Quality Systems Manual ISO 9001:2000 & ISO 13485:2003

Page 1 of 13

TABLE O !O"TE"TS
1%0 2%0 2%1 3%0 3%1 3%2 4%0 I"T&O'(!TIO"))))))))))))))))))))))))))))))) S!O#E ))))))))))))))))))))))))))))))))))) E*!L(SIO"S )))))))))))))))))))))))))))))))) 'E I"ITIO"S A"' &E E&E"!E )))))))))))))))))))))))% $OALS A"' OB+E!TI,ES )))))))))))))))))))))))))) O&$A"I-ATIO"AL !.A&T/MISSIO" STATEME"T ))))))))))))))%%% Q(ALIT0 MA"A$EME"T S0STEM ))))))))))))))))))))))% 4%1 Q(ALIT0 S0STEM ))))))))))))))))))))))))))))% 4%2 'O!(ME"TATIO" ))))))))))))))))))))))))))))% 4%1 #&O!ESS A"' I"TE&A!TIO" !.A&T ))))))))))))))))))) MA"A$EME"T &ES#O"SIBILIT0 ))))))))))))))))))))))) 5%1 MA"A$EME"T !OMMITME"T ))))))))))))))))))))))%%% 5%2 !(STOME& O!(S )))))))))))))))))))))))))))%% 5%3 Q(ALIT0 #OLI!0 ))))))))))))))))))))))))))))%%% 5%4 #LA""I"$ )))))))))))))))))))))))))))))))) 5%5 &ES#O"SIBILIT03 A(T.O&IT03 A"' !OMM("I!ATIO" ))))))))))%% 5%5%5 &ES#O"SIBILIT0 A"' A(T.O&IT0 )))))))))))))))%% 5%5%2 MA"A$EME"T &E#&ESE"TATI,E )))))))))))))))%%% 5%5%3 I"TE&"AL !OMM("I!ATIO" ))))))))))))))))))%% 5%1 MA"A$EME"T &E,IE4 )))))))))))))))))))))))))%% &ESO(&!E MA"A$EME"T )))))))))))))))))))))))))%% 1%1 #&O,ISIO" O &ESO(&!ES )))))))))))))))))))))))% 1%2 .(MA" &ESO(&!ES ))))))))))))))))))))))))))%%% 1%3 I" &AST&(!T(&E )))))))))))))))))))))))))))) 1%4 4O&5 E",I&O"ME"T ))))))))))))))))))))))))))% #&O'(!T &EALI-ATIO" ))))))))))))))))))))))))))%%% 2%1 #LA""I"$ O #&O'(!T &EALI-ATIO" )))))))))))))))))) 2%2 !(STOME& &ELATE' #&O!ESSES )))))))))))))))))))) 2%2%1 'ETE&MI"ATIO" O &EQ(I&EME"TS ))))))))))))))% 2%2%2 &E,IE4 O &EQ(I&EME"TS ))))))))))))))))))%% 2%2%3 !(STOME& !OMM("I!ATIO" )))))))))))))))))) 2%3 'ESI$" A"' 'E,ELO#ME"T ))))))))))))))))))))))) 2%4 #(&!.ASI"$ ))))))))))))))))))))))))))))))% 2%5 #&O'(!TIO" A"' SE&,I!E #&O,ISIO" )))))))))))))))))% 2%5%1 !O"T&OL O #&O'(!TIO" A"' SE&,I!E #&O,ISIO" )))))) 2%5%2 ,ALI'ATIO" O #&O!ESSES ))))))))))))))))))% 2%5%3 I'E"TI I!ATIO" A"' T&A!EABILIT0 ))))))))))))))% 2%5%4 !(STOME& #&O#E&T0 ))))))))))))))))))))) 2%5%5 #&ESE&,ATIO" O #&O'(!T )))))))))))))))))%% 2%1 !O"T&OL O MO"ITO&I"$ A"' MEAS(&I"$ 'E,I!ES )))))))))) MEAS(&EME"T3 A"AL0SIS3 A"' IM#&O,EME"T ))))))))))))))%% 8%1 $E"E&AL )))))))))))))))))))))))))))))))) 8%2 MO"ITO&I"$ A"' MEAS(&EME"T )))))))))))))))))))) 8%2%1 !(STOME& SATIS A!TIO" ))))))))))))))))))) 8%2%2 I"TE&"AL A('IT )))))))))))))))))))))))) 8%2%3 MO"ITO&I"$ A"' MEAS(&EME"T O #&O!ESSES ))))))) 8%2%4 MO"ITO&I"$ A"' MEAS(&EME"T O #&O'(!T ))))))))% 8%3 !O"T&OL O "O"!O" O&MI"$ #&O'(!T )))))))))))))))% 8%4 A"AL0SIS O 'ATA ))))))))))))))))))))))))))%%% 8%5 IM#&O,EME"T )))))))))))))))))))))))))))))% 8%5%1 !O"TI"(AL IM#&O,EME"T ))))))))))))))))))%%% 8%5%2 !O&&E!TI,E6#&E,E"TI,E A!TIO" )))))))))))))))% 8%5%3 #&E,E"TI,E A!TIO" ))))))))))))))))))))))

#A$E
3 3 4 4 4 5 1 1 1 2 8 8 8 8 8 8 8 9 9 9 9 9 9 9 10 10 10 10 10 10 10 10 10 11 11 11 11 11 11 11 11 11 12 12 12 12 12 12 13 13 13 13 13

5%0

1%0

2%0

8%0

Page 2 of 13

1%0

I"T&O'(!TIO"

Deringer - Ney is a vertically integrated manufacturer of high performance alloys, precision metal components, precision insert molded components & part assemblies. ypical products are electrical contacts & rivets, ultra-small metal components, scre! machine parts, fine !ire, films & medical devices. he "uality management system at Deringer-Ney encourages employee participation and is supported by a strong top management commitment to "uality e#cellence. $uality initiatives focus on continuous process improvements, process control, production support, employee training and monitoring of customer satisfaction. his document defines the Deringer-Ney $uality %ystem Policy for governing the design &as applicable', development, manufacture, and distribution of all Deringer-Ney products. Deringer-Ney is pleased to provide the "uality manual to our customers upon !ritten re"uest. (nderstandably, Deringer-Ney)s processes and procedures are considered proprietary and shall be considered confidential and used solely for the purposes of evaluating Deringer-Ney. *anuals provided to our customers are uncontrolled and !ill not be updated unless specifically re"uested by the customer.

2%0

S!O#E

Deringer-Ney ac+no!ledges its responsibility as a manufacturer of precious metal alloys and precision metal components and assemblies to adhere to all applicable regulatory and industry standards. he "uality systems of all divisions of Deringer-Ney are compliant !ith the ,%- .//10 2/// standard for $uality *anagement %ystems and each division maintains their respective systems in compliance !ith the standards listed on their registration certificates. Deringer-Ney corporate offices are located at0 Deringer-Ney ,nc. 111 2trium Drive %uite 1// 3ernon 4ills, ,llinois 1//11 Phone0 567-.32-15// 8a#0 567-317-1/2. 9ebsite0 !!!.deringerney.com he scope for the 3ernon 4ills corporate office is 4uman :esources, 2ccounting, and *,%;, %ervices. -ther operating units include manufacturing facilities in <loomfield, =onnecticut> *arshall, North =arolina, and Nogales, *e#ico, as !ell as an office in ucson, 2ri?ona providing corporate administrative functions. Deringer-Ney ,nc. . 2 Douglas %treet Ney ,ndustrial Par+ <loomfield, = /1//2 P40 51/-262-2251 82@0 51/-262-A155 he scope of the "uality management system for the <loomfield site is for the design, development, and manufacture of precious metal alloys and components, =N= machining of precious metal alloys, plastic inBection molding, electrical contacts, and refining of precious metal. he corporate functions of =ontrol of the $uality *anual, and Purchasing, are performed at this site.

Page 3 of 13

Deringer-Ney ,nc. 1AA Derringer Drive *arshall, N= 257A3 P40 525-16.-3232 82@0 525-16.-32/. !!!.deringerneymarshall.com he scope of the "uality management system for the *arshall site is the manufacture of electrical contacts, contact assemblies, and micro-manufacturing. Deringer-Ney ,nc Par"ue ,ndustrial de Nogales Nogales, %onora, *e#ico P40 /11A2-13131-111A/ 82@0 /11A2-13131-631/5 !!!.deringerneynogales.com he scope of the "uality management system for the Nogales site is the manufacture of electrical contacts, assemblies, and stampings. Deringer-Ney ,nc. Palo 3erde =enter 351/ %. Palo 3erde %uite 3/5 ucson, 2C 5A716 P40 A2/-12.-3333 82@0 A2/-761-26.1 he scope for the ucson -ffice is =ontract :evie!, =ustomer %ervice and ,nterface, and *onitoring of =ustomer %atisfaction, as !ell as Dngineering support for the Nogales and *arshall sites.

2%1 E78lusi9ns
2s a contract manufacturer to customer dra!ings and specifications, all Deringer-Ney sites, e#cept for DeringerNey, <loomfield, e#clude clause 7.3. his e#clusion shall not affect the company)s ability, or responsibility, to provide product that meets customer and applicable regulatory re"uirements. Procedures for design and development &7.3' are established and maintained at the <loomfield site of Deringer-Ney ,nc. he resulting output of all production processes in the Deringer-Ney organi?ation can be verified by subse"uent monitoring and measurement.

3%0 'e:initi9ns an; &e:e<en8es

(nless other!ise specified, definitions referenced in ,%- .//102/// and ,%- 1365A !ill be used as the official definitions. his manual is organi?ed and !ritten to comply !ith the provisions of ,%- .//102/// and ,%- 1365A. 2s they apply to the respective divisions, Deringer-Ney !ill comply !ith the most recent edition of the aforementioned documents and ma+e necessary revisions to its "uality systems to insure continued compliance !ith applicable standards. 2ll references to specific policy, procedure, or !or+ instruction in this manual are the latest revision of that document unless other!ise noted. 2ll references to personnel in this manual are that person or his;her designated representative unless other!ise stated.

3%1 $9als an; O=>e8ti?es

Deringer-Ney has many obBectives that it uses to gauge the health of the company and it)s $uality %ystem. hese obBectives can include, but are not limited to, <usiness;8inancial, *anufacturing Performance &including Delivery and $uality', *aterials, Program *anagement, Dngineering, =ustomer %atisfaction, and 4uman :esources. o drive continuous improvement, top management !ill define goals against these obBectives> both short and long term. Eoals and obBectives are defined and distributed annually !ith updates as deemed necessary by top management. Performance to!ard the stated goals is revie!ed periodically as defined in corporate and divisional management revie! procedures.

Page 6 of 13

3%2

O&$A"I-ATIO"AL !.A&T

DERINGER-NEY INC.
<oard of Directors

=.D.-.

PresidentG =--

3P *ar+eting

=8-

3P <usiness Development

Dng & *+t Director

Plant *gr. %9

=ustomer %erv. *E:

3P -perations <loomfield

3P of :&D

4: *anager

*,%G, *gr

%ales

Plant *gr. *arshall

Plant 4: *anager

2ccounting

Purchasing

MISSIO" STATEME"T
DD:,NED:-NDF ,N= !ill promote a team!or+ environment for all of its constituencies to e#pand its position as the !orld)s best in contact manufacturing, contact assembly, and micro-manufacturing.

4%0 Q(ALIT0 MA"A$EME"T S0STEM

Page A of 13

4%1 Quality System

Deringer-Ney has defined and manages the processes necessary to ensure that products conform to customer re"uirements. he se"uence and interaction of the processes is described in the figure belo!. 2s a means of implementing and demonstrating the defined processes, Deringer-Ney has established, documented, and maintains a "uality management system that is continually improved. Deringer-Ney has prepared "uality system procedures that describe the processes and systems re"uired to implement the "uality management system. he "uality manual, along !ith several tiers of supporting procedures and documents, define the "uality management system. 2 master list of all "uality system procedures is maintained at the corporate and divisional levels, and includes the procedure name and number, and the current revision. :efer to the Process *ap on the ne#t page for a graphical representation of the Deringer-Ney $uality *anagement %ystem.

4%2 '98umentati9n
Deringer-Ney ,nc. has implemented and maintains procedures for controlling all documents and records related to processes and the "uality system. his includes Deringer-Ney ,nc. documentation, e#ternal documentation, and customer supplied documentation. he "uality manual is maintained and updated under the direction of the President;=-- and is available to all personnel as !ell as customers upon !ritten re"uest. he manual is revie!ed at least annually to ensure its compliance !ith the ,%- .//1 and ,%- 1365A standards, and its continuing suitability for Deringer-Ney ,nc)s improvement initiatives. he creation, approval, maintenance and storage of all documents related to processes and the "uality system for the purpose of delivering conforming product is carried out in accordance !ith documented procedures. his system also controls all documents of e#ternal origin and supplied by customers, and ensures that current applicable documents are readily available to personnel performing their Bobs. he structure of the documentation used in the "uality management system is as follo!s> $uality *anual- ierGHevel 1 =orporate and Divisional Hevel Procedures that support the clauses of the respective standards- ier GHevel 2 Divisional Hevel 9or+ ,nstructions for specific tas+s- ierGHevel 3 8orms and :ecords- ierGHevel 6 $uality records are maintained to sho! that the re"uired "uality levels are achieved and to verify the effectiveness of the "uality system. $uality records are stored and maintained in such a !ay that they are protected and readily available. &e:e< t9 in;i?i;ual ;i?isi9nal @<98e;u<es tAat su@@9<t tAis 8lause an; su=/8lauses%

Page 1 of 13

' Sam@le
SALES & MARKETING MA"A$EME"T MIS\IT ACCOUNTING QUALIT Y HUMAN RESOURCES PURCHASING

COSTING & QUOTATIONS

MA"A$EME"T & A'MI"IST&ATIO"

#LA"T .(MA" &ESO(&!ES I"TE&"AL A('ITS

M$MT &E,IE4

! ( S T O M E & & E Q ( I & E M E " T S

O&'E& &E!EI,E' B0 !(STOME& SE&,I!E B!SC EXTERNAL ENGINEERING REVIEW

I"TE&"AL

O&'E& #&O!ESSI"$

PURCHASING

S!.E'(LI"$

#&O'(!TIO" !O"T&OL

! ( S T O M E & S A T I S I A ! T I O "

ENGINEERING

SECONDARY OPERATIONS-(MAY BE OUTSOURCED)

PRODUCTION

PRODUCTION SUPPORT SERVICES

#LA"T MAI"TE"A"!E

STORAGE & SHIPPING

PACKAGING LABELING

INSPECTION

N- D0 N- =-NND= ,NE H,ND ,ND,=2 D% %(PP-: -8 2HH *2,N P:-=D%%D%

LEGEND:

CORPORATE SUPPORT

MAIN PROCESS

SECONDARY PROCESS

PLANT LEVEL SUPPORT PROCESS

Page 7 of 13

5%0 MA"A$EME"T &ES#O"SIBILIT0

5%1 ManaDement !9mmitment
he management group, under the direction of the President;=--, has the management responsibility at Deringer-Ney. hey are committed to driving the development and improvement of the "uality system, !hich includes0 ensuring the availability of resources establishment and revie! of the "uality policy and "uality obBectives implementing a plan of improvement to the "uality management system. op management also has the responsibility to communicate the importance of meeting customer, safety and regulatory re"uirements throughout the organi?ation. =ommunication meetings are held periodically throughout the organi?ation to disseminate necessary information to all employees.

5%2

!ust9me< 98us

he business model and systems at Deringer-Ney are designed !ith customer needs being the core focus. op management accurately identifies adBustments that must be made to ensure a strong alignment !ith customer needs. o achieve this alignment they revie! ne! customer re"uirements, customer surveys, and mar+et analysis reports to determine if the currently defined Deringer-Ney processes meet or e#ceed the customer needs and that Deringer-Ney is able to effectively translate these needs into the re"uired formats for the product reali?ation process. op management !ill determine !hether the systems and resources should be changed or upgraded to accommodate the ne! re"uirements or !hether the customer)s business is not a good fit for the company.

5%3

Quality #9li8y

(nder the direction of the President;=--, top management has established the "uality policy and instills Deringer-Ney s commitment to the policy. hey also ensure that the policy is communicated throughout the organi?ation and is understood by all personnel. he "uality policy shall be periodically revie!ed by management to ensure it is appropriate and suitable for Deringer-Ney, that it includes a commitment to meeting all re"uirement and continual improvement of the "uality system, and that it provides a frame!or+ for establishing and revie!ing the "uality obBectives. he defined "uality policy for the organi?ation is0

'e<inDe</"ey In8% is 89mmitte; t9 meetinD 9< e78ee;inD 9u< 8ust9me<Es <eFui<ements an; t9 89ntinually im@<9?e tAe e::e8ti?eness 9: 9u< Fuality manaDement system%

5%4 #lanninD
he "uality management system and sustaining processes support the "uality policy and obBectives. 2n effective "uality management system !ill assist Deringer-Ney in meeting the needs of our customers through the on time delivery of error free products. op management maintains a strategic plan &%ee 3.1' to achieve the "uality obBectives and other re"uirements. hey revie! this plan periodically to ensure its integrity and synchroni?ation !ith ne! re"uirements.

5%5 &es@9nsi=ility3 AutA9<ity3 an; !9mmuni8ati9n 5%5%1 &es@9nsi=ility an; AutA9<ity

*anagement is responsible for ensuring that responsibilities and authorities are defined and communicated !ithin the organi?ation. Iob descriptions are maintained by the 4uman :esources department at the division level, and define the responsibilities and re"uired competencies for all employees. hese responsibilities are communicated during the employee revie! process and outlined in !or+ procedures. 2ll levels of personnel have the authority to halt nonconforming processes and recommend corrective or preventive responses using the proper documented procedures.

Page 5 of 13

5%5%2 ManaDement &e@<esentati?e

(nder the direction of the President;=--, the 3P -perations serves as the management representative at the corporate level. 2s the $uality :epresentative for the organi?ation he is responsible for ensuring that the "uality obBectives are met and that continual improvement proBects are implemented !ith the goal of meeting each obBective. Plant *anagers serve as on-site management representatives and are responsible for the implementation of the "uality system at the plant level.

5%5%3 Inte<nal !9mmuni8ati9n

op management is responsible for identifying and establishing the +ey communication processes at DeringerNey. hese processes are designed to revie! the status of +ey production and "uality obBectives and to identify the corrections or resources needed to achieve the obBectives. he t!o primary communication forums used are management revie!s and periodic employee meetings.

5%1

ManaDement &e?ieG

o monitor the effectiveness of the "uality system, Deringer-Ney revie!s its "uality obBectives at established intervals, !hich are adBusted based on the business needs, ris+ assessment of the obBective, and stability of the metrics. op *anagement revie!s the "uality management system at least annually to ensure its suitability, ade"uacy and effectiveness. he revie! assesses opportunities for improvement and the need for changes to the "uality management system, and shall include inputs from audit results, customer feedbac+, process performance, product conformity, preventive and corrective actions, and any recommendations and changes that could affect the "uality system. :ecords of revie!s are maintained that include decisions and actions related to improvement of the "uality management system, improvement of processes, improvement of product, and resource needs. &e:e< t9 89<@9<ate an; in;i?i;ual ;i?isi9nal @<98e;u<es tAat su@@9<t tAis 8lause an; su=/8lauses%

1%0
1%1

&ESO(&!E MA"A$EME"T

#<9?isi9n 9: &es9u<8es

Deringer-Ney has determined and provides, in a timely manner, all resources needed to implement and improve the processes of the "uality management system, and to address customer satisfaction.

1%2 .uman &es9u<8es

2ll personnel !ho are assigned positions defined in the "uality management system shall be competent on the basis of applicable education, training, s+ills, and e#perience. Deringer-Ney shall provide all necessary training to satisfy the needs of the "uality system. Personnel at each relevant function and level shall be made a!are of0 the re"uirements of the "uality system the importance of conformance the impact of their !or+ on "uality the benefits of improved performance their roles and responsibilities in achieving conformance the potential conse"uences of departure from the specified procedures specific responsibilities and competencies for their assigned positions

1%3

In:<ast<u8tu<e

Deringer-Ney has determined, provides, and maintains the facilities re"uired to achieve the product conformity, including, but not limited to, !or+space and associated facilities, e"uipment, and supporting services. Page . of 13

1%4 49<H En?i<9nment

Deringer-Ney has determined and manages the !or+ environment re"uired to achieve product conformity. 2s a minimum, the facilities, including !or+stations and e"uipment, shall be maintained in a state of order, cleanliness, and repair that is appropriate to the process. &e:e< t9 !9<@9<ate an; in;i?i;ual ;i?isi9nal le?el @<98e;u<es tAat su@@9<t tAis 8lause an; su=/8lauses%

2%0
2%1

#&O'(!T &EALI-ATIO"
#lanninD 9: #<9;u8t &ealiIati9n

Deringer-Ney begins to develop its plan for product reali?ation during the re"uest for "uote &:8$' process. ,t is at this time that the re"uirements of the ne! product are evaluated and it is determined !hether these re"uirements can be incorporated into the current business and manufacturing process models. 2fter the customer accepts the "uote, the product re"uirements are integrated into the Deringer-Ney system.

2%2

!ust9me< &elate; #<98esses

2%2%1 'ete<minati9n 9: &eFui<ements &elate; t9 tAe #<9;u8t

he %ales and *ar+eting department establishes communication !ith the customer and uses a sales process to identify the needs of the customer and ho! Deringer-Ney can address these needs. ,f %ales determines that the customer needs are a potential match for Deringer-Ney)s capabilities the re"uest for "uote process is initiated. =ustomer in"uiries may also be received at the divisional level !ith appropriate personnel at that level determining product re"uirements and initiating appropriate actions to meet customer needs.

2%2%2 &e?ieG 9: &eFui<ements &elate; t9 tAe #<9;u8t

During the re"uest for "uote process and any subse"uent order processes, personnel from %ales and *ar+eting, =ustomer %ervice and;or Dngineering functions revie! the documentation provided by the customer to ensure that all re"uirements can be met by the currently defined production and "uality processes. :ecords are maintained to document results of revie!.

2%2%3 !ust9me< !9mmuni8ati9n

Primary customer communication regarding product information, order or other in"uiries, contracts, amendments, customer feedbac+, or complaints are typically channeled through the customer service department. hat function !ill contact the applicable division and personnel to handle the specific customer issue. ,n many cases, each business segment of Deringer-Ney has long-established customer relationships and customers may contact the specific division directly, or conversely> usually by phone or email.

2%3

'esiDn an; 'e?el9@ment

his section applies only to Deringer-Ney facility in <loomfield, = . &e:e< t9 tAat s@e8i:i8 ;i?isi9nEs @<98e;u<es tAat su@@9<t tAis su=/8lause% 8or all other facilities in the organi?ation, Deringer-Ney)s customers are responsible for the control and verification of the design of their product, and therefore this portion is e#cluded.

2%4

#u<8AasinD

Deringer-Ney maintains documentation to control all purchases that are re"uired for manufacturing product that conforms to customer re"uirements. Purchases are procured from approved suppliers in accordance !ith purchasing procedures. :eceived products are verified and;or inspected to ensure the purchased product meets the specified purchase re"uirements. Page 1/ of 13

2%5

#<9;u8ti9n an; Se<?i8e #<9?isi9n

2%5%1 !9nt<9l 9: @<9;u8ti9n an; se<?i8e @<9?isi9n

o clearly define and control manufacturing processes, Deringer-Ney maintains detailed procedures, !or+ instructions, dra!ings, and "uality plans, !hich merge the customer re"uirements !ith industry specific manufacturing standards to define the specific process that is used to accurately manufacture, inspect, and test a given product. he $uality and Dngineering departments in each division are responsible for creating and maintaining the necessary process documentation. Plant *anagement are responsible to ensure ade"uate resources, e"uipment suitable for manufacturing the product, and any necessary monitoring and measuring e"uipment, and implementation of those activities.

2%5%2 ,ali;ati9n 9: @<98esses :9< @<9;u8ti9n an; se<?i8e @<9?isi9n

Deringer-Ney e#cludes 7.A.2> the resulting output from all manufacturing processes is monitored. No division of Deringer-Ney has special processes !hose output cannot be verified by subse"uent monitoringGmeasurement.

2%5%3 I;enti:i8ati9n an; t<a8ea=ility

Deringer-Ney uses various identifiers to trac+ material and products through the reali?ation process. he products are also identified at applicable stages of reali?ation to sho! inspection status. *aterials, components, and assemblies have uni"ue identification characters that are recorded at various stages in the reali?ation process in order to maintain traceability.

2%5%4 !ust9me< @<9@e<ty

=ustomer o!ned property is controlled in accordance !ith applicable division level procedures.

2%5%5 #<ese<?ati9n 9: @<9;u8t

Deringer-Ney preserves the conformity of product during internal processing and delivery to the intended destination. :efer to individual divisional level procedures that support this sub-clause and address the identification, handling, pac+aging, storage, and protection of product, as !ell as the constituent parts of the product.

2%1

!9nt<9l 9: M9nit9<inD an; Measu<inD 'e?i8es

Deringer-Ney maintains documented procedures for controlling, calibrating, and maintaining all test and measurement e"uipment that affect product "uality. he accuracy of test and measurement e"uipment is controlled to assure compliance !ith test, inspection, and process instructions. &e:e< t9 !9<@9<ate an; in;i?i;ual ;i?isi9nal @<98e;u<es tAat su@@9<t tAis 8lause an; su=/8lauses%

8%0
8%1

MEAS(&EME"T3 A"AL0SIS A"' IM#&O,EME"T

$ene<al

Deringer-Ney uses procedures, !or+ instructions, and "uality control plans to validate product conformity. hese documents specify the re"uirements needed to correctly manufacture a product and !hat validation mechanisms &,nspection, est, and Dvaluation' are used to measure these re"uirements. Dach of these validation mechanisms generates reBect information for the product. :eBect or scrap information is aggregated into a "uality database as a "uality record and maintained for revie! by management. he defect information is also summari?ed in defect charts !ith trends and progress to defined goals. *anagement may use the summary data Page 11 of 13

to prioriti?e or initiate improvement plans. Deringer-Ney also utili?es the ,nternal 2udit Process to measure and monitor the conformity of the "uality management system, as !ell as continually improving its effectiveness.

8%2

M9nit9<inD an; Measu<ement

8%2%1 !ust9me< satis:a8ti9n

Deringer-Ney uses the follo!ing +ey obBectives to determine customer satisfaction. these obBectives and correlates them to customer perception. he organi?ation monitors

-n-time delivery J 8ormal "uality metric. *easures Deringer-Ney)s ability to meet the scheduling re"uirements of the customer. PP* value J 8ormal "uality metric. *easures the product that the customer returns to Deringer-Ney for re!or+ because of !or+manship andGor material defects. 2nalysis of these test or inspection escapes is performed and corrective action is implemented to eliminate future returns. =ustomer survey J:eport generated every t!o years. Deringer-Ney vie!s the formali?ed customer survey as a +ey performance indicator of trends in areas that are of importance to our customers. =ustomer performance meetings J 8ace to face communication bet!een +ey contacts. hese meetings, e#ecuted on an informal schedule, allo! solid relationships to be developed and maintained bet!een the +ey customer and Deringer-Ney sta+eholders. No obBective "uality evidence is maintained for these meetings. *anagement uses all these customer satisfaction indicators to define elements in the business plan.

8%2%2 Inte<nal au;it

Dach individual division of Deringer-Ney conducts internal audits at planned intervals to assess the processes of the "uality management system and to determine !hether the system conforms to applicable international standards, and planned arrangements, and !hether the "uality system is effectively implemented and maintained.

8%2%3 M9nit9<inD an; measu<ement 9: @<98esses

Deringer-Ney uses its "uality obBectives, internal audits, and management revie! processes to measure the effectiveness of the $uality *anagement %ystem. *etrics and progress to planned goals are revie!ed> !hen planned results are not achieved, remedial and corrective action is initiated according to procedural re"uirements.

8%2%4 M9nit9<inD an; measu<ement 9: @<9;u8t

Deringer-Ney monitors and measures characteristics of the product during the manufacturing process to verify all customer re"uirements and manufacturing standards have been met. 9ritten !or+ instructions are used throughout the manufacturing process to define specified monitoring and measurement criteria re"uired for each product. In/#<98ess Ins@e8ti9ns ,n process inspections are performed by production in accordance !ith the procedures, !or+ instructions, "uality plans, and;or !or+manship criteria. inal Ins@e8ti9n an; Test 8inal inspection includes a verification of completeness for all activities specified in the !or+ instructions. he final inspection confirms critical characteristics of the lot through audit and inspection using the applicable customer specified re"uirements, industry specifications andGor Deringer-Ney !or+manship criteria. -nly !hen conformance to all re"uirements have been confirmed is the product released for shipment.

8%3

!9nt<9l 9: "9n/!9n:9<minD #<9;u8t

2ll non-conforming product is controlled to prevent its use in the process or shipment to the customer. he responsibilities and authorities for dealing !ith nonconforming product are defined in divisional level 2 procedures hese procedures also outlines the controls and overall re"uirements, such as, identification, segregation,

Page 12 of 13

disposition, corrective action, and "uality records. 2ny nonconforming product that is corrected or re!or+ed shall be subBected to re-verification in order to demonstrate conformity to the re"uirements.

8%4 Analysis 9: 'ata

2t a minimum, performance data is analy?ed during management revie! activities to assess progress to defined goals and obBectives and to assess the overall effectiveness of the "uality management system. Nonconformance data is analy?ed to determine the necessity of corrective action or continual improvement proBects. Process trends and supplier data are also used to evaluate opportunities for improvements and preventive activities. Deringer-Ney performs analysis of the "uality obBectives and +ey predictors &D#0 =2: and audit performance' of a !ell functioning "uality system to identify continual improvement proBects that can be implemented to ensure that established goals are met.

8%5 Im@<9?ement 8%5%1 !9ntinual Im@<9?ement

Deringer-Ney is constantly striving to improve the effectiveness of the "uality management system. his trait is demonstrated by the company consistently meeting its "uality obBectives by adhering to the "uality policy and maintaining strong "uality processes li+e internal audits, analysis of data, correctiveGpreventive action, and management revie!s. ,deas that promote continual improvements to costs, "uality, service, and delivery are actively solicited throughout the organi?ation.

8%5%2 !9<<e8ti?e J #<e?enti?e A8ti9n

he corrective and preventive action program provides a systematic approach to problem &or potential problem' identification, analysis, corrective action and reporting. his approach is predicated on documented procedures and open communication for early detection of potential or actual "uality problems and for correcting these issues promptly. horough root cause analysis of a process or product issue follo!ed by a verification of the corrective actions ensures that the discrepancy !as resolved. 9hen applicable, permanent changes resulting from corrective actions are documented in !or+ instructions andGor process procedures. %ignificant issues and the actions ta+en to resolve the issue are revie!ed as part of management revie!s. 2ll corrective and preventive actions shall be to a degree appropriate to the magnitude of the problem and commensurate !ith the ris+ encountered.

8%5%3 #<e?enti?e A8ti9n

%ee section 5.A.2 &e:e< t9 !9<@9<ate an; in;i?i;ual ;i?isi9nal @<98e;u<es tAat su@@9<t tAis 8lause an; su=/8lauses%

Page 13 of 13