1. Business Policy Analyst
ISO 9001
Mary Anne Felicetti
Business Policy Analyst
May 15, 2018

2. Purpose of Higher-Level Quality Requirements
Control work operations, in-process controls, testing and inspections.
Bring attention to organization, planning, work instructions, documentation control, and advanced methodology.
Help ensure quality requirements are met on complex and critical items.
Enable the determination of risk (both the likelihood and the impact) of nonconformance.

3. Quality Management System-QMS
Contracts with higher-level quality requirements require supplier to establish and maintain a documented QMS
QMS documentation may consist of:
Supplier quality manual/contract-specific quality plan
Support process procedures
Manufacturing process procedures, to include inspection and testing
DCMA does NOT approve/accept supplier’s QMS, but reserves the right to disapprove procedures based on the results of GCQA surveillance.

4. Contractor (Supplier) Responsibilities
FAR states the supplier must carry out contractual QA obligations by:
Controlling quality of product/service.
Tendering to the Government only products/services that conform to contract requirements.
Ensuring their vendor’s have acceptable quality control system.
Maintaining substantiating evidence that products/ services conform to contract quality requirements.
Furnishing such information to the Government as required.

5. HIGHER LEVEL QUALITY SYSTEMS
In 1995 MIL-I and MIL-Q-9858 were cancelled with guidance issued to use ISO 9001, ISO 9002, ISO 9003, ANSI/ASQC Q9001, Q9002, Q9003 or a comparable non- Government quality system.
In 1996 a second notice was published cancelling both specifications without replacement.
ISO 9002 was the original replacement for MIL-I ISO was cancelled/replaced in 1994 by ISO 9001.
These specifications are occasionally still referenced by contractors.
Effective November 01, 2013, MIL-I and MIL-Q-9858 no longer considered an acceptable quality management standard when higher level quality is required on the material (FAR Clause ) Notice was published in DLA Internet Bid Board System (DIBBS) and Supplier Information Resource Center (SIRC.)

6. Higher Level Contract Quality Requirements
Many manufacturers will find their current quality management system conforms to either a tailored ISO 9001 or SAE AS9003 with only minor adjustments necessary to their own quality plan.
Examples of higher-level quality standards include overarching quality management system standards such as ISO 9001, ASQ/ANSI E4; ASME NQA-1, SAE AS9100, SAE AS9003, and ISO/TS 16949, and product or process specific quality standards such as SAE AS5553. [FAR (b)]

7. Higher Level Contract Quality Requirements
Higher-Level Contract Quality requires the contractor to implement one or more of the documented quality systems that meets the applicable standard(s) cited in the contract:
International Standardization Organization (ISO) standard(s)
Other recognized applicable industry standard(s) and/or
Specified Government requirement
For evaluation purposes, any higher-level contract quality system proposed by the contractor needs to provide for the Government's ability to audit/validate its capabilities to ensure the safety and satisfaction of our customers.

8. International Standards Organization - ISO
ISO 9001 is a standard that sets out the requirements for a quality management system. It helps businesses and organizations to be more efficient and improve customer satisfaction.
It does not dictate how the objectives should be met in any particular organization. Requires organizations to define these objectives themselves and continually improve their processes in order to reach them.
It promotes the adoption of a process-approach and continual improvement.
Specifies requirements for a quality management system that can be used by any organization for certification, or for contractual purposes.
Generic Management System Standards

9. International Standards Organization - ISO
The organization ITSELF may audit its ISO 9001 based quality system to verify that it is managing its processes effectively (to check that it is fully in control of its activities.)
The organization may invite its clients to audit the quality system in order to give them confidence.
Organization may engage the services of an independent quality system certification body to obtain a ISO certificate of conformity (Third Party Certification.)

10. International Standards Organization - ISO
Reference: (ISO 9001:2015 for Small Enterprises – What to do? – Advice from ISO/TC 176)
This handbook provides small and medium enterprises (SMEs) with guidance on developing and implementing an effective quality management system based on ISO 9001:2015 – Quality management systems – Requirements
For SMEs using the previous version of ISO 9001, this handbook will assist you in modifying your current system to better align with the requirements stated in the 2015 edition.
Transition Planning Guidance – How do I get started? - Correlation Matrices - ISO 9001 and Risk

11. Higher Level Quality DIBBS
Defense Internet Bid Board System (DIBBS) referenced ISO 9001:2000.
Wording on Web Quote form and Batch Quote field changed from:
ISO 9001:2000 to ISO 9001:2015 OR
ISO 9001: 2000 tailored to SAE AS9003 or ISO tailored to meet SAE AS9003
NOTE added below HLQ question: “If offering either AS or a standard not listed, please select “OTHER” then type those standards with the revision number that applies to your company in the provided text box.”
NOTE added at the end of file format: “Select “2” (Other) then type those standards with the revision number that applies to your company in the Higher-Level Quality Remarks (119)”

12. Higher Level Quality DIBBS
Automated Award Higher Level Quality Statements:
When the first position of the quality control code is F, L, R, E, K, or Q the following statement prints:“When Technical Note RQ001 is cited in the award, FAR , Higher-Level Contract Quality Requirement and FAR , Inspection of Supplies-Fixed Price applies. “
When the first position of the quality control code is F, L, R, the following statement prints:“THE CONTRACTORS INSPECTION SYSTEM MUST COMPLY WITH ISO ”
When the first position of the quality control code E, K, or Q, the following statement prints:“THE CONTRACTORS INSPECTION SYSTEM MUST COMPLY WITH SAE AS9003 or ISO 9001 tailored to meet SAE AS9003.”

13. Standard Text Object RQ001
HIGHER LEVEL CONTRACT QUALITY REQUIREMENTS (MANUFACTURERS AND NON- MANUFACTURERS)
1. The minimum Higher Level Contract Quality Requirements for manufacturers for DLA is either SAE AS9003, or ISO tailored to the requirements of SAE AS9003.
Such  tailoring shall not  affect  the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
MIL-I and MIL-Q-9858 are canceled and no longer acceptable when higher level quality is required.

14. Standard Text Object RQ001
2. Manufacturing contractors may also choose to offer a quality management program meeting the requirements of full ISO 9001:2000, full ISO 9001:2008, full ISO 9001:2015, or a program that exceeds ISO Examples of higher-level quality standards include overarching quality management system standards such as ASQ/ANSI E4; ASME NQA-1, SAE AS9100, and ISO/TS
3. Higher-Level Contract Quality Requirement for Non- Manufacturers:
(a) If a non-manufacturer is supplying the material, the non-manufacturer shall:
(i) Furnish items produced at a manufacturing facility conforming to the higher-level contract quality requirement for manufacturers as specified in paragraph one; or

15. Standard Text Object RQ001
(ii) Maintain and provide documented evidence that material furnished under this contract was produced at a manufacturing facility conforming to the specified higher-level contract quality requirement and that the material meets all requirements. At a minimum, the documented evidence shall be sufficient to establish the identity of the product and its manufacturing source; and include the basic item description, the item(s) part number and/or national stock number, the item(s) manufacturing source , the manufacturing source’s commercial and government entity code (e.g. CAGE code), and clear identification of the name and location of supply chain intermediaries from the manufacturer to the direct source of the product for the offeror/contractor, to the item(s) acceptance by the Government. It should also include, where available, the manufacturer's batch identification for the part(s), such as date codes, lot codes, or serial numbers (End of TQ Requirement)

16. Defense Contract Management Agency-DCMA
DCMA assures compliance with higher level quality requirements when they do their QMS audits/reviews.
DCMA QA personnel prepare the audit report. The report is retained by DCMA in accordance with the DCMA Records Management instruction.
The System Audit is performed in accordance with the GCQA Surveillance plan.
If the audit results require the supplier to take corrective action, the appropriate level Corrective Action Request (CAR) will be issued in accordance with the Corrective Action Process instruction with responsibility for follow up and closure assigned to the applicable QA personnel.

17. Comparison of ISO 9001-2008 and ISO 9001-2015
1 Scope
Scope
1.1 General
1.2 Application
Determining the scope of the quality management system
Quality management system
Context of the organization
Understanding the organization and its context
Understanding the needs and expectations of interested parties
4.4 Quality management system and its processes
General requirements
Quality management system and its processes
Control of externally provided processes, products and services
Documentation requirements
Documented information
General
General
Taken from: Correlation matrices between ISO 9001:20008 and ISO 9001:2015

18. Comparison of ISO 9001-2008 and ISO 9001-2015
Quality manual
Determining the scope of the quality management system
General
Quality management system and its Processes
Control of documents
Creating and updating
Control of documented Information
Control of records
Management responsibility
Leadership
Management commitment
Leadership and commitment
General
Customer focus
Customer focus
Quality policy
Policy
Establishing the Quality policy
Communicating the Quality policy
Taken from: Correlation matrices between ISO 9001:20008 and ISO 9001:2015

19. Comparison of ISO 9001-2008 and ISO 9001-2015
Planning
Planning
Quality objectives
Quality objectives and planning to achieve them
Quality management system planning
Organizational roles, responsibilities and authorities
Actions to address risks and opportunities
Planning of changes
Responsibility, authority and communication
Leadership
Responsibility and authority
Management representative
Internal communication
Communication
Taken from: Correlation matrices between ISO 9001:20008 and ISO 9001:2015

20. Comparison of ISO 9001-2008 and ISO 9001-2015
Management review
Quality management system
Understanding the organization and its context
Understanding the needs and expectations of interested parties
Management review
General
General
Review input
Management review input
Review output
Management review output
Resource management
Support
Resources
Provision of resources
General
People
Human resources
Competence
General
Competence
Taken from: Correlation matrices between ISO 9001:20008 and ISO 9001:2015

21. Comparison of ISO 9001-2008 and ISO 9001-2015
Competence, training and awareness
Competence
Awareness
Infrastructure
Infrastructure
Work environment
Environment for the operation of processes
Product realization
Operation
Planning of product realization
Operational planning and control
Customer-related processes
Requirements for products and services
Determination of requirements related to the product
Determination of requirements for products and services
Review of requirements related to the product
Review of the requirements for products and services
Changes to requirements for products and services
Customer communication
Customer communication
Taken from: Correlation matrices between ISO 9001:20008 and ISO 9001:2015

22. Comparison of ISO 9001-2008 and ISO 9001-2015
Design and development
Design and development of products and services
Design and development planning
General
Design and development planning
Design and development inputs
Design and development Inputs
Design and development outputs
Design and development outputs
Design and development review
Design and development controls
Design and development verification
Design and development validation
Control of design and development changes
Design and development changes
Control of changes
Taken from: Correlation matrices between ISO 9001:20008 and ISO 9001:2015

23. Comparison of ISO 9001-2008 and ISO 9001-2015
Purchasing
Control of externally provided processes, products and services
Purchasing process
General
Type and extent of control
Purchasing information
Information for external providers
Verification of purchased product
Release of products and services
Production and service provision
Production and service provision
Control of production and service provision
Control of production and service provision
Post-delivery activities
Validation of processes for production and service provision
Identification and traceability
Identification and traceability
Taken from: Correlation matrices between ISO 9001:20008 and ISO 9001:2015

24. Comparison of ISO 9001-2008 and ISO 9001-2015
Customer property
Property belonging to customers or external providers
Preservation of product
Preservation
Control of monitoring and measuring equipment
Monitoring and measuring resources
General
Measurement traceability
8 Measurement, analysis and improvement
9 Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
General
General
Monitoring and measurement
Monitoring, measurement, analysis and evaluation
Customer satisfaction
Customer satisfaction
Internal audit
Internal audit
Taken from: Correlation matrices between ISO 9001:20008 and ISO 9001:2015

25. Comparison of ISO 9001-2008 and ISO 9001-2015
Monitoring and measurement of processes
General
Monitoring and measurement of product
Release of products and services
Control of nonconforming product
Control of nonconforming outputs
Nonconformity and corrective action
Analysis of data
Analysis and evaluation
Improvement
Improvement
Continual improvement
General
Continual Improvement
Corrective action
Preventive action
Actions to address risks and opportunities (see 6.1.1, 6.1.2)
Taken from: Correlation matrices between ISO 9001:20008 and ISO 9001:2015

26. REFERENCES FAR 46.202-4 – HIGHER LEVEL CONTRACT QUALITY REQUIREMENTS
FAR 46.4 GOVERNMENT CONTRACT QUALITY ASSURANCE
FAR – GOVERNMENT CONTRACT QUALITY ASSURANCE AT SOURCE
FAR 46.5 ACCEPTANCE
FAR HIGHER LEVEL CONTRACT QUALITY REQUIREMENT
DFARS HIGHER LEVEL CONTRACT QUALITY REQUIREMENTS

27. REFERENCES DLAD 46.202-4 HIGHER LEVEL CONTRACT QUALITY REQUIREMENTS
DLAD 46.4 GOVERNMENT CONTRACT QUALITY ASSURANCE
DLAD 46.5 ACCEPTANCE
DCMA Inst 303 CRITICAL SAFETY ITEMS-QA
DCMA Inst 309 GOVERNMENT CONTRACT QUALITY ASSURANCE (GCQA) SURVEILLANCE PLANNING
DCMA Inst 322 QUALITY SYSTEM AUDIT
DCMA Inst 326 RISK ASSESSMENT

28. REFERENCES
ISO QUALITY MANAGEMENT SYSTEMS REQUIREMENTS – fourth edition
ISO QUALITY MANAGEMENT SYSTEMS REQUIREMENTS – fifth edition
ISO 9002 QUALITY SYSTEMS – MODEL FOR QUALITY ASSURANCE IN PRODUCTION, INSTALLATION AND SERVICING
MIL-I INSPECTION SYSTEM REQUIREMENTS
MIL-Q-9858 QUALITY PROGRAM REQUIREMENTS
SAE AS9100 QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS FOR AVIATION, SPACE AND DEFENSE ORGANIZATIONS
SAE AS9003 INSPECTION AND TEST QUALITY SYSTEMS REQUIREMENTS FOR AVIATION, SPACE AND DEFENSE ORGANIZATIONS

29. REFERENCES RISK-BASED THINKING IN ISO 9001:2015
RISK-BASED THINKING IN ISO 9001:2015
CORRELATION MATRICES BETWEEN ISO 9001:2008 AND ISO 9001:2015
ISO 9001:2015 FOR SMALL ENTERPRISES – WHATTO DO?
(DRAFT) TRANSITION PLANNING GUIDANCE FOR ISO 9001:2015
ISO 9001:2015 – HOW DO I GET STARTED (slide presentation)