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NAVSEA
STANDARD ITEM
FY-23
ITEM NO: 009-04
DATE: 01 OCT 2021
CATEGORY: I
1. SCOPE:
1.1 Title: Quality Management System; provide
2. REFERENCES:
2.1 Standard Items
2.2 ANSI/ISO/ASQ Q9001-2015, Quality Management Systems – Requirements
|
2.3 ISO/IEC 17025, General Requirements for the Competence of Testing and
Calibration Laboratories
2.4 NAVSEA 04-4734, Navy and Marine Corps Calibration Laboratory
Audit/Certification Manual
2.5 SSPC QP1 Application, Instructions, and Program Rules
2.6 NAVSEA OD 45845, Metrology Requirements List (METRL)
3. REQUIREMENTS:
3.1 Establish, document, implement, and maintain a Quality Management System (QMS)
as a means of ensuring that product conforms to specified requirements.
3.2 A written QMS Manual addressing all elements of 2.2 and supporting documented
procedures must be submitted to the SUPERVISOR for review and acceptance. Required
documented procedures may be contained in either the Manual or Level II QMS procedures. The
contractor must have an accepted QMS, in accordance with this Standard Item, in place to
receive an award of a Job Order. Include the following documented procedures if not addressed
in the contractor’s Quality Manual:
3.2.1 Support: Address all areas of Paragraphs 7.1.5, 7.2 and 7.5 of 2.2.
3.2.1.1 Calibration laboratories must be accredited to either 2.3 by a |
Commercial Accreditation Activity, or certified by a Navy Certification Activity to 2.4. The
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calibration laboratory’s scope must include the parameters required to execute the calibration at
the appropriate ranges and tolerances.
3.2.1.2 Calibration intervals assigned to Measuring and Test Equipment
used by the contractor for acceptance testing must meet those recommended in 2.6 and shall
reflect TMDE end of period reliability of greater than 85 percent. TMDE reliability data must
be provided upon request.
3.2.1.3 Test uncertainty ratios must be greater than 4:1, or ensure a
probability of false acceptance of 2 percent or less, and a probability of false rejections of 15
percent or less.
3.2.2 Operation: Address all areas of Paragraphs 8.2, 8.4, 8.5, 8.6, 8.7 of 2.2
3.2.2.1 Verification of Purchased Product: Identify, in the purchasing
documents, verification arrangements at the subcontractor or vendor location/premises.
Purchasing documents must contain the following statement when the SUPERVISOR requests
government inspection: "Government Inspection is required prior to shipment from your plant.
Upon receipt of this order, promptly notify and furnish a copy to the Government representative
who normally services your plant so that appropriate planning for government inspection can be
accomplished. In the event the government representative or office cannot be located, our
purchasing agent must be notified immediately.
3.2.2.2 Unless otherwise specified in a higher tier document, Receipt
Inspection of contractor furnished materials must be based on supplier performance history and
one or more of the following: certificate of compliance, vendor material test certification data,
manufacturer's mill certificate, or testing using sampling techniques.
3.2.3 Performance evaluation: Address all areas of
Paragraphs 9.2 and 9.3 of 2.2
3.2.4 Improvement: Address all areas of
Paragraph 10.2 of 2.2.
3.2.5 The documented QMS must include a matrix listing the correlation between
2.2, 3.2 and the corresponding paragraph/sub-paragraph(s) of the submitted documented
procedures.
3.3 Subsequent to SUPERVISOR acceptance, a contractors QMS certification is
acceptable in any other geographic location in which the contractor maintains the same QMS,
providing:
3.3.1 The contractor uses the same QMS Manual.
3.3.2 The contractor uses the same QMS Manager as the final decision authority for
QMS policy.
3.3.3 Successful completion of Contractor’s QMS Review Checklists (Attachment
B, C, and D) in their entirety by the SUPERVISOR.
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3.4 The QMS must be subject to audits by the SUPERVISOR throughout the contract.
Retain documented information to demonstrate the processes are carried out as planned. Audits
must be conducted on active contracts, but may be conducted on completed contracts when there
are limited or no active contracts available.
3.5 Submit one legible copy, in hard copy or approved transferrable
media, of any
revisions, including the planned implementation date, to the accepted QMS identified
in 3.2 to the
SUPERVISOR within 7 days of contractor approval.
3.6 Submittal of procedures invoked by NAVSEA Standard Items, MIL-STDs,
drawings, technical publications, and specifications, although an integral part of the QMS, must
be submitted to and approved by the SUPERVISOR independent of the QMS a minimum of 14
days prior to start of required process for planned availabilities, or as otherwise approved by
SUPERVISOR.
3.7 The corrective action program must require that a copy of the written responses to
contractor generated corrective actions will be provided to the SUPERVISOR when requested.
3.8 Respond in writing to each SUPERVISOR issued Method B/C/D Corrective Action
(CA) within 3 business days unless otherwise specified by the SUPERVISOR. Initial response
must include immediate corrective action taken and a plan of action for CA completion,
including estimated completion dates. Final response must include preventive action for
recurrence of identified nonconformance, root cause analysis using Attachment “E“ and
Objective Quality Evidence (OQE) for corrective action completed. When a corrective action
response is unsatisfactory, revised response required within 3 business days unless otherwise
specified by the SUPERVISOR.
3.8.1 Inform the SUPERVISOR when corrective actions are complete for each
SUPERVISOR issued Method A (CA). Response required within 3 business days unless
otherwise specified by the SUPERVISOR. Response must state that the non-conformance has
been corrected.
3.8.2 Use NMD, or approved Web interface, to perform all CAR functions for
contracts managed in NMD.
3.9 Attend SUPERVISOR conducted fact-finding/investigative meetings when requested
by the SUPERVISOR not to exceed 4 hours. (See 4.4)
3.10 Develop a Test and Inspection Plan (TIP) incorporating each Work Item in the job
order, LOA Chits or Statements of Work (SOW). The initial TIP must include all inspections
and tests required by zero-tier references and first tier references, as well as symbols (I), (V),
(Q), test/inspections and (G) government notification identified in the Work Item, and any
additional tests and inspections the contractor deems necessary to substantiate product
conformance.
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3.10.1 Submit the initial copy of the TIP to the SUPERVISOR prior to start of
productive work for non-CNO availabilities and no later than 3 days prior to the availability start
date for CNO availabilities.
3.10.1.1 Use NMD, or approved Web interface, to perform all TIP
functions for contracts managed in NMD. TIP development in NMD using a Web interface
satisfies the requirements of 3.10.1.
3.10.1.2 Submit one legible copy of the initial TIP, in hard copy or
approved transferrable media that can be sorted (e.g., Excel spreadsheet) for contracts not
managed in NMD.
3.10.1.3 Submit one legible copy, in hard copy or approved transferrable
media that can be sorted (e.g., Excel spreadsheet) of an updated TIP when requested by the
SUPERVISOR not to exceed one per week for contracts not managed in NMD.
3.10.2 A TIP must:
3.10.2.1 Be revised prior to the start of productive work and updated as
work proceeds on each Work Item. Supporting data for tests and inspections requiring
government notification (G), including accept/reject criteria, must be available at the location of
each test and inspection. Include provisions for documenting the date, time, and identification of
the SUPERVISOR's representative notified and government representative attending each (G)-
Point on the TIP. The TIP must annotate the relationship to a specific key event unless otherwise
agreed upon by the SUPERVISOR. The following key events must be considered at a minimum
(as applicable): Undocking, Production Completion Date (PCD), Command, Control,
Communications, Computer, Combat Systems, and Intelligence (C5I) Light-Off (C5ILO), Work
Complete (WC), Dock Trials (DT), Fast Cruise (FC), Sea Trials (ST), and Availability
Completion (AC).
3.10.2.2 Each test and inspection must be identified by its respective Work
Item number and Work Item paragraph number, including Standard Item paragraph number,
unique identifier (number) that is used in both the TIP and IPS of 009-60, and must include
inspection symbols (I), (Q), (V), and the government notification (G) Point symbol where
applicable.
3.10.2.3 Provide identification of the item to be inspected by name,
number, and location (e.g., number 3 main feed pump, 5-180-0-E).
3.10.2.4 Provide identification of each characteristic of the items to be
inspected and provide the criterion for acceptance for each characteristic (e.g., air test; 2 PSIG
for 10 minutes; no drop).
3.10.2.5 Each test and inspection must not be removed.
3.10.2.6 Provide unique identification of test equipment used.
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3.11 Test and Inspection records must:
3.11.1 Include the ship's name and hull number, Job Order and Work Item number, a
unique serialization number, applicable PCP number, paragraph number, component
identification, accept/reject criteria, date, time, unique identification of test equipment used,
signature blocks for the Government and contractor authorized representatives who witnessed or
performed the test or inspection. The signature occurs after the checkpoint is determined to be
satisfactory or unsatisfactory and any exceptions are documented.
3.11.2 Be maintained at a contractor location accessible to the site of the work
required by the Job Order.
3.11.3 Be documented within one day of accomplishment or prior to the subsequent
tests or inspections, whichever is less. The records must indicate the results of the test and or
inspection accomplished. Test or inspection records will clearly identify each location or
component when multiple locations or multiple components are listed on a single record.
Records must be incorporated into the TIP within 4 days after completion of each test or
inspection.
3.11.3.1 For tests and inspections involving (G)-points, records must be
documented upon acceptance or rejection and a hard copy (or electronic copy as authorized by
the SUPERVISOR) provided to the SUPERVISOR at the conclusion of each (G)-Point. (See
4.5)
3.11.4 Required reports resulting from tests or inspections must include the
appropriate design criterion for each attribute or measurement required by the Work Item.
3.12 The SUPERVISOR will consider the Work Item incomplete if the contractor's
documentation and records are not complete.
3.13 Accomplish (I), (V) and (Q) tests/inspections that do not have associated (G)-points,
with qualified and/or currently certified personnel where required by the technical documents
(e.g., NBPI, NACE, nondestructive testing, electrical cableway inspection, Oxygen Cleanliness
Inspector, etc.) as follows:
3.13.1 (I) inspections require verification and documentation by a separate
individual, other than the person who has accomplished the work, who is qualified as an
inspector.
3.13.2 (V) inspections require verification and documentation by the qualified
tradesperson, trade supervisor, or inspector.
3.13.3 (Q) inspections require verification and documentation by a qualified
Technical Representative in accordance with 009-90 of 2.1 and associated PCP requirements.
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3.13.4 The authority to accomplish, document, accept and reject (I) and (V)
inspections may be delegated to qualified subcontractor personnel, without regards to
geographical location, subject to SUPERVISOR approval.
3.14 Accomplish (G)-Point (government notification) as follows:
3.14.1 (G) is a symbol inserted in a Work Item to establish a point in the sequence
of accomplishment of work at which time the SUPERVISOR must be notified by the prime
contractor in all cases to permit observation of a specific test or inspection (I)(V) by the
government. When the symbol (G) precedes tests or inspections in a Work Item which are
applicable to more than one action, the symbol (G) must identify the action required, e.g., (G)
"HYDROSTATIC TEST". When more than one unit is involved, the (G) notification
requirement applies to each unit.
3.14.2 Notify the SUPERVISOR's designated representative as directed by the
SUPERVISOR via FAX, hard copy, or by electronic method.
3.14.2.1 Notify the SUPERVISOR prior to commencing the specific
requirements in a paragraph annotated with the symbol (G), during normal day shift working
hours with at least 2 hours, but not more than one-day notice. Following the required
notification, the requirements in the | paragraph annotated with the symbol (G) may proceed
prior to the scheduled time as approved by the SUPERVISOR. Notify the SUPERVISOR to
cancel a scheduled test or inspection no later than 30 minutes prior to the scheduled event or as
negotiated with the SUPERVISOR.
3.14.2.2 Notify the SUPERVISOR not later than 4 hours before the end of
the last preceding normal work day when tests or inspections following a (G) Point are scheduled
after normal day shift working hours, on a weekend, or on a federal holiday. Following the
required notification, the requirements in the paragraph annotated with the symbol (G) may
proceed prior to the scheduled time as approved by the SUPERVISOR. Notify the
SUPERVISOR to cancel a scheduled test or inspection as soon as known, but no later than one
hour prior to the scheduled event.
3.14.2.3 Notify the SUPERVISOR at least 48 hours, but not more than 72
hours, prior to commencing (G)-Points at contractor's/subcontractor's plants located in excess of
50 miles by the most direct roadway nearest to the place of performance of the contract.
Document the date, time, and identification of the SUPERVISOR's representative notified.
Following the required notification, the requirements in the paragraph annotated with the symbol
(G) may proceed prior to the scheduled time as approved by the SUPERVISOR. Notify the
SUPERVISOR to cancel a scheduled test or inspection as soon as known, but no later than one
hour prior to the scheduled event.
3.14.3 Proceed with the test or inspection if the SUPERVISOR is not present,
provided the required advance notice has been furnished to the SUPERVISOR and the contractor
has completed and documented the preceding tests and inspections.
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3.14.4 A partial test or inspection requiring (G) notification may be accomplished in
the event that all work cannot be completed and work progress would be delayed in waiting for
total completion of work. Comply with the requirements of 3.14.2 when the incomplete work is
completed and ready for the remainder of the test or inspection. Note partial inspections on the
test or inspection form.
3.14.5 A qualified contractor representative must be present to accomplish, accept
or reject and document tests or inspections associated with the symbol (G).
3.14.5.1 The authority to witness or perform, document and accept/reject
(I)(G), (Q)(G), and (V)(G) tests and inspections is a prime contractor's responsibility but, subject
to SUPERVISOR approval within a 50-mile radius of the contractor’s plant nearest to the place
of performance of the contract, may be delegated to subcontractors who are MSRA or ABR
agreement holders, SSPC QP1 certified, NDT certified, or have a current QMS accepted by the
SUPERVISOR.
3.14.5.2 The contractor may delegate responsibility to subcontractors to
perform, document and accept/reject (I)(G) and (V)(G) tests and inspections performed at plants
located outside a 50-mile radius of the contractor's plant nearest to the place of performance of
the contract subject to SUPERVISOR prior approval.
3.14.5.3 Associated (G)-Point notification requirements must not be
delegated.
3.15 For work being performed outside a 50-mile radius of the place of contract
performance, the prime contractor must submit one legible copy, in hard copy or approved
transferrable media, of purchase orders to the SUPERVISOR within 2 days or otherwise as
directed by the SUPERVISOR, prior to issue of purchase order and shipment of equipment. For
contractors who do not utilize purchase orders as a vehicle for accomplishing work within their
company, a report identifying the delineation of the specific Work Item requirements, in lieu of
the purchase order must be submitted to the SUPERVISOR.
3.16 Maintain a current list for reference by the SUPERVISOR, designating the
contractor's qualified and currently certified inspectors who witness or perform and sign for
symbol (I) inspections, indicating the type of tests and inspections for which each inspector is
qualified and currently certified. When subcontractors are delegated responsibility, the
subcontractor's qualified and currently certified inspectors must be included on this list.
3.17 Certify to the SUPERVISOR that work is completed technically correct with all
required OQE. All supporting documentation must be submitted in support of the following
applicable Key Events: Undocking (if applicable), PCD, C5ILO, WC, DT, FC, ST, and AC.
Applicable Key Event ties must also be annotated for each item in the TIP as required by
3.10.2.1. |
3.17.1 Notify the SUPERVISOR of the condition and status of each individual
Work Item in the availability within 3 days of Work Item completion or a minimum of 5 days
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prior to the scheduled Key Event to which that item is tied, whichever occurs first, by one of the
following methods:
3.17.1.1 Completion and submission of one legible copy of Attachment A,
in hard copy or approved transferrable media.
3.17.1.2 Completion and submission of one legible copy of Event
Readiness List (ERL), in hard copy or approved transferrable media.
3.17.1.3 Completion and submission of centralized signature sheet in record
book maintained by the SUPERVISOR.
3.17.2 If work is incomplete or complete with discrepancies, supporting rationale
and impact statement with recovery plan must be provided to the SUPERVISOR using one of the
methods from 3.17.1. Upon completion of work or correction of discrepancies, an updated status
must be submitted to the SUPERVISOR.
4. NOTES:
4.1 ANSI/ISO/ASQ Q9001:2015 commercial third party registrar certification is not
required.
4.2 The QMS submitted in 3.2 requires a one-time submittal/acceptance unless this
NAVSEA Standard Item and/or references change or contractor's status changes.
4.3 A "zero-tier reference" is a specification, standard, drawing, that is cited in the
contract (including its attachments). A "first-tier reference" is either: (1) a specification,
standard, or drawing cited in a zero-tier reference, or (2) a specification cited in a first tier
drawing. All zero-tier and first tier references are mandatory for use. All lower tier references
must be used for guidance only.
4.4 Contractor-run critiques or fact findings are accomplished in accordance with 009-
120 of 2.1.
4.5 A partial (G)-point may be accomplished for a fraction of the work specification
components. When elected, the contractor is responsible to account for the inspection status of
each component. A final (G)-point is required for the last remaining component(s).
4.6 ISO compliant Quality Management Systems typically follow a 4-tiered hierarchy
comprised of:
a. “first-tier” document related to the QMS is the Quality Manual, which is the high-level
document that is authored and approved by upper management of the organization and is the
guiding organizational document for which all subsequent tiers within the system should be
aligned with.
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b. The “second-tier” documents are the Quality Procedures making up the center of the
documentation system. These procedures span all the required processes and practices within the
organization and should include references both upward to the Quality Manual and downward to
the Work Instructions associated with each process.
c. The “third-tier” documents are Work Instructions comprised of instructions that describe the
specific actions required to achieve a quality product.
d. The “fourth-tier” documents are the Quality Records which capture all the data, information,
records, forms and become the objective evidence which will prove the QMS is being executed
per procedure.
4.7 NAVSEA 04RM3 Approved list of Accrediting Bodies (AB).
. ANSI-ASQ National Accreditation Board (ANAB), http://anab.org/
. Laboratory Accreditation Bureau (L-A-B), http://l-a-b.com/
. Perry Johnson Registrars (PJLA), http://www.pjr.com/
. The American Association for Laboratory Accreditation (A2LA), https://www.a2la.org/
. National Voluntary Laboratory Accreditation Program (NVLAP), https://www.nist.gov/nvlap
. International Accreditation Service (IAS), http://www.iasonline.org
Contact NAVSEA 04RM3 for information on commercial accreditation in accordance with 2.3
by NAVSEA approved commercial Accrediting Bodies (AB).
4.8 Scope: The official and detailed statement of the calibration services for which the
laboratory is accredited. Alternative terms include scope of accreditation, scope of competency,
and scope of calibrations.
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Attachment A
Work Completion Certification
SHIP’S NAME :
HULL NO.:
WORK ITEM NO:
SSP NO.:
KEY EVENT:
Undocking (UD)
Production Completion Date (PCD)
Dock Trials (DT)
Fast Cruise (FC)
Sea Trials (ST)
Availability Completion (AC)
Command, Control, Communications, Computer, Combat Systems,
and Intelligence Light-Off (C5ILO)
Work Complete (WC)
Other ______________________
1) All contracted production work (original, new and growth) has been satisfactorily reviewed,
accurate and complete. All non-conformances have been corrected and corrective action request
(CAR) are at an acceptable level of completion.
RESULTS/STATUS:
Complete
Complete w/ Discrepancies
Incomplete
Note: If work is incomplete or complete with discrepancies, supporting rational and impact
statement with recovery plan in the Comments block below.
Comments:
Print and Sign Name: Date:
Position and Responsibility:
2) All Tests and Inspections have been completed satisfactorily reviewed, accurate, complete and
properly documented in the T&I Plan.
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RESULTS/STATUS:
Complete
Complete w/ Discrepancies
Incomplete
Note: If work is incomplete or complete with discrepancies, supporting rational and impact
statement with recovery plan in the Comments block below.
Comments:
Print and Sign Name: Date:
Position and Responsibility:
3) All required reports and all accompanying required data have been submitted, reviewed,
accurate, complete and satisfactory.
RESULTS/STATUS:
Complete
Complete w/ Discrepancies
Incomplete
Note: If work is incomplete or complete with discrepancies, supporting rational and impact
statement with recovery plan in the Comments block below.
Comments:
Print and Sign Name: Date:
Position and Responsibility:
Attachment B
CONTRACTOR QMS MANUAL REVIEW CHECKLIST
Company's Name:
Document's Date of Submission:
Reviewer's Name:
Checklist Completion Date:
(1) Support
Item
Reference
Paragraph
Requirement/Audit Question
Compliant?
Noncompliant?
1.1
NSI 009-04
Para 3.2
Requirement: Does the organization’s Quality Management System (QMS) Manual address all
elements of ISO 9001:2015?
Comments:
NSI 009-04
Para 3.2.5
Requirement: Does the documented QMS include a matrix listing the correlation between 2.2 (ISO
9001:2015), 3.2 (A written QMS Manual), and other submitted documents?
Comments:
Item
ISO 9001:2015 Para
7.1.5
NSI 009-04
Monitoring and Measuring Resources
1.2
ISO 9001:2015 Para
7.1.5.1
Requirement: Does the organization have a documented procedure to determine and provide the
resources needed to ensure valid and reliable results, when monitoring or measuring is used to verify
the conformity of products and services to requirements?
Comments:
Requirement: Does the documented procedure ensure that the resources provided are suitable for the
specific type of monitoring and measurement activities being undertaken?
Comments:
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Attachment B
(1) Support
Item
Reference
Paragraph
Requirement/Audit Question
Compliant?
Noncompliant?
1.2
ISO 9001:2015 Para
7.1.5.1
Requirement: Does the documented procedure ensure that the resources provided are maintained
to ensure their continuing fitness for their purpose?
Comments:
ISO 9001:2015 Para
7.1.5.1
Requirement: Does the organization retain appropriate documented calibration information as
evidence of fitness for purpose of the monitoring and measuring equipment?
Comments:
1.3
ISO 9001:2015
Para 7.1.5.2
NSI 009-04
Para 3.2.1.1
Requirement: Does the documented procedure ensure monitoring and measuring equipment is
calibrated against devices traceable to international or national measurement standards? (See NSI
009-04 Para 3.2.1.1 for accreditation requirements). When no such standards exist, the basis used
for calibration or verification shall be retained as documented information.
Comments:
ISO 9001:2015
Para 7.1.5.2
NSI 009-04
Para 3.2.1.2
Requirement: Does the documented procedure ensure calibration intervals are assigned to Measuring
and Test Equipment used for acceptance testing, meet the requirements of the NAVSEA Metrology
Requirements List (METRL), unless alternate calibration intervals were established IAW
ANSI/NCSL Z540-3, Requirements for the Calibration of Measuring and Test Equipment?
Comments:
ISO 9001:2015
Para 7.1.5.2.b
Requirement: Does the documented procedure ensure devices are identified (i.e. tagged with
stickers showing calibration status and due date)?
Comments:
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Attachment B
(1) Support
Item
Reference
Paragraph
Requirement/Audit Question
Compliant?
Noncompliant?
1.3
ISO 9001:2015
Para 7.1.5.2.c
Requirement: Does the documented procedure ensure all devices are safeguarded from
adjustments, damage, or deterioration that would invalidate the calibration status and subsequent
measurement results?
Comments:
ISO 9001:2015
Para 7.1.5.2
Requirement: Does the documented procedure direct and describe how previous measurement
results will be validated, if measuring equipment is found to be unfit for intended purposes, and
direct appropriate necessary actions?
Comments:
Item
ISO 9001:2015 Para
7.2
Competence
1.4
ISO 9001:2015
Para 7.2.a
Requirement: Does the organization have a documented procedure to determine the necessary
competence of person(s) doing work under its control, that affects the performance and effectiveness
of the QMS?
Comments:
ISO 9001:2015
Para 7.2.b
Requirement: Does the organization have a documented procedure in place to ensure that persons are
competent on the basis of appropriate education, training, or experience?
Comments:
ISO 9001:2015
Para 7.2.c
Requirement: Does the organization have a documented procedure to take actions to acquire the
necessary competence? If so, does the organization have a procedure to evaluate the effectiveness
of those actions taken?
Comments:
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Attachment B
(1) Support
Item
Reference
Paragraph
Requirement/Audit Question
Compliant?
Noncompliant?
1.4
ISO 9001:2015
Para 7.2.d
Requirement: Does the organization have a documented procedure to retain appropriate personnel
records (i.e. education, training, skills, and experience) as evidence of competence?
Comments:
Item
ISO 9001:2015
Para 7.5
NSI 009-04
QMS Documented Information
1.5
ISO 9001:2015
Para 7.5.2.a
Requirement: When creating and updating documented procedures, does the organization have a
documented procedure to ensure appropriate:
a) identification and description?
Comments:
1.5
ISO 9001:2015
Para 7.5.2.b
Requirement: b) format (e.g. language, software version, graphics) and media (e.g. paper,
electronic)?
Comments:
ISO 9001:2015
Para 7.5.2.c
Requirement: c) review and approval for suitability and adequacy of documented information (i.e.
procedures and records)?
Comments:
ISO 9001:2015
Para 7.5.3.1
Requirement: Does the organization have a documented procedure to control documented
information to ensure its protection (e.g. from loss of confidentiality, improper use, or loss of
integrity) and availability at locations essential to the effectiveness of the QMS?
Comments:
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Attachment B
(1) Support
Item
Reference
Paragraph
Requirement/Audit Question
Compliant?
Noncompliant?
1.6
ISO 9001:2015
Para 7.5.3.2.a
Requirement: Does the organization’s document control procedure:
a) address distribution, access, retrieval, and use of documented information?
Comments:
ISO 9001:2015
Para 7.5.3.2.b
Requirement: b) ensure adequate storage and preservation (including preservation of legibility) of
documented information?
Comments:
ISO 9001:2015
Para 7.5.3.2.c
Requirement: c) control of changes (e.g. version control)?
Comments:
ISO 9001:2015
Para 7.5.3.2.d
Requirement: d) retention and disposition of documents? Are obsolete documents prevented from
unintended use IAW the approved procedure?
Comments:
ISO 9001:2015
Para 7.5.3.2
Requirement: Does the organization’s document control procedure ensure that documents of
external origin determined by the organization to be necessary for the planning and execution of the
QMS, are identified and controlled?
Comments:
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Attachment B
(1) Support
Item
Reference
Paragraph
Requirement/Audit Question
Compliant?
Noncompliant?
1.6
ISO 9001:2015
Para 7.5.3.2
Requirement: Does the organization’s documented procedure ensure documented information is
retained as evidence of conformity and the information is protected from unintended alteration?
Comments:
Auditor:
Date:
Printed Name and Signature
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Attachment C
CONTRACTOR QMS MANUAL REVIEW CHECKLIST
Company's Name:
Document's Date of Submission:
Reviewer's Name:
Checklist Completion Date:
(2) Operation
Item
Reference
Paragraph
Requirement/Audit Question
Compliant
?
Noncomplian
t?
Item
ISO
9001:2015
Para 8.2
Requirements for Products and Services
2.1
ISO 9001:2015
Para 8.2.1
Requirement: Does the organization have a documented procedure for customer communication
that:
a) provides information related to products and services?
Comments:
Requirement: b) identifies and implements arrangements for inquiries, contracts, and orders,
including changes?
Comments:
Requirement: c) provides for customer feedback relating to products and services, including
complaints?
Comments:
Requirement: d) addresses handling or controlling customer property
Comments:
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?
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2.1
ISO 9001:2015
Para 8.2.1
Requirement: e) establishes specific requirements for contingency actions, when relevant?
Comments:
2.2
ISO 9001:2015
Para 8.2.2
Requirement: When determining the requirements for the products and services to be offered
to customers, does the organization’s documented procedure ensure requirements for products
and services offered are defined, including:
a) applicable statutory and regulatory requirements and those considered necessary by the
Comments:
Requirement: b) meeting claims for the products and services it offers?
Comments:
ISO 9001:2015
Para 8.2.3.1
Requirement: Does the organization’s documented procedure direct a review prior to the
commitment of the services and products offered to ensure they meet the requirements of the
customer, including:
a) requirements specified by the customer, including the requirements for delivery and post-
Comments:
Requirement: b) requirements not stated by the customer, but necessary for the specified or
intended use, when known?
Comments:
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?
Noncomplian
t?
2.2
ISO 9001:2015
Para 8.2.3.1
Requirement: c) requirements specified by the organization?
Comments:
Requirement: d/e) statutory and regulatory requirements applicable to the products and
services and contract or order requirements differing from those previously expressed?
Comments:
Requirement: f) confirmation that contract or order requirements differing from those
previously defined are resolved?
Comments:
ISO 9001:2015
Para 8.2.3.1
Requirement: g) confirmation by the organization before acceptance, when the customer does
not provide a documented statement of their requirements?
Comments:
ISO 9001:2015
Para 8.2.3.2
Requirement: Does the organization’s documented procedure ensure the results of the review for
products and services and any new requirements for products and services are documented?
Comments:
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Attachment C
(2) Operation
Item
Reference
Paragraph
Requirement/Audit Question
Compliant
?
Noncomplian
t?
2.2
ISO 9001:2015
Para 8.2.4
Requirement: Does the organization’s documented procedure ensure that relevant documented
information is amended and relevant persons are made aware of the changed requirements when
customer requirements for products and services change?
Comments:
Item
ISO
9001:2015
Para 8.4,
NSI 009-04
Control of Externally Provided Processes, Products, and Services
2.3
ISO 9001:2015
Para 8.4.1
Requirement: Does the organization’s documented procedure ensure that externally provided
processes, products, and service conform to requirements and determine the controls to be
applied to externally provided processes, products, and services when:
a) products and services from external providers are intended for incorporation into the
Comments:
Requirement: b) products and services are provided directly to the customer(s) by external
providers on behalf of the organization?
Comments:
Requirement: c) a process, or part of a process, is provided by an external provider as a result of
a decision by the organization?
Comments:
Requirement: Does the organization’s documented procedure determine and apply criteria for
the evaluation, selection, monitoring of performance, and re-evaluation of external providers,
based on their ability to provide processes or products and services in accordance with
requirements? Does the organization retain documented information of external providers and
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?
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Comments:
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?
Noncomplian
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2.4
ISO 9001:2015
Para 8.4.2
Requirement: Does the organization’s documented procedure ensure that externally provided
processes, products, and services do not adversely affect the organization’s ability to consistently
deliver conforming products and services to its customers? The procedure shall:
a) ensure that externally provided processes are controlled by their QMS?
Comments:
Requirement: b) define both the controls that it intends to apply to an external provider and
those it intends to apply to the resulting output?
Comments:
Requirement: c.1) take into consideration potential impact of the externally provided processes,
products, and services on the organization’s ability to consistently meet customer and applicable
statutory and regulatory requirements?
Comments:
Requirement: c.2) take into consideration the effectiveness of the controls applied by the
external provider?
Comments:
Requirement: determine the verification, or other activities, necessary to ensure that the
externally provided processes, products, and service meet requirements?
Comments:
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(2) Operation
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Reference
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?
Noncomplian
t?
2.4
NISI 009-04
Para 3.2.2.2
Requirement: Does the organization have a process for Receipt Inspection of CFM based on
supplier performance history and one or more of the following: certificate of compliance, vendor
material test certification data, manufacturer’s MIL certificate, or testing using sampling
techniques?
Comments:
2.5
ISO 9001:2015
Para 8.4.3
Requirement: Does the organization’s documented procedure ensure the adequacy of
requirements prior to their communication to the external provider? The procedures shall
communicate to external providers it’s requirements for:
a) the processes, products, and services to be provided
Comments:
ISO 9001:2015
Para 8.4.3
Requirement: b) the approval of:
1.
products and services
2.
methods, processes, and equipment
3.
the release of products and services
Comments:
ISO 9001:2015
Para 8.4.3
Requirement: c) competence including any required qualification of persons
Comments:
ISO 9001:2015
Para 8.4.3
Requirement: d) the external provider’s interactions with the organization
Comments:
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?
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2.5
ISO 9001:2015
Para 8.4.3
Requirement: e) control and monitoring of the external provider’s performance to be applied by
the organization
Comments:
ISO 9001:2015
Para 8.4.3
Requirement: f) the verification or validation activities that the organization, or its customer,
intends to perform at the external providers’ premises.
Comments:
NSI 009-04
Para 3.2.2.1
Requirement: The organization’s documented procedure identifies, in purchasing documents,
verification arrangements at the SKTR/vendor location/premises IAW NSI 009-04 Para 3.2.2.1?
Comments:
Item
ISO
9001:2015
Para 8.5
Production and Service Provision
2.6
ISO 9001:2015
Para 8.5.1
Requirement: Does the organization’s documented procedure implement production and
service provision under controlled conditions? Controlled conditions include:
a) the availability of documented information that defines:
1) the characteristics of the products to be produced, the services to be provided, or the
activities to be performed;
Comments:
Requirement: b) the availability and use of suitable monitoring and measuring resources
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Comments:
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2.6
ISO 9001:2015
Para 8.5.1
Requirement: c) the implementation of monitoring and measurement activities at appropriate
stages to verify that criteria for control of processes or outputs, and acceptance criteria for
products and services, have been met
Comments:
Requirement: d) the use of suitable infrastructure and environment for the operation of
processes
Comments:
Requirement: e) the appointment of competent persons, including any required qualification
Comments:
Requirement: f) the validation, and periodic revalidation, of the ability to achieve planned
results of the processes for production and service provision, where the resulting output cannot
be verified by subsequent monitoring or measurement
Comments:
Requirement: g) the implementation of actions to prevent human error
Comments:
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2.6
ISO 9001:2015
Para 8.5.1
Requirement: h) the implementation of release, delivery, and post-delivery activities
Comments:
2.7
ISO 9001:2015
Para 8.5.2
Requirement: Does the organization’s documented procedure specify suitable means to identify
outputs, when necessary, to ensure the conformity of products and services?
Comments:
Requirement: Does the organization’s documented procedure identify the status of outputs, with
respect to monitoring and measurement requirements throughout production and service
provision?
Comments:
Requirement: When traceability is a requirement, does the organization’s documented
procedure control and record the unique identification of the product?
Comments:
2.8
ISO 9001:2015
Para 8.5.3
Requirement: For property belonging to customers or external providers, does the
organization’s documented procedure ensure:
a) the exercise of care with property belonging to customers or external providers while it is
under the organization’s control or being used by the organization?
Comments:
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Noncomplian
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2.8
ISO 9001:2015
Para 8.5.3
Requirement: b) the identification, verification, protection, and safeguarding of customers’ or
external providers’ property provided for use or incorporation into the products and services?
Comments:
Requirement: c) that when the property of a customer or external provider is lost, damaged, or
otherwise found to be unsuitable for use, the organization reports this to the customer or external
provider and retain documented information on what has occurred?
Comments:
ISO 9001:2015
Para 8.5.4
Requirement: Does the organization’s documented procedure preserve the outputs during
production and service provision, to the extent necessary to ensure conformity of product with
customer requirements?
Comments:
ISO 9001:2015
Para 8.5.5
Requirement: Does the organization’s documented procedure have a process to meet post-
delivery activities associated with the products and services? The organization shall consider:
a) statutory and regulatory requirements
Comments:
Requirement: b) the potential undesired consequences associated with its products and services
Comments:
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?
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2.8
ISO 9001:2015
Para 8.5.5
Requirement: c) the nature, use, and intended lifetime of its products and services;
Comments:
Requirement: d) customer requirements
Comments:
Requirement: e) customer feedback.
Comments:
ISO 9001:2015
Para 8.5.6
Requirement: Does the organization’s documented procedure require review and control of
changes for production or service provision, to the extent necessary to ensure continuing
conformity with requirements and retain documented information of the review of changes, the
person(s) authorizing the change, and any necessary actions rising from the review?
Comments:
Item
ISO
9001:2015
Para 8.6
Release of Products and Services
2.9
ISO 9001:2015
Para 8.6
Requirement: Does the organization’s documented procedure implement planned arrangements
at appropriate stages, to verify product and service requirements are met?
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Reference
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Compliant
?
Noncomplian
t?
Comments:
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?
Noncomplian
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2.9
ISO 9001:2015
Para 8.6
Requirement: Does the organization’s documented procedure ensure the release of products and
services to the customer proceed only after the planned arrangements have been satisfactorily
completed, unless otherwise approved by a relevant authority and, as applicable, by
the customer?
Comments:
Requirement: Does the organization’s documented procedure require the retention of relevant
documented information, including the evidence of conformity with the acceptance criteria, and
traceability to the person(s) authorizing the release?
Comments:
Item
ISO
9001:2015
Para 8.7
Control of Nonconforming Outputs
2.10
ISO 9001:2015
Para 8.7.1
Requirement: Does the organization’s documented procedure ensure that nonconforming
outputs are identified and controlled to prevent their unintended use or delivery?
Comments:
Requirement: Does the organization’s documented procedure deal with nonconforming outputs
in one or more of the following ways, based on the nature of the nonconformity and its effect on
the conformity of products and services (this shall also apply to nonconforming products and
services detected after delivery of products, during or after the provision of services):
Comments:
Requirement: b) segregation, containment, return, or suspension of provision of products and
services
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Comments:
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Reference
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Compliant
?
Noncomplian
t?
2.10
ISO 9001:2015
Para 8.7.1
Requirement: c) informing the customer
Comments:
Requirement: d) and/or obtaining authorization for acceptance under concession?
Comments:
Requirement: Does the organization’s documented procedure ensure verification of conformity
to the requirements, when nonconforming outputs have been corrected?
Comments:
Requirement: Does the organization’s documented procedure require retention of documented
information that:
a) describes the nonconformance?
Comments:
Requirement: b) describes actions taken?
Comments:
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Reference
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?
Noncomplian
t?
2.10
ISO 9001:2015
Para 8.7.1
Requirement: c) describes concessions obtained?
Comments:
Requirement: d) identifies the authority deciding the action in respect to the nonconformity?
Comments:
Auditor:
Date:
Printed Name and Signature
35 of 42 ITEM NO: 009-04
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Attachment D
CONTRACTOR QMS MANUAL REVIEW CHECKLIST
Company's Name:
Document's Date of Submission:
Reviewer's Name:
Checklist Completion Date:
(3) Performance Evaluation & Improvement
Item
Reference
Paragraph
Requirement/Audit Question
Compliant?
Noncompliant?
Item
ISO 9001:2015 Para
9.2
Internal Audit
3.1
ISO 9001:2015
Para 9.2.1
Requirement: Does the organization’s documented procedure require internal quality audits be
performed at planned intervals to ensure the QMS:
a) conforms to:
1.
the organization’s own requirements for its QMS?
2.
the requirements of ISO 9001:2015?
3.
the requirements of NSI 009-04?
Comments:
Requirement: b) is effectively implemented and maintained?
Comments:
ISO 9001:2015
Para 9.2.2
Requirement: Does the organization’s documented procedure:
a) plan, establish, implement, and maintain an audit program(s) including the frequency, methods,
responsibilities, planning requirements and reporting, which shall take into consideration the
importance of the processes concerned, changes affecting the organization, and the results of
previous audits?
Comments:
Requirement: b) define the audit criteria and scope for each audit?
Comments:
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Attachment D
(3) Performance Evaluation & Improvement
Item
Reference
Paragraph
Requirement/Audit Question
Compliant?
Noncompliant?
3.1
ISO 9001:2015
Para 9.2.2
Requirement: c) select auditors and conduct audits to ensure objectivity and the impartiality of the
audit process?
Comments:
Requirement: d) ensure that the results of the audits are reported to relevant management?
Comments:
Requirement: e) take appropriate correction and corrective actions without undue delay?
Comments:
Requirement: f) retain documented information as evidence of the implementation of the audit
program and the comments?
Comments:
Item
ISO 9001:2015 Para
9.3
Management Review
3.2
ISO 9901:2015
Para 9.3.1
Requirement: Does the organization’s documented procedure require top management to review the
organization’s QMS at planned intervals, to ensure its continuing suitability, adequacy,
effectiveness, and alignment with the strategic direction of the organization?
Comments:
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Attachment D
(3) Performance Evaluation & Improvement
Item
Reference
Paragraph
Requirement/Audit Question
Compliant?
Noncompliant?
3.2
ISO 9001:2015
Para 9.3.2
Requirement: Is the organization’s management review documented procedure planned and
carried out taking into consideration:
a) the status of actions from previous management reviews
Comments:
Requirement: b) changes in external and internal issues that are relevant to the QMS;
Comments:
Requirement: c) information on the performance and effectiveness of the QMS, including trends in:
1)
customer satisfaction and feedback from relevant interested parties
2)
the extent to which quality objectives have been met
3)
process performance and conformity of products and services
4)
nonconformities and corrective actions
5)
monitoring and measurement results
6)
audit results
7)
the performance of external providers
Comments:
Requirement: d) the adequacy of resources
Comments:
Requirement: e) the effectiveness of actions taken to address risks and opportunities (see 6.1 of ISO
9001:2015)
Comments:
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Attachment D
(3) Performance Evaluation & Improvement
Item
Reference
Paragraph
Requirement/Audit Question
Compliant?
Noncompliant?
3.2
ISO 9001:2015
Para 9.3.2
Requirement: f) opportunities for improvement?
Comments:
ISO 9001:2015
Para 9.3.3
Requirement: Does the organization’s management review documented procedure include
decisions and actions related to:
a) opportunities for improvement?
Comments:
Requirement: b) any need for changes to the QMS?
Comments:
Requirement: c) resource needs?
Comments:
Requirement: Does the organization’s documented procedure require retention of the results of the
management reviews?
Comments:
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Attachment D
(3) Performance Evaluation & Improvement
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Reference
Paragraph
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Compliant?
Noncompliant?
Item
ISO 9001:2015 Para
10.2
Nonconformance and Corrective Action
3.3
ISO 9001:2015
Para 10.2.1
Requirement: Does the organization’s documented procedure require, when a nonconformance
occurs, including any arising from complaints, the organization to:
a)
react to the nonconformity and, as applicable:
1)
take action to control and correct it
2)
deal with the consequences?
Comments:
Requirement: b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order
that it does not recur or occur elsewhere, by:
1)
reviewing and analyzing the nonconformity;
2)
determining the causes of the nonconformity;
3)
determining if similar nonconformities exist or could potentially occur?
Comments:
Requirement: c) implement any action needed?
Comments:
Requirement: d) review the effectiveness of any corrective action taken?
Comments:
Requirement: e) update risks and opportunities determined during planning, if necessary?
Comments:
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(3) Performance Evaluation & Improvement
Item
Reference
Paragraph
Requirement/Audit Question
Compliant?
Noncompliant?
3.3
ISO 9001:2015
Para 10.2.1
Requirement: f) make changes to the QMS, if necessary?
Comments:
Requirement: Does the documented procedure require that the Corrective Actions are appropriate to
the effects of the nonconformities encountered?
Comments:
ISO 9001:2015
Para 10.2.2
Requirement: Does the organization’s documented procedure require retention of documented
information about:
a) the nonconformance and corrective action taken?
Comments:
Requirement: b) results of the corrective actions?
Comments:
Auditor:
Date:
Printed Name and Signature
41 of 42 ITEM NO: 009-04
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42 of 42 ITEM NO: 009-04
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Attachment E
Root Causes
Category Description
Personnel
o Work Practices
o Training
o Supervision
Procedures
Design
o Technical
Documentation
Material
Work Practices- Craftsman knows or
understands the requirements, but
fails to follow them
Training- Training of employees and
subcontractors.
Supervision- Lack of preparation or
follow through for the original
planned event.
Procedures- Issues with procedures
provided by outside agency or another
activity utilized during the unplanned
event.
Tech Documentation- Issues with DWGs,
Specifications or Design aspect.
Material- Failure of material to
perform under designed conditions and
uses.
Category
Attribute
Work Practices
Failure to follow Procedure
Use of incorrect or outdated
Procedures
Inattention to detail
Improper tools/use of tools
Training
Nonexistent training or qualification
Content is inadequate
Inadequate training or qualification
frequency
Supervision
Assignment of unqualified personnel
Inadequate direction provided
Inadequate review of worksite or
Documents
Procedures
Procedure contains inadequate or
unclear direction
Procedure contains incorrect direction
Technical Documentation
Error in Drawing or Technical Document
Design deficiency
Material
Material Failure
