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Nuclear Quality Standard Association
This document is the property of NQSA Its copying, use or communication is subject to prior authorization
General information about Quality Management System in the nuclear industry
A relevant answer to a changing context
New needs identified by:
Buyers
Nuclear authorities
Suppliers
INCREASING DEMAND for safety and quality
NEWCOMERSincluding countries with poor nuclear
culture
TECHNICAL SUPPORTdevelopment support for their local
economies
CUSTOMER EXPECTATIONS for quality of products, services and
lead time
���� Long-term trend
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.2
An improved approach of Suppliers
� Evaluation of the supplier and its supply chain
Assessing capability to execute in compliance with the requirements
� Requirements based on « standards »
Capacity to understand and cascade the requirements
� Control of product execution
Performance of proficient Inspection
Integration of a new standard
« NSQ-100 »
« Inspection » Performance
To better manage risks related to the construction of the nuclear power plant all along the supply chain
* NQSA Nuclear Quality Standard Association
*
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.3
� NQSA (Nuclear Quality Standard Association)
A non profit association of major nuclear industry actors created to :
� Promote the application of a robust quality standar d (NSQ-100)
� Provide a framework for further evolutions of the s tandard
� Set a “nuclear oriented” supplier evaluation proces s to further prepare a new certification scheme
� Qualify certification bodies & NSQ-100 Auditors
www.nqsa.org
From the NQSA website, download with free access:
•NSQ-100 (in English, French, Russian & Spanish)
•Procedures Qualification of CBs & Auditors
•The correspondence matrices with: GS-R-3 (IAEA), RD 0034 (RSA), RPP-1 (AFCEN), 10 CFR 50 Appendix B (USA) and KTA 1401 (GER)
•8 Guidelines
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.5
An already long-lasting story
NSQ-100 v0 GuidelinesCorrespondence
matricesBV Certification
qualified by NQSA
2011 2012 2013 2014
•GS-R-3 (IAEA)•RD-0034 (SA)•RPP1 (Fr)•10 CFR 50 (USA)•KTA 1401 (GER)
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.6
Our results
� NQSA is a dynamic association, with already 9 full members (industry leaders)
� NSQ-100 is becoming a well-known standard (thousand s of downloads worldwide: utilities, suppliers, regulato ry bodies…)
� A popular website
� Productive discussions with ISO: NSQ-100 is set to be the new nuclear standard for quality management system
� Take part in the redaction of the Guidelines (shari ng experience and best practices)
� Development of the certification process
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.7
The method used to develop NSQ -100
� Based upon ISO 9001:2008 structure : an industry co nsensus quality standard ensuring the integration of Nuclea r QA requirements in well-known industrial quality pract ices
� Key elements integration of two major nuclear refer ence codes and experience� IAEA GS-R-3:2006 � ASME NQA-1-2008 (18 criteria)� Experience feedback from recent constructions
� Development process inspired by the approach follow ed in other industries, mainly Aircraft Industry (EN 9100 Quality Management Systems / Requirements for Aviation, Space and Defense Org.)� Similar context: strong safety requirements, high q uality and industrial
expectations combined with a product/process and lo w production volume orientation
� Integration of specific requirements into a largely deployed standard
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.8
The NSQ-100 story
Project Specifications
Project Specifications
Project Specifications
ISO 9001
Project Specifications
Generic Project
Specifications
Project Specifications
Project Specifications
InternationalTrans projectOver the time
NSQ-100Standard
based onISO 9001:2008
structureand on
IAEA GS-R-3:2006
ASME NQA-1:2008 2009 addenda principles
CorrespondenceMatrix
Specific Request(local regulation)
Buyers, Safety Authorities
90%*
* 90% of generic specifications of a management sys tem certification for the nuclear industry is addressed by NSQ-100
Impl
emen
tatio
n G
uide
s
Sub
-Con
trac
tors
Before NSQ-100
Certification Process
Project Adaptation
Process
ISO 9001
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.9
The quality of the certificate is guaranteed by:
� NQSA Industry Members oversight: periodic surveilla nce and witnessing audits
� The Impartiality Committee oversight, of the comple te NQSA process
NQSACertification Committee
(Industry Members Only)
Qualification of Certification
Bodies
Audit Specification
Certificate issuance Process
Certification Bodies
Issuance of Certificate
SUPERVISION
Certification process
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.10
NSQ-100 standard:
� includes detailed requirements for quality manageme nt, applicable to a supplier of goods or services used in the construction and maintenance of a nuclear installat ion,
� is not intended to substitute for regulatory or con tractual requirements, but is designed to help to answer the m.
Reminder : position of NSQ-100 standard versus Regu lations
NSQ-100 in details …
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.11
NSQ-100 - Main Requirements
� In addition to ISO 9001, NSQ-100 requirements mainly focus on:�Quality Management Program
�Safety Culture
�Graded approach
�Independence of verification
�Competences management
�Language / Translation
�Project Management
�Supplier Assessment
�Procurement control
GRADED APPLICATION OF
QUALITY REQUIREMENTS
PRODUCT CLASSIFICATION
TIME MANAGEMENTRISK MANAGEMENT
INTERNATIONAL ENVIRONMENT
MANAGEMENT OF COMPETENCIES
CONTROL OF PRODUCTION
PROCESSES AND NON-CONFORMING
PRODUCT
INDEPENDENCE OF REVIEW AND
SURVEILLANCE
NUCLEAR INDUSTRIAL PRACTICES
RELATIONS WITH NUCLEAR SAFETY
AUTHORITIES
« SAFETY CULTURE »
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.12
Main orientations of the new standard NSQ -100
Project Quality
� Independence of review and surveillance activities
� Control of non conforming product and production processes
� Management of competencies – qualification of personnel
� Safety culture� Grading and cascading
application of quality requirements
� Classification of product
� Time management : planning and time schedule
� Risk management and mitigation
� International environment -language
On what to focus for evaluation of Suppliers?
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.13
The contents of NSQ -100
5 MANAGEMENT RESPONSIBILITY5.1 Management Commitment5.2 Customer Focus5.3 Quality Policy5.4 Planning5.4.1 Quality Objectives5.4.2 Quality Management System Planning5.5 Responsibility, Authority and Communication5.5.1 Responsibility and Authority5.5.2 Management Representative5.5.3 Internal Communication 5.5.4 Communication with Regulatory Bodies5.6 Management Review5.6.1 General5.6.2 Review Input5.6.3 Review Output
6 RESOURCE MANAGEMENT6.1 Provision of Resources6.2 Human Resources6.2.1 General6.2.2 Competence, Qualification, Training and
Awareness6.3 Infrastructure6.4 Work Environment
Basics of ISO 9001:2008 dealing with quality system replicated as is
Slight adaptation to complement with nuclear specificities
Addition of chaptersspecific to nuclear context
In depth modificationto comply with nuclear specificities and standards (e.g. training to safety culture)
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.14
� The correspondence matrices to the following standa rds with NSQ-100, are available on the NQSA website:
�GS-R-3 (IAEA), � RD 0034 (RSA), � RPP-1 (FRANCE - AFCEN), � 10CFR 50 Appendix B (USA)� KTA 14001 (GER)
The Correspondence matrices with NSQ -100
These matrices show that NSQ-100 is fully in line w ith the requirements of GS-R-3 (IAEA) and 10 CFR 50 Appendi x B
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.15
A Win-Win Quality Standard
Benefits to Buyers
� Simplifies the process for assessment of Suppliers
� Relies on a panel of certified nuclear industry suppliers
� Gives to buyers the assurance of a standardized level of quality in products and services
� Provides charts for comparisons with country requirements
� Optimizes the buyer’s project schedule and improves productivity
Benefits to Suppliers
� Helps for acquiring a genuine safety culture
� Fills the gap between the nuclear requirements and common industrial requirements
� Eases implementation of the requirements through online guides and tools
� Leads for getting a certification of the nuclear Safety & Quality Management System
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.16
8 Guidelines
Preamble
� A : General
� B : Safety Culture
� C : Graded Approach
� D : Planning
� E : Design
� F : Purchasing
� G : Production & Inspection
� H : Audits & NCR
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.17
Our objectives
Topic Currently In the future
Promote good behaviorsSpread and share best practices through harmonized u nderstanding of
the requirements (Guidelines)
Share experience
Communication Promote NSQ-100 Promote ISO standard
Reduce cost of poor qualityIntroduce a culture of nuclear quality, of nuclear safety and of project
management, as early as possible in the value strea m
Certification process Define the process Oversight it s implementation
Nuclear safety authorities Coordinate initiative and activities
Process databaseDevelop and
maintain a list of:
-recognized Accreditation Bodies-accredited Certification Bodies-Qualified auditors-certified organizations
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.19
Our future model
EN
9100
Certification Bodies
AccreditationBodies
Training Bodies
Auditors
AEROSPACE COMPANIES
A model and method inspired by aircraft industrySimilar context:•strong safety requirements (risky industry)•high quality and industrial expectations•low production volume
Accreditation
Certification
NSQ
100
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.20
NUCLEAR SUPPLIERS
Our vision
2015 2016 2017 2018
Association ISO Certification process
Welcome newcomers
Objective:Publication of the international
standard ISO 19443 within2 years
• Qualify new CB• Qualify training bodies • Deliver certificates
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NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.21
In conclusion� The management of the quality of the supply chain i s a major
challenge in the construction and maintenance of nu clear plants
Further DevelopmentWith ISO: The working group WG 4 has been created within ISO TC 85 (Nuclear), for:“Development of enhanced requirements for nuclear industry, with respect to ISO 9000/17000 series,
ISO/TC85/WG4 is currently developing the new projec t on quality management systems, on the basis of NSQ-100 :ISO 19443 “Specific requirements for the application of ISO 9001 and
IAEA GS-R, by organizations in the Supply Chain of t he Nuclear Energy sector”
With IAEA: One basis for updating:GSR- Part 2 guides for suppliers
NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.22