FOI 245-1112 document 21

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TBfBA PEU TIC SIIIIDS

A DM INIS rRA TlON

Manufacturer Assessment Section

Organisation Name:.'

Poly Implants Protheses

Quality System Requirement

4.1 Management responsibilitv

4.1.1 Quality policy

The suppliers management with executive responsibility shall define and document its policy for quality,including objectives for quality and its commitment to quality. The quality policy'shall be relevant to the supplier's organisational goals and .the expectations and needs of Its ' customerS. The supplier shall en,sure that this policy is understood, implemented and maintained at all levels of the organisation . , '

4.1.2 Organisation

4.1.2; 1 Responsibility and a�thority

The responsibility, authority and the interrelation of personnel who manage, perfonn and verify work affecting,

, quality shall be defined and documented I particularly for personnel who need the organisational freedom and authority to:

a) initiate action to prevent the occurr�nce of any non to the '

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Prepared by:

u " ... " 0, ISO 1 3485:1 996 Qualitv System ALidit Checklist

H<,cL'L 0-l V � TO;'" � c..-. Conformity Assessment Audit date(s): ' of 55

17-19 November 2003.

Document Review

Is quality policy documented?

Is the policy relevant and' appropriate?

Is the policy communicated and understo�d by aD staff?

. How are the responsibilities and authorities defined?

. Are an organisational chart and position· descriptions for head of production and head of quality funct�on available?

Audit observations

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FormXXX.Y

TG/\ rHERAPEurlC' filiUS JlDM'II'STRATltJN

Manufacturer Assessment SectIon

'Organisation Name:


system;

b) identify arid record any problems relating to the product,

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u ' , ISO 13485: 1 996 Quality System Audit Checklist

Conformity: Assessment Audi(dat�(s):

17-19 November 2003. of 55

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process and quality system; Are they appropriate?,

er initiate, recommend or provide solutions throug h designated channels;

d) verify the implementation of solutions;

, e) control further processing, delivery orin�allation of . nonconfonning produ'ct until the deficiency or ,unsatisfactory condition has been corrected.

4.1 .2.2 Resources

The supplier shall identify resource requirements and provide adequate resources,including �he assignment of trained personnel (see 4.18), for' management,

, performance of work and verification activities including InternaJ quality audits.

4.1.2.3 Management Representative

The supplier's management with executive responsibility shall ap'point a member of the supplier's own management who, irrespective of other responsibilities, shall have defined authority for

a) ensuring that a quality system is established, implemented and maintained in accordance with this International Standar�, and

Prepared,by: _

Who'is the Management Representative?

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TG/\ THERAPEUTIC GOODS ABI\f INIS TIAr,,,.

Manufacturer Assessment Section Organisation Name:


b) reporting on the performance 6f the quality system to the supplier's management for review and as a basis for improvement of the quality system.

NOTE 5 The responsibility of a management representative may also indude liaison with extemal parties on matters relating to the supplier's quality system

4.1.2.4 lVianagement review The suppliers management with exeGutive responsibility shall review the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of this Internation�[ Standard and the suppliers stated quality policy and objectives (see' 4.1.1). Records of such reviews shal l be maintained (see 4.16).

Prepared by: •••

0· ,. " ', U IS� 13485:1996 Quality System Audit Checklist

Conformity Assessment Audit date(s):


What is the evidence that these requirements have been effectively met?

Is there a formal periodic review of the quality system and how is it done?

. Are the intervals . between reviews appropriate?

Do the reviews meet the . requirements?

Are records of the reviews maintained?

of 55

FormXXX.Y

TGJ\ THERAPEU TIC 6 0 0 D S A DMINIS rRATl1IN '


Organisation Name:


4.2 Qualit� sllstem

4.2.1 General

, The supplier shall e�tablish document and maintain a qual ity system as a means of ensuring that product conforms to specified requirements. The supplfer shall prepare a

, quality manual covering the requirements of this International Standard. The quality manual shall include or make reference to the quality, system procedmes and outJj'ne. the structure of the documentation used in the quality system.

NOTE 6 Guidance on quality manuals is given In ISO 10013. The supplier shall establish and document the specified requirements.

' , '

Note: If this Standard is usedforcompOance with regulatory requirements, the relel/ant regulatory requirements of the . regulations should be included in the spec/fled requirements.

4.2.2 ,Quality system procedures

The supplier shall

a) prepare documented procedures consistent with the requirements of this International Prepared by: •••

U ISO 13485:1996 QuaHtv System Audit Checklist



Page40f 55

Has a quality manual been prepared?

Does the quality manual address the requirements of the standard?

Does tbe quality manual include or reference the QS procedures and outline the structure of'the documentation of the QS system?

Are there documented procedures for each of the elements of the qualitY standard? .

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TG/\ TBERAPEUrtfJ IIOODS' ADMINISTRATlDN


Organisation Name:

Poly Implants Protheses·

Standard and the s uppliers stated quality policy, and

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b) effectiyely implement the quality system and its documented procedures.

For the purposes of this International Standard, the range and detail of the procedures that form part of the quality system shall be dependent upon the complexity of the work, the methods used; and the skills and training needed by personnel involved in carrying out the activity. NOTE 7 Documented procedures may make reference to work instructions that define how an activity is performed.

The supplier shall establish a.nd maintain a file(Device Master Fi/e) containing documents defining the product specifications, including complete manufacturing and quality assurance specifications for each type/model of medical device, or referring to the location of this

.

information (se,!, a/so 4.5.2 and 4. 16).

4.2.3 Quality planning .

The supplier shall define and document how the requirements for quality will be met. Quality planning .shall be consistent with all other·


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. ISO 13485: 1996 Quality System Audit' Checklist <,J

Conformity Assessment .Audit date(s):


Are the qu�dity system procedures implemented effectively? _ SlIl%]ec.;h0C. .

How are the requirements f9r quality dotumented?

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TG·A TNERAPEurlC SDODS A DMINIS TRATION


Organisation Name: Poly Implants Protheses

requirements of a supplier's quality system and shall be documented in a format to suit the supplier's method of. operation.

The supplier shall give consideration to the following activities, as appropriate, in meeting the specified requirements for products, projects or contracts:

a) the preparation of quality plans;

b) the identification and acquisition of any controls, processes, equ ipment (including. inspection and test equipment), fixtures, resources and skills that may be needed to achieve th� required quality;

c) ensuring the compatibility of the deSign, the production proCass, installation, servicing, . inspection and test procedures and the applicable documentation;

d) the updating, as necessary, of quality control, inspection. and testing techniques; Including the development of new instrumentation;

e) the id�ntification of any measurement require-ment involving capability that exceeds the known state of the art,in sufficient time for the needed

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capability to be developed

Prepared by:

u. (� ISO 13485:1996 Quality System Audit Checklist


17-19'November 2003.

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TG·/\ THERAPEUTIC . GOODS

ADMINISTRA TIDN


Organisation Name:

Poly Impiants Protheses

f) the identification of suitable verifiCation at appropriate stages in the realisation of product;

g) the clarification of standards of acceptability for all features and requirements, including 'those which contain a subjective element;

h) the identification and preparation of quality records (see 4.16) ..

NOTE 8 The quality plans referred to [see 4.2.3a)] may be in 1he form of a reference to the �ppropriate documented procedures that form an integral part of the supplier's quality system� .

Prepared by:

G ISO 13485:1996 Quality System Audit Checklist

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. Conformity Assessment Audit date(s):


of 55

FormXXX.V

TG/\ 1HERlfpEUTIC BOODS

. A DMINISTRATION

. Manufacturer Assessment Section

Organisat ion Name:


4.3 Contract review

4.3.1 General

The supplier shafi establish and maintain . documented procedures for· contract review and for the coordination of these activities.

4.3.2 Review

Before submission of a tender, or the acceptance of a contract or order (statement of requirement), the tender, contract or order shall be reviewed by the supplier to ensure that:

a) the requirements are adequately defined and documented; where no written statement of re-quirememt is available for an order received by verbal means, the supplier shall ·ensure that the order requirements are agre�d before their acceptance;

b) any differences between the contract or order requirements and those in the tender are resolved;

c) the supplier has the capability to meet the contract or order requirements.


u (--J ISO 13485: 1996 Quality Sys�em Audit Checklist

Confo rmity Assessment Audit date(s):

17-.19 November 2003.

. Are there documented procedures for contract review?

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of 55 .

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FonnXXX.Y

TGA THERAPEUTIC GOODS A DIIINISTRATION


Organisation Name:


4.3.3 Amendment to a contract

The supplier shall identify how an amendment to a contract is made and correctly transferred to the functions concerned within the supplier's' organisation .

. 4.3.4 Records

Records of.contract reviews shall be maintained (5ee 4.16):

NOTE 9 Channels for communication and interfaces with the customer's organisation in these contraot matters should be established.


u � '. U . ISO 13485: 1996 Qual ity System Audit Checklist

Conformity As�essment Audit date(s): of 55'

17-19 November 2003 • .

FormXXX.V

T.G 1\ THERAPEUTIC SODDS

.

ADMINISTRA TION

. Manufacturer Assessment Section

Organisation Nam·e:

Poly Implants Protheses.

4.4 Design control (ISO 13485 only)

4.4.1 General

The supplier shall establish and maintain . do�mented procedures to control and \f;erifY the design of the product in order to ensure that the spf�cified requirements are met.

4.4.2 Design and development planning The supplier shall prepare plans for each design tand development activity. The plans shall describe or reference these activities, and define responsibility for their implementation.· The design and development activities shalt be assigned to qualified personnel equipped with adequate resources. The plans shall be updated as the design evolves.

4.4.3 Organisational and technical interfaces

Organisational and technical interfa�s between different groups which input into the design process shall be defined and the necessary information documented, transmitted and regularly reviewed.


,/'" '. U ISO 13485: 1996 Quality System Audit Checklist

Conform ity Assessment Audit date(s): 17-19 November 2003.

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Select and review example(s) of design -� � . projects.

Was the project plan clearly documented?

. How were changes to the plan controlled?

Were the interelationships of difT�rent /' groups involved in design activities

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defined?

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FormXXX.Y

·T.G/\ THERAPEUTIC IlDflDS A DNINUTlA 7ION


Organisation Name: Poly Implants J.Jrotheses

4.4.4 Design input

Design input requirements relating to the product, including applicable statutory and regulatory requirements, shall be identified, documented and their selection reviewed by the supplier for adequacy, Incomplete, ambiguous or· conflicting requirements shall be resolved with those responsible for imposing these requirements.

Design input shall take into consideration the results of arlY contract review activities .

. The supplier shall identify requirem�nts that are related to the safety of the medical device and shall include such requirements as design input' data.

4.4.5 .Design output

Design output shall be documented and expressed in terms that can be verified and validated against design input requirements.

Design output shall: .

a) meet the deSign input requirements

b contain or make reference to acce tance

Prepared by: _

.... , U (j ISO 1.3485:1996 Quali�v System 'Audit Checklist

. Conformity Assessment Audit date(s):

i7"19 November 2003.

How did the deSign groups document and review information?

Was the safety of the device included as an input into design?

How was design output documented?

. Was the output verified against input?

of 55

TG/\ THERA PEU TIC· SODDS A D MINISTRATION

Manufaeturer Assessment Section

Organisation Name: .


. criteria;

c) identify those characteristics of the design that are crucial to the safe and proper functioning of the product (e.g. ·operating storage, handling, maintenance and disposal requirements).

De!=iign output documents sh�lI· be reviewed before release.

4.4.6 Design review

At appropriate stages of deSign, formal documented reviews of the design results shall be planned and conducted. PartiCipants at each design review shall include representatives of all functions concerned with the·design stage being reviewed, as well as other specialist personnel, as required. Records of such· reviews shall be maintained (see 4.16) ..

4.4.7 Design verification

At appropriate stages of deSign, design verification shall be performed to ensure that the design stage output meets the design stage

. input requirements. The design verification measures shall be recorded (see 4. 16).


o ISO 1 3485:1 996 Quality System Audit Checklist

. Conformity ASsessment Audit date(s):

. 1749 November 2003 •

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How were design output documents reviewed before release?

Were reviews of the design project carried out at appropriate interValS?

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Were appropriate personnel involved? �� I �+6��+le,Ao.O�� Were the reviews documented?

. . Was design verification carried out and recorded?

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Form XXX.Y

TGA rHEBAPEUTfC GIIIIBS ADMINISTRATION


Organisation Name:


The supplier shall document and maintain records (see 4.16) o(.a/l design verification ac.tivities including those where clinical investigation was involved.

NOTE 10 In addition to conducting design reviews (see 4.4.6}, design verification may include activities such as

- perfolJT1lng alternative calculations,

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\.J U ISO 1 3485:1996 Quality System Audit Checklist

Conformity AS$eSSment Audit date(s):


. of 55

- comparing the new design with a similar proven design, if 4--..:.--------------1ravailable,

- undertaking tests and demonstrations, and . . - reviewing the design stage documents before release.

4.4.8 Design validation '

Design validation shall be performed to ensure . t'hat product conforms to defined user needs ·and/or requirements.

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NOTES 11 Design validation follows successful design verification (see 4.4.7).

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12 Validation Is normally performed under defined operating .conditions.

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How was design validation carried out?

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TG/\ TIIEllJlPEU7IC BIIIIDS AIIMINIS TRATlDN


Organisation Nart:le:

Poly Implants .Protheses

completion ..

14 Multiple validations may be perfonned ifthere are different intended uses.

4.4.9 Design changes

All design changes and modifications shall be identified, documented; revl nd approved by authorised personnel before thel implementation.

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Conformity Assessment Audit date{s):


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·Were· design changes appropriately managed?

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Maljufacturer Assessment Section

Organisation Name:

Poly Impl�nts Protheses

4.5 Document and data control

4.5.1 General

The supplier shall establish and maintain documented procedures to control all documents and data that relate to the requirements of this International Standard including, to the extent

.

applicable, documents of external origin such a:s standards and customer draWings.

NOTE 15 Documents and data can be in the form of any type of media, such as hard copy or electronic media.

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Are·ther� documented procedures for document and' data control?

4.5.2 Document and data approval and issue

The documents .and data shall be reviewed and approved for adequacy by authorised personnel Who approves documents prior to issue?' prior to issue. A master list or equivalent document control procedure identifying the current revision status of documents shall be established and be readily available to preclude the use of invalid and/or obsolete documents.

This control shall ensure. that: . Are appropriate documents available at

a) the pertinent issues of appropriate documents points of use? are available at all locations where 0 erations

Prepared by:

Page 1 5 of 55

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T'G J\ rllERAPEurrc BODDS

'

jllMINISTRATIOII

Manufactyrer Assessment Sectloo

Organisation Name:

,I Poly Implants Protheses

ssential to the effective fun'ctioning of the quality system are performed; b) invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use;

c) any obsolete documents retained for legal and/or knowledge-preselYati�n purposes are suitably idel")tified.

The supplier shall define the period for which at least one copy of obsolete documents shall be retained. This period shall ensure that specifications to which medic;al devices have been manufactured are availa,b/e for at least the lifetime of the medical device as defined by the supplier (see 4. 16}.

.. .

4.5.3 Document and data changes

Changes to documents and data shall be reviewed and approved by the same functions/organisations that performed the original review and approval, unless specifiCally rJesignated otherwise. The designated , :functions/organisations shall have access to pertinent background information upon which to . base their review and approval.

Pr�pared by: ....

r \ U ISO 13485:1996 Quality System Audit Checklist

Conformity Assessment Audit date(s): �'v.:>II.9-. , ".5' 17-19 November 2003., ' �VJ \fI: .

Were invalid o'r obsole�e documents found in the workplace? -c of'l/j

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How long are obsolete documents retained for? ,

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F.orm XXX,Y

THERAPEUTIC 6 0 0DS A DMINIS TRA TION


Organisation Name:

Poly Implants'Protheses

Where practicable, the nature of the change shall be Identified in the document or the appropriate attachments.


Cj () ISO 13485:1996 Quality System Audit Checklist



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FormXXX.Y

TG!\ THERAPEUTIC 60 0DS A DMINISTUTION


O rganisation Name: .

. Poly Implants Protheses

4.6 Purchasing

4.6.1 General

The supplier shall establish and maintain documented procedures to ensure that purchased product (see 3.1) conforms. to specified requirements.

.

.4.6.2 Evaluation of subcontra.ctors

The supplier shall

a) evaluate and select subcontractors ori the basis of their ability to meet subcontract requirements including the quality system and any specific quality assurance requiremen.ts;

b) define the type and extent of control exercised by the supplier over subcontractors. This shall be dependent upon the type of product; the impact of subcontracted product on the quality of final pr6�uct and, where appli.cable, o� the quality audit reports and/or quality records of the . previously demonstrated capability and

. performance of subcontractors;

d} establish and ·maintain Qualitv records of


0. 180·13485:1996 Quality 8ystem Audit Checklist

Conformity Assessment Audit date(s): . of 55

17-19 Novemb�r 2003.

Are there documented procedures for . purchasing and ensuring that purchased product conforms to specifie� requirements?

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How are subcontractors evaluated and selected?

Is there periodic review of subcontractors once selected.

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evaluation/selection and ongoing controls . L:b�'1"��7'i_....:· -=. :.....:,.\ V\.. ___ �-=-_---_____ +--, of some subcontraCtors

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TG/\ THERAPEU TIC IU1DDS A IIMINI.S TRA TIrJN


Organisation Name: . .


acceptable subcontractors (See 4.16).

4.6,3 Purchasin� data

Purchasing documents shall contain data clearly describing the product ordered, including where applicable: •

a) the type, class, grade or other precise identification;

b) the title or other positive identification. and. applicable .issues of specifications, drawings, process'requirements, inspect ion ' instructions .and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment and personnel;

,

c) the title, number and issue of the quality system standard to be applied.

The supplier shall, review and. approve pu'rchasing documents for adequacy of the specified requirements prior to release.

To the extent required by the particular requirements for traceability in 4.8, the supplier

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.... '\ U ISO 13485: 1996 Quality System Audit Checklist <..J

Conformity AS,sessment Audit date(s):


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FormXXX.V

THERAPEUTIC 600DS ADMINISTRATION

Manufacturer Assessment' Section

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· ISO 1 3485": 1 996 Quality System Audit Checklist

Organisation Name: Co.nformity Assessment Audit date(s}:

17-19 November.2003.

of 55


shall retain copies (see 4.16) afre/evant · purchasing docum�nts. .

4.6.4 Verification of purchased product

4.6.4.1 Supplier verification at subcontractors premises . ' .

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7 Where the supplier proposes to verify purchased h.6..S 1 lA- � ? product at the subcontractor's premises, the .?vvrc "" (\ �.__ � \ u..&11

supplier shall specify verification ar�angements . W If �+ t �� at tr e.� � --f-: 't5lrt� f"V""-� I'l . and the method of product release In the

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Where specified in the contract, the supplier's customer or t�e customer's representative shall be afforded the right to verify at the · subcontractor's premises and the supplier's

· premises.that subcOntracted product conforms to . specified requirements. Such verification·shall not be used by the �upplier as .evidence of effective control of quality by the subcontractor.

Verification by the customer shall not absolve .the supplier of the responsibility to provide acceptable product, nor shall it-preclude. subsequent rejection by the customer.

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FormXXX.Y

TG/\ . .

THERAPEU TIC 6 0 0BS A D MINISTIIATlDN


Organisation Name:


4.7 Control of customer-SuRRlied t;!roduct

The supplier shall establish and maintain .

documented procedures for the �ontrol of . verification, storage and maintenance of customer-supplied product provided for incorporation into the supplies or for related ac-tivities .. Any such product that is ·Iost, damaged or is otherwise unsuitable for use shall be recorded and reported to the customer (see 4.6).

Verification by the supplier does not absolve tlie customer of the responsIbility to provide acceptable proouct.


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(j ISO 13485:1996 Quality System Audit Checklist


17�19 November 2003.

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FormXXX.V

TG/\ THERA PEUTIC BOODS A D.'lilS TRAT/ON


Organisation N'ame:


4.8 Product identification and traceability

Where appropriate, the s�pplier shall establish and maintain documented procedures for identifyin'g the product by suitable means from receipt and during all stages of production, delivery and installation.

Where and to the extent that traceability is a specified requirement, the supplier shall establish and maintain documented procedures for unique identification of individual product or batches. This identification shall be recorded (see 4.16).

Particular requirement for all medical devices:

a) Identification

The supplier shall establish and maintain procedures to ensure that medical devices received for refurbishing are identified and

" distinguished at all times ffr)m nbrmal production.

b} Traceability

The supplier shall establish, document and maintain procedures for traceability., The Prepared by:

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FormXXX.Y

TG/\ THERAPEUTIC 6 0 0DS ADMINIS TRA TIOfl


Organisation Name:


procedures shall define the extent of traceability and facilitate corrective and preventive �ction (see 4.14.2)

Addifional.requlrements for active implant able med/cal devices and Implantable medical devices: -

........ �-----The extent oftraceability shall include all . components and materials used, and [!3cords 91. th�ntal conditions (see 4.9B)d), when these, could cause the medical device not to ' satisfy its specified requirements.

The' supplier shall require that its agents �r distributors maintain records of the distribution of medical devices with regard to traceability and that such records ate available for inspections ..

Prepared by:

. () \ ... I ISO 1.3'485: 1 996 Quality System Audit dhecklist

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Conformity Assessment Audit date(s): ."age 23 of 55

17-19 November:2003.

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FormXXX.Y

T G /\ , THERA PEUTIC li D OOS "

A DMIN ISTRATlDN


Organisation Name:

Poly Implants J.»rotheses

4.9 Process control

The supplier shall identify and plan the production, installation and servicing processes which directly affect quality and shall ensure that these proCesses are carrie� out under controlled coriditions. Controlled conditions shall include , the following:

a) documented procedures defining the manner of production, installation and servicing, where the absence of such procedures could adversely , affect quality; ,

b) use of suitable production, installation and servicing equipment, and a suitable working environment;

c) compliance with reference standards/codes, quality plans and/or documented procedures;

d) monitOring and control of suitable process parameters and product characteristics; ,

e) the approval of processes and equipment, as appropriat�;

f) criteria for workmanship, which, shall be in the ractical M!:'!,nn.:.or

" Prepared by: _

V ISO 1 3485: 1 996 Quality System Audit Checklist


, 17-19 November 2003.

of 55

" Form XXX.Y

T G /\- THERA PEUTIC GIIIIDS

- -

A DMINIS 1RA �'ON


Organisation Name:


written standards, r�presentative samples or illustrations);

g) suitable maintenance of equipment to ensure continuing process capability.

Where the results of processes cannot be fUlly verified by subsequent inspection and testing of the _product and where; for example, processing deficiencies may become apparent only after the produCt is in use, the processes shall be carried out by qualified operators and/or shall require continuous monitoring and control of process parameters to ensure that the spec ified requirements are met.

The requirements for any qualification of process operations, including associated equipment and personnel (see 4. 1 8), shall be specified.

NOTE 16 Such processes requiring pre-qual ification of their process capability are frequently referred to as special processes.

Records shall be maintained for qualified - processes, equipment and personnel, as

approprIate- (see 4.16).

Prepared by: _

u U 180 1 3485:1996 Quality System Audit Checklist

Conformity Assessment Audit date( s):


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T G /\ , lllEBA P I UTlC 6 00DS . A DMINIS TlATIDN

'Manufacturer Assessment Section

U ISO 1 3485: 1 996 iuality System Audit Checklist " il�\.�mi , .

Organisation Name: C®nfllllrmity Assessment Audit date(s): 17-19 November 2 •• 3 • .

of 55


J�) Personnel Ud � (ee -�()f> ' bOO / o� , O I \ !O J � 8 rY., t / 0 '2 ",CS 0 10 The supplier shall establish, document and maintain requirements for health, cleanliness and clothing of personnel if contact between such personnel and product or environment could adversely affect the quality of prod.uct. �

t�"{,ct � VtOo� , 1� rr�& M �J. 2. (.(1

. B) Environmental control rn manufacture tot"" -f..{� � A1. cl, ,�� l� 0 ·2 J-A- . For medical devices

'4 ' -"k \!o-a) that are supplied sterile; or g�(,-..k& OVl o.W lA V .

b) that are supplied no�/e �nd 'intended for J :ce F':{; J.� L �.8 (,1 k. :::====�'=()J--==, =1..e={/I?=.f'=e::rule==.1= ' :=.' ===':�c.:-""-� .

sterilization before ,t?e; 0-;-· ' , _+_�,--_____ --:---:-y...!:,--�ctC&/- roJ.e . . c' where the microbiological and/orparliculate -�� deanliness or other'environmental conditions �(X) %11 �'f:..�� are of significance in their use; or \� � 'f AI\ ,. nOY ,- J> O P . �A· � if" 'P"". \,I!. - Id�<..� . d) where the environmental conditions are of . � .. ,.1 . 0L' � MV' P-l olN significance in their manufacture; the supplier, ' ". � (.,�/G � if .r/] (,ov'� . 1 shall establish and document requirements for � L,�v +� pl� r . the environment to which product is exposed.

f--o ':-.H V,) o-.vv I.\-� . If appropriate, the environmental ,conditions shall � " �, \iI r �_� l be control/ed and/or monitored. ' 'J V" �I . �

Form XXX.Y

T G /\ THERAPEUTIC . B O D D S . A D MINIS TRA TION

U ' U Manufacturer Assessment Section Organisation Name:


C) Cleanliness of product

The supplier shall establish, document and maintain requirements for cleanliness of product if:

a) product is cleaned by the supplier prior to sterilization and/or its use; or

b) product is supplied non-s le to be subjected to a cleaning process ' . r to sterilization and/or its use; or

c) product is supplied t e used non-stenle and its cleanliness is ol rgnificance in use; or

d) process agents are to be removed from �.ILQ :-- � product during manufacture.

If appropriate, product cleaned in accordance with a) or b) above need to be subject fa the preceding particular requirements, i.e. A) Personnel and B) Environmental control in manufacture, prior to the cleaning procedure.

DJ Maintenance

The supplier shal/ establish and document

Prepared by:

ISO 13485:1 996 Quality System Audit Checklist

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-

Forrn XXX.Y

() U THERAPEUTIC S D D D S . ADMINlSTRATtDN ISO 1 3485:1 996 Quality System Audit Checklist





· 17-19 November 2003;

If,T . .JfV' .. ._. : [.lj..:;>

� requirements for maintenance qctivities when such activities may affect product quality. 0-vVI'� ��· Records of such maintenance shall be kept (see 4. 16) . .

E) Instaflation

If appropriate, the supplier shall e and . document both l and acceptance criteria ti . s lIing and checking the medical de",· . . Records of installation an �dormed · by the supplier or . . uthorized representative shall be reta ' (see 4. 16).

If the ·contract (see 4.3) allows inst . n other than by the supplier orbi orized.

: representative, t 'Pplier shall provide the purcha . written instructions for installation and checking . .

. . ) � M � �'� F) SpecIal processes . �\�\O- ). . The supplier shall ensure that the quality records . . of special processes (se� 4. 16 and note in 4,9 of EN ISO 9001 : 1994) identify:

a) the work instruction used;

Prepared by:·_·

of 55

Form XXX.v

T G /\ TIIERArEUTIG G O O D S A D M''''S rRAr,o"


Organisation Name:

Poly Implants Protheses · .

b) the date the specia/process was performed; c) the identity of the operator of the spee;ia/ process.

Additional requirement for sterile medical devices:

. The supplier shall subject the medical devices to a validated sterilization process and record (see 4. 16) all the control parameters of the sterilization process.


(' \) .. ,-" ISO 13485: 1 996 Qu§lity System Audit Checklist

Conformity Assessment Audit date{s) : 17-19 November 2003.

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THERAI'EU7It: 6011115 A IIM,,,IS TRA Tl9N


Organisation Name:


4.1 0 InsDection and testing

4.10.1 General

The supplier shall establish and maintain . documented procedures for inspection and te.sting activities in order to verify that the specified requirements for the product are met. The required inspection and testing, and·the records to be established, shall be detailed in the . quality plan or documented procedures .

. 4. 10.2 Receiving inspection and testing

4.1 0.2. t The supplier shall ensure that Incoming . product is not used or processed (ex�ept in the circumstances described in 4.10.2.3) until it has been inspected or otherwise verified as conforming to I?pecified requirements. Verification of conformance to the specified

. requirements shall be in accordance with the quality plan and/or documented procedures.

4.10.2.2 In determining the amount and nature of receiving inspection, consideration shall be given to the amount of control exercised at the subcontractor's premises and t�e recorded. evidence of conformance provided. Pr�pared by: _

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T G A rIlEBA I' E U rlC S O DJS A DMINls rRA TION

Manufacturer Assessment S!i!ctlon

Organisation Name:

Poly Implants ;protheses

4.10.2.3 Where incoming product is released for.

urgent production purposes prior to verification, it shall be positively identified and recorded (see 4.16) in ,order to permit immediate recall and replacement in'the event of nonconformity to specified requirements.

4.10.3 In-process inspection and testing

The supplier shall:

a) inspect and test the product as required by the, quality plan and/or documented procedures;

b) hold product until the required inspection and tests have been completed, or necessary reports have ,teen received and verified" except when product is released under positive-recall pro- ' cedures '(see 4.10.2 .3). Release under positive recall procedures shall not preclude the activitie� outlined in 4.10.3 a).

4.10.4 Final inspection and testing

The supplier shall carry out all final inspection and testing in accordance with the, quality plan and/or documented procedures to complet� the evidence of conformance of the finished product to the specified requirements.

Prepared by: _

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Form XXX.Y

T G /\ THERAPEUTIC 6 0 0 D S A D MINISTRA TION

Manufacturer Asses5ITlent Section

Organisation Name:


The quality plan and/or documented procedures for final inspection and testing shall require that all specified inspection and tests, including those specified either on receipt of product or inprocess, have been carried out and that the results meet specified requirements.

No product shall be dispatched until all the activities specified in the quality plan and/or documented procedures have been satisfactorily completed and the associated data and documentation are available and authorised.

4.1 0.5 Inspection and test records

The supplier shall establish and maintain records which provide evidence thatthe product has been inspected and/or tested. These records shall show clearly whether the product has passed or failed the inspections and/or tests according to defined acceptance criteria. Where the product fails to pass any inspection and/or test, the procedures for control of nonconforming product shall apply (see 4.13).

Records shall identify the inspection authority rssponsible for the release of product (see4.1 6).

The supplier shall record (see 4. 16) the identity of personnel performing any ins ection or

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Form XXX.V

T G A 'HEIlAPE Urtc G O O D S A DMINIS TRATI O N




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ISO 1 3485:1 996 Quality System Audit Checklist



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T G /\ TRfRA I'EUT" SDDDS A DMINIS TRA TI O N


Organisation Name:


\.J ISO 1 3485:1 996 Qualitv System Audit Checklist



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4.11 Control of inspection. measuring and test equipment

4.1 1 .1 General

The supplier shall establish and maintain documented procedures to control , calibrate and maintain inspection , measuring and test equipment (including test software) used by the supplier to demonstrate the conformance of product to the specified requirements. Inspection, measuring and test equipment shall be used in a manner whi�h ensures that the measurement uncertainty is known and is cons istent with the required measurement capability .

Where test software or comparative references such as test hardware are used as suit forms of inspection, they shall be c eked to

rove that they are capable of rifying the c�tability of product, . r to release for use

during production , in atlon or serviCing, and shall be rechec at prescribed intervals. The supplier sha stablish the extent and frequency of such ecks and shall maintain records as evid ce of control (see 4.16).

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Form XXX.Y

T G /\ THERAPEUTIC BOODS AIJMINIS TIlATlON ISO 13485: 1996 Quality System Audit Checklist


Organisation Name:


is a specified requirement, such data shall be made available, when required by the customer or customer's representative, for verification that the inspection, measuring and test equipment is functionally adequate.

NOTE 17 For the purposes of this International Standard the term " measuring equipment" includes measurement devices.

4.1 1 .2 Control procedure

The supplier shall:

a) determine the measurements to be made and the accuracy required and select the appropriate inspection, measuring and test equipment that is capable of the necessary accuracy and precision;

Conformity Assessment Aud it date(s): 17-19 November 2003.

b) identify all inspection, measuring and test �K. �� equipment that can affect product quality, and calibrate and adjust them at prescribed intervals; . or prior to use, against certified eqUipment having a known valid relationship to internationally or nationally recognised standards. Where no such standards exist, the basis used for calibration shall be documented;

c) define the process em�oyed for the


of 55

Form XXX.Y

T G/\ THERAPElIlIC II D flflS A DMlalSTRATIDN

Manufacturer Ass essm ent S ection

Organisation Name:


calibration of inspection , measuring and test equipment, including details of equipment type, un ique identification, location, frequency of checks, check method, acceptance criteria and the action to be taken when results are unsatisfactory;

d) identify inspection , measuring and test equipment with a suitable indicator or approved identification record to show the calibration

.

status;

e) maintain calibration records for inspection, measuring and test equipment (see 4. 16);

f) assess and document the validity of previous inspection and test results when inspection, measuring or test equipment is found to be out of calibration;

g) ensure that the environmental conditions are suitab le for the calibrations, inspections, measurements and tests being carried out;

h) ensure that the handling, preservation and storage of inspection, measuring and test eqUipment is such that the accuracy and fitness for use are maintained;

i) safeguard ins ection , measurin and test facili-

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T G 1\ THERAPEUTIC . 6 0 0 D S A D.,NIS TRA TltIN


Organisation Name:


ties, including both test hardware and test software, from adjustments which would invalidate the calibration setting. 1t'

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T G A THERAPEu rlC StlDDS A IIMINIS rRA rlON


Organisation Name:


4.1 2 Ins�ection and test status

The inspection and test status of product shall be identified by suitable means, which indicate the conformance or nonconformance of product with regard to inspection and tests performed. The identification of inspection and test status shall be maintained, as defined in the quality plan and/or documented procedures throughout production, installation and servicing of the product to ensure that only product that has passed the required inspections and tests [or re-leased under an authorised concession (see 4. 13.2)] is dispatched, used or installed


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Form XXX.Y

THERA PEUTIC G O ODS A D MINIS TRA TI ON


Organisation Name:


�.13 Control of nonconforming product

4.13.1 General

The supplier shall establish and maintain documented procedures to ensure that product �hat does not conform to specified requirements IS �revented from unintended use or installation. This control shall provide for identification, documentation, evaluation, segregation (when practical), disposition of nonconforming product and for notification to the functions concerned.

'

4.1 3.2 Review and disposition of nonconforming product

The responsibility for review and authority for the disposition of non conforming product shall be defined.

Nonconforming product shall be reviewed in accordance with documented procedures. It may be

.

a) reworked to meet the specified requirements,

b) accepted with or without repair by concession,


V ISO 1 3485:1 996 Quality System Audit Checklist


17-19 November 2003. of 55

Form XXX.Y

'NERAPEU" t: \..J V T G /\ BDDDS A "MINIS 7RATIDN ISO 1 3485: 1 996 Quality System Audit Checklist


Organisation Name:


c) regraded for alternative applications, or

"- d) rejected or scrapped.

Where required by the contract, the proposed use or repair of product [see 4. 1 3.2b)} which does not conform to specified requirements shall be reported for concession to the customer or customer's representative. The description of the nonconformity that has been accepted, and of repairs. shall be recorded to denote the actual condition (see 4.16).



Repaired and/or reworked product shall be re- \ do"" ..\" � . inspected in accordance with the quality plan ) Or'" re"v-I and/or documented procedures.

The supplier shall ensure that nonconforming product is accepted by concession only if regulatory requirements are met. The identity of the person authorizing the concession shall be recorded (see 4. 16).

If produ · s to be reworked, the supplier shall document ork in a work instruction that has undergone the sa orization and approval proc;edure as the original work instruction.

Prepared by:

of 55

Form XXX.Y

T G/\ THE.APEU rlC SOODS A DMINIS TRATION


Organisation Name:


4.14 Corrective and preventive action

4.1 4.1 General

The supplier shall establish and maintain documented procedures for implementing corrective and preventive action.

Any corrective or preventive action taken to eliminate the causes of actual or potential nonconformities shall be to a degree appropriate to the magnitude of problems and commensurate with th� risks encountered.

The supplier shall implement and record any changes to the documented procedures resulting from corrective and preventive action .

4. 14.2 Corrective action

The procedures for corrective action shall include:

a) the effective handling of customer complaints and reports of product nonconforrnities;

b) investigation of the cause of non conformities relating to product, process and Prepared by:

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/

: j '-' ISO 13485: 1996 QClality System Audit Checklist

Conformity Assessment Audit date( s):


of 55

Form XXX.Y

T G 1\. THERA PEUTIC 6 00llS A D MIII'SlI1AlI D N


Organisation Name:


quality system, and recording the results of the investigation (see 4. 1 6);

c) determination of the corrective action needed to eliminate the cause of nO!'lconformities;

d). application of controls to ensure that corrective action is taken and that it is effective.

'The supplier shall establish and maintain a documented feedback system to provide early warning of quality problems and for input into the corrective action system.

If this standard is used for compliance with regulatory requirements which require post marketing surveillance, this surveillance shall form part of the feedback system.

All feedback information, including reported customer complaints and returned product, shall be documented, investigated, interpreted, collated and communicated in accordance witfLdefined procedures by a deSignated person. .

If any customer complaint is not followed by corrective action, the reason shalf be recorded.


U ISO 1 3485:1 996 Quality System Audit Checklist


17-19 November 2003. ."..

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T G /\ TIlERA PEU TlC BOOBS ADMIIlIS TRATl tJ N

Manufacturer Assessment SectIon

Organisation Name:


aI/ complaint investigations. When the investigation determines that the activities at remote premises played a part in the complaint, a copy of the report shall be sent to those premises.

If this Standard is used for compliance with regulatory requirements, the supplier shall establish, document and maintain procedures to notify the regulatory authority of those incidents which meet the reporting criteria.

The supplier shall establish, document and maintain procedures for the issue of advisory notices and the recall of medical devices. These procedures shall be capable of being implemented at any time.

4.14.3 Preventive action

The procedures for preventive action shall include:

a) the use of appropriate sources of information such as processes and work operations which affect product·quality, concessions, audit result�, quality records. service reports and customer comp laints to detect, analyse and eliminate potential causes of non conformities;

Prepared by: _

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T G /\ THERA PEU TIC B O OD S A D MINIS TRA TI O N

Manufaoturer Assessment Seotlon

Organisation Name:


b) determination of the steps needed to deal with any problems requiring preventive action;

c) initiation of preventive action and application of controls to ensure that it is effective;

e) ensuring that relevant information on actions taken is submitted for management review (see 4. 1 .3).

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T G /\ THERAP E U TIC SODDS A DM/IfIS TRATlDN


Organisation Name:


4.1 5 Handling, storage. packaging. preservation and delivery

4.15.1 General

The supplier shall establish and maintain documented procedures for handling, storage, packaging, preservation and delivery of product.

The supplier shall establish and maintain documented procedures for the control of product with a limited shelf life or requiring special storage conditions. Such special storage conditions shall be control/ed and recolded.

If appropriate, special provisions shall be made for the handling of used product in order to prevent contamination of other product, the manufacturin.g environment or personnel.

4. 1 5.2 Handling

The supplier shall provide methods of handling product that prevent damage or deterioration.

4.15.3 Storage

The supplier shall use deSignated storage Prepared by: I

U ISO 1 3485:1 996 Quality System Audit Checklist



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T G /\ THERA P EUlIt: 6000S ABM/tlIS 1RATION



Organisation Name: Conformity Assessment Audit date(s):


of 55


areas or stock rooms to prevent damage or '\� deterioration of product, pending use or -1--�n.1J.-v . delivery. Appropriate methods for authorising \)V V" 0 receipt to and dispatch from such areas shall be stipulated

.

In order to ·detect deterioration, the condition of product in stock shall be assessed at appropriate intervals.

4.1 5.4 Packaging

The supplier shall control packing, packaging and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements.

The supplier shall establish and maintain procedUfss to ensure that:

a) the medical device is presented in a container which maintains the sterility of the medical device, except for those medical devices which only the inner surfaces of the medical device are sterile and the medical device is such that the sterility of the inner surfaces is maintained;

b) the medica/device is c,apable of being presented in an aseptic manner, if its use so requires;

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Form XXX.Y

\...J

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T G /\ THERAPEUTIC GOODS A DMINIS r"ATlO N


Omanisation Name:


c) the package, or medical device if only the inner surface is sterile, clearly reveals that it has been opened.

Additional requirements for active implantable medical devices and implantabfe medical devices:

The supplier shall record the identity of persons who perform the fina/ labelling operation (see 4. 16)

4. 15.5 Preservation

The supplier shall apply appropriate methods for preservation and segregation of product when the product is under the supplier's control.

4.1 5.6 Delivery

The supplier shall arrange for the protection of the quality of product after final inspection and test. Where contractually specified, this protection shall be extended to include delivery to destination.

The supplier shall ensure that the name and address of the shipping package consignee is included in the quality records (see 4. 16).


u "" " �) ISO 1 3485:1 996 Quality System Audit Checklist



of 55

Form XXX.Y

[ . T G /\ THEBA PEBlIC BOODS ADMlfWl TRATION


Organisation Name: Poly Implants Protheses

The supplier shall require that any authorized representative maintains records of distribution of medical devices and that such records are available for inspection.


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ISO 1 3485: 1 996 Q uality System Audit Checklist



of 55

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Form XXX.Y

T G /\ THERA PEB7Ir: 6000S A DMIIIIS TRATIOR


Organisation Name:


4.16 Control of quality records

The supplier shall establish and maintain documented procedures for identification, collection, indexing, access, filing, storage, maintenance and disposition of quality records.

Quality records shall be maintained to df3monstrate conformance to specified requirements and the effective operation of the quality system. Pertinent quality records from the fsubcontractor shall be an element of these data.

All. quality records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Retention

. times of quality records shall be established and recorded. Where agreed contractually, quality records shall be made available for evaluation by the customer or the customer's representative for an agreed period .

NOTE 1 9 Records may be in the form of any type of media such as hard copy or electronic media

The su lier shall retain the quality records for a Prepared by:




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T G /\ THERA P E U TI C 1I00DS A DM'NIS TRA rlO N


Organisation Name:


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period of time at least equivalent to the lifetime of __ lfe.-k V'-L �� the medical device defined by the supplier, but ,._, Q.A--t.. !lo-v FroC.e.S,1 Or (V!�� 40 4-0 Cj12tM'6

� t� t,1�S -� � It· 5 . not less than two years from the date of dispatch from the supplier.

The supplier shall establish and maintain a record for each batch of medical devices that provides traceability to the extent required by 4. 8 and identifies the quantity manufactured and quantity released for distribution. The batch · record shall be verified and authorized. - C!-� c..k- -

Note: A batch may be a sfngle medical riev/ce.

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Form XXX.Y

T G /\ THEBA P I D 7It: IiflDIIS . A DMlflIS 1RArl D N

Manufacturer. A�e�ment Section

Organisation Name:


4.17 Internal qualitv audits

The supplier shall establish and maintain documented procedures for planning and implementing intemal quality audits to verify whether quality activities and related results comply with planned arrangements and to determine the effectiveness.of the quality system.

Internal quality audits shall be scheduled on the basis of the status and importance of the activity to be audited and shall be carried out by personnel independent of those having direct responsibility for the activity being audited.

The results of the audits shall be recorded (see 4. 16) and brought to the attention of the personnel having responsibility in the area audited. The management personnel responsible for the area shall take timely corrective action on deficiencies found during the audit .

Follow-up audit activities shall verify and record the implementation and effectiveness of the corrective action taken (see 4. 16).

Prepared by:

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ISO 1 3485: 1 996 Quality System Audit Checklist '-"

Conformity Assessment Audit date(s): of 55

17-19. November 2003.

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T G A TBEIlA PEUTlC SOOD S A DMIN I S TRA TION

Manufacturer A.ssessment Section

Organisation Name:


The results of internal quality audits form an integral part of the input to management review activities (see 4.1 .3).

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ISO 13485: 1996 Quality System Audit Checklist \_/

Conformity Assessment Audit date(s) :

· 17-19 November 2003.

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Form XXX.Y

THERAPEUTI C v'

T G /\ SO l1li. S A D MINISTRATION ISO 1 3485:1 996 Quality System Audit Checklist

Manufacturer Assessment Secllon

Organisation Name:


4.1 8 Training



The supplier shall establish and maintain ' IShAea �re.[,..� v

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documented procedures for identifying training AC)Ii\t;. Lv po _�: A t>AN [ . R . - ( Jv<T ��

needs and provide for the training of all \V. , J, .pP1 ) , • - M�e--. L.-er�r co...k C Syc.v-.. personnel performing activities affecting quality. Ib 0- (l"' ..I Personnel performing specific assigned tasks • 0 � � . � � cu..d t;<.Jo-'�l'"� shall be qualified on 'the basis of appropriate 2. OM \e.,t,oov\'?, � 'r � � - M-e�-ioY �tcff 'I� S+cff education, training and/or experience as I � '� � � J.-.r:" ( ! J required. Appropriate records of training shall be dM�� \/}!fl � � (t) Idenhfj h..e..ed . -e.dh £r(,.( tL� -ex.j::>e,0 maintained (see 4.16) , \Olo"". \ �,QA�� '� ltJ",rk::, o w- �� £1dv;) I*' The supplier shall ensure that all personnel who 't'\.ed�(o.t 4-eDh�� po- vpe� � \ �v I are required to work under special environmental .

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conditions or who perform special processes . ) A It . fu.cc. 1fD �, � .RoI--o,cL QIAU 0... uWf . m wrV10 \Y ' IJ (see 4.9) orfunctions are appropriately trained or LJ t:l f v fA 11 l��eJ-eVl c........ � t:' efLM --¥,c,...c..� supervised by a trained person. Who £)0 '\v-WO <::J.e.,tLn o...rta... 0lN€.. � ".� �e S <;. • :....J ... -r.J.-e.k-:>

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Form XXX_V

T G /\ rllERAPEUnC 11 11 fillS A 11 IrflNIS TRA TI D N


Organisation Name: "


4.1� Where servicing is a specified requirement, the supplier shall establish and maintain documented procedures for performing, verifying and reporting that the servicing meets the specified requirements.

Prepared by:

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Form XXX.Y

T 8 /\ · fllfBAPE U TIC t:ll 1I1IS A 11 M' "'STRIITION


Organisation Name:


4.20 Statistical techniaues

4.20.1 Identification of need

The supplier shall identify the need for statistical techniques required for establishing, controlling and verifying process capability and product characteristics .

The supplier shalf establish and maintain procedures to ensure that sampling methods are regularly reviewed in the light of the occurrence of nonconforming product, quality audit reports, feedback information (see 4. 14) and other appropriate considerations.

4.20.2 Procedures

The supplier shall establish and maintain documented procedures to implement and control the application of the statistical techniques identified in 4.20.1.

Prepa red by: •••

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\...) ISO 13485: 1996 Quality System Audit Checklist

Conformity Assessment Audit date(s): of 55


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Form XXX.Y

FOI 245-1112 document 21

Documents

Transcript of FOI 245-1112 document 21