1. Nuclear Quality Standard Association
General information about Quality management System in the nuclear industry
Ce document est la propriété de NQSA.
Il ne peut être utilisé, reproduit ou communiqué sans autorisation préalable.
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.1

2. Which quality standard for the nuclear industry?
WNA Symposium, September 2013

3. The objectives of NSQ-100 standard
Improve understanding of quality requirements by the suppliers
Helps increasing the safety culture
Translating very general requirements and providing guidance for implementation
Standardize the requirements
Is a way to capitalize on industrial practices already well understood and applied in other industries while strengthening the integration of the nuclear requirements
Promote all major nuclear industry players to work in the same direction with their suppliers
Help suppliers through a unique and shared quality platform
Represents a greater attractiveness for suppliers as an international and recognized standard, trans project and over the time  cost reduction, quality enhancement
Creates a capitalization of know-how and competence of supply chain  create a high quality platform of nuclear suppliers
Suppliers work for many customers/manufacturers -> need to set in place a convergence between clients (DO)
Increase the experience feedback by creating a shared platform
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.3

4. www.nqsa.org NQSA (Nuclear Quality Standard Association)
A non profit association of Major Nuclear Industry Actors created to :
Promote the application of a robust quality standard (NSQ-100)
Provide a framework for further evolutions of the standard
Set a “nuclear oriented” supplier evaluation process to further prepare a new certification scheme
Accredit certification bodies
From the NQSA website,
download with free access,
NSQ 100 (in English and French versions)
The correspondence matrices with: GS-R-3 (IAEA), RD 0034 (RSA), RPP-1 (AFCEN)
8 Guidelines
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.4

5. A joint work open to partners
NQSA members :
And with an observer status
Discussions under progress with: Eskom, MHI, EDF, WNA
But non exclusive and designed to be open to all major nuclear procurement organizations: utilities, engineering, major vendors as well as other certification bodies: e.g. HSB
NSQ-100 standard is the property of NQSA
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.5

6. The method used to develop NSQ-100
Based upon ISO 9001:2008 structure : an industry consensus quality standard ensuring the integration of Nuclear QA requirements in well-known industrial quality practices
Key elements integration of two major reference nuclear codes
IAEA GS-R-3:2006
ASME NQA
Development process inspired by the approach followed in other industries, mainly Aircraft Industry (EN 9100 Quality management systems / Requirements for Aviation, Space and Defense Organizations)
Similar context: strong safety requirements, high quality and industrial expectations combined with a product/process and low production volume orientation
Integration of specific requirements into a largely deployed standard
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.6

7. The NSQ-100 story
ISO 9001
ISO 9001
International Trans project Over the time
NSQ-100 Standard based on ISO 9001:2008 structure and on IAEA GS-R-3:2006
ASME NQA-1: addenda principles
Implementation Guides
Sub-Contractors
90%*
Generic
Project
Specifications
Project Specifications
Project Specifications
Project Specifications
Project Specifications
Certification Process
n projects
Project Specifications
Project Specifications
n projects
Correspondence Matrix
Project Adaptation Process
Specific Request (local regulation)
Before NSQ-100
Buyers, Safety Authorities
* 90% of generic specifications of a management system certification for the nuclear industry is addressed by NSQ-100
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.7

8. Apply for approved vendor
Suppliers qualification process
TODAY’S PROCESS
Prequalification
Qualification
Execution
Sourcing
Pre-Qualification
Qualification Audit
Process findings
Final Review
AVL
Long interactions between customer and supplier
NQSA PROCESS
Qualification
Execution
Application
Certification Audit
Apply for approved vendor
Application Review
Certified
AVL
Shorter interactions/
allows a focus on the product compliances
Certification bodies
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.8

9. Progress status: Where are we today ?
Standard = QA specification
Version 0 of NSQ-100 standard has been developed and can be downloaded on NQSA website: Reference in English and French translation available
Guidelines = provide additional explanations and proposal of implementation methods
8 Guidelines available on NQSA website, to be downloaded
Correspondence matrixes = formalize correspondence between NSQ-100 and major nuclear QA standards
Done for GS-R-3 (IAEA) , RD-0034 (RSA), RPP-1 (AFCEN) : respectively NSQ-110, NSQ-140 & NSQ-150, available on NQSA website, to be downloaded
in progress for : NQA-1 (USA), KTA 1401 (Germany)
Procedures available on NQSA website, to be downloaded for Certification Body candidates
Qualification process for Certification Bodies
Qualification of auditor and lead auditor
Pilot phase with some selected suppliers
Has given confidence on adequacy of the requirements to nuclear safety objectives
Next step :
Qualification of Certification Bodies and auditors
2nd semester 2013: Launching the NSQ-100 certification process for companies
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.9

10. Certification process
Qualification of Certification Bodies
SUPERVISION
NQSA
Certification Committee
(Industry Members Only)
Audit Specification
Certification Bodies
Certificate issuance
Process
Issuance of Certificate
The quality of the certificate is guaranteed by the Industry Members through NQSA oversight by performing periodic surveillance and witness audits
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.10

11. Reminder : position of NSQ-100 standard versus Regulations
NSQ-100 in details …
Reminder : position of NSQ-100 standard versus Regulations
NSQ-100 standard:
includes detailed requirements for quality management, applicable to a supplier of goods or services used in the construction of a nuclear installation,
is not intended to substitute for regulatory or contractual requirements, but is designed to help to answer them.
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.11

12. 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
NUCLEAR INDUSTRIAL PRACTICES
RELATIONS WITH NUCLEAR SAFETY AUTHORITIES
MANAGEMENT OF COMPETENCIES
PRODUCT CLASSIFICATION
INDEPENDENCE OF REVIEW AND SURVEILLANCE
GRADED APPLICATION OF QUALITY REQUIREMENTS
CONTROL OF PRODUCTION PROCESSES AND NON-CONFORMING PRODUCT
TIME MANAGEMENT
RISK MANAGEMENT
INTERNATIONAL ENVIRONMENT
« SAFETY CULTURE »
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.12

13. Main orientations of the new standard NSQ-100
On what to focus for evaluation of Suppliers?
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
Nuclear Quality
Nuclear Safety
Project Quality
Time management : planning and time schedule
Risk management and mitigation
International environment - language
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.13

14. The contents of NSQ-100
5 MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.5.4 Communication with Regulatory Bodies
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6 RESOURCE MANAGEMENT
6.1 Provision of Resources
6.2 Human Resources
6.2.1 General
6.2.2 Competence, Qualification, Training and Awareness
6.3 Infrastructure
6.4 Work Environment
Basics of ISO 9001:2008 dealing with quality system replicated as is
Slight adaptation to complement with nuclear specificities
Addition of chapters specific to nuclear context
Depth modification to comply with nuclear specificities and standards (e.g. training to safety culture)
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.14

15. A Win-Win Quality Standard
Benefits to Buyers
Simplifies the buyer’s assessment of Suppliers
Provides charts for comparisons with country requirements
Gives buyers assurance of a standardized level of quality in products and services
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 nuclear quality label
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.15

16. 8 Guidelines Preamble A : General B : Safety Culture
C : Graded Approach
D : Planning
E : Design
F : Purchasing
G : Production & Inspection
H : Audits & NCR
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.16

17. Examples of Guidelines content Objective of the guidelines is to answer question that the supplier may have for a correct implementation of the NSQ-100 Standard requirements
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.17

18. Concept of Safety Culture
Guideline B
Concept of Safety Culture
Safety Culture Definition : Overall characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, protection and nuclear safety issues receive the attention warranted by their significance
NSQ-100 Guideline – Section B : Safety Culture
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.18

19. CLASSIFICATION / GRADED APPROACH
Guideline C
CLASSIFICATION / GRADED APPROACH
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.19

20. CLASSIFICATION / GRADED APPROACH
Guideline C
CLASSIFICATION / GRADED APPROACH
The “PRODUCT” has to be the subject to an analysis by the manufacturer in order to determine the importance of:
Each item on the product safety function or the product final quality,
Each activity (during design, development, manufacturing, erection, commissioning and related services), which may affect the product safety function or the product final quality.
To perform this analysis, it may be useful to refer to one or more of the different type of methods as listed in EN standard (Risk management – Risk assessment techniques).
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.20

21. Guideline D Product Realisation List of IFS items or Activities
Determination of product requirements
List of IFS items or Activities
Identifying needs for monitoring (audits, inspections and tests, ...) and records required (methods of proof of compliance with requirements)
Design
Design verification
Purchasing
Purchasing specs verification
Project Management
Risk Management
Production & Tests
Inspection of product, items, activities
Configuration Management
Surveillance
Surveillance of production
Internal Audit
Auditor independent of the activity
Verification by a person different than those who have participated to the activity
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.21

22. DESIGN & DEVELOPMENT Example of suggested follow-up table
Guideline E
DESIGN & DEVELOPMENT Example of suggested follow-up table
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.22

23. Planning of inspection et surveillance
Guideline G
Planning of inspection et surveillance
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.23

24. NON CONFORMANCE CONTROL : SUGGESTED SCHEME
Guideline H
NON CONFORMANCE CONTROL : SUGGESTED SCHEME
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.24

25. Further Development within ISO
A new working group is being created within ISO TC 85, for “development of enhanced requirements for nuclear industry, with respect to ISO 9000/17000 series, with the main objective of conformity assessment guaranties in coherence with the safety importance / classification”
Proposed basis for this development is NSQ-100 and its associated procedures
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, p.25

26. Thank you