Internet is brilliant. Back in the early 90’s we had 14K4 modems and no Google at all, if you wanted background information on something like ISO9001, good luck. Nowadays you can dig up anything on the web.
Formal quality systems did not appear until the early 1950s. Quality Control as an element of quality management emerged as a function in industry after WWII and the principles were codified by J M Juran in his Quality Control Handbook of 1951, now in its fourth edition and still the most notable book on the subject today.
In 1959 the first national standard, Mil Std 9858 on quality program requirements was issued by the American Department of Defense. This standard formed the foundation of all quality system standards that followed. The requirements for corrective and preventive action, data analysis, improvement, removal of special cause variation, contract review, work instructions, records, document control and many more were all in this standard of the 1950s.
Afaik this is the Military Standard 9858 that ISO9001 is part derived of.
This specification has been approved by the Department of Defense and is mandatory for use by all Agencies
This specification shall apply to all supplies (including equipment, sub-systems and systems) or services when referenced in the item specification, contract or order.
1.2 Contractual Intent
This specification requires the establishment of a quality program by the contractor to assure compliance with the requirements of the contract. The program and procedures used to implement this specification shall be developed by the contractor. The quality program, including the procedures, processes and product shall be documented and shall be subject to review by the Government Representative. The quality program is subject to disapproval of the Government Representative whenever the contractor’s procedures do not accomplish their objectives. The Government, at its option, may furnish written notice of the acceptability of the contractor’s quality program.
An effective and economical quality program, planned and developed in consonance with the contractor’s other administrative and technical program’s, is required by this specification. Design of the program shall be based upon consideration of the technical and manufacturing aspects of production and related engineering design and materials.
The program shall assure adequate quality throughout all areas of contract performance; for example, design, development, fabrication, processing, assembly, inspection, test, maintenance, packaging, shipping, storage and site installation.
All supplies and services under the contract, whether manufactured or performed within the contractor’s plant or at any other source, shall be controlled at all points necessary to assure compliance to contractual requirements. The program shall provide for the prevention and ready detection of discrepancies and for timely and positive corrective action. The contractor shall make objective evidence of quality conformance readily available to the Government Representative. Instructions and records for quality must be controlled. The Authority and responsibility of those in charge of the design, production, testing, and inspection of quality shall be clearly stated.
The program shall facilitate determinations of the effects of quality deficiencies and quality costs on price. Facilities and standards such as drawings, engineering changes, measuring equipment and the like which are necessary for the creation of the required quality shall be effectively managed.
The program shall include an effective control of purchased materials and subcontracted work. Manufacturing, fabrication and assembly work conducted within the contractor’s plant shall be controlled completely. The quality program shall also include effective execution of responsibilities shared jointly with the Government or related to Government functions, such as control of Government property and Government source inspection.
1.4 Relation to Other Contract Requirements
This specification and any procedure or document executed in implementation thereof, shall be in addition to and not in derogation of other contract requirements. The quality program requirements set forth in this specification shall be satisfied in addition to all detail requirements contained in the statement of work or in other parts of the contract.
The contractor is responsible for compliance with all provisions of the contract and for furnishing specified supplies and services which meet all the requirements of the contract. If any inconsistency exists between the contract schedule or its general provisions and this specification, the contract schedule and the general provisions shall control. The contractor’s quality program shall be planned and used in a manner to support reliability effectively.
1.5 Relation to MIL-I-45208
This specification contains requirements in excess of those in specification MIL-I-45208, Inspection System Requirements, inasmuch as total conformance to contract requirements is obtained best by controlling work operations, manufacturing processes as well as inspection and tests.
2. SUPERSEDING, SUPPLEMENTAL AND ORDERING
2.1 APPLICABLE documents
The FOLLOWING DOCUMENTS OF THE ISSUE IN EFFECT ON DATE OF the solicitation form a part of this specification herein.
SPECIFICATIONS – MILITARY
MIL-I-45208A Quality Program Requirements
MIL-STD-45662 Calibration System Requirements
2.2 Amendments and Revisions
Whenever this specification is amended or revised subsequent to its contractually effective date, the contractor may follow or authorize his subcontractors to follow the amended or revised document provided no increase in price or fee is required. The contractor shall not be required to follow the amended or revised document except as a change in contract.
If the contractor elects to follow the amended or revised document, he shall notify the Contracting Officer in writing of this election. When the contractor elects to follow the provisions of an amendment or revision, he must follow them in full.
2.3 Ordering Government Documents
Copies of specifications, standards and drawings required by contractors in connection with specific procurements may be obtained from the procuring agency, or as otherwise directed by the Contracting Officer.
3. QUALITY PROGRAM MANAGEMENT
Effective management for quality shall be clearly prescribed by the contractor. Personnel performing quality functions shall have sufficient, well defined responsibility, authority and the organizational freedom to identify and evaluate quality problems and to initiate, recommend or provide solutions. Management regularly shall review the status and adequacy of the quality program. The term “quality program requirements” as used herein identifies the collective requirements of this specification.
It does not mean that the fulfillment of the requirements of this specification is the responsibility of any single contractor’s organization, function or person.
3.2 Initial Quality Planning
The contractor, during the earliest practical phase of contract performance, shall conduct a complete review of the requirements of the contract to identify and make timely provision for the special controls, processes, test equipment, fixtures, tooling and skills required for assuring product quality. This initial planning will recognize the need and provide for research, when necessary, to update inspection and testing techniques, instrumentation and correlation of inspection and test results with manufacturing methods and processes. This planning will also provide appropriate review and action to assure compatibility of manufacturing, inspection, testing and documentation.
3.3 Work Instructions
The quality program shall assure that all work affecting quality (including such things as purchasing, handling, machining, assembling, fabricating, processing, inspection, testing, modification, installation, and any other treatment of product, facilities, standards or equipment from the ordering of materials to dispatch of shipments) shall be prescribed in clear and complete documented instructions of a type appropriate to the circumstances. Such instructions shall provide the criteria for performing the work functions and they shall be compatible with acceptance criteria for workmanship. The instructions are intended also to serve for supervising, inspecting and managing work.
The preparation and maintenance of and compliance with work instructions shall be monitored as a function of the quality program.
The contractor shall maintain and use any records or data essential to the economical and effective operation of his quality program. These records shall be available for review by the Government Representative and copies of individual records shall be furnished him upon request. Records are considered one of the principal forms of objective evidence of quality. The quality program shall assure that records are complete and reliable. Inspection and testing records shall, as a minimum, indicate the nature of the observations made and the number and type of deficiencies found. Also, records for monitoring work performance and for inspection and testing shall indicate the acceptability of work or products and the action taken in connection with deficiencies. The quality program shall provide for the analysis and use of records as a basis for management action.
3.5 Corrective Action.
The quality program shall detect promptly and correct assignable conditions adverse to quality. Design, purchasing, manufacturing, testing or other operations which could result in or have resulted in defective supplies, services, facilities, technical data, standards or other elements of contract performance which could create excessive losses or costs must be identified and changed as a result of the quality program. Corrective action will extend to the performance of all suppliers and vendors and will be responsive to data and product forwarded from users. Corrective action shall include as a minimum:
(A) Analysis of data and examination of product scrapped or reworked to determine extent and causes;
(B) Analysis of trends in processes or performance of work to prevent nonconforming product; and
(C) Introduction of required improvements and corrections, an initial review of the adequacy of such measures and monitoring of the effectiveness of corrective action taken.
3.6 Costs Related to Quality.
The contractor shall maintain and use quality cost data as a management element of the quality program. These data shall serve the purpose of identifying the cost of both the prevention and correction of nonconforming supplies (e.g., labor and material involved in material spoilage caused by defective work, correction of defective work and for quality control exercised by the contractor at the subcontractor’s or vendors facilities). The specific quality cost data to be maintained and used will be determined by the contractor. These data shall, on request, be identified and made available for “on-site” review by the Government Representative.
4. FACILITIES AND STANDARDS
4.1 Drawings, Documentation and Changes
A procedure shall be maintained that concerns itself with the adequacy, the completeness and the currentness of drawings and with the control of changes in design. With respect to the currentness of drawings and changes, the contractor shall assure that requirements for the effectively point of changes are met and that obsolete drawings and change requirements are removed from all points of issue and use. Some means of recording the effective points shall be employed and be available to the Government. With respect to design drawings and design specifications, a procedure shall be maintained that shall provide for the evaluation of their engineering adequacy and an evaluation of the adequacy of proposed changes. The evaluation shall encompass both the adequacy in relation to standard engineering and design practices and the adequacy with respect to the design and purpose of the product to which the drawing relates.
With respect to supplemental specifications, process instructions, production engineering instructions, industrial engineering instructions and work instructions relating to a particular design, the contractor shall be responsible for a review of their adequacy, currentness and completeness.
The quality program must provide complete coverage of all information necessary to produce an article in complete conformity with requirements of the design. The quality program shall assure that there is complete compliance with the contract requirements for proposing, approving, and effecting of engineering changes. The quality program shall provide for monitoring effectively compliance with contractual engineering changes requiring approval by Government design authority. The quality program shall provide for monitoring effectively the drawing changes of lesser importance not requiring approval by Government design authorities. Delivery of correct drawings and change information to the Government in connection with data acquisition shall be an integral part of the quality program.
This includes full compliance with contract requirements concerning rights and data both proprietary and other. The quality program’s responsibility for drawings and changes extend to the drawings and changes provided by the subcontractors and vendors for the contract.
4.2 Measuring and Testing Equipment
The contractor shall provide and maintain gages and other measuring and testing devices necessary to assure that supplies conform to technical requirements.
These devices shall be calibrated against certified measurement standards which have known valid relationships to national standards at established periods to assure continued accuracy. The objective is to assure that inspection and test equipment is adjusted, replaced or repaired before it becomes inaccurate. The calibration of measuring and testing equipment shall be in conformity with military specification MIL-C-45662. In addition, the contractor shall insure the use of only such subcontractor and vendor sources that depend upon calibrated systems which effectively control the accuracy of measuring and testing equipment.
4.3 Production Tooling Used as Media of Inspection.
When production jigs, fixtures, tooling masters, templates, patterns and such devices are used as media of inspection, they shall be proved for accuracy prior to release for use. These devices shall be proven again for accuracy at intervals formally established in a manner to cause their timely adjustment, replacement or repair prior to becoming inaccurate.
4.4 Use of Contractor’s Inspection Equipment.
The contractor’s gages, measuring and testing devices shall be made available for use by the Government when required to determine conformance with contract requirements. If conditions warrant, contractor’s personnel shall be made available for operation of such devices and for verification of their accuracy and condition.
4.5 Advanced Metrology Requirements.
The quality program shall include timely identification and report to the Contracting Officer of any precision measurement need exceeding the known state of the art.
5. CONTROL OF PURCHASES
. The contractor is responsible for assuring that all supplies and services procured from his suppliers (subcontractors and vendors) conform to the contract requirements. The selection of sources and the nature and extent of control exercised by the contractor shall be dependent upon the type of supplies, his supplier’s demonstrated capability to perform, and the quality evidence made available.
To assure an adequate and economical control of such material, the contractor shall utilize to the fullest extent objectives evidence of quality furnished by his suppliers. When the Government elects to perform inspection at a supplier’s plant, such inspection shall not be used by contractors as evidence of effective control of quality by such suppliers. The inclusion of a product on the Qualified Products List only signifies that at one time the manufacturer made a product which met specification requirements. It does not relieve the contractor of his responsibility for furnishing supplies that meet all specification requirements or for the performance of specified inspections and tests for such material. The effectiveness and integrity of the control of quality by his suppliers shall be assessed and reviewed by the contractor at intervals consistent with the complexity and quantity of product. Inspection of products upon delivery to the contractor shall be used for assessment and review to the extent necessary for adequate assurance of quality. Test reports, inspection records, certificates and other suitable evidence relating to the supplier’s control of quality should be used in the assessment and review. The contractor’s responsibility for the control of purchases includes the establishment of a procedure for (1) the selection of qualified suppliers, (2) the transmission of applicable design and quality requirements in the Government contracts and associated technical requirements, (3) the evaluation of the adequacy of procured items, and (4) effective provisions for early information feedback and correction of nonconformances.
5.2 Purchasing Data.
The contractor’s quality program shall not be acceptable top the Government unless the contractor requires of his subcontractors a quality effort achieving control of the quality and services and supplies which they provide. The contractor shall assure that all applicable requirements are properly included or referenced in all purchase orders for products ultimately to apply on a Government contract. The purchase order shall contain a complete description of the supplies ordered including, by statement or reference, all applicable requirements for manufacturing, inspection, testing, packaging, and any other requirements for Government or contractor inspections, qualification or approvals. Technical requirements of the following nature must be included by statement or reference as a part of the required clear description: all pertinent drawings, engineering change orders, specifications (including inspection system or quality program requirements) reliability, safety, weight, or other special requirements, unusual test or inspection procedures or equipment and any special revision or model identification.
The description of products ordered shall include a requirement for contractor inspection at the subcontractor or vendor source when such action is necessary to assure that the contractor’s quality program effectively implements the contractor’s responsibility for complete assurance of product quality. Requirements shall be included for chemical and physical testing and recording in connection with the purchase of raw materials by his suppliers. The purchase orders must also contain a requirement for such suppliers to notify and obtain approval from the contractor of changes in design of the products. Necessary instructions should be provided when provision is made for direct shipment from the subcontractor to the Government activities.
6. MANUFACTURING CONTROL
6.1 Materials and Materials Control.
Supplier’s materials and products shall be subjected to inspection upon receipt to the extent necessary to assure conformance to technical requirements. Receiving inspection may be adjusted upon the basis of the quality assurance program exercised by suppliers. Evidence of the suppliers’ satisfactory control of quality may be used to adjust the amount and kind of receiving inspection. The quality program shall assure that raw materials to be used in fabrication or processing of products conform to the applicable physical, chemical, and other technical requirements. Laboratory testing shall be employed as necessary. Suppliers shall be required by the contractor’s quality program to exercise equivalent control of the raw materials utilized in the production of the parts and items which they supply to the contractor. Raw material awaiting testing must be separately identified or segregated form already tested and approved material but can be released for initial production, providing that identification and control is maintained. Material tested and approved must be kept identified until such time as its identity is necessarily obliterated by processing. Controls will be established to prevent the inadvertent use of material failing to pass tests.
6.2 Production, Processing and Fabrication.
The contractor’s quality program must assure that all machining, wiring, batching, shaping and all basic production operations of any type together with all processing and fabrication of any type is accomplished under controlled conditions. Controlled conditions include documented work instructions, adequate production equipment, and any special working environment. Documented work instructions are considered to be the criteria for much of the production, processing and fabrication work. These instructions are the criteria for acceptable or unacceptable “workmanship”. The quality program will effectively monitor the issuance of and compliance with all of these work instructions. Physical examination, measurement or tests of the materials or products processed is necessary for each work operation and must also be conducted under controlled conditions. If physical inspection of processed material is impossible or disadvantageous, indirect control by monitoring processing methods, equipment and personnel shall be provided. Both physical inspection and process monitoring shall be provided when control is inadequate without both, or when contract or specification requires both. Inspection and monitoring of processed material or products shall be accomplished in any suitable systematic manner selected by the contractor. Methods of inspection and monitoring shall be corrected any time their unsuitability with reasonable evidence is demonstrated. Adherence to selected methods for inspection and monitoring shall be complete and continuous. Corrective measures shall be taken when noncompliance occurs. Inspection by machine operators, automated inspection gages, moving line or lot sampling, setup or first piece approval, production line inspection station, inspection or test department, roving inspectors – any other type of inspection – shall be employed in any combination desired by the contractor which will adequately and efficiently protect product quality and the integrity of processing. Criteria for approval and rejection shall be provided for all inspection of product and monitoring of methods, equipment, and personnel. Means for identifying approved and rejected product shall be provided. Certain chemical, metallurgical, biological, sonic, electronic, and radiological processes are of so complex and specialized a nature that much more than the ordinary detailing of work documentation is required. In effect, such processing may require an entire work specification as contrasted with the normal work operation instructions established in normal plant-wide standard production control issuances such as a job operation routing books and the like. For these special processes, the contractors’ quality program shall assure that the process control procedures or specifications are adequate and that processing environments and the certifying, inspection, authorization and monitoring of such processes to the special degree necessary for these ultra-precise and super-complex work functions are provided.
6.3 Completed Item Inspection and Testing.
The quality program shall assure that there is a system for final inspection and test of completed products. Such testing shall provide a measure of the overall quality of the completed product and shall be performed so that it simulates, to a sufficient degree, product end use and functioning. Such simulation frequently involves appropriate life and endurance tests and qualification testing. Final inspection and testing shall provide for reporting to designers any unusual difficulties, deficiencies or questionable conditions. When modifications, repairs or replacements are required after final inspection or testing, there shall be re-inspecting and retesting of any characteristics affected.
6.4 Handling, Storage and Delivery.
The quality program shall provide for adequate work and inspection instructions for handling, storage, preservation, packaging, and shipping to protect the quality of products and prevent damage, loss, deterioration, degradation, or substitution of products. With respect to handling, the quality program shall require and monitor the use of procedures to prevent handling damage to articles. Handling procedures of this type include the use of special crates, boxes, containers, transportation vehicles and any other facilities for materials handling.
Means shall be provided for any necessary protection against deterioration or damage to products in storage. Periodic inspection for the prevention and results of such deterioration or damage shall be provided. Products subject to deterioration or corrosion during fabrication or interim storage shall be cleaned and preserved by methods which will protect against such deterioration or corrosion.
When necessary, packaging designing and packaging shall include means for accommodating and maintaining critical environments within packages, e.g., moisture content levels, gas pressures.
The quality program shall assure that when such packaging environments must be maintained, packages are labeled to indicate this condition. The quality program shall monitor shipping work to assure that products shipped are accompanied with required shipping and technical documents and that compliance with Interstate Commerce Commission rules and other applicable shipping regulations is effected to assure safe arrival and identification at destination. In compliance with contractual requirements, the quality program shall include monitoring provisions for protection of the quality of products during transit.
6.5 Nonconforming Material.
The contractor shall establish and maintain an effective and positive system for controlling nonconforming material, including procedures for its identification, segregation, and disposition. Repair or rework of nonconforming material shall be in accordance with documented procedures acceptable to the Government. The acceptance of nonconforming supplies is a prerogative of and shall be as prescribed by the Government and may involve a monetary adjustment.
All nonconforming supplies shall be positively identified to prevent unauthorized use, shipment and intermingling with conforming supplies. Holding areas or procedures mutually agreeable to the contractor and the Government Representative shall be provided by the contractor.
The contractor shall make known to the Government upon request the data associated with the costs and losses in connection with scrap and with rework necessary to reprocess nonconforming material to make it conform completely.
6.6 Statistical Quality Control and Analysis.
In addition to statistical methods required by the contract, statistical planning, analysis, tests and quality control procedures may be utilized whenever such procedures are suitable to maintain the required control of quality. Sampling plans may be used when tests are destructive, or when the records, inherent characteristics of the product or the non-critical application of the product, indicate that a reduction in inspection or testing can be achieved without jeopardizing quality. The contractor may employ sampling inspection in accordance with applicable military standards and sampling plans (e.g., from MIL-STD-105, MIL-STD-414, or Handbooks H 106, 107, and 108).
If the contractor uses other sampling plans, they shall be subject to review by the cognizant Government Representative.
Any sampling plan used shall provide valid confidence and quality levels.
6.7 Indication of Inspection Status.
The contractor shall maintain a positive system for identifying the inspection status of products. Identification may be accomplished by means of stamps, tags, routing cards, move tickets, tote box cards or other normal control devices. Such controls shall be of a design distinctly different from Government inspection identification.
7. COORDINATED GOVERNMENT/ CONTRACTORS ACTIONS
7.1 Government Inspection at Subcontractor or Vendor Facilities.
The Government reserves the right to inspect at source supplies or services not manufactured or performed with the contractor’s facility. Government inspection shall not constitute acceptance; nor shall it in any way replace contractor inspection or otherwise relieve the contractor of his responsibility to furnish an acceptable end item.
The purpose of this inspection is to assist the Government Representative at the contractor’s facility to determine the conformance of supplies or services with contract requirements. Such inspection can only be requested by or under authorization of the Government Representative. When Government inspection is required, the contractor shall add to his purchasing document the following statement: “Government inspection is required prior to shipment from your plant.
Upon receipt of this order, promptly notify the Government Representative who normally services your plant so that appropriate planning for Government inspection can be accomplished.”
When, under authorization of the Government Representative, copies of the purchasing document are to be furnished directly by the subcontractor or vendor to the Government Representative at his facility rather than through Government channels, the contractor shall add to his purchasing document a statement substantially as follows: “On receipt of this order, promptly furnish a copy to the Government Representative who normally services your plant, or, if none, to the nearest Army, Navy, Air Force, or Defense Supply Agency inspection office. In the event the representative or office cannot be located, our purchasing agent should be notified immediately” All documents and referenced data for purchases applying to a Government contract shall be available for review by the Government Representative to determine compliance with the requirements for the control of such purchases. Copies of purchasing documents required for Government purposes shall be furnished in accordance with the instructions of the Government Representative. The contractor shall make available to the Government Representative reports of any nonconformance found on Government source inspected supplies and shall (when requested) require the supplier to coordinate with his Government Representative on corrective action.
7.2. GOVERNMENT PROPERTY.
7.2.1 Government-furnished Material.
When material is furnished by the Government, the contractor’s procedures shall include at least the following: a) Examination upon receipt, consistent with practicability to detect damage in transit;
b) Inspection for completeness and proper type; c) Periodic inspection and precautions to assure adequate storage conditions and to guard against damage from handling and deterioration during storage; d) Functional testing, either prior to or after installation, or both, as required by contract to determine satisfactory operation; e) Identification and protection from improper use or disposition; and f) Verification of quantity.
7.2.2 Damaged Government-Furnished Material.
The contractor shall report to the Government Representative any Government-furnished material found damaged, malfunctioning, or otherwise unsuitable for use. In the event of damage or malfunctioning during or after installation, the contractor shall determine and record probable cause and necessity for withholding material from use.
7.2.3 Bailed Property.
The contractor shall, as required by the terms of the Bailment Agreement, establish procedures for the adequate storage, maintenance and inspection of bailed Government property. Records of all inspections and maintenance performed on bailed property shall be maintained. These procedures and records shall be subject to review by the Government Representative.
(The following information is provided solely for guidance in using this specification.
It has no contractual significance.)
8.1 Intended Use.
This specification will apply to complex supplies, components, equipment and systems for which the requirements of MIL-I-45208 are inadequate to provide needed quality assurance. In such cases, total conformance to contract requirements cannot be obtained effectively and economically solely by controlling inspection and testing. Therefore, it is essential to control work operations and manufacturing processes as well as inspections and tests. The purpose of this control is not only to assure that particular units of hardware conform to contractual requirements, but also to assure interface compatibility among these units of hardware when they collectively comprise major equipment, sub-systems and systems.
This specification will not be applicable to types of supplies for which MIL-I-45208 applies.
The following do not normally require the application of this specification. (a) Personnel services, and (b) Research and development studies of a theoretical nature which do not require fabrication of articles.
8.3 Order Data.
Procurement documents should specify the title, number and date of this specification.