The internal audit checklist summarizes the key documentation requirements for a quality management system. It outlines that organizations must establish, document, implement and maintain a quality management system in accordance with ISO 13485 and FDA 21 CFR Part 820 requirements. It also specifies that key documents like quality manuals, procedures, specifications and records must be properly controlled and retained. Records must be organized, stored and maintained to demonstrate conformity of products, processes and the quality system.
The internal audit checklist summarizes the key documentation requirements for a quality management system. It outlines that organizations must establish, document, implement and maintain a quality management system in accordance with ISO 13485 and FDA 21 CFR Part 820 requirements. It also specifies that key documents like quality manuals, procedures, specifications and records must be properly controlled and retained. Records must be organized, stored and maintained to demonstrate conformity of products, processes and the quality system.
The internal audit checklist summarizes the key documentation requirements for a quality management system. It outlines that organizations must establish, document, implement and maintain a quality management system in accordance with ISO 13485 and FDA 21 CFR Part 820 requirements. It also specifies that key documents like quality manuals, procedures, specifications and records must be properly controlled and retained. Records must be organized, stored and maintained to demonstrate conformity of products, processes and the quality system.
The internal audit checklist summarizes the key documentation requirements for a quality management system. It outlines that organizations must establish, document, implement and maintain a quality management system in accordance with ISO 13485 and FDA 21 CFR Part 820 requirements. It also specifies that key documents like quality manuals, procedures, specifications and records must be properly controlled and retained. Records must be organized, stored and maintained to demonstrate conformity of products, processes and the quality system.
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INTERNAL AUDIT CHECKLIST
Issued by: QA Date: 00-00-00 Revision: A QF-82-02-3
Refs Requirements What to look for and how Compl Auditor notes and evidence 4 Quality Management System 4.1 General requirements 4.1 820.5 Is the quality management system documented, imlemented and maintained in acco!dance "ith !equi!ements o# I$% 1&485 and '(R 21 )a!t 820* Are processes needed for the quality management system identified and established (process map)? Is the sequence and interaction between these processes determined (process map)? Are criteria and methods for the operation and control of quality system processes established (operational procedures)? Are required resources available? Are quality system processes monitored and measured (internal audit, customer feedback, manufacturing process performance, etc.)? 4.1 +!e outsou!ced !ocesses adequately cont!olled* ow are outsourced processes controlled? Are outputs of outsourced processes verified? Are subcontractors and suppliers required to operate and maintain quality management systems (I!" #$$%, for e&le)? 4.2 Documentation requirements 4.2.1 General 4.2.1 820.20,e- +!e the #ollo"ing tyes o# documents established, maintained and cont!olled: quality olicy and quality ob.ectives/ quality manual/ oe!ational !ocedu!es/ device seci#ications including d!a"ings, comosition, #o!mulation, comonents, so#t"a!e etc. ,Device 0aste! Reco!d-/ !oduction !ocess seci#ications including equiment, !oduction methods and !ocedu!es, oe!ato! ,"o!1- inst!uctions, !oduction envi!onment seci#ications, etc. ,Device 0aste! Reco!d-/ quality assu!ance !ocedu!es and seci#ications including cont!ol lans, insection equiment and !ocedu!es, accetance c!ite!ia, etc. ,Device 0aste! Reco!d-/ ac1aging and labeling seci#ications, including methods and !ocesses used Are quality policy and quality ob'ectives documented? (here? Is there a quality manual? "perational procedures? Are drawings, specifications, work instructions, work orders, control plans, etc., issued and maintained as controlled documents (as required in ).*.+)? Are electronic documents (computer files) backed up? INTERNAL AUDIT CHECKLIST Doc: QF-82-02- Revision: A )g. 2 o# ! Refs Requirements What to look for and how Compl Auditor notes and evidence ,Device 0aste! Reco!d-/ installation, maintenance and se!vicing !ocedu!es and methods ,Device 0aste! Reco!d-/ othe! documents needed to ensu!e the e##ective lanning and oe!ation o# the quality system/ and !eco!ds ,!e# to I$% 1&485 4.2.4-* 4.2.2 Quality manual 4.2.2 820.20,e- Does the quality manual include: the scoe o# the quality management system and e2clusions, oe!ational !ocedu!es o! !e#e!ences to them, desc!ition o# the inte!action bet"een the !ocesses o# the quality system, and outline o# the st!uctu!e o# the quality system documentation* Is the quality manual addressing all relevant requirements of I!" %+),- and ./0 *% 1art ,*$? Are e&clusions from !ection 2, 1roduct 0eali3ation, documented in the quality manual (if any)? Are operational procedures included or referenced in the quality manual? ow is the interaction between the processes of the quality system documented (process map, flowcharts, etc.)? ow is the structure of the quality system documentation outlined in the manual? 4.2.3 Control of documents 4.2.& 820.40,a- Is the!e a "!itten !ocedu!e de#ining the cont!ols needed to !evie" and a!ove documents !io! to issue, !evie", udate and !e3a!oved documents, identi#y changes and cu!!ent !evisions o# documents, ma1e !elevant and cu!!ent documents available at oints o# use, ensu!e that documents a!e legible and identi#iable, identi#y and cont!ol the dist!ibution o# documents o# e2te!nal o!igin, and identi#y !etained obsolete documents and !event thei! unintended use* Is the !ocedu!e #ully imlemented* Is there a written procedure for control of documents? Are controlled documents reviewed and approved? ow is the approval evidenced (signature)? Is there a process for reviewing, updating and re4approving documents? Are documents identified with their revision level? ow are changes identified (change brief, highlighted, etc.?) (hat measures are implemented to ensure that relevant and current documents are available at points of use (distribution lists, current master lists, etc.)? Are documents uniquely identified (unique title and 5or code4 number) and are they legible? Is there a process for receiving, reviewing, approving (for use) and distributing documents of e&ternal origin (form customers, regulators, suppliers, etc.) (hen obsolete documents are retained, is it for a specific, stated reason? Are obsolete documents clearly marked to distinguish them from current revisions? (hat other measures are implemented to prevent unintended use of obsolete documents? 4.2.& Is the e!iod #o! !etention o# obsolete cont!olled documents de#ined* Is a retention period defined for each type of controlled documents? ow is this period determined? Is the retention period at least equal to the lifetime of the INTERNAL AUDIT CHECKLIST Doc: QF-82-02- Revision: A )g. o# ! Refs Requirements What to look for and how Compl Auditor notes and evidence device? Is it coordinated with the retention period for corresponding records? Are regulatory requirements considered? 4.2.& 820.40,b- +!e document changes !evie"ed and a!oved by the same #unction that e!#o!med the o!iginal !evie" and a!oval ,unless seci#ically designated othe!"ise-* +!e change !eco!ds maintained, including desc!ition o# the change, identi#ication o# the a##ected documents, a!oval signatu!es and date, and "hen the change becomes e##ective* Is there a clearly stated requirement that changes to documents must be reviewed and approved by the same function that issued the original document, or by another, e&plicitly designated function? Is it implemented? Are changes in documents (mostly product and process specifications) backed by design change and5or process change records, such as engineering change notices? ow is it defined5documented when document changes become effective? 4.2.4 Control of Records 4.2.4 Is the!e a documented !ocedu!e #o! the identi#ication, sto!age, !otection, !et!ieval, !etention, and disosition o# !eco!ds* Are there documented instructions how to identify, organi3e, store, protect, and retrieve records? Are storage locations for records defined? 4.2.4 820.180,b- +!e !etention e!iods #o! !eco!ds de#ined* +!e !eco!ds !etained #o! at least the e!iod o# time equivalent to the e2ected li#e o# the device, and no less than 2 yea!s* Is a retention period defined for each type of record? ow is this period determined? Is the retention period at least two years or equivalent to the lifetime of the device, whichever is greater? Are regulatory requirements considered? 4.2.4 820.180 +!e !eco!ds o!gani4ed and maintained to ensu!e that they !emain legible, !eadily identi#iable and !et!ievable, and to !event dete!io!ation and loss* +!e !eco!ds accessible to the !egulato!y insections* +!e elect!onic !eco!ds bac1ed u* Are records stored in dry, clean locations to minimi3e deterioration? Is there a system for organi3ing the records? Are bo&es, drawers, binders holding records properly identified? Are records easily retrievable (test by asking for retrieval of specific records)? Are records kept in a location that is accessible to regulatory inspections? Are electronic records backed up? Are there specific schedules, instructions, etc. for backing up data? (here are the back4up media (tapes, disks, etc.) kept? 4.2.4 820.181 (o! each tye o# device, is the!e a Device 0aste! Reco!d ,D0R- including, o! !e#e!!ing to a!o!iate device seci#ications, !oduction !ocess seci#ications, quality assu!ance !ocedu!es, ac1aging and labeling ow is the 670 organi3ed? Is it a file containing the actual specifications documents, or is it a list referring to these documents and their locations? Is the 670 complete, e.g., includes all required categories of documents? (ho decides, and how, which documents are included in the 670? Are all documents included in INTERNAL AUDIT CHECKLIST Doc: QF-82-02- Revision: A )g. " o# ! Refs Requirements What to look for and how Compl Auditor notes and evidence seci#ications, and installation, maintenance and se!vicing !ocedu!es and methods* the 670 correctly identified, reviewed, approved and otherwise controlled? Are the 670 documents the same (and the same revisions) as those used in production? 4.2.4 820.184 +!e Device 5isto!y Reco!ds ,D5R- maintained #o! each manu#actu!ed batch, lot o! unit* ,Re#e! also to I$% 1&485 'lause 6.5.1 and 820.184- Are 60 records properly identified to specific batches, lots or units8 and are the records easily retrievable? (/or other questions refer to 2.-.%) 4.2.4 820.187 +!e 8uality $ystem Reco!ds ,8$R- maintained, including cu!!ent and obsolete quality system manuals and !ocedu!es, and !eco!ds o# quality system activities such as management !evie"s, co!!ective and !eventive actions, inte!nal audits, etc.* ow is it determined and documented what quality system records are maintained (in 97! 7anual and lists of procedures and quality forms, and in operational procedures and work instructions)? Are retention periods specified for obsolete quality system documentation and for quality system records? 4.2.4 +!e su##icient !eco!ds maintained to !ovide evidence o# con#o!mity and e##ectiveness o# the quality management system* Is there a list (or other documented specification) of quality system records that are maintained by the company? Are the records sufficient to demonstrate product and process conformity, and the conformity and effectiveness of the quality management system and its implementation? 5 Management Resonsi!ility 5.1 Management Commitment 5.1 Is the to management communicating to the o!gani4ation the imo!tance o# meeting custome! and othe! alicable !equi!ements, establishing the quality olicy, establishing quality ob.ectives, conducting management !evie"s, and ensu!ing availability o# !esou!ces* ow is importance of meeting customer and other requirements communicated? 6o employees understand the consequences of failing to meet requirements? Is there a quality policy? Are quality ob'ectives defined? Are management reviews being conducted regularly? Are adequate resources necessary for the quality system provided? 5.2 Customer "ocus 5.2 Is the to management ensu!ing that custome! !equi!ements a!e dete!mined and a!e met* (hat measures are implemented to ensure that customer requirements are determined and met (processes, procedures, training, monitoring, auditing, etc.)? 5.3 Quality #olicy 5.& Is the!e a documented quality olicy/ and Is the quality policy appropriate (relevant to the types of INTERNAL AUDIT CHECKLIST Doc: QF-82-02- Revision: A )g. ! o# ! Refs Requirements What to look for and how Compl Auditor notes and evidence 820.20,a- Is it a!o!iate to the u!ose o# the o!gani4ation* Does it include a commitment to comly "ith !equi!ements and maintain the e##ectiveness o# the quality management system* Does it !ovide a #!ame"o!1 #o! establishing the quality ob.ectives* Is it communicated and unde!stood th!oughout the o!gani4ation* Is it e!iodically !evie"ed #o! continuing suitability* products, type of market, customer e&pectations, etc.)? 6oes it include e&plicit commitment to comply with requirements and maintain (or improve) the effectiveness of the quality system? Is it related to quality ob'ectives? (ould achievement of the quality ob'ectives bring the company closer to achieving its overall quality policy? 6o employees know the meaning of the quality policy and understand how they can contribute to achieving the policy? Is the quality policy periodically reviewed by management reviews? as the policy ever been modified since it was initially formulated? The remainder of Section 5 and Sections 6, 7 and 8 are not included in the Demo file The complete checklist is 30 pages long.
