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ASME NQA-1 Certification
Matthew Vazquez
September 4, 2017
NQA-1 Certification
The ASME NQA-1 Certification Program seeks to meet the needs of the nuclear industry by expanding the supply chain with organizations who are committed to understanding quality and providing high quality products and services.
Conformity Assessment
Programs
Product Certification
BPV
Nuclear Component
RTP
BPE
Quality Program
Certification
NQA-1
Nuclear Materials
Accreditation
AIA
PRD
Personnel Certification
GDTP
QRO
ANDE
November
Conformity Assessment
Requirements
Most CA Schemes including ASME have the
following:
1. Inspection
2. Examination
3. Testing
4. Evaluation
5. Auditing
6. Certification
NQA-1 Certification Program
• Applies to organizations supplying items or services which
provide a safety function for nuclear facilities
• The ASME NQA-1 Certification program provides a means for an
organization supplying items or services that are safety related to
have its Quality Assurance Program recognized by ASME.
• The ASME NQA-1 Certification program audits an organizations
Quality Assurance Program and is verified to be in conformance
with the requirements of the ASME NQA-1 Standard.
• The ASME Certification program applies to organizations whose
Quality Assurance Program is based upon the ASME NQA-1-
2008 Standard and subsequent editions/addenda of the Standard.
NQA-1 Certification Program
• Having an NQA-1 QA Program recognized by an independent
organization that is internationally known and respected.
• Provides confidence to your customers that you have the knowledge
and resources to implement an NQA-1 QA program.
• Assist new suppliers gaining entry into the supply chain.
• Reduce amount of time, effort and resources to purchasers in
determining if a potential supplier has an acceptable NQA-1 program.
• Provides confidence to Senior Management that the established QA
program is being satisfactorily implemented by their employees.
• Creates a level “playing field” with promoting consistent application
of NQA-1 standard within the industry and supply chain.
ASME Certification Scheme
• Quality Manual –Describes how ASME will administer its accreditation and certification programs in a competent, consistent and impartial manner. It meets the essential requirements and principles of:
• ISO 17011 Conformity Assessment –General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies
• ISO 17065 Conformity Assessment –Requirements for Bodies Certifying Products, Processes and Services
• ASME Certification Scheme
NQA-1, The QA Manual and
meeting the following conditions:
• The Manual cannot be a reiteration of the NQA-1 Standard, but rather, an auditable detailed written document which clearly describes the controls for each quality element.
• The Manual should not be written to address multiple quality programs; it should only address the requirements of the ASME NQA-1 Standard.
• The Manual needs to describe the scope of the items, products and services provided by the organization.
• The Manual must be in written in English. A version of the Manual may be in one’s native language; however, the English version will govern.
Things to do prior to submitting an
application
– Review relevant information about the desired certification program on ASME's website
– Decide on scope of work that will be certified by ASME
– Obtain required standards
– Prepare the quality manual, a written description of the quality program
– Indoctrinate and train personnel to implement the quality program
Applying for NQA-1
Certification
• New applicants will need to create an account in CA Connect
• Existing account holders should first ensure that the primary contact for the account is correct. Changes to contact are made through CA Connect
• Complete the NQA-1 application
• Submit the signed accreditation and Certification agreement form
CA Connect
CA Connect
Application
• The application forms for the NQA-1 Certification Program is constructed to obtain a significant amount of information to allow ASME to determine:
I. the expertise needed
II. the size of the audit team
III. the locations to be audited
IV. the duration of the audit.
Application
• Information required by the application includes the following:
I. Name, address and organization contacts.
II. Identification and descriptions of locations performing
activities affecting or controlling quality.
III.Identification of activities affecting quality performed
and/or subcontracted by the organization, including the
applicability of each NQA-1 Part I and II requirement.
IV.Identification of the type of product/services being
provided.
Complete NQA-1 Package
• A completed application package contains:
• A controlled and approved copy of the Quality Assurance Manual;
• A completed "NQA-1 Quality Assurance Manual Checklist".
• The Checklist can be downloaded from the Nuclear Quality
Assurance (NQA-1) Certification web page;
• Completed application forms; (Submitted on line)
• The advanced deposit fee.
Manual Checklist
Certification Timeline
Successful QA Manual Implementation
19
Quality Manual vs Implementing
Procedures
20
0 20 40 60 80 100
How
Where
When
Who
What
QA Manual
ImplementingProcedures
2
1
Implementation and the NQA-1
Manual • Organization
Verify Indoctrination
Indoctrination
How are personnel identified
to receive indoctrination;
Identify indoctrination topics;
Codes and standards
Company procedures,
QA program requirements
Records;
Topic
Training Logs
Attendance sheets
Dates
Records
Topic
Identify
Personnel Indoctrination
Quality
Manual
2
2
• Organization
Verify Training
Training
Written procedures for the
qualification of personnel:
Welders & Operators
NDE Personnel
Auditors & Lead Auditors
Inspection & Test Personnel
Only personnel who meet the
requirements are permitted to
perform these activities;
Records contain required
information;
Records
of Training &
Certification
Personnel
Permitted to
Perform
Activity
Written
Procedures
Training
Quality
Manual
Implementation and the NQA-1
Manual
2
3
• Design Control
Verify
The Design Outputs has been
reviewed, and certified by the
responsible persons
Software when used has been
validated
Drawings show required
information.
Calculations are complete
Document Changes are identified
Design Output Documents when
required has been prepared
Control of Records
Final
Records
Design
Output
Revision
Calculations Drawings
Software
User’s
Design
Spec-
Quality
Manual Design
Control
Implementation and the NQA-1
Manual
2
4
• Procurement Document Control
Verify
The transfer of information
from design documents;
Purchase documents indicate
required information;
Preparation of Approved
Vendors List (AVL);
Maintenance of Approved
Vendors List (AVL);
Selected of Vendor(s) are from
AVL;
Transfer of information for
receiving inspection.
Information
Transmitted
for Receiving
Selected
Vendors
On AVL
Maintenance
of AVL
Preparation
of AVL
Required
Info Included
in PO
Transfer from
Design Doc.
Procurement
Document
Control
Quality
Manual
Implementation and the NQA-1
Manual
2
5
Final
Records
Audit
Records
Calibration
Records
NCR’s
Insp. &
Test
Records
Purchasing
Documents
Design
Documents
Procedures
Instructions
Document
Control
• Document Control
Verify
Only current documents
that have been prepared,
reviewed, and approved or
certified by the responsible
persons, distributed to
where they are used, and
that obsolete versions are
removed.
Quality
Manual
2
6
• Identification & Control of Items
Verify
Only correct and accepted
items are used or installed;
Identification is maintained on
the items or in documents
traceable to the items or in a
manner which assures that
identification is established
and maintained.
Review of
Objective
Evidence
Receiving
Inspection
Records
Information
Transmitted
for Receiving Traceability
To Original
Required
Marking
Transfer of
Material
Marking
System
How are
accepted
Items are
Identified
Identification
& Control
of Items
Quality
Manual
Implementation and the NQA-1
Manual
2
7
• Identification & Control of Items
Verify
Only correct and accepted
items are used or installed;
Identification is
maintained on the items or
in documents traceable to
the items or in a manner
which assures that
identification is
established and
maintained.
Traceability
To Original
Required
Marking
Transfer of
Material
Marking
System
How
accepted
Items are
Identified
Identification
& Control
of Items
Quality
Manual
Implementation and the NQA-1
Manual
2
8
Implementation
• Control of M & T Equipment
Verify
Calibration schedule established with
prescribed times or intervals;
traceable to certified equipment or Standards
Procedures
Reference Standards four times greater than that of the
measuring and test equipment being calibrated
Control overdue for calibration or found
to be out-of-calibration identified
Application traceable to its application and
use
Status Indication
Records
Records
Status
Application
Control
Reference
Standards
Calibration
Procedures
Calibration
Traceable to
Standards
Calibration
Schedule
Control of
M & T
Equipment
Quality
Manual
2
9
• Nonconforming Items
Verify
How items are identified;
Nonconformity Report
Form contains required
information;
Were revision to
documents required;
Proposed resolution
approved;
Approval of
Resolution
Document
Revisions
Nonconformity
Report Form
Identification
of Items
Nonconformity Quality
Manual
Implementation and the NQA-1
Manual
3
0
• QA Records
Verify
List of Records to be
maintained;
How records are
protected;
How is access to
records controlled;
How are records
revised when required;
Who is responsible for
maintaining records.
Maintaining
Records
Revision to
Records
Access to
Records
Protection of
Records
Lists of
Records
QA Records Quality
Manual
Implementation and the NQA-1
Manual
3
1
• Audits
Verify
Auditor Qualifications
Training Records
Audit Scheduling;
Audit Records
Internal Audits
External Audits
Management Review of
Internal Audits
Management
Review
Audit
Records
Audit
Scheduling
Training
Records
Auditor
Qualifications
Audits Quality
Manual
Implementation and the NQA-1
Manual
