IS 16070: Quality Management Systems - Particular Requirements for the Application of ISO 9001:2008 For Power Sector Equipment Manufacturing, Service and Utility Organization

2013·0.86 MB·English

by  Bureau of Indian Standards

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IS 16070 (2013): Quality Management Systems - Particular
Requirements for the Application of ISO 9001:2008 For Power
Sector Equipment Manufacturing, Service and Utility
Organization [MSD 2: Quality Management]
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Indian Standard
QUALITY MANAGEMENT SYSTEMS — PARTICULAR
REQUIREMENTS FOR THE APPLICATION OF
ISO 9001 : 2008 FOR POWER SECTOR
EQUIPMENT MANUFACTURING,
SERVICE AND UTILITY
ORGANIZATION
ICS 03.120.10;27.100
© BIS 2013
B U R E A U O F I N D I A N S T A N D A R D S
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002

February 2013 Price Group 10
Quality Management Sectional Committee, MSD 2
FOREWORD
This Indian Standard was adopted by the Bureau of Indian Standards, after the draft finalized by the
Quality Management Sectional Committee had been approved by the Management and Systems Division
Council.
The power demand in India is very high and to keep up the pace with development of Indian economy
high availability and plant load factors are essential. The power plant equipment and system is very
complex and requires effective quality assurance system and procedure in order to achieve high
availability and reliability. This standard is formulated to meet this objective and the specific requirements
for power sector specially taking care of Indian conditions. The experience of leading power utilities
operating in India has been carefully considered while formulating these requirements. The requirements
should help the Indian power sector a great deal in their quality initiative.
Wherein the text in the boxes gives the text of IS/ISO 9001:2008 ‘Quality management systems —
Requirements (third revision)’ and the text outside the boxes gives the requirement.
In formulating this standard considerable assistance has been taken from IS/ISO/TS 16949:2009 ‘Quality
management systems — Particular requirements for the application of ISO 9001:2008 for automotive
production and relevant service part organizations (second revision)’, IS/ISO 9001:2008 ‘Quality
management systems — Requirements (third revision)’ and IS/ISO 9004:2009 ‘Managing for the
sustained success of an organization — A quality management approach (sixth revision)’.
The composition of the Committee responsible for the formulation of this standard is given in Annex C.
IS 16070 : 2013
Indian Standard
QUALITY MANAGEMENT SYSTEMS — PARTICULAR
REQUIREMENTS FOR THE APPLICATION OF
ISO 9001 : 2008 FOR POWER SECTOR
EQUIPMENT MANUFACTURING,
SERVICE AND UTILITY
ORGANIZATION
1 Scope
1.1 General
ISO 9001:2008, Quality Management Systems — Requirements
1 Scope
1.1 General
This International Standard specifies requirements for a quality management system where an
organization
a) needs to demonstrate its ability to consistently provide product that meets customer and
applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including
processes for continual improvement of the system and the assurance of conformity to customer
and applicable statutory and regulatory requirements.
NOTE 1 In this International Standard, the term “product” only applies to
a) product intended for, or required by, a customer,
b) any intended output resulting from the product realization processes.
NOTE 2 Statutory and regulatory requirements can be expressed as legal
1.1.1 This standard, in combination with IS/ISO 9001:2008 ‘Quality management systems —
Requirements (third revision)’ defines the quality management system requirements for the design and
development, manufacture, installation, operation and services of power sector products.
1.2 Application
ISO 9001:2008, Quality Management systems — Requirements
1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all
organizations, regardless of type, size and product provided. Where any requirement(s) of this
International Standard cannot be applied due to the nature of an organization and its product, this can
be considered for exclusion. Where exclusions are made, claims of conformity to this International
Standard are not acceptable unless these exclusions are limited to requirements within Clause 7,
and such exclusions do not affect the organization’s ability, or responsibility, to provide product that
meets customer and applicable statutory and regulatory requirements.

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IS 16070 : 2013
1.2.1 This standard is applicable to the organization where equipment for generation, transmission, and
distribution of power are designed, manufactured, installed, operated and maintained.
1.2.2 Exclusions are not permitted for this standard as for power projects a systems design is essential
for any project in view of site specific requirements and hence design needs to be controlled and permitted
exclusions do not include manufacturing process design.
2 References
The standards listed below contain provisions, which through reference in this text constitute provisions
of this standard. At the time of publication, the editions indicated were valid. All standards are subject to
revision and parties to agreements based on this standard are encouraged to investigate the possibility
of applying the most recent editions of the standards indicated below:
IS No. Title
12040:2001 Guidelines for development of supplier rating system (first revision)
IS/ISO 9000:2005 Quality management systems — Fundamentals and vocabulary (third
revision)
IS/ISO 9001:2008 Quality management systems — Requirements (third revision)
IS/ISO 9004:2009 Managing for the sustained success of an organization — a quality
management approach (sixth revision)
IS/ISO/IEC 17025:2005 General requirements for the competence of testing and calibration
laboratories
3 Terms and Definitions
3.1 Terms and Definitions for the Power Industry
For the purpose of this standard, the terms and definitions given to ISO 9000 and the following shall
apply.
3.1.1 Quality Control Plan (QCP) — A document setting out the specific quality practices and procedures
relevant to a particular component, part or a material (see Annex A).
3.1.2 CIP — CIP ‘Customer Interaction Point’ is a stage identified by customer in quality plan, which is
to be offered to customer or authorized representative for witnessing, verification or review, beyond
which the work shall not proceed without the written consent of the customer.
3.1.3 Non-conformance — Non-conformances have two categories major and minor. Major non-
conformances are those which have a direct or indirect adverse effect on performance, reliability, safety,
interchangeability, maintainability or on working life of the material, equipment or service. All other non-
conformances are classified as minor.
3.1.4 Categorization of QCP/Quality Control Plan
a) Category I — Quality control plan approval by customer and physical inspection by customer is
envisaged.
b) Category II — Quality control plan approval by customer but no physical inspection by customer
is envisaged.
c) Category III — No quality control plan approval by customer is envisaged. The controls shall be
applicable as per supplier’s own quality assurance system.
3.1.5 Field Welding Schedule — The form used to document field weld locations, numbers, welding
procedure to be used, technical requirements, code requirements and non-destructive examination
requirements for a specific contract.

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IS 16070 : 2013
4 Quality Management System
4.1 General Requirements
ISO 9001:2008, Quality Management systems — Requirements
4 Quality management system
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system
and continually improve its effectiveness in accordance with the requirements of this International
Standard. The organization shall
a) determine the processes needed for the quality management system and their application
throughout the organization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these
processes are effective,
d) ensure the availability of resources and information necessary to support the operation and
monitoring of these processes,
e) monitor, measure where applicable, and analyse these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these
processes.
These processes shall be managed by the organization in accordance with the requirements of this
International Standard.
Where an organization chooses to outsource any process that affects product conformity to
requirements, the organization shall ensure control over such processes. The type and extent of
control to be applied to these outsourced processes shall be defined within the quality management
system.
NOTE 1 Processes needed for the quality management system referred to above include processes for management
activities, provision of resources, product realization, measurement, analysis and improvement.
NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and which
the organization chooses to have performed by an external party.
NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity
to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced
process can be influenced by factors such as
a) the potential impact of the outsourced process on the organization’s capability to provide product that conforms
to requirements,
b) the degree to which the control for the process is shared,
c) the capability of achieving the necessary control through the application of 7.4.
4.1.1 General Requirements — Supplemental
Ensuring control over outsourced processes shall not absolve the organization of the responsibility of
conformity to all customer requirements.
Outsourcing shall be subject to any contractual agreement. If outsourcing is required after order has
been received then the customer shall be suitably involved
NOTE — See also 7.4.1 and 7.4.1.3.
4.2 Documentation Requirements
4.2.1 General

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IS 16070 : 2013
ISO 9001:2008, Quality Management systems — Requirements
4.2 Documentation requirements
4.2.1 General
The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures and records required by this International Standard, and
d) documents, including records, determined by the organization to be necessary to ensure the
effective planning, operation and control of its processes.
NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the
procedure is established, documented, implemented and maintained. A single document may address the requirements
for one or more procedures. A requirement for a documented procedure may be covered by more than one document.
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
NOTE 3 The documentation can be in any form or type of medium.
4.2.1.1 Organization shall ensure latest versions of documents are accessable to all concerned in all
work places and preferably in soft form.
4.2.2 Quality Manual
ISO 9001:2008, Quality Management systems — Requirements
4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any
exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference to
them, and
c) a description of the interaction between the processes of the quality management system.
4.2.3 Control of Documents
ISO 9001:2008, Quality Management systems — Requirements
4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special
type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin determined by the organization to be necessary
for the planning and operation of the quality management system are identified and their
distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to
them if they are retained for any purpose.

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4.2.3.1 Quality control plans (shop activities/field services) and engineering drawings/datasheets
The organization shall have a process to assure the timely review, approval, and distribution for
implementation of all customer approved engineering drawings, datasheets, Quality control plans and
including customer effected changes.
The organization shall maintain a record of the date on which each change is implemented in production.
4.2.4 Control of Records
ISO 9001:2008, Quality Management systems — Requirements
4.2.4 Control of records
Records established to provide evidence of conformity to requirements and of the effective operation
of the quality management system shall be controlled. The organization shall establish a documented
procedure to define the controls needed for the identification, storage, protection, retrieval, retention
and disposition of records. Records shall remain legible, readily identifiable and retrievable.
4.2.4.1 Records retention
The control of records shall satisfy statutory and regulatory and customer requirements.
4.2.4.2 The records as agreed to be submitted to the customer as history of the equipment shall be
compiled and submitted to the customer within agreed time of dispatch of respective products.
5 Management Responsibility
5.1 Management Commitment
ISO 9001:2008, Quality Management systems — Requirements
5 Management responsibility
5.1 Management commitment
Top management shall provide evidence of its commitment to the development and implementation
of the quality management system and continually improving its effectiveness by
a) communicating to the organization the importance of meeting customer as well as statutory
and regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews, and
e) ensuring the availability of resources.
5.1.1 Process Efficiency
Top management shall periodically review the product realization processes and the support processes
including timely deliveries to assure their effectiveness and efficiency .
5.2 Customer Focus
ISO 9001:2008, Quality Management systems — Requirements
5.2 Customer focus
Top management shall ensure that customer requirements are determined and are met with the aim
of enhancing customer satisfaction (see 7.2.1 and 8.2.1).

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