Appx_D_QualityManagementSystem-DRAFT.pdf

Solicitation No. FA4890-13-R-0117

DRAFT

D-1

APPENDIX D

QUALITY MANAGEMENT SYSTEM REQUIREMENTS

1. Registration

a. The contractor shall develop, document, implement, maintain and continuously improve a comprehensive higher-level Quality Management System (QMS) that assures compliance with the most current ANSI/ISO/ASQ 9001 QMS standard (currently 9001:2008) and all requirements of this PWS, (see Solicitation/Contract Part I, Section E, FAR Clauses 52.246-

3, 52.246-4, 52.246-5, and 52.246-11). Current copies of ISO 9001:2008 can be purchased at http://www.asq.org/quality-press or call 1-800-248-1946.

b. Where any requirement(s) of the ISO 9001:2008 standard cannot be applied, the requirement(s) can be considered for exclusion; however, any exclusion is limited to requirements within clause seven. Such exclusions cannot affect the organization’s ability, or responsibility, to provide products that meets customer and applicable regulatory requirements. Provide complete justification for any exclusion to the standard.

2. Quality Management System

a. The QMS shall document the organizations quality management structure, personnel authority and responsibility, identify personnel designated to perform QC functions at each location (to include dedicated and additional duty personnel), and skill set for each QC representative.

b. The QMS shall incorporate a comprehensive risk management plan to include a risk matrix/table that identifies all high and moderate risks and how each will be monitored, measured and controlled. The plan shall be updated annually as a minimum.

c. The QMS shall describe the processes and procedures used to:

1. Enforce strict use of tech data. Strict use of tech data means ensuring all applicable

TOs and directives are complete, current with applicable changes, available in the immediate work area, and open to applicable task/step/paragraph.

2. Establish and maintain proficiency of personnel.

3. Establish and maintain the training program.

3. Quality Management Representative

The Quality Management Representative shall be an American Society for Quality Certified

Quality Auditor and ISO 9001 Lead Auditor trained or equivalent by contract start. Certified

Quality Auditor shall maintain the certification through the life of the contract.

http://www.asq.org/quality-press

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4. Requirements after contract award

a. Draft Quality Manual and the six mandatory procedures are due to the Government 30 days after the start of the transition period. The final Quality Manual and procedures are due to the Government on the last day of the transition period. A desktop review will be accomplished by the Government.

b. The contractor’s comprehensive QMS shall be in place and performing NLT 30 days after full performance start date, as identified in Section B and F of the contract (to include

Operating Instructions, Site Operating Procedures, Work Instructions, etc. required to meet contract requirements).

c. The contractor shall notify ACC AMIC/DRQ of any changes to the QMS within two business days of implementation and provide the changed document(s) with references to the changes.

d. The contractor shall maintain and make available to the Government their measurement, analysis and improvement (Clause 8 of ISO 9001:2008) processes and supporting documentation.

e. The contractor shall be responsible for the quality of all products and/or services regardless of a validated QMS.

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E-1 (currently pg 112 of 154)

CLAUSES INCORPORATED BY FULL TEXT

52.246-11 HIGHER-LEVEL CONTRACT QUALITY (FEB 1999)

For the purposes of this clause, the blank(s) are completed as follows:

Title Number Date Tailoring

Quality Management

Systems –

Requirements

ANSI/ISO/ASQ

Q9001-2008

November 15, 2008 See Section C (PWS), Appendix D of this contract

Note: The most current version shall be used.