Professional Documents
Culture Documents
M-IRM-001 - Quality Management Manual - Rev.13
M-IRM-001 - Quality Management Manual - Rev.13
M-IRM-001 - Quality Management Manual - Rev.13
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
13 1 de 40
REVISION CONTROL
REVISION DATE DESCRIPTION
0 15/10/09 Initial Issue.
General Revision for Adaptation, Integration and Implementation for NBR ISO
1 01/09/10
9001/2008.
2 02/12/10 General Pre-Audit Review.
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 2 de 40
SUMMARY
Item Title
1 PRESENTATION OF IRM SERVICES AND SCOPE
1.1 General Data
1.2 Clarify the needs and expectations of interested parties
1.3 Identify and understand IRM SERVICES and its unique context
1.4 IRM Vision
1.5 IRM Mission
1.6 IRM Values
1.7 Introduction
1.8 Purpose
1.9 Scope
1.10 Exclusions
2 NORMATIVE REFERENCES
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 3 de 40
5 PRODUCT REALIZATION
5.1 Contract Review
5.1.1 General
5.1.2 Determination of Requirements
5.1.3 Review of Requirements
5.2 Planning
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 4 de 40
5.5 Contingency planning
5.5.1 General
5.5.2 Planning Output
5.6 Purchasing
5.6.1 Purchasing Control
5.6.1.1 Procedure
5.6.1.2 Initial Supplier Evaluation-Critical Purchases
5.6.1.3 Initial Supplier Evaluation-Noncritical Purchases
5.6.1.4 Supplier Re-evaluation
5.6.1.5 Supplier Evaluation-Records
5.6.1.6 Outsourcing
5.6.2 Purchasing Information
5.6.3 Verification of Purchased products or Activities
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 5 de 40
8 REGISTERS
8.1 Not applicable.
9 APPENDIX
9.1 Not applicable.
QUALITY MANAGEMENT SYSTEM
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 6 de 40
PRESENTATION OF IRM SERVICES
1.1 General Data
Company Name: IRM SERVIÇOS EIRELI.
Trade Name: IRM SERVICES.
CNPJ: 07.932.094/0001-86
State Registration: 78.212-497
Municipal Registration: 0200-93
Address: Av. Prefeito Aristeu Ferreira da Silva – 1205 - Galpão C - Granja dos Cavaleiros - Macaé -
RJ, ZIP CODE: 27930-070.
Site: www.irmserv.com
E-mail: qualidade@irmserv.com.br
Phone/Fax:(22) 2105 - 2800
1.2 Identify and understand IRM SERVICES and its unique context
IRM SERVICES, founded in October 2, 2007 is a genuine Brazilian company, providing
expertise and innovative techniques to the Oil, Gas, Marine and Energy Industries, possessing high-
level professionals with knowledge and expertise proven in Services Of Inspection, Conventional
Industrial And Naval Repair And Maintenance And Rope Access & Threading and Gauging of
Rotary Shouldered Thread Connections and Drill Stem Elements.
Currently, we are among of the top four companies in the segment and we are developing strategies
to keep ourselves competitive through new certifications and intensified development of employee
competencies.
IRM SERVICES has been in the forefront of developing multidisciplinary range of services, and has
two major operations:
OCTG, applying various inspection techniques for non-destructive testing, maintenance and
repair of tubular products and fittings made onshore
Offshore, with the application of diverse inspection techniques for non-destructive tests,
maintenance and repair of tubular products and accessories carried out in marine or offshore
environments.
IRM SERVICES has been in the forefront of developing multidisciplinary range of services, providing
benefits to the client, resource optimization, reduced costs, improved efficiency and full compliance
with the contract, all these essentials for successful projects.
Capitalizing on the increasing use of Rope Access technique onshore and offshore, the company is
gaining a leadership position in the performance of services in areas of difficult or limited access. In
parallel, the development of similar capabilities in the underwater environment is seen by IRM
SERVICES as a workplace that offers the same degree of challenge for a workforce that is competent
and focused on high performance results.
The great difference of the company is the application of these techniques in an innovative way,
respecting the legal and contractual parameters and with maximum security and quality.
QUALITY MANAGEMENT SYSTEM
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 7 de 40
1.3 Clarify the needs and expectations of stakeholders
Clients, who expect high quality technical performance and maximum safety, in compliance with
applicable legislation and standards;
Employees, who expect to be recognized and paid in an adequate way and who can grow
professionally;
Owner, who expects to have the company recognized as a Brazilian leader and a world reference
in the follow-up of Inspection, Repair and Maintenance, in addition to reference of quality of life and
valorization of its employees;
Society, which expects the generation of job opportunities and action in a sustainable way in social
and environmental parameters;
Government, which has the expectation of an action in accordance with the legislation.
1.7 Introduction
This manual establishes the requirements to guarantee the services provided by IRM SERVICES,
specified quality levels, consistent with the requirements and needs of its customers, aiming primarily
to prevent nonconformity at all stages of implementation processes as well as the full satisfaction of
its customers.
The Quality Management System described in this Manual is structured to meet the requirements
established in Standards API Specification Q1 and ISO 9001/20015.
QUALITY MANAGEMENT SYSTEM
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 8 de 40
1.8 Purpose
The purpose of this Manual is to establish structure of Quality Management System, describing its
main components, their interaction and reference to associated documents, as well as the Policies of
IRM SERVICES for Quality and strategies for implementation and operationalization of the system.
The Quality Management System aims to meet the full satisfaction of its customers and meet the
requirements established by API Specification Q1 and ISO 9001/20015, customer requirements,
legal requirements and other requirements applicable to services provided by IRM SERVICES.
1.9 Scope
The scope of this Manual is defined by IRM SERVICES in the following range certifiable:
IRM Services provides products and services to the oil, gas, energy & marine industries,
including:
- Inspection, Repair and Maintenance services including non-destructive testing
conventional & rope access methods.
- Rental of equipment specifically for services provided.
- Threading and Gauging of Rotary Shouldered Thread Connections and Drill Stem
Elements.
1.10 Exclusions
There is no exclusion to any section of API Specification Q1 and ISO9001:2015, latest edition.
2. Normative references
The following referenced documents are indispensable for the application of this specification. The
latest edition of the referenced documents (including any amendments) applies.
- API Specification Q1 – Specification for Quality Management System Requirements for
Manufacturing Organizations for the Petroleum and Natural Gas Industry
- ISO 9000 – Quality Management Systems – Fundamentals and Vocabulary
- ISO 9001 - Quality Management Systems – Requirements
3.1 Definitions
3.1.1 Top Management – Person or group of people who directs and controls the IRM SERVICES
at the highest level.
3.1.3 Quality Management System Audit – Systematic, documented and, where possible,
independent examination destined to determine whether the activities and results related are in
accordance with the provisions planned, and if these provisions are implemented effectively and are
appropriate for the achievement of IRM SERVICES Policy and Objectives.
3.1.4 Quality Management Manual – A document that specifies the Quality Management System
of IRM SERVICES.
QUALITY MANAGEMENT SYSTEM
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 9 de 40
3.1.5 Improvement – Actions implemented throughout the company, in order to increase
effectiveness, efficiency of the activities and processes, to provide additional benefits to both the
company and customers.
3.1.6 Target – Detailed performance requirement, quantified where applicable to IRM SERVICES
resulting Quality objectives, which needs to be established and attended to ensure that these
objectives are achieved.
3.1.8 Objective – Purpose of Quality established by IRM SERVICES, with the goal to be achieved
that should be quantified where possible.
3.1.9 Policy – Intentions and overall guidelines of IRM SERVICES, formally expressed by Top
Management, related to quality, exposing its intentions and principles in relation to its overall
performance, which provides a framework for action and goal definition.
3.1.10 Process – Series of resources or interrelated activities that transform inputs into products.
3.1.13 Quality Management System – QMS – Management System destined to direct and control
the IRM SERVICES with respect to quality, including organizational structure, planning activities,
responsibilities, practices, procedures, processes and resources for developing, implementing,
achieving, reviewing and maintaining the Policy.
3.2 Abbreviations
F – IRM Forms.
R – IRM Records.
I – IRM Work Instructions.
M – IRM Quality Management Manual.
P – IRM Procedure.
QCP – IRM Quality Control Plan.
PG – IRM Program.
API – American Petroleum Institute.
DAC – Design Acceptance Criteria.
ISO – International Organization for Standardization.
KPI – Key Performance Indicator.
MAC – Manufacturing Acceptance Criteria.
QUALITY MANAGEMENT SYSTEM
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 10 de 40
MOC – Management of Change.
MPS – Manufacturing Process Specification.
QM – Quality Manual.
QMS – Quality Management System.
4.1.1 General
4.1.1.1 Context
IRM Services is a Brazilian company in the field of Inspection, Repair and Maintenance of construction
ships, with a focus on the Oil and Gas industry. We operate in Brazil and our services are
concentrated in the Campos bay.
Our goal is to be a Brazilian leader and the world reference in inspection, repair and maintenance
market. We are currently among the top four companies in the industry and are developing strategies
for our development, new skills and efforts development.
IRM Services has two major operations: OCTG, with application of various inspection techniques for
nondestructive testing, maintenance and repair of tubular products and accessories made offshore,
with an application of various inspection techniques for non-destructive testing, maintenance and
repair of tubular products and fittings performed in marine or offshore environments The great
differential of the company is an application of innovative training techniques, respecting the legal and
contractual requirements and with maximum safety and quality.
IRM SERVICES has established, documented, implemented, and maintains at all times a QMS for all
products and servicing provided for use in the oil, gas, energy & marine industries industry and
measures and improves upon the effectiveness of the QMS in accordance with the requirements of
this Quality Manual as per QMS Process Flow Interaction and IRM Macro Flow.
QUALITY MANAGEMENT SYSTEM
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 11 de 40
IRM Processes Macro Flow (Figure 1)
MANAGEMENT
PROCESSES
MANAGEMENT
Resources PROCESSES SUPPORT
Management PROCESSES
Comercial
Documents and Administrative
Register Control
Planning
Non-conforming Customer
Financial
product control Satisfaction
Supply Chain
Training and
Information
Competence Continual
Technology
Logistics Improvement
Measuring and
Monitoring of Customer
satisfaction for Accounting
Materials
products & services
Internal Audit
Legal
Measuring Devices Service and
Control and Products
Operational Technical
Control / Engineering
Performance Evaluation
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 12 de 40
4.1.2 Quality Policy
IRM SERVICES’s Quality Policy has been defined, documented, and approved by top management.
This policy is communicated, understood, implemented, and maintained at all relevant functions and
levels within IRM SERVICES. The policy includes a commitment to comply with requirements and
continually improve the effectiveness of the QMS.
To implement Quality Policy and to keep them updated and understood, the following exposure
measures can be taken:
a) Notice Boards situated in appropriate locations, in order to keep them permanently
exposed;
b) Corporate website and e-mails;
c) Induction Training.
d) Meetings with IRM SERVICES team, to explain how the policies should be understood
and practiced by the Organization;
Quality Policy
IRM SERVICES is a Brazilian company that offers innovative techniques in Inspection, Repair and
Maintenance at the Oil & Gas, Energy and Marine activities, establishes, maintains and publishes
their policy of Integrated Management System - IMS and agrees to:
Working carefully for excellence, maintaining the best practices on issues related to Quality,
Health, Safety and Environment compliance with the legislation, with the contractual requirements,
statutory and regulatory requirements applicable to their activities, satisfying the needs and
improving customer satisfaction.
Establishing and reviewing the results and the goals and objectives consistents with their
policy aimed at continuous improvement of the effectiveness of the management system.
Conduct their operations preserving the environment, preventing pollution in all their ways,
using products ecologically appropriate, rationalizing the use of non-renewable resources, applying
recycling programs, minimizing the generated waste and mitigating environmental impacts.
Prevent the occurrence of injuries and work diseases related to their activities, promoting a
proper workplace to their employees.
All managers and supervisors are responsible to lead for the example the employees working
under your supervision, conducting operations safely at all times, involving and motivating the
employees to commit in keeping the best rates in HSEQ.
All the IRM SERVICES personnel, regardless of the position, has expressed authority to suspend
any operation that constitutes a risk to the life and safety of any person, the environment or
surrounding communities.
QUALITY MANAGEMENT SYSTEM
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 13 de 40
4.1.3 Quality Goals and Objectives
As part of the Management Review process top management establishes measurable Quality
Objectives, including those needed to meet customer and product requirements, consistent with the
Quality Policy at relevant functions and levels within IRM SERVICES.
The objectives must be extracted from IRM SERVICES Policies and deployed in organizational
goals for the relevant processes. Achieving these goals and objectives must be demonstrated,
where possible, by using indicators, that are quantifiable forms of representation of variables to be
assessed, according to Performance Metrics Spreadsheet (F-QUA-034), established annually,
always seeking continuous improvement and attendance to the requirements applicable to services.
The quality level of services provided should also be monitored through customer satisfaction
survey.
Objectives of the Quality Management System IRM are:
- Increase the satisfaction of the Client;
- Reduce the number of non-compliances identified by customers;
- Continually improve the management system;
Customer Focus
IRM SERVICES establishes the Quality Management Procedures - Marketing, Planning and
Service Performance (P-PLAN-001a) – and - Measurement and Monitoring of Customer
Satisfaction, Processes and Products (P-QUA-009) -, through areas: Operational, Commercial
Planning and Quality, to ensure understanding and meeting the customers' needs.
During the performance of the services, where possible, Technical/Operational area seeks to
identify the additional requirements from the customer, working toward implementing them.
4.1.4 Planning
The Planning of Quality Management System of IRM SERVICES is outlined in the documents
components of the System that describe and define the activities, equipment used and the resources
available, indicating the stages of measurement and monitoring and specifying the criteria of
acceptance to ensure that the System is adequate and its goals understood, and that they are
efficient and effective.
The purpose of planning of the Quality Management System of IRM SERVICES is to comply with
the Quality Policy and with the objectives established, to ensure and demonstrate the abilities to
satisfy customers and applicable legal and regulatory requirements and to develop continuous
improvement.
The documents components of the Quality Management System that substantiate the
implementation of processes and activities planned are: Quality Management Procedures, Programs,
Work Instructions, Quality Plans, Forms and Registers, and any other eventual.
The resources needed to fulfill the objectives are identified and specified in the respective Action
Plans, when applicable.
The planning is established in such way as to meet the objectives, providing, also, that any
change in QMS to be made in a controlled manner in accordance with the actions defined in the
Action Plans, while maintaining its integrity.
QUALITY MANAGEMENT SYSTEM
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 14 de 40
4.1.5 Communication
IRM SERVICES establishes the Quality Management Procedures Organizational Knowledge
Management (P-GA-001).
4.1.5.1 Internal
IRM SERVICES ensures that appropriate communication processes are established within IRM
SERVICES and the effectiveness of the QMS is communicated.
IRM SERVICES has established processes to ensure that the:
a) importance of meeting customer, legal, and other applicable requirements is communicated at
relevant functions within IRM SERVICES, and that the
b) results of analysis of data (see 6.3) are communicated at relevant levels and functions within
IRM SERVICES.
4.1.5.2 External
IRM SERVICES has determined and implemented a process for communicating with external
organizations, including customers, to ensure requirements are understood throughout contract
execution and product realization. The communication process addresses:
a) execution of customer inquiries, contracts, order handling, and amendments (see 5.1);
b) provision of product information, including product nonconformities identified after delivery to the
customer (see 5.10.4);
c) feedback and customer complaints (see 6.2.1); and
d) when required by contract, the provision of information required by Product Quality Plans and
subsequent changes to those plans (see 5.7.2).
4.2.1 General
IRM SERVICES ensures the availability of resources essential to establish, implement, maintain, and
improve the QMS.
Resources can include human resources and specialized skills, organizational infrastructure,
technology, and financial resources.
IRM SERVICES provides evidence of its commitment to the development and implementation of the
QMS and the continual improvement of its effectiveness by:
a) ensuring that Quality Objectives are established, including KPIs, for use in data analysis; and
b) conducting Management Reviews (see 6.5).
c) Management Commitment
QUALITY MANAGEMENT SYSTEM
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 15 de 40
The Management Board of IRM SERVICES demonstrates, through the implementation of QMS and
monitoring of its performance, the level of commitment that maintains with its development and
improvement.
IRM SERVICES has its organizational structure as Corporate Organogram (Figure 2) IRM Corporate
Organogram.
DIRECTORS
Management
Representative
Board Strategic
Management
The QMS documents Responsibilities and Authority are correlated on the QMS Responsibility
and Authority Matrix.
All the documents of the QMS of IRM SERVICES are correlated in the Master List of
Documents (R-QUA-010).
QUALITY MANAGEMENT SYSTEM
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 16 de 40
RESPONSIBILITY / AUTHORITY
DOCUMENT
D R A P
DR – QUALITY DR – QUALITY
QUALITY MANAGEMENT MANUAL DIRECTORS ALL THE EMPLOYEES
RESPONSIBLE RESPONSIBLE
DR – QUALITY
DOCUMENTS OF PROCESS FOR DR – QUALITY
RESPONSIBLE / DIRECTORS ALL INVOLVED
QUALITY ASSURANCE RESPONSIBLE
QUALITY DEPARTMENT
DR – QUALITY
DOCUMENTS RELATED TO THE HR DEPARTMENT / HR RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF HUMAN RESOURCES RESPONSIBLE QUALITY
DEPARTMENT
OPERATIONS
DR – QUALITY
DOCUMENTS RELATED TO THE DEPARTMENT / DIRECTORS /
RESPONSIBLE /
PROCESSES OF PLANNING / OPERATIONS DESIGNATED ALL INVOLVED
QUALITY ASSURANCE
OPERATIONS MANAGER / PERSON
DEPARTMENT
DESIGNATED PERSON
SUPPLY CHAIN
DOCUMENTS RELATED TO THE DR – QUALITY
DEPARTMENT / SUPPLY DIRECTORS ALL INVOLVED
PROCESSES OF SUPPLY CHAIN RESPONSIBLE
CHAIN RESPONSIBLE
REPORTS
DEPARTMENT / DR – QUALITY
DOCUMENTS RELATED TO THE OPERATIONS RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF REPORTS DEPARTMENT / QUALITY ASSURANCE
OPERATIONS DEPARTMENT
MANAGER
DR – QUALITY
DOCUMENTS RELATED TO THE HSE DEPARTMENT / RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF HSE SAFETY ENGINEER QUALITY ASSURANCE
DEPARTMENT
DR – QUALITY
DOCUMENTS RELATED TO THE ADMINISTRATIVE RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF IT RESPONSIBLE QUALITY
DEPARTMENT
CONTROLLERSHIP DR – QUALITY
DOCUMENTS RELATED TO THE DEPARTMENT / RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF CONTROLLERSHIP CONTROLLERSHIP QUALITY ASSURANCE
RESPONSIBLE DEPARTMENT
OPERATIONS DR – QUALITY
DOCUMENTS RELATED TO THE DEPARTMENT / RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF LOGISTICS OPERATIONS QUALITY ASSURANCE
MANAGER DEPARTMENT
FACILITIES DR – QUALITY
DOCUMENTS RELATED TO THE DEPARTMENT / RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF FACILITIES ADMINISTRATIVE QUALITY ASSURANCE
RESPONSIBLE DEPARTMENT
COMMERCIAL DR – QUALITY
DOCUMENTS RELATED TO THE DEPARTMENT / RESPONSIBLE /
DIRECTORS ALL INVOLVED
PROCESSES OF COMMERCIAL OPERATIONS QUALITY ASSURANCE
MANAGER DEPARTMENT
Note: The remaining departments and their managers presented in chart should prepare their documents, submit to the Quality
QUALITY MANAGEMENT SYSTEM
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 17 de 40
Assurance Department for review and the director for approval.
4.3.2.1 General
IRM SERVICES establishes the Quality Management procedure – Competences Development
(P-TD-002) - and the specific instructions which defines how the process of competence
development, training and awareness should be performed.
Each person who works for IRM SERVICES, whatever the function he performs, has
responsibilities in QMS such as monitoring, correction and corrective and / or preventive actions of
QMS.
To properly perform their duties, employees should be aware of their importance and share the
contribution for the achievement of goals.
To enable them to perform their responsibilities, training must be conducted. The effectiveness of
the training should be evaluated by monitoring performed by Coordinators / Managers of involved
areas.
IRM SERVICES must maintain appropriate records of education, training, skills and experience.
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 18 de 40
QMS.
To properly perform their duties, employees should be aware of their importance and share the
contribution for the achievement of goals.
To enable them to perform their responsibilities, training must be conducted. The effectiveness of
the training should be evaluated by performance monitoring by Coordinators / Managers of involved
areas.
IRM SERVICES must maintain appropriate records of education, training, skills and experience.
4.4.1 General
The Documentary Structure (Figure 3) of IRM SERVICES is structured in four hierarchical levels.
These levels are developed in such way that the activities and responsibilities are available to its
users, in the language and necessary amount appropriate to necessary methods and criteria, to
ensure the effective operation of the Quality Management System processes.
Other than documentation in figure 3, IRM SERVICES uses an external software to identify legal and
other applicable requirements to which the organization claims compliance that are needed to achieve
product and service conformity.
Levels
Quality
Management
1 Manual
Management of Quality
Programs and Procedures
2
QUALITY MANAGEMENT SYSTEM
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 19 de 40
Work instructions
and Quality Plans
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 20 de 40
4.4.2 Procedures
The main definitions of the documents that are part of QMS are listed below:
a) Level 1 – Quality Management Manual – M. Document that defines and sets out the Policy and
describes the Quality Assurance Department, showing how the processes should be performed by
IRM SERVICES to meet the requirements of the Quality Management System, covering the scope
certifiable.
b) Level 2 – IRM Quality Management Procedures – P and IRM Programs - PG. Documents that
describe the processes of IRM SERVICES defining what to do and, when appropriate, how to do,
meeting the requirements established by the standard API Q1 and ISO 9001/2015 and other specific
standards.
c) Level 3 – IRM Work Instructions - I and IRM Quality Control Plans - QCPs – objectively establish
the methodology of a Level III process.
d) Level 4 – IRM Forms – F; IRM Registers – R;
Registers and Forms are the objective evidence that shows that the planned activities are being
performed.
All procedures referenced within this Quality Manual are established, documented, implemented, and
maintained for continued suitability. A single document can address the requirements of one or more
procedures. A requirement for documented procedures can be satisfied by more than one document.
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 21 de 40
and if they are readily available in order to avoid the use of invalid and / or obsolete documents.
4.4.3.3 The QMS documents to be kept legible, readily identifiable and retrievable to provide
evidence of compliance with the requirements and the effective operation of QMS.
4.4.3.4 Changes to QMS documents to be promptly made after Quality Department critical analysis
and the nature of the change identified.
5 PRODUCT REALIZATION
5.1.1 General
IRM SERVICES maintains a documented procedure P-PLAN-001a - Marketing, Planning and
Realization of Services and P-PLAN-001b - Marketing Planning and Realization of Services
OCTG for the review of requirements related to the provision of products and required servicing.
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 22 de 40
Where the customer provides no documented statement of the requirements, the customer
requirements are confirmed by IRM SERVICES and records maintained (see 4.5).
5.1.3 Review of Requirements
IRM SERVICES reviews the requirements related to provision of products. This review is conducted
prior to IRM SERVICE´s commitment to deliver product to the customer and ensures that:
a) requirements are identified and documented;
b) requirements differing from those previously identified are resolved; and
c) IRM SERVICES has the capability to meet the documented requirements.
Where contract requirements are changed, IRM SERVICES ensures that relevant documents are
amended and that relevant personnel are made aware of the changed requirements.
Records of the results of the review, including resulting actions, are maintained (see 4.5).
IRM SERVICES employees are empowered to meet any doubt related to services that are
performed as well as to attend the complaints and measurement of customer satisfaction
according to Quality Management Procedure – Measurement and Monitoring of Customer
Satisfaction and Processes (P-QUA-009).
5.2 PLANNING
IRM SERVICES identifies and plans the processes and documents needed for product realization.
Planning of product realization is consistent with the requirements of the other processes of the QMS
(see 4.1.4). In planning, IRM SERVICES addresses the following:
a) required resources and work environment management (see 4.3);
b) product and customer-specified requirements (see 5.1);
c) legal and other applicable requirements;
d) contingencies based on risk assessment (see 5.3 and 5.5);
e) design and development requirements (see 5.4);
f) required verification, validation, monitoring, measurement, inspection, and test activities specific
to the product and the criteria for product acceptance;
g) management of change (see 5.11); and
h) records needed to provide evidence that the product realization processes meet requirements
(see 4.5).
The output of planning is documented and updated as changes occur. The plans are maintained in a
structure suitable for IRM SERVICES’s method of operations, in accordance with procedure - P-
PLAN-001 - Marketing, Planning and Service Realization of Services.
The purpose of planning of the Quality Management System of IRM SERVICES is to comply with
the Quality Policy and with the objectives established, to ensure and demonstrate the abilities to
satisfy customers and applicable legal and regulatory requirements and to develop continuous
improvement.
QUALITY MANAGEMENT SYSTEM
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 23 de 40
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 24 de 40
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 Design and Development Inputs
Inputs are identified and reviewed for adequacy, completeness, and lack of conflict.
Inputs include functional and technical requirements and the following, as applicable:
a) customer-specified requirements (see 5.1);
b) requirements provided from external sources, including API product specifications;
c) environmental and operational conditions;
d) methodology, assumptions, and formulae documentation;
e) historical performance and other information derived from previous similar designs;
f) legal requirements; and
g) results from risk assessments (see 5.3).
Records of design inputs are maintained (see 4.5).
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 25 de 40
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 26 de 40
5.6 Purchasing
5.6.1.1 Procedure
IRM SERVICES maintains documented procedures P-COM-001 – Purchasing and P-COM-002 -
Selection, Classification, Evaluation and Supplier Registration - to ensure that purchased
products or outsourced activities and registration, evaluation and re-evaluation of vendors conform to
specified requirements.
This procedure addresses:
a) determination of the criticality of the activities or products as they are applicable to conformance
to product or customer specifications;
b) initial evaluation and selection of suppliers based on their ability to supply products or activities
in accordance with IRM SERVICES’s requirements (see 5.6.1.2 and 5.6.1.3);
c) type and extent of control applied to the supplier based on the criticality of the product or
activity;
d) criteria, scope, frequency, and methods for re-assessment of suppliers;
e) maintaining a list of approved suppliers and scope of approval; and
f) type and extent of control to be applied to outsourced activities (see 5.6.1.6).
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 27 de 40
a) verification that the supplier’s QMS conforms to IRM SERVICES’s specified quality system
requirements; and
b) assessment of the supplier to ensure its capability to meet IRM SERVICES’s purchasing
requirements by:
I performing an on-site evaluation of relevant activities; or
II performing first article inspection to ensure conformance to stated requirements; or
III identifying how the supplied product conforms to stated requirements when limited by
proprietary, legal, and/or contractual arrangements.
5.6.1.6 Outsourcing
When IRM SERVICES chooses to outsource any activity within the scope of its QMS, it ensures that
all applicable elements of its QMS are satisfied and maintains responsibility for product conformance
to specified requirements, including applicable API product specifications associated with product
realization.
Records of outsourced activities are maintained (see 4.5).
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 28 de 40
appropriate:
a) requirements for approval of supplier’s procedures, processes, and equipment;
b) applicable version of specifications, drawings, process requirements, inspection instructions,
traceability, and other relevant technical data;
c) requirements for qualification of supplier’s personnel; and
d) QMS requirements.
5.7.1.2 Servicing
QUALITY MANAGEMENT SYSTEM
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 29 de 40
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 30 de 40
Where it chooses to outsource a process that requires validation, IRM SERVICES requires that the
supplier conform to these requirements (see 5.6.1.6).
IRM SERVICES maintains a documented procedure P-QUA-015 - Validation of Special Processes
- to address methods for review and approval of special processes including:
a) required equipment;
b) qualification of personnel;
c) use of specific methods, including identified operating parameters;
d) identification of acceptance criteria;
e) requirements for records (see 4.5); and
f) revalidation.
Product Quality Plans and any revisions to them are documented and approved by IRM SERVICES to
ensure customer requirements are met. Product Quality Plans and any revisions are communicated to
the customer.
A Product Quality Plan may make references to other QMS documents.
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 31 de 40
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 32 de 40
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 33 de 40
This procedure includes requirements for the specific equipment type that addresses:
a) unique identifier;
b) calibration status;
c) traceability of calibration standards used to international or national measurement standards;
d) frequency of calibration, at specific intervals or prior to use;
e) calibration or verification method, including adjustments and readjustments as necessary; and
f) acceptance criteria
This procedure also addresses:
a) the control of equipment identified as out-of-calibration in order to prevent unintended use;
b) assessment of the validity of previous measurements and necessary actions related to the
equipment and delivered product when the equipment is found to be out-of-calibration; and
c) maintenance of records and evidence of notification to the customer and to API, if applicable
(see 4.1.5.2).
Testing, measuring, and monitoring equipment is:
1) calibrated or verified, or both, against measurement standards (verification against identified
acceptance criteria is performed on non-adjustable equipment);
2) identifiable by the user as to its calibration status for the activities being performed at all times;
3) safeguarded from adjustments that would invalidate the measurement result or the calibration
status;
4) protected from damage and deterioration during handling, maintenance, and storage; and
5) used under environmental conditions that are suitable for the calibrations, inspections,
measurements, and tests being carried out.
When used in the testing, monitoring, or measurement of specified requirements, the ability of
computer software to satisfy the intended application is confirmed prior to initial use and reconfirmed
as necessary.
When monitoring and measuring equipment is provided from an external source, including third party,
proprietary, employee and customer-owned equipment, IRM SERVICES verifies that the equipment is
suitable and provides evidence of conformity to the requirements of this section 5.8.
IRM SERVICES maintains a list of the required testing, measurement, and monitoring equipment
used to determine product conformity to requirements that includes a unique identifier specific to each
piece of equipment.
Records of the results of calibration and verification are maintained (see 4.5).
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 34 de 40
authority and, where applicable, by the customer as identified in documented procedure P-DS-003 -
Receiving, Handling, Storage, Packaging and Delivery of Equipment.
Records are maintained to enable identification of the individual releasing the product (see 4.5).
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 35 de 40
5.10.5 Records
Records of the nature of nonconformities and any subsequent actions taken, including concessions
obtained, are maintained (see 4.5).
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 36 de 40
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 37 de 40
Records of the audits provide objective evidence that the QMS is implemented and maintained (see
4.5).
All processes of the QMS required to meet the specifications of API Q1 and ISO 9001 and any other
applicable specifications are audited prior to claiming conformance to the requirements of these
specifications.
Product specification requirements may be embedded throughout the QMS processes and audited in
conjunction with one or more QMS processes.
6.2.2.3 Audit Review and Closure
IRM SERVICES identifies response times for addressing detected nonconformities in accordance with
the corrective action documented procedure. The management responsible for the area being audited
ensures that any necessary corrections and corrective actions follow the requirements of 6.4.2. The
results of internal audits and status of corrective actions are reported in the Management Review (see
6.5). Records of internal audits are maintained (see 4.5).
6.4 IMPROVEMENT
QUALITY MANAGEMENT SYSTEM
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 38 de 40
6.4.1 General
IRM SERVICES continually improves the effectiveness of the QMS through the use of the quality
policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and
management review.
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 39 de 40
Document Nº:
M-IRM-001
Quality Management Manual Revision: Page:
12 40 de 40
are documented and records of these reviews are maintained (see 4.5).
7.2 RECORDS
7.2.1 Documentation required for applicable API Specifications product compliance is maintained for
a minimum of ten (10) years following date of manufacture and/or the period specified contractually.
7.2.2 IRM SERVICES maintains a current design package for all the applicable products that fall
under the scope of monogram license. These design packages are available to API Representatives
upon request.
7.2.3 Newly manufactured products are identified by serial number, batch number, job number, or
other forms of identification as specified in the API Specifications or as appropriate to the newly
manufactured product. The listing also includes a description of the newly manufactured product and
the date of manufacture. The file is made available to API Representatives upon request.
7.2.4 Records supporting the effective operation of the IRM SERVICES’s QMS are maintained for a
minimum of ten (10) years.
8. REGISTER
8.1 Not applicable.
9. APPENDIX
9.1 Not required.