INTERNALAUDITCHECKLISTIssued by: QA Date: Revision: AISO13485 Requirements What to look for and how Documents checked and auditor notes 4 Generalrequirements QualityManagementSystem4.1 4.1 Is the quality management system ueueuenb epepesu sassodaydocumented implemented and maintained in system identied and estabished (process map)? Is the OI jo suewanbau ugm aouepuocoe determined (process map)? Are criteria and methods forestabilshed (operationa/ proceduresj? Are required theoperationandtrofqualty systemprcesessssussyenbaqe sense monitored andmasuredinemalaudit customerfeedback manufacturing process perfomance etc.)?4.1 Are outsourced processes adequately controlled? How are outsourced processes controtlied? Are outputs of outsourced processes verifed? Are subcontractorsand suppiers requred fo operate and maintain quality management systems (ISO 900f for example)?4.2 Documentationrequirements4.2.1 4.2.1 General Are the following types of documents Are quality polcy and qualty ohjectives documented?established maintained and controlled: Where? quality manual; • quality policy and quality objectives; Is there a qualty manual? Operationaf procedures?device speificatlonsincluding drawings • operational procedures; controtied documents (as required in 4.2.3)? orders contro plans efc. issued and maintainedf as Are drawings specifications work instructions workposition formulation ponents Are electronic documents (puter ffes) becked up?Bupnpu suogeoyoeds sseooud uogonpoud software etc. (Device Master Record);equipment production methods and procedures operator (work) instructions production environment specifications etc. (Device Master Record); quaity assurance procedures and specifcationsindingconol plasinspection equipment and procedures Record]; acceptance criteria etc. (Device Master• maintenance and servicing procedures and methods (Device Master Record);• other documents needed to ensure the effective planning and operation of the
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Refs Requirements What to look for and how Documents checked and auditor notes• records (ref to ISO 13485 4.2.4)? quality system; and4.2.2 Qualitymanual4.2.2 Does the quality manual include: the scope of the qualitymanagement Is the qualtymanuf aressing al relevant requirements of ISO13485?Are exclusions from Section•operational procedures orreferences system and exclusions 7 Product Realization documented in the quaity manual (if any)? Are operationaf procedures incuded orthem between the prooesses of the quality system referenced in the qualty manua? How is the intersction• description of the interaction between the processes of the quality system and documented (process map flowcharts efc.)? How is the structure of the quality system documentation outined in• outine of the structure of the quality system documentation? the manual?4.2.3 Control ofdocuments4.2.3 Is there a writen procedure defining the Istherewritpr frnff dcuet? review and approve documents prioto controls needed to ssd s seeus)peouepe snodde Are controlled documents reviewed and approved? How review update and re-approve documents issue for reviewing. μpdating and re-approving documents? Are documents identied with thelr revison /evel? Hw• identify changes and current revisions of quppe siu J nsu puud aesn j• make relevant and current documents documents and cuef documents are available at points of use distuio s cumests etc.？Are• ensure that documents are legible and available at points of use documents unqguely identied (unique tle and /rcode- number) andare they/egibe? is there a process fr• identify and control the distribution of identiable s s uy fuojuxejo suun Sugquppue asno Suoeuaudocuments of external origin and Suppilers etc? When obsalee documents are retained is i for a specific stated reson?Are bsoiete• identify retained obsolete documents and prevent their unintended use? documents clearly marked o distinguish them from currenf revisons? What othermeasures areIs the procedure fully implemented? implemented to prevent e nintended use of bsoete documents?4.2.3 Is the period for retention of obsolete Is aretentionperiod defined freach type of controlledcontrolled documents defined? documents? How is ths period determined? Is the retentionperiod at last equa/to the fetime of thedevice? Is if coordinated with the retention period forcons/dered'? corresponding records? Are regulatory requirements4.2.3 Are document changes reviewed and Is there a cleary stated requirement that changes foapproved by the same function that performed dcuments must be revewed and approved by the same
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Refs Requirements What to look for and how Documents checked and auditor notesfunction that issued the riginsl document or by another the original review and approval unless specifically designated otherwise)? explicitly designated function? /s i mplemented?Are change records maintained including description of the change identification of the Are changes in documents mostly product and process sdeuuipqpgsusaffected doouments aproval signatures and How is it defined/dfocumented wffen documenf changes change records such as engineering change notices?date and when the change bees effective? bee effective?Control of RecordsIs there a documented procedure for the identificaton storagerottion rieal Are here documented instructions how to idenify. organize store protect ang retreve ecords?Areretention and disposition of records? storage locations for records defined?Are retention periods for records defined? Is a retention period defined forech type ofrecord?time equivalent to theexpected ife of the Are records retained for at least the period of How is this period detemined? s the retention period at east woyears oreguivalent to the ifetime of the dvice device and no less than 2 years? suuanbe ojenfa ay ea seneyp considered?Are records organized and maintained to Are records stored indry clean cations tminimzeensure that they remain legible readily identifiable and retrievable and to prevent deterioration? Isthere asystem for organizing the records?Are oxes draer bnders th hof recosdeterioration and loss? properly identiled? Are records easily retrievabfe (test by asking for retreva/ of specific records?Are records accssible totheregulatory inspections? Are records keprin a focation that is accessibfe toAre electronic records backed up? regulatory inspections? Are electronic reconds bscked up? Are there specifcschedules instructions efc. for becking μp dta? Where are the beck-up medle (tapes disks efc.) kept?For each type of device is there aDevice How is the DMR organized? Isit a fle containing theappropriate device speofcations producfion Master Record (DMR) including or referring to actuaf specifications dcuments oris if alist referring o these documents and their locations? Is the DMRprocess specifications quality assurance documents?Who decides nd how which documents piete e.g includes al required cafegores ofprocedures and methods? procedures maintenance and servicing are included in the DMR? Are al documents included in the DMR correctly idenified reviewed approved andothenwise controiled? Are the DMR documents the sameAre DHR records property identifed to speaific batches (and the same revsions) as those usedf in production?for each manufactured batch lot or unit? Are Device History Records (DHR) maintained lots or units; and are the records esily retrievabe? (For
4.2.44.2.44.2.44.2.44.2.44.2.4
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Refs Requirements What to look for and how Documents checked and auditor notesother questions refer to 7.5. 1)(Refer also to ISO 13485 Clause 7.5.1)4.2.4 maintainedinlding untandle Are Quality System Records (QSR) How is if deteminedf and documented wfat quaity system records are maintained (in QMS Manuaf and Aistsquality system manuals and procedures and records of quality system actities such as of procedures and qualty foms and in operational procedures and work instructions)? Are retention periodspreventive actions intemal audits etc.? management reviews corrective and for qualty system records? pue uogeueunp as/s Agenb sqooypaoedsIs there ast (ortherocumented specifcation) of4.2.4 Are sufficient records maintained to provide evidence of conformity and effectiveness of pany? Are the recors suffcient to denstrte the quality management system? product and process confmity and the confoity andimplementation? effectiveness of the qualitymanagemenf system andis5 ManagementResponsibility5.1 Management Commitment5.1 Is the top management • municating to the organization the How is importance of meeting customer and other requrements municsted? Do empioyees understandimportance of meeting customer and other applicable requirements thereaqualtyply?Are qualtyjectivesdfed the consequences of fadling to meerrequiements? ls establishing the qualty poliy. management reviews beng conducted regufarly? Are adequate resources necessary frthe quaitysystem• conducting management reviews and • establishing quality objectives proviled?CustomerFocus • ensuring availablity of resources?5.2 5.2 Is the top management ensuring that What measures are implemented to ensure thafare met? customer requirements are determined and customerrequrements are detemined and mef processes proedres raing mniring g.efc.)?5.3 QualityPolicy Is there a dooumented quality poicy; and5.3 Isiaroprate to thepurpose the products type of market customerexpectations fc.? • Does it include a mitment to ply with organization? Does if iclude exploit mitment to py with requrements and malntain (orimprove) the effectivenessrequirements and maintain the effectiveness of the quality management system? Aogod Ayen epo fuueu o mouy soafoue og of the quality system? Is if related to qualty objectives? Doesit provide aframework for establishing policy? Is the quality policy periodically reviewed for and understand how they can contribute fo achieving thethe quality objectives?
Refs Requirements What to look for and how Documents checked and auditor notescontinuing sultabity? • Is it municated and understood throughout the organization?Isit periodically reviewed for continuing suitabity?PlanningAre measurable qualty objectives How many objectives are estabished? Are they measurable? Are methods to measure progress defined?established? Are the objectives consistent with the quality Who is responsible for doing his? Is anyone responsiblepolicy? for implementation of the objectives? What happens when an objective is achieved? What is the mechanismfor establishing new objectives?Is the quality system planned to meet requirements and qualty objectives? ssfeue deenueuAynb pepuenoop ued au sm uoym q pue peued uajs Ayenb au s momaintained when changes are implemented? Is the integrity of the quality system there an evaluation af the impecf of the change or the checkist etc.? Wher changes are implemented isResponsibility authorityand munication overatf system?Are responsibilies and authories defed Is there an organizationaf chart (or othertype oforganization? and are they municated throughout the pue squjugzueijoeods authorites)? Does it clearly show who isresponsible forFor personnel who manage perfom and processes needed for he qualty system? Do operational procedures and work instructions assign responsibitiesinterrelation defined and do theyhave verify work affecting quality is their for perfoming activities that are defined in these documents? How are responsibities and authoritiessuficient independence and authorty t municated to emplyees (quality marual. procedures training)? Do personnef wo verify theperform these tasks? Apso) quuo pnpod puessaodwes/s Aaenb auditors and nspectors) have suffcient indpendenceand authonity?Is there a management representative for the eaduueu sepde sAre hishrepnsibiiesdefne tn quality management system? How is this appointment documented? Are defined?Dspsentives responsibities and autforities of the representative• ensuring that processes needed for the qualty system are estabished mlementd authority fo ensure tht qualty system is estabished and maintained implemented and maintained? What evience is there ud• reporing to top management on the performance of the quality system and need maeuwefeueul weps/s Aenb eu jo aoueuousd metings)? What exampies are there of thefor improvement and pue enfapo sseueeme Supouod engeuesadar customer requirements?
5.45.4.15.4.25.55.5.15.5.2 promoting the awareness of regulatory and
