control of Non conformances
or use, provided the product or documented evidence is available UNISCO[P]MS010 Rev-03
to facilitate the determination of the cause (see 5.10);
8.4c d) characteristics and trends of processes and products including Customer Complaints, Corrective & Preventive action
opportunities for preventive action (see 6.4.3);
UNISCO[P]MS011 Rev-04
8.4d e) supplier performance (see 5.6); and Purchase Control

UNISCO[P]MS004 Rev-05
NR in 9001* f) quality objectives (see 4.1.3). Management Responsibility

8.4 The organization shall use data to evaluate where continual Analysis of data
improvement of the effectiveness of the quality management UNISCO[P]MS 017 Rev-03
system can be made.
6.4 Improvement
6.4.1 8.5.1 General The organization shall continually improve the effectiveness of Analysis of data
the quality management system through the use of the quality UNISCO[P]MS 017 Rev-03
policy, quality objectives, audit results, analysis of data,
corrective and preventive actions, and management review.
6.4.2 8.5.2 Corrective Action The organization shall maintain a documented procedure to Measurement, Analysis & Improvement Customer Compliants, Corrective and Preventive Actions
correct nonconformities and to take corrective actions, both UNISCO[M]MS 011 Rev-02 Section 1.5.3
internally and within the supply chain, to eliminate the causes of UNISCO[P]MS 011 Rev-04
a nonconformity in order to minimize the likelihood of its
recurrence.
8.5.2 Corrective actions shall be appropriate to the effect(s) of the Measurement, Analysis & Improvement Customer Compliants, Corrective and Preventive Actions
nonconformity encountered. UNISCO[M]MS 011 Rev-02 Section 1.5.2
8.5.2 The procedure shall identify requirements for:

8.5.2a a) reviewing a process nonconformity (including customer Measurement, Analysis & Improvement Customer Compliants, Corrective and Preventive Actions
complaints); UNISCO[M]MS 011 Rev-02 Section 1.5.3
UNISCO[P]MS 011 Rev-04 Section 6.1 and 6.2
6.4.2 Corrective Action
Instructions
Date: 25.10.2015
8.5.2c; 8.5.2d b) determine and implement corrections; Measurement, Analysis & Improvement Customer Compliants, Corrective and Preventive Actions
8.5.2b; 8.5.2d c) identifying the root cause of the nonconformity and evaluating Measurement, Analysis & Improvement Customer Compliants, Corrective and Preventive Actions
the need for corrective actions; UNISCO[M]MS 011 Rev-02 Section 1.5.3
8.5.2d d) implementing corrective action to reduce the likelihood that a Measurement, Analysis & Improvement Customer Compliants, Corrective and Preventive Actions
nonconformity recurs; UNISCO[M]MS 011 Rev-02 Section 1.5.3
NR in 9001* e) identifying the timeframe and responsible person(s) for Measurement, Analysis & Improvement Customer Compliants, Corrective and Preventive Actions
addressing corrections and corrective action; UNISCO[M]MS 011 Rev-02 Section 1.5.3
8.5.2f f) verification of the effectiveness of the corrections and Measurement, Analysis & Improvement Customer Compliants, Corrective and Preventive Actions
corrective action taken; and UNISCO[M]MS 011 Rev-02 Section 1.5.3
NR in 9001* g) MOC (see 5.11) when the corrective actions require new or Measurement, Analysis & Improvement Customer Compliants, Corrective and Preventive Actions
changed controls within the quality management system. UNISCO[M]MS 011 Rev-02 Section 1.5.3
8.5.2e Records of the activities for control of a nonconforming process Measurement, Analysis & Improvement Customer Compliants, Corrective and Preventive Actions
shall be maintained (see 4.5). UNISCO[M]MS 011 Rev-02 Section 1.5.3
UNISCO[P]MS 011 Rev-04 Section 6.3.7 and 7
NR in 9001* Records shall identify the activities performed to verify Measurement, Analysis & Improvement Customer Compliants, Corrective and Preventive Actions
effectiveness of the corrective actions taken. UNISCO[M]MS 011 Rev-02 Section 1.5.3
6.4.3 8.5.3 Preventive The organization shall maintain a documented procedure to Customer Compliants, Corrective and Preventive Actions
Action determine and implement preventive actions, both internally and
within the supply chain, to eliminate the causes of potential UNISCO[P]MS 011 Rev-04
nonconformities in order to minimize the likelihood of their
occurrence.
8.5.3 Preventive actions shall be appropriate to the effect(s) of the Customer Compliants, Corrective and Preventive Actions
potential problems.
8.5.3 The procedure shall identify requirements for:

8.5.3c a) Identifying opportunities for improvements; Customer Compliants, Corrective and Preventive Actions
6.4.3 Preventive
Action
Instructions
Date: 25.10.2015
8.5.3a b) identifying a potential nonconformity and its potential Customer Compliants, Corrective and Preventive Actions
cause(s);
8.5.3b c) evaluating the need for preventive action, including any Customer Compliants, Corrective and Preventive Actions
immediate or short term action required, to prevent occurrence
of a nonconformity; UNISCO[P]MS 011 Rev-04 Section 6.3
NR in 9001* d) identifying the timeframe and responsible person(s) for Customer Compliants, Corrective and Preventive Actions
implementing a preventive action;
8.5.3e e) reviewing the effectiveness of the preventive action taken; Customer Compliants, Corrective and Preventive Actions
and
NR in 9001* f) MOC (see 5.11) when the preventive action require new or Customer Compliants, Corrective and Preventive Actions
changed controls within the quality management system.
8.5.3d Records of the activities for control of potential process Customer Compliants, Corrective and Preventive Actions
nonconformities shall be maintained (see 4.5).
6.5 Management Review

6.5.1 5.6.1; 5.1d General The organization‘s quality management system shall be reviewed Management Review
at least every twelve months by the organization’s management UNISCO[P]MS 001 Rev-03
to evaluate the quality management system’s continuing
suitability, adequacy, and effectiveness.
5.6.1; 5.3e This review shall include assessing opportunities for improvement Management Review
and the need for changes to the quality management system, UNISCO[P]MS 001 Rev-03
including the quality policy and quality objectives.
6.5.2 5.6.2 Input The input to management review shall include, as a minimum:
Requirements
5.6.2e a) effectiveness of actions resulting from previous management Management Review

reviews; UNISCO[P]MS 001 Rev-03
Section 6.5
5.6.2a b) results of audits (see 6.2.2); Management Review
Section 6.5
5.6.2f c) changes that could affect the quality management system, Management Review
including changes to legal and other applicable requirements UNISCO[P]MS 001 Rev-03
(such as industry standards); Section 6.5
Instructions
6.5.2 Input
Date: 25.10.2015
Requirements
5.6.2b d) analysis of customer satisfaction, including customer feedback Management Review

(see 6.2.1); UNISCO[P]MS 001 Rev-03
Section 6.5
NR in 9001* e) process performance (see 6.2.3 and 6.3 d); Management Review
Section 6.5
NR in 9001* f) results of risk assessment (see 5.3); Management Review
Section 6.5
5.6.2d g) status of corrective and preventive actions (see 6.4.2 and Management Review
6.4.3); UNISCO[P]MS 001 Rev-03
Section 6.5
NR in 9001* h) analysis of supplier performance (see 5.6); Management Review
Section 6.5
5.6.2c i) review of the analysis of product conformity, including Management Review
nonconformities identified after delivery or use (see 5.10); and UNISCO[P]MS 001 Rev-03
Section 6.5
5.6.2g i) recommendations for improvement. Management Review

Section 6.5
6.5.3 5.6.3a Output The output from the management review shall include a Management Review
Requirements summary assessment of the effectiveness of the quality UNISCO[P]MS 001 Rev-03
management system.
5.6.3 The assessment shall include:

5.6.3a any required changes (see 5.11) to the processes and any Management Review
decisions and actions ; UNISCO[P]MS 001 Rev-03
Section 6.5
5.6.3c required resources, Management Review
Section 6.5 and 6.6
5.6.2b and improvement to products in meeting customer requirements Management Review

(see 5.11). UNISCO[P]MS 001 Rev-03
Section 6.5 and 6.6
5.6.1 Top management shall review and approve the output of Management Review
management reviews. UNISCO[P]MS 001 Rev-03
Section 6.6, 6.7
5.6.1 Management reviews shall be documented and records of these Management Review
reviews shall be maintained (see 4.5). UNISCO[P]MS 001 Rev-03
Section 6.5 and 6.6
Annex A Use of API Monogram by Licensees
Instructions
Date: 25.10.2015
A.4 NR in 9001* Quality An organization applying the API Monogram to products shall Quality Manual
Management develop, maintain, and operate at all times a quality UNISCO[M]MS 001 to MS017
System management system conforming to API Q1.
Requirements
A.5 NR in 9001* Control of the Each licensee shall control the application and removal of the API
Application and Monogram in accordance with the following:
Removal of the
NR in 9001* API Monogram a) Products that do not conform to API specified requirements API Monogram Marking
shall not bear the API Monogram. UNISCO[P]MS 016 Rev-02 Section 6.8
NR in 9001* b) Each licensee shall develop and maintain an API Monogram API Monogram Marking
marking procedure that documents the marking/monogramming UNISCO[P]MS 016 Rev-02
requirements specified by this annex and any applicable API
product specification(s) and/or standard(s).
NR in 9001* The marking procedure shall:

NR in 9001* 1) define the authority responsible for application and removal of API Monogram Marking
the API Monogram; UNISCO[P]MS 016 Rev-02 Section 5 and 6.6
NR in 9001* 2) define the method(s) used to apply the Monogram; API Monogram Marking
UNISCO[P]MS 016 Rev-02 Section 6
NR in 9001* 3) identify the location on the product where the API Monogram API Monogram Marking
is to be applied; UNISCO[P]MS 016 Rev-02 Section 6.2
NR in 9001* 4) require the application of the licensee's license number and API Monogram Marking
date of manufacture of the product in conjunction with the use UNISCO[P]MS 016 Rev-02 Section 6.4
of the API Monogram;
NR in 9001* 5) require that the date of manufacture, at a minimum, be two API Monogram Marking
digits representing the month and two digits representing the UNISCO[P]MS 016 Rev-02 Section 6.4
year (e.g. 05-12 for May 2012) unless otherwise stipulated in the
applicable API product specification(s) or standard(s); and
NR in 9001* 6) require application of the additional API product API Monogram Marking
specification(s) and/or standard(s) marking requirements, as UNISCO[P]MS 016 Rev-02
applicable.
NR in 9001* c) Only an API licensee shall apply the API Monogram and its API Monogram Marking
designated license number to API monogrammable products. UNISCO[P]MS 016 Rev-02
Instructions
Date: 25.10.2015
NR in 9001* d) The API Monogram license, when issued, is site-specific and API Monogram Marking
subsequently the API Monogram shall only be applied at that site UNISCO[P]MS 016 Rev-02 Section 6.5
specific licensed facility location.
NR in 9001* e) The API Monogram may be applied at any time appropriate API Monogram Marking
during the production process but shall be removed in UNISCO[P]MS 016 Rev-02 Section 6.8
accordance with the licensee’s 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 NR in 9001* Design Package Each licensee and/or applicant for licensing shall maintain a Design and Development Control
Requirements current design package for all of the applicable products that fall UNISCO[P]MS 018 Rev-02
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.
*No Requirement in ISO 9001:2008
I hereby declare that UNISCO has 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 : Mr.Senthil Kumar
Title : General Manager
Date

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Company: M/S.United Industrial services Co LLC,Plot No.

142-144, Sohar Industrial Estate,

4 Quality Management System Requirements

4.1.4 4.1a; 7.1 Planning Management shall ensure that:

5.1a The organization shall establish processes to ensure that:

4.2 Management Responsibility

Management shall provide evidence of its commitment to the

5.1d b) conducting management reviews (see 6.5). Management Responsibility

4.3.2 Human Resources

NR in 9001* Evidence of the determination of competence of personnel shall Resource Management

4.3.2.3 6.2.2 Training and The organization shall:

4.4 Document Requirements

4.2.1c c) documented procedures established for the quality List Of Procedures

Company: M/S.United Industrial services Co LLC,Plot No.142-144, Sohar Industrial Estate,

5.1.2 7.2.1 Determination of The organization shall determine:

7.1 In planning, the organization shall address the following:

NR in 9001* Risk assessment associated with product delivery shall include:

5.4 Design and Development

5.4.3 Design and

5.5 Contingency planning

7.4.2a including acceptance criteria, and where appropriate:

NR in 9001* b) applicable version of specifications, drawings, process Purchase Control UNISCO[P]MS

Company: M/S.United Industrial services Co LLC,Plot No.142-144, Sohar Industrial Estate,

7.5.2 The organization shall maintain a documented procedure to

7.5.2b a) required equipment; Monitoring and measuring of Product

7.5.2a d) identification of acceptance criteria; Monitoring and measuring of Product

7.6 Testing, measuring, monitoring equipment shall: Product Realization

7.6 When used in the testing, monitoring, or measurement of Product Realization

8.2.4 where applicable, by the customer. Monitoring and measuring of Product

5.10 Control of Nonconforming Product

8.3 The procedure for addressing nonconforming product identified

5.10.2 NR in 9001* Nonconforming The organization shall address nonconforming product by

5.11 Management of Change (MOC)

NR in 9001* a) changes in the organizational structure (see 4.3.2) Management Responsibility

6 Quality Management System Monitoring, Measurement, Analysis, and Improvement

6.2 Monitoring, Measuring, and Improving

6.2.2 Internal Audit

6.3 Analysis of Data

The data analysis output shall provide information relating to:

8.4d e) supplier performance (see 5.6); and Purchase Control

NR in 9001* f) quality objectives (see 4.1.3). Management Responsibility

8.5.2 The procedure shall identify requirements for:

8.5.3 The procedure shall identify requirements for:

UNISCO[P]MS 011 Rev-04

6.5 Management Review

5.6.2e a) effectiveness of actions resulting from previous management Management Review

5.6.2b d) analysis of customer satisfaction, including customer feedback Management Review

5.6.2g i) recommendations for improvement. Management Review

5.6.3 The assessment shall include:

5.6.2b and improvement to products in meeting customer requirements Management Review

Annex A Use of API Monogram by Licensees

NR in 9001* The marking procedure shall:

*No Requirement in ISO 9001:2008

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