RELIABLE TOOL AND MACHINE INC. /
RELIABLE MACHINE & ANODIZE
Quality Manual
AS9100 & ISO9001: 2000
NTI/QM/001
CONTENTS
Clauses of the standard Pg. #
1. Scope 4
1.1 General 4
1.2 Permissible exclusions 4
2. Normative reference 4
3. Terms & Definitions 4
3.1 Product 4
4. Quality Management System 5
4.1 General requirements 5
4.2 Documentation requirements 5
4.2.1 General 5
4.2.3 Control of documents 5
4.2.4 Control of records 6
5. Management Responsibility 6
5.1 Management Commitment 6
5.2 Customer focus 6
5.3 Quality Policy 7
5.4 Planning 8
5.4.1 Quality Objectives 8
5.4.2 Quality management system planning 8
5.5 Responsibility, authority and communication 8
5.5.1 Responsibility & Authority 8
5.5.2 Management Representative 9
5.5.3 Internal communication 9
5.6 Management Review 9
5.6.1 General 9
5.6.2 Review input 9
5.6.3 Review output 9
6. Resource Management 10
6.1 Provision of resources 10
6.2 Human resources 10
6.2.1 General 10
6.2.2 Competency, awareness & training 10
6.3 Infrastructure 10
6.4 Work environment 10
CONTENTS
Clauses of the standard Pg. #
7. Product realization 11
7.1 Planning of product realization 11
7.2 Customer related processes 11
7.2.1 Determination of requirements related to the product 11
7.2.2 Review of requirements related to the product 12
7.2.3 Customer communication 12
7.3 Design & development 12
7.3.1 Design & development planning 12
7.3.2 Design & development inputs 12
7.3.3 Design & development outputs 12
7.3.4 Design & development review 12
7.3.5 Design & development verification 12
7.3.6 Design & development validation 12
7.3.7 Control of design & development changes 12
7.4 Purchasing 12
7.4.1 Purchasing process 12
7.4.2 Purchasing information 13
7.4.3 Verification of purchased product 13
7.5 Production & service provision 14
7.5.1 Control of Production & Service provision 14
7.5.2 Validation of processes for Production & Service provision 14
7.5.3 Identification & Traceability 15
7.5.4 Customer Property 15
7.5.5 Preservation of product 15
7.6 Control of monitoring & measuring devices 16
8. Measurement, analysis & improvement 17
8.1 General 17
8.2 Monitoring & Measurement 17
8.2.1 Customer satisfaction 17
8.2.2 Internal audits 17
8.2.3 Monitoring & Measurement of processes 18
8.2.4 Monitoring & Measurement of product 18
8.2.5 First article Inspection 18
8.3 Control of nonconforming product 19
8.4 Analysis of data 19
8.5 Improvement 16
8.5.1 Continual improvement 19
8.5.2 Corrective action 20
8.5.3 Preventive action 20
Glossary 21
Correspondence between ISO 9001:2000 and ISO 9001:1994 22
1. ScopeRELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE
specializes in the precision Engineering of Aerospace parts. Our processes include 3D
CNC machining, 3D programming, conventional machining.
Our quality system has been written to the AS9100 & ISO9001: 2000 standard and has
been certified by United Registrar of Systems.
Note:- United Registrar of Systems (URS) is accredited by UKAS.
1.1 General
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has
developed a quality system to ensure that our product is inspected and controlled for
consistency to the specifications of our customers and regulatory requirements.
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE also
has a system in place to review, evaluate and address customer satisfaction through a
process of continual improvement and prevention of nonconformities.
1.2 Permissible exclusions
The following sections of the ISO 9001: 2000 standard are not applicable to
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE
7.3 Design & development
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE
has no control over the design of the products supplied by the manufacturers or its
authorized distributors. Our business is programming and machining.
2. Normative referenceThe following standards reference in the ISO9001: 2000 & AS9100 will be checked for
their latest revision. If these standards should change this change will be notified to
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE
through our Registrar (URS) and any effect this change might have. Below is a list of
these standards:-
ISO 9000: 2000 (This standard will be used for vocabulary and fundamentals)
ISO 10007 (This standard is for guidance on design changes and is N/A at
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE)
ISO 10012 (This standard is for calibration)
ISO 10011 (This standard is for conducting internal audits)
A list of all other standards is controlled by RELIABLE TOOL AND MACHINE INC. /
RELIABLE MACHINE & ANODIZE and is covered under procedure P4.0 & P4.1
3. Terms & DefinitionsThe following terms and definitions will apply at RELIABLE TOOL AND MACHINE
INC. / RELIABLE MACHINE & ANODIZE
Supplier Organization Customer
Supplier = RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE &
ANODIZE suppliers
Organization = RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE &
ANODIZE
Customer = RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE &
ANODIZE customers
3.1 Product
The term product used at RELIABLE TOOL AND MACHINE INC. / RELIABLE
MACHINE & ANODIZE is used to describe the Engineering and machining of parts to
our customers specifications. The machining & Engineering services supplied are our
product.
4. Quality Management System
4.1 General requirements
To define how our Quality System is documented, implemented and checked to ensure it
is understood.
Policy
All processes have been identified and documented within our quality system, the
sequence and interaction of our operations are described below.
The criteria and methods of operation have all been documented within the quality
system with reference to information as required. All our processes are measured,
monitored, analyzed and continually improved upon.
4.2 Documentation requirements
4.2.1 General
All procedures and documents needed to meet the ISO 9001: 2000 standard have been
identified within this Quality Manual. These will be made readily available to all
personnel who require them for their work and also to any customer or regulatory
authority as required. (Ref:- 4.2.2c AS9100)
4.2.2 Quality Manual
This Manual shall be known as the “Quality Manual”. It will reference all procedures
and will also show the sequence of operations and how they interact with each other. This
manual is a controlled document and is subject to the controls outlined within section
4.2.3.
QUALITY SYSTEM STRUCTURE – Quality Manual Operational Procedures
Quality Records
4.2.3 Control of documents (REF ISO94 sec 4.5)
All documents (electronic and hardcopy) required for the quality system (internal &
external documents) will be controlled as defined in P4.0 Document Control. All
documents shall:-
• Be approved, reviewed and updated for adequacy prior to issue.
• The correct version of the document will be available at point of use
• All documents will be legible and remain legible through out the life of the document
• Documents will be readily identified and retrievable, this will include obsolete
documents which may be kept for reference purposes and will be suitably marked.
• Any customer supplied digital data or hard copy data will be entered into the
document control system the same as any other document for control of it’s
distribution and revision level and any other customer requirements. (Ref:- 4.5.2
AS9100)
• Any changes to any document within our quality system shall be reviewed in a
timely manner to ensure correct implementation and distribution. A record of
the incorporation of these changes shall be maintained and if required customers
and regulatory authorities shall be informed. Ref:- 4.5.3 AS9100)
Procedures Reference:-
P4.0 Document control & P4.1 Control of cnc programs
4.2.4 Control of quality records
All quality records generated as a result of maintaining this quality system shall be kept
as evidence of the effectiveness and compliance of the system. All records shall be
identified and retained for a minimum of 7 years unless otherwise specified or required
by contract. All records will be stored in a suitable environment so that they can be
protected, retrieved and eventually disposed.
All records shall be made available for review by regulatory authorities as required.
(Ref:- 4.16 AS9100)
5. Management responsibility
5.1 Management commitment
The Management at RELIABLE TOOL AND MACHINE INC. / RELIABLE
MACHINE & ANODIZE has communicated the importance of this quality system,
meeting customer, regulatory and legal requirements and will continue to do so to all
employees. Some of the ways in which this is achieved are detailed below:-
• Regular reviews of our Quality policies and objectives
• Conducting management reviews
• Ensuring that adequate time, space, equipment, training and other resources are
provided for.
5.2 Customer focus
Top Management at RELIABLE TOOL AND MACHINE INC. / RELIABLE
MACHINE & ANODIZE has the responsibility of ensuring that the customers needs are
always identified and provided for. We do this at the top level within our Management
review process by discussing concerns of our customers and special needs. This is then
filtered down into the sales order process as specific customer needs and will be
identified within the customer’s order.
5.3 Quality Policy
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE
has committed to providing it’s customers the best services from receipt of an
enquiry through to completion of the job. This shall also include follow up with the
customer to ensure that continual improvement is made to our processes.
Objectives:
• Measure and determine the level of compliance to the quality system
• Use these measures to set forward thinking goals in all areas of the business
• Goals will include:-
Increase sales while providing increased value to the customer
Maintain on time order completion rate while ensuring the integrity of the
product
Maintain & foster good supplier relationships
Detect any defective parts and prevent from shipping
Ship 100% on time delivery
Monitor and improve corrective action requests
Continuously train and improve employees’ knowledge
The signatures below indicate acceptance, review and approval of all policies and
objectives within this quality manual.
Signed:- Chad Goforth President
Signed:- QA Manager
Date:- 8/22/2007 Date:-
5.4 Planning
5.4.1 Quality Objectives
Quality Objectives have been identified and are documented within the Management
review procedure. These objectives are measurable and the results will be reviewed and
adjusted to ensure that our Overall Company objectives are being met.
5.4.2 Quality Management System Planning
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has
established a quality system, which is documented and implemented, this and the
procedure(s) outline in Sec 7.1 will be our plan for ensuring quality. If changes in our
organization occur which could affect our quality system these will be reviewed and
planned for in advance and in a controlled manner. These changes will also form part of
our Management review process
5.5 Responsibility, authority & Communication
5.5.1 Responsibility and authority
All of the persons at RELIABLE TOOL AND MACHINE INC. / RELIABLE
MACHINE & ANODIZE have their responsibilities defined within the procedures. Each
person has been assigned with the authority to carry out their responsibilities. Each
procedure within our quality system clearly shows how each function of our operation
interfaces with each other. This is achieved through documentation of our processes.
Any processes where there is only one individual who can perform that task will
have an individual procedure written for them outlining their responsibilities and
training requirements. (Ref:- 4.1.2.4 AS9100)
5.5.2 Management Representative
The QA Manager has been appointed as the Management Representative. His
responsibilities will include:-
• Ensuring that the Quality Management System is maintained
• Reporting to the President on the performance of the Quality Management System
and areas for improvement
• Promoting awareness of quality and customer requirements to all personnel
• Liaison with the registrar.
• The Management Representative has the authority and organizational freedom
to resolve quality related problems. (Ref:- 4.1.2.3 AS9100)
5.5.3 Internal communication
Communication between all personnel of the Quality system processes is achieved
through documentation of the systems and regular meetings and reviews between all
personnel. The Management representative will also be responsible for checking the
understanding of the Quality Management System and that it is communicated.
5.6 Management review
5.6.1 General
To measure the continued suitability & effectiveness of our quality system. Our quality
system will be reviewed by management on a twice yearly schedule against a prior set
agenda. Minutes from this meeting will be kept (see 4.2.4) & any actions resulting from
this will be carried out in accordance with sections 8.5.2 & 8.5.3.
5.6.2 Review input
Inputs have been identified as part of our set agenda for the Management review. These
inputs include all of the requirements of the standard and a few extra ones.
5.6.3 Review output
The output from the Management review will be recorded in the form of minutes and a
list of action items. The list of action items will show:-
• any areas of system/process improvements,
• researching of new processes and equipment to meet customer requirements
• resource needs
• Objective and policy changes
Procedures reference:-
P5.0 Management review
6. Resource management
6.1 Provision of resources
Resources will be provided by RELIABLE TOOL AND MACHINE INC. / RELIABLE
MACHINE & ANODIZE to ensure that all processes are implemented and that any
customer concerns are dealt with in a timely manner.
6.2 Human resources
6.2.1 General
All personnel at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE &
ANODIZE will be trained, educated, or have experience to ensure that they can fulfill
their responsibilities.
6.2.2 Competency, awareness and Training
To develop our most important resource: people through training and reviews of their
progress, needs and the effectiveness of the training. Training will be carried out against
needs which have been identified and this training will be recorded in accordance with
section 4.2.4. Also any tasks which are identified as requiring specific skills, training,
education or qualifications will be provided for.
Training will also be provided for the use, understanding and awareness of the
Quality system and the standards used at RELIABLE TOOL AND MACHINE
INC. / RELIABLE MACHINE & ANODIZE (Ref:- 4.18 AS9100)
Procedures Reference:-
P6.0 Training
6.3 Infrastructure
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE
Facilities are maintained, temperature controlled and clean. There is adequate workspace
and equipment to perform all processes within the quality system. This includes control
of the inspection & calibration areas.
6.4 Work environment
The work environment is air-conditioned and each person is provided with a workspace
and associated equipment and furniture to be able to perform their tasks. The work
environment is controlled for temperature, humidity, lighting and cleanliness (Ref:-
4.9.1b AS9100)
7. Product realization
7.1 Planning of product realization
To plan, control, approve, monitor and set standards so as to prevent problems which
may arise during Order processing, engineering, manufacturing, scheduled receipt, sub-
contract services and shipping.
These processes will be scheduled, planned & carried out under controlled conditions &
will include: (When/where applicable)
• Job Checklist
• Work Instructions
• Suitable working environment & reference to any standards applicable.
• Scheduling Inspection & checks and acceptance criteria
• Keeping records to support conformity of the processes.
• Any key characteristics identified by the customer as requiring tooling to
measure variables will be provided for.
• Any in-process verification points that cannot be verified at a later stage will be
identified on the “Shop Traveler”
• Any processes that require sub-contractors will be identified on the “Shop
Traveler”
• The development of process controls and plans for key characteristics as
required by the customer.
• The integration of material, processes and services which support the product
will be identified on the “Shop Traveler”.
• (Ref:- 4.2.3 AS9100)
7.1.1 Configuration Management
If a customer requires configuration management of a product built at RELIABLE
TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE then the
exact build of each job will be recorded and controlled by Job I.D # or customer
part serial #’s on each part and be maintained with the individual “Shop Traveler”.
(Ref:- 4.2.4 AS9100)
Procedures Reference:-
P7.6 Receiving
P7.7 Packaging & shipping
P7.8 Production scheduling & Traveler flow
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
As part of our RFQ/Order process RELIABLE TOOL AND MACHINE INC. /
RELIABLE MACHINE & ANODIZE will determine what requirements are needed to
fulfill the customers needs. These requirements will include:-
• delivery times
• engineering support
• regulatory & legal requirements are identified such as traceability & FAA clauses.
• Material selection
• Best method of manufacture
Any requirements to review a Tender will be handled the same way as any other
contract review. (Ref:- 4.3.1 AS9100)
7.2.2 Review of requirements related to the product
To ensure that our customers get what they requested on time, traceable and to the quality
they expect from RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE &
ANODIZE all orders, quotations & enquires will be reviewed by RELIABLE TOOL
AND MACHINE INC. / RELIABLE MACHINE & ANODIZE to ensure that;
• Customer’s requirements are unambiguous, clearly defined & documented.
• changes to requirements are resolved with the customer, documented and
communicated to all persons affected by the change.
• we can meet customer requirements.
• Any risks associated with new technologies, new materials or short lead times
are evaluated (Ref:- 4.3.2d AS9100)
• The records produced will be kept in accordance with section 4.2.4.
7.2.3 Customer Communication
Communication between RELIABLE TOOL AND MACHINE INC. / RELIABLE
MACHINE & ANODIZE and it’s customers is to ensure that any updates, amendments,
additions etc.. are handled effectively. This will include also any customer complaints,
customer feedback and product requirements.
Any contractual amendments are also subject to contract review. (Ref:- 4.3.3
AS9100)
Procedures Reference:-
P7.1 Receipt of Customer Orders
7. 3 – 7.3.7 Design & development
These sections are permissible exclusions to our quality system.
7.4 Purchasing
7.4.1 Purchasing process
To ensure that RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE &
ANODIZE receives supplied product to our specified and implied needs a list of
approved suppliers will be maintained and will also show the scope of each
suppliers/sub-contractors approval. This list will be prepared on results obtained from
one of the following sources:-
• SCAR’s,
• questionnaires,
• audits or approved to AS9100/ISO9001 etc...
Our purchases will also take into account physical condition of material/service, cost,
availability and traceability. The purchasing system and the selection of suppliers will be
reviewed to ensure its continued suitability and follow up action taken on vendor
problems (see 5.6 & 8.3).
Any sub-contractors used and the quality of the work that they provide will be the
responsibility of RELIABLE TOOL AND MACHINE INC. / RELIABLE
MACHINE & ANODIZE (Ref:- 4.6.1 AS9100)
All suppliers and sub-contractors will be evaluated to ensure:-
• they use customer approved sources for any special processes
• any that fail to meet Newtech requirements are disapproved as required by the
QA Manager
• suppliers/sub-contractor performance is monitored, maintained and recorded.
These reviews will be used to determine the controls required in place for each
supplier/sub-contractor.
• (Ref:- 4.6.2d-g AS9100)
7.4.2 Purchasing information (REF ISO94 sec 4.6.3)
All purchase documentation used will clearly describe the material/service ordered
including where applicable:-
• Quantities, condition, traceability, part numbers, type or other precise identification,
• Inspection requirements which will be reported on a certificate of Conformity where
required. Also any standards/codes which maybe referenced
• Any quality system standard to be applied to the product/service.
• Any design, test, examination, inspection or customer acceptance requirement
and it’s related instructions
• The right of access by the customer, their customer and regulatory authorities to
all facilities involved in the Order and also access to all applicable records.
• Any requirements for test specimens.
• Any requirements to notify RELIABLE TOOL AND MACHINE INC. /
RELIABLE MACHINE & ANODIZE of any anomalies, changes in definition or
approval for the process being used.
• Any requirements which require to be flowed down to sub tier suppliers will be
identified on the document.
• All purchase documents will be reviewed for adequacy prior to issue. (Ref:-
4.6.3d-h AS9100
Procedures reference:
P7.4 Purchasing procedure
P7.11 Approval & monitoring of suppliers quality systems
7.4.3 Verification of purchased product
All product received at RELIABLE TOOL AND MACHINE INC. / RELIABLE
MACHINE & ANODIZE will be verified in accordance with inspection procedures and
may also include:-
• Records to support the quality of the product from the supplier (e.g.:- C of C,
test reports, SPC charts etc..)
• Inspecting or auditing the supplier
• Inspection of the product upon receipt
• Asking the supplier/sub-contractor to complete inspection and certification,
however if this is the case then this will be defined within the purchase
documents. (Ref:- 4.6.4 AS9100)
If verification of the parts is to take place by the customer at RELIABLE TOOL AND
MACHINE INC. / RELIABLE MACHINE & ANODIZE facilities or RELIABLE TOOL
AND MACHINE INC. / RELIABLE MACHINE & ANODIZE chooses to verify the
parts at the suppliers facilities, then this will be arranged and documented on the contract
documents from the customer.
7.5 Production and service provision
7.5.1 Control of production and service provision
The production and service operations at RELIABLE TOOL AND MACHINE INC. /
RELIABLE MACHINE & ANODIZE are controlled to ensure that the following
requirements are met:-
• Technical data is available to verify the parts being manufactured/supplied
• Procedures have been documented for all processes where required.
• Measuring instruments are used as required to verify product
• Compliance with reference standards / codes, quality plans and/or documented
procedures.
• Monitoring of receiving, inspection, packaging & shipping processes.
• Criteria for workmanship other than those defined in any other documentation shall
be called out on the "Shop Traveler"
• Equipment shall be suitable maintained to ensure continuing process capability.
• Key characteristics identified by the customers contract are monitored (These
will be recorded on the “Shop Traveler” or inspection report.
• All material and parts will be accounted for during production, inspection and
prior to shipping, this will include any “Slit Orders/lots”.
• The “Shop Traveler will be used to record all operations and their sequence of
completion
• Processes are in place to prevent, detect and remove “Foreign objects”
• Any utilities which can affect the quality of the product in the future will be
controlled. At present there are none.
• All jobs are completed using the supplied documentation attached to the “Shop
Traveler”. This may include drawings and inspection plans, tooling required,
CNC program references.
• If a “Shop Traveler” has to be revised to alter the process then these changes
will be made by the originator and if required be identified back to the
customer. The change and it’s impact shall also be reviewed by Quality to ensure
no adverse impact.
• When a CNC program is written it shall be validated by a 1st article inspection
as required. See 8.2.5 First Article Inspection
• Any tooling which is held in storage for any amount of time shall be verified
prior to use, these will be controlled through either the 1st piece or final
inspection process.
• Any work carried out at a sub-contractors facility will first be agreed with the
Customer and then secondly be the subcontractors facilities will either be
audited or the procedures defined for how to control their work. (Ref:- 4.9.1 –
4.9.1.4 AS9100)
7.5.2 Validation of processes for production and service provision
Most processes at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE
& ANODIZE can be verified using inspection results.
Any special processes identified at RELIABLE TOOL AND MACHINE INC. /
RELIABLE MACHINE & ANODIZE will be qualified prior to use and their
process parameters defined. (Ref:- 4.9.2 AS9100)
7.5.3 Identification and traceability (REF ISO94 sec 4.8)
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will
identify all parts during all stages of receipt, manufacture, inspection, packaging &
shipping for traceability and its inspection status. All materials purchased will be
traceable back to their source of supply if required by the customer. For example using a
C of C. All goods received into RELIABLE TOOL AND MACHINE INC. / RELIABLE
MACHINE & ANODIZE will be identified as to their inspection status by using
accompanying paperwork. This is done at each stage of the Traveler. The inspection
status will be recorded on the inprocess inspection report with an inspector’s or operator's
initials and date.
If the customer requires by contract, regulatory or other established requirement
that the parts be traceable then RELIABLE TOOL AND MACHINE INC. /
RELIABLE MACHINE & ANODIZE shall provide the following where
applicable:- The identification method shall be defined by the customer.
• Identification of parts throughout the life of the product
• Any batch traceability requirements, including scrap to be maintained and
traceable to the raw material
• Any assembly traceability requirement to be traceable to the components and to
the next higher assembly level.
• Any product that requires the sequence of production, inspection and assembly
operations will be recorded on the “Shop Traveler” and kept as a record ref:-
4.2.4.
The actual configuration of the built product will be kept as a record to identify any
differences between the agreed configuration. (Ref:- 4.8 AS9100)
The Inspection records shall also identify who the is responsible and authorized to
verify, certify and release product. This will be indicated by an authorized signature
which is controlled internally. (Ref:- 4.12.1 & 4.12.2 AS9100)
7.5.4 Customer property (REF ISO94 sec 4.7)
To establish a documented system for receipt, control and maintenance of Customer
Supplied Material (CSM). Documented procedures shall be established so that all CSM
shall be examined, upon receipt, for damage, quantity, completeness and the correct
material or characteristic. Any discrepancy shall be reported to the Customer whom
supplied the materials. The necessary precautions taken and inspections performed to
assure that no damage or deterioration occurs during storage. All CSM shall be identified
and protected from unauthorized use or disposition. CSM will include, tooling, drawings,
electronic files, parts and raw materials.
Procedures reference:
P7.5.1 Control Of Customer Supplied Materials_R0.doc
7.5.5 Preservation of product
To prevent materials being damaged and to control our inventory for maintaining an
efficient cycle time on stock materials, RELIABLE TOOL AND MACHINE INC. /
RELIABLE MACHINE & ANODIZE will:-
• Handle materials to prevent damage, & deterioration problems.
• Materials will be controlled from receipt into storage and dispatch
• Any goods which are kept for any amount of time will be checked for shelf
life/damage as required.
• All Orders will be packaged in accordance with procedures and customer
requirements to prevent damage and to preserve the integrity of the original item.
• Our procedures will ensure that all goods are protected against damage and loss
during shipping & receipt to customer. Records of shipments will be maintained in
accordance with section 4.2.4.
• Procedures shall also include, cleaning, Foreign Object Damage (F.O.D), any
special handling requirements for sensitive parts, marking and labeling,
hazardous materials as required. (Ref:- 4.15.1 AS9100)
• Also any documents which are required to accompany the shipments will be
present, correct and protected from damage, loss and deterioration. (Ref:- 4.15.6
AS9100)
Procedures Reference:-
P7.6 Receiving
P7.7 Packaging & shipping
7.6 Control of measuring & monitoring devices
All measuring, test equipment which could affect the quality of the finished parts will be
calibrated by an external sub-contractor or in-house in accordance with ISO 100012 &
Traceable to the national institute of standards and technology (NIST). RELIABLE TOOL
AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will also ensure that:
• Personnel will select appropriate equipment for the measurement to be made.
• All of this equipment and standards will be identified and calibrated.
• The sub-contractor will record details of equipment, identification number, location,
checking frequency and method, tolerances and what to do when equipment is out of
specification, when required by contract.
• Our equipment will be maintained in a suitable state of accuracy.
• All equipment will be in a known state of calibration.
• Records of calibration will be maintained (5.5.7).
• Our procedures will explain what to do with previous results when equipment is
found out of calibration.
• All calibrations will be conducted in a suitable environment where necessary,
temperature, cleanliness etc..
• Our equipment will be handled, cleaned, maintained and stored accordingly.
• Adjustments to equipment will be controlled.
• Inspection, measuring and test equipment shall also include any personal tools used
for final verification, also any hardware and automated test equipment.
• A list of all equipment shall be maintained within the Inspection department
• Any calibration result that indicates that product maybe non-conforming will require
that the Quality Manager investigate the material and determine if disposition is
required.
• Gauges are recorded in a spreadsheet by date and will be recalled by the QA Manager
within a month of the due date.
• All responsibilities have been defined within the procedures for the control of the
above referenced tools. (Ref:- 4.11.1 AS9100)
Procedures Reference:-
P7.10 Calibration overview
8. Measurement, analysis and improvement
8.1 General
All materials will be inspected as it is received, machined and prior to shipping to assure
conformity to the product and purchase order specifications. If statistical techniques are
identified to monitor these activities these will be provided for.
Any procedures identified shall include:-
• identification of authorized persons
• limits of authorization
• training & qualification requirements.
Inspection documentation shall be maintained as evidence of product & process
conformance, these records shall show:-
• Acceptance & rejection criteria or reference to them.
• The sequence of operations on the “Shop Traveler” shall show when Inspection
took place.
• Actual results
• Any unique inspection equipment shall be recorded on the Inspection record
• Any sub-contracted inspection activities shall be recorded and controlled in
accordance with section 7.4.1 (Ref:- 4.10.1 AS9100)
8.2 Monitoring and Measurement
8.2.1 Customer satisfaction
A procedure has been documented within our quality system to monitor customer
feedback for positive and negative information. This information will be reviewed as part
of the Management review and corrective action system to implement continuous
improvement.
Procedures Reference:-
P8.1 Corrective Action Procedure
8.2.2 Internal audits
To verify the effectiveness of our quality system and implement any improvements
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has
documented procedures to ensure:-
• Audits will be carried out against procedures and a schedule
• The schedule has also been set based on importance of areas to be audited.
• Follow up action and the results of these audits will be documented and reported.
• Records will be maintained of the audit in accordance with section 5.5.7
• All auditors have been trained and will be selected independent of the area to be
audited.
• Audits will assess compliance to RELIABLE TOOL AND MACHINE INC. /
RELIABLE MACHINE & ANODIZE procedures and also to the AS9100 &
ISO9001: 2000 standards.
• The AS9100 checklist will be used to audit for compliance and determine our
overall effectiveness.
• All auditors will be qualified and trained through a recognized training
program. (Ref:- 4.17 AS9100)
Procedures Reference:-
P8.2 Internal audits
8.2.3 Monitoring and Measuring of processes
All processes at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE &
ANODIZE will be measured and monitored to ensure that they are suitable at ensuring
the customer requirements are being met. This will be achieved through the internal audit
program and the inspection process.
8.2.4 Monitoring and Measurement of product
All materials received, machined, stored, packaged and shipped from RELIABLE TOOL
AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will be inspected to
procedures and a record of the results will be kept. Parts will not be processed in the
system until all inspections have been completed unless the customer approves otherwise.
If certificates of conformance/analysis are supplied and are to be used by
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE
as acceptance of the parts, materials or service then these certificates are to be
inspected to the specifications required by the contract. A sample of these test
reports will also be independently verified on an annual basis as required by
contract. (Ref:- 4.10.2.4 AS9100)
The Inspection records shall also show actual results when required by contract or
specification and also qualification of the product produced.
All employees of RELIABLE TOOL AND MACHINE INC. / RELIABLE
MACHINE & ANODIZE shall sign the R8.3 Inspection report data recording
policy. Indicating that they have read, understand and will follow the policy
described.
8.2.5 First Article Inspection
Any 1st article inspections carried out at RELIABLE TOOL AND MACHINE INC.
/ RELIABLE MACHINE & ANODIZE will be carried out as follows:-
They will be sent to the QC department for mark up of the key characteristics that
are to be checked according to the contract or specification. These will be marked
up either on the drawing with circles and numbers or as a list on the Inspection
sheet.
The actual results of the inspections will be recorded and any test results and
required tolerances.
Any production or process changes will require that the 1st article Inspection plan
be updated by QC. (Ref:- 4.10.6 AS9100)
Procedures Reference:-
P8.3 Receiving Inspection
P8.4 In-process & Final Inspection
8.3 Control of nonconformityTo detect Non-conformance’s and prevent them from being sent to the Customer,
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has
documented and implemented a system procedure to:-
• Identify, "REJECTED", "RETURN TO VENDOR" or “SCRAP” parts
• Segregated where possible etc. and the problem documented.
• Review the problem to determine what to do with the goods.
• When this has been decided the persons concerned will be notified.
• Goods which are non conforming will be reviewed, categorized and documented and
action taken. If a customer needs to return items then these will be issued an NCR #
and tracked for disposition.
• These procedures shall also include the review and disposition of process non-
conformities, the returns from customers and the notification of all persons
required including customer, sub-contractor, regulatory etc... as required (Ref:-
4.13.1 AS9100)
• At Newtech a team approach to disposition of Non-conformances is used, the
team is made up from Quality, Management and Production. They have the
following disposition choses:-
• Use-as-is or repair (Only if authorized by the customer.
• Re-grading material which will require that the parts or material are clearly
identified as re-grade and adequate test reports are available and updated to
show re-grade.
• Scrap:- the parts or materials will be permanently marked or cut up to
prevent re-use
• Any non-conformities discovered which may affect product already shipped or
in use will be notified to the Customer in a timely manner. The notification will
include a description of the parts, quantities, serial numbers and dates as
required. (Ref:- 4.13.2.1 – 4.13.2.4 AS9100)
Procedures Reference:-
P8.1 Corrective Action Procedure
8.4 Analysis of dataRELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has
systems in place to collect and analyze data from our quality management system. This
data will include:-
• Results of internal audits
• NCR’s from customers and SCAR’s to the vendors
• Corrective action log
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will
then use this data to make improvements to the quality system.
8.5 Improvement
8.5.1 Planning for continual improvement
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has a
documented system in place which uses a planned approach to solving and implementing
continual improvement. This continual improvement is tracked, documented and
measured to the quality policy and it’s objectives. Continual improvement is one of the
agenda items at the Management review.
8.5.2 Corrective action
A documented system procedure is established at RELIABLE TOOL AND MACHINE
INC. / RELIABLE MACHINE & ANODIZE for taking corrective action to eliminate
causes of nonconformance, the action that is taken is also to a degree depended on the
impact of the problem. Below is described the policy steps for corrective action at
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE:-
• The nonconformance is identified and documented
• The cause of the nonconformance is investigated and documented
• An action will be taken as appropriate to prevent the recurrence of the problem
• This action will also be documented
• Follow up on the effectiveness of the action taken will be completed as part at the
next Internal audit unless it can be closed out earlier.
• If a sub-contractor/supplier is required to take corrective action then this will be
documented using a SCAR and flowed down to them for action to be taken.
• If for any reason a corrective action is not effective or timely then specific
actions will be instigated by the QA Manager and documented on the CAR
issued. (Ref:- 4.1.4.2e & f. AS9100)
8.5.3 Preventive action
RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will
identify areas of potential improvement and actions to be taken to prevent
nonconformance. This will be done as part of our internal audit and Management review
process. This process will include: -
• Identifying areas of potential nonconformance and documenting them into the
corrective action system.
• Taking action appropriate to prevent the nonconformance
• Recording the results of the action and reviewing the effectiveness of the action
taken.
Procedures Reference:-
P8.1 Corrective Action Procedure
GLOSSARY
CONFIGURATION MANAGEMENT: The serialization of parts within an assembly.
Correspondence between ISO 9001:2000 and ISO 9001:1994© ISO 2000 – All rights reserved
ISO 9001:1994 ISO 9001:2000
1 Scope 1
2 Normative reference 2
3 Definitions 3
4 Quality system requirements [title only]
4.1 Management responsibility [title only]
4.1.1 Quality policy 5.1 + 5.3 + 5.4.1
4.1.2 Organization [title only]
4.1.2.1 Responsibility and authority 5.5.1
4.1.2.2 Resources 6.1 + 6.2.1
4.1.2.3 Management representative 5.5.2
4.1.3 Management review 5.6.1 + 8.5.1
4.2 Quality system [title only]
4.2.1 General 4.1 + 4.2.2
4.2.2 Quality system procedures 4.2.1
4.2.3 Quality planning 5.4.2 + 7.1
4.3 Contract review [title only]
4.3.1 General
4.3.2 Review 5.2 + 7.2.1 + 7.2.2 + 7.2.3
4.3.3 Amendment to a contract 7.2.2
4.3.4 Records 7.2.2
4.4 Design control [title only]
4.4.1 General
4.4.2 Design and development planning 7.3.1
4.4.3 Organizational and technical interfaces 7.3.1
4.4.4 Design input 7.2.1 + 7.3.2
4.4.5 Design output 7.3.3
4.4.6 Design review 7.3.4
4.4.7 Design verification 7.3.5
4.4.8 Design validation 7.3.6
4.4.9 Design changes 7.3.7
4.5 Document and data control [title only]
4.5.1 General 4.2.3
4.5.2 Document and data approval and issue 4.2.3
4.5.3 Document and data changes 4.2.3
4.6 Purchasing [title only]
4.6.1 General
4.6.2 Evaluation of subcontractors 7.4.1
4.6.3 Purchasing data 7.4.2
4.6.4 Verification of purchased product 7.4.3
4.7 Control of customer-supplied product 7.5.4
4.8 Product identification and traceability 7.5.3
4.9 Process control 6.3 + 6.4 + 7.5.1 + 7.5.2
4.10 Inspection and testing [title only]
4.10.1 General 7.1 + 8.1
4.10.2 Receiving inspection and testing 7.4.3 + 8.2.4
4.10.3 In-process inspection and testing 8.2.4
4.10.4 Final inspection and testing 8.2.4
4.10.5 Inspection and test records 7.5.3 + 8.2.4
4.11 Control of inspection, measuring and test equipment[title only]
4.11.1 General 7.6
4.11.2 Control procedure 7.6
4.12 Inspection and test status 7.5.3
4.13 Control of nonconforming product [title only]
4.13.1 General 8.3
4.13.2 Review and disposition of nonconforming product 8.3
4.14 Corrective and preventive action [title only]
4.14.1 General 8.5.2 + 8.5.3
4.14.2 Corrective action 8.5.2
4.14.3 Preventive action 8.5.3
4.15 Handling, storage, packaging, preservation & delivery[title only]
4.15.1 General
4.15.2 Handling 7.5.5
4.15.3 Storage 7.5.5
4.15.4 Packaging 7.5.5
4.15.5 Preservation 7.5.5
4.15.6 Delivery 7.5.1
4.16 Control of quality records 4.2.4
4.17 Internal quality audits 8.2.2 + 8.2.3
4.18 Training 6.2.2
4.19 Servicing 7.5.1
4.20 Statistical techniques [title only]
4.20.1 Identification of need 8.1 + 8.2.3 + 8.2.4 + 8.4
4.20.2 Procedures 8.1 + 8.2.3 + 8.2.4 + 8.4