Does ISO 13485 have a Periodic Document Review Requirement?

IZAKK

Registered
#1
Hi, First off, this is a great forum; I can?t believe all of the information that is available here. Second, this is my first post so please take it easy on me.

I have recently been given the task of reviewing our QMS documents and performing gap analysis to ISO 13485. In the Document Control procedure that I am reviewing there is a section for periodic document review with a requirement to have review performed on controlled documents every two years at a minimum.

My question is where exactly is the requirement / clause for this in the 13485 standard? And since documents of external origins are controlled do they need to have this review as well? Thanks in advance for any help.
 
Elsmar Forum Sponsor

DannyK

Trusted Information Resource
#2
The requirement for periodic review originates from: ISO 13485 clause 4.2.3 b
"b) to review and update as necessary and re-approve documents,"

There is no stated requirement to review every 2 years.

Some companies who want a lean system state that they review their documents as part of the internal audit process which they perform every year, therefore they do not need to create a formal review.
 

Ajit Basrur

Staff member
Admin
#3
Hi, First off, this is a great forum; I can?t believe all of the information that is available here. Second, this is my first post so please take it easy on me.

I have recently been given the task of reviewing our QMS documents and performing gap analysis to ISO 13485. In the Document Control procedure that I am reviewing there is a section for periodic document review with a requirement to have review performed on controlled documents every two years at a minimum.

My question is where exactly is the requirement / clause for this in the 13485 standard? And since documents of external origins are controlled do they need to have this review as well? Thanks in advance for any help.
Welcome to the Cove, IZAKK :bigwave:

In addition to Danny's response, the periodic review frequency could be determined by your organization based on the document type (Manual, Procedures and WI) and typically none exceeding 5 years.
 

somashekar

Staff member
Super Moderator
#4
Hi, First off, this is a great forum; I can’t believe all of the information that is available here. Second, this is my first post so please take it easy on me.

I have recently been given the task of reviewing our QMS documents and performing gap analysis to ISO 13485. In the Document Control procedure that I am reviewing there is a section for periodic document review with a requirement to have review performed on controlled documents every two years at a minimum.

My question is where exactly is the requirement / clause for this in the 13485 standard? And since documents of external origins are controlled do they need to have this review as well? Thanks in advance for any help.
Hello IZAKK... Welcome to the COVE.
Reviewing QMS documents is just not for the sake of reviewing after any defined time. This is rather an undesireable method which seems to have got into your doc procedure, and is nowhere asked for.
The "as necessary" part in the 4.2.3 b) are the various necessary situations that you will come upon during your business journey.
Like...
1. Medical device engineering change
2. Audit finding
3. Internal non-conformance
4. Customer complaint
5. New or revised regulation
6. Other external changes and information
... and some more
Any of these can trigger a revisit and review of effected documented procedures.
Do not just put into your document control procedure a time based necessity for document review. Some of the necessary points for review are as I have listed up. When you agree, use these as the basis for deciding when document will be reviewed and approved, and be aware and sensitive to these necessities.
 

v9991

Trusted Information Resource
#5
apart from triggers viz., audits, complaints/incidents/deviations etc., there is no specific determined review criteira; all regulation asks for is to have change control,,,effective implementation of changes etc.,

it is also an rule of thumb to set a time period (2-years, 3 - years etc)which will trigger standard review mechanism for effectiveness/aligning/optimization of existing system...
 
#6
Thanks everyone for the help! Are documents of external origin handled differently? Meaning, does 13485 require that I should have a scheduled time period, say annually maybe, to review external documents to ensure the most current or applicable / appropriate revisions are being used?
 

Ajit Basrur

Staff member
Admin
#7
Thanks everyone for the help! Are documents of external origin handled differently? Meaning, does 13485 require that I should have a scheduled time period, say annually maybe, to review external documents to ensure the most current or applicable / appropriate revisions are being used?
Section 4.2.3 (f) for "documents of external origin" mentions "...to ensure that documents of external origin are identified and their distribution controlled...".

Therefore, there is no periodic review but not a bad idea if you can manage.
 
#8
it is also an rule of thumb to set a time period (2-years, 3 - years etc)which will trigger standard review mechanism for effectiveness/aligning/optimization of existing system...
v991, this may be what my procedure is referring to, could you expand on this please? Thanks!
 
Thread starter Similar threads Forum Replies Date
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
M Does ISO 13485 or MDR require you to state the origins of customer requirements or user needs? Design and Development of Products and Processes 2
L Does anybody have quiz's available? ISO 13485:2016 Training Material Training - Internal, External, Online and Distance Learning 2
K Does ISO 13485:2016 - 7.2.3 Customer Communication include Marketing? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Does MDSAP replace ISO 13485, or do both have to be maintained? ISO 13485:2016 - Medical Device Quality Management Systems 25
A Does anyone have a comparison between ISO 9001:2015 and ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
S BSI's ISO 13485 certificate does not mention AC 2009 corrigendum Registrars and Notified Bodies 5
G Does anyone have a ISO 13485 Gap Analysis form they'd be willing to share? Quality Manager and Management Related Issues 3
M Does ISO/IEC 17021 Accreditation work for 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
I Does my company need to be ISO 13485 registered? ISO 13485:2016 - Medical Device Quality Management Systems 7
T Does ISO 13485 require Gauge R&R's? ISO 13485:2016 - Medical Device Quality Management Systems 3
E Does European Manufacturer with ISO 13485 need QSR820 for FDA registration? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
W Can a site that does not manufacture or assemble a device be ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 18
D Does anyone know about ISO 13485:2004? ISO 13485:2016 - Medical Device Quality Management Systems 7
C Does ISO 13485 certification require a company to follow 21 CFR Part 820? ISO 13485:2016 - Medical Device Quality Management Systems 13
T Does ISO 13485 have any Trainer Requirements ISO 13485:2016 - Medical Device Quality Management Systems 8
N Poor control of testing chemicals ? which ISO 13485/9001 clause does it contravene? ISO 13485:2016 - Medical Device Quality Management Systems 8
H cGMP calendar and ISO 13485 - Does ISO 13485 QMS require a cGMP calendar? ISO 13485:2016 - Medical Device Quality Management Systems 10
Le Chiffre ISO 13485 Process Model Diagram - Does anyone have one? ISO 13485:2016 - Medical Device Quality Management Systems 9
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 35
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
C Does ISO 9001-2015 have a requirement for manufacturing equipment to be numbered? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
P Why does the standard clause use the term Issues in place of Context - ISO 27001 4.1 IEC 27001 - Information Security Management Systems (ISMS) 3
Q Does our material suppliers’ supplier have to be at least ISO 9001 certified? IATF 16949 - Automotive Quality Systems Standard 3
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
M Does ISO 9001 mandates cooking procedure for restaurants ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Tagin Does ISO 9001:2015 require a full internal audit annually? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
N Does anyone know a registrar that offers both ISO 9001 and ISO 17020? Registrars and Notified Bodies 6
Q Does ISO 9001 require CARs for all customer complaints? Customer Complaints 2
S RSL (Remote Site Location) Laboratory - Does it need to be ISO 17025 IATF 16949 - Automotive Quality Systems Standard 5
Q ISO 9001 Cl. 4.1 and 4.2 - What does monitoring and review mean? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Sidney Vianna ASQ apparently doesn't know ISO does not issue ISO 9001 certificates? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
M Does ISO 10993 Apply to Packaging? (e.g. Travel Case) Other Medical Device Related Standards 4
thisby_ ISO 14971 - ALARP and P2 - New ISO 14971 does not allow the concept of ALARP? ISO 14971 - Medical Device Risk Management 3
C Optic Patchcord Cables - Does 8.3 (Design) Apply Here? ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Does AS9100 require Suppliers to be Certified to ISO or AS? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
G Does ISO 9001:2015 call for a Policy or a Statement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q Does ISO 9001 Requirement for Document Approval (a service organization) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Does Calibration to ISO/IEC 17025 conform to Z540.3? ISO 17025 related Discussions 1
J Does the word "claim" in ISO 9001 Clause 8.2.2 mean "requirement"? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S ISO 14001 Clause 4.1 Organization and its context - What does an Auditor expect? ISO 14001:2015 Specific Discussions 12
T Does your Quality Dept Control Procedures Outside the Scope of ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S ISO 9001:2008 Certification Scope does not mention "manufacturing" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Where does 5S technique fit into ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Similar threads


















































Top Bottom