Definition Actively Manufacturing - ISO 13485 Definition and clarification



Hi guys :bigwave:,

I'm confused by what seems like a basic issue..and would like to clarify with all you knowledgeable people out there, hope you may pardon my noobness... :(

My organization has been re-certified to ISO 13485 last May, and our surveillance audit is coming up soon. We're certified for the production scope - we run production for a short while (over a span of 2months), and move on to the next one. I would like to know if there is a need for us to have at least one new production project between our last audit and upcoming one to have something for the auditors to see.

Reason why i'm asking this is because of this statement on the ISO 13485 wiki page, which states that " an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task Force supply chain manufacturer can seek registration."

Appreciate your kind help in advance! :D
Elsmar Forum Sponsor


The auditor should be willing to take your unique situation into consideration. The only issue that may arise is the auditor may have been planning on auditing the production process.
Perhaps you could contact the auditor so that adjustments could be made the the audit schedule leaving out the affected areas.
If possible maybe you could schedule the next audit during a time of production.


chasf, somashekar,

thank you so much for the advice! Looks like this is best left to our CB to make a decision, and I will be contacting my CB to discuss further on this.
Thread starter Similar threads Forum Replies Date
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
Ed Panek Inactive key supplier question - We are not actively buying from them ISO 13485:2016 - Medical Device Quality Management Systems 2
H Latest customer standards - Actively search for and implement new customer standards? IATF 16949 - Automotive Quality Systems Standard 9
optomist1 Hybrid or Pure Electric Aircraft Manufacturing Standards Federal Aviation Administration (FAA) Standards and Requirements 0
B Hi , everyone i need a procedure for validation of design prototype api 6d (valve manufacturing) Oil and Gas Industry Standards and Regulations 0
J Medical Device Manufacturing Manufacturing and Related Processes 3
J Dry room for gummy manufacturing and floor storage US Food and Drug Administration (FDA) 4
E Please help! ! I AM FRASTRATED SO MUCH! Should inactive ingredient be included in the unit formula if it is removed during the manufacturing process? US Food and Drug Administration (FDA) 0
M Role of Quality Manager in a manufacturing company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
N Writing Risk Management procedure for small manufacturing and we don't know where to start. Manufacturing and Related Processes 9
dgrainger Informational Guidance on In-House manufacturing UK Medical Device Regulations 0
U Change to the manufacturing Date for a device in the field US Medical Device Regulations 0
K Pharmaceuticals and Manufacturing Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
C Training for Manufacturing Nonconformances and CAPS with focus on the wording Nonconformance and Corrective Action 4
A How would a candidate for Quality Systems Manager role answer questions in a med device manufacturing org ISO 13485:2016 - Medical Device Quality Management Systems 11
D Shopfloor drawings & manufacturing requirements Document Control Systems, Procedures, Forms and Templates 2
Sortinghat Auditing the Manufacturing Process IATF 16949 - Automotive Quality Systems Standard 3
J Outsourced Purchasing for Contract Manufacturing vs more typical/simple Supplier Management ISO 13485:2016 - Medical Device Quality Management Systems 5
Zafortner EU Manufacturing Incident Report (MIR) version 7.3 ISO 13485:2016 - Medical Device Quality Management Systems 9
D Out of specification procedure for Medical device manufacturing Manufacturing and Related Processes 7
malasuerte Performance of ISO 9001 certified vs. non-certified manufacturing companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
A Layered Process Audits for Medical Device Manufacturing? ISO 13485:2016 - Medical Device Quality Management Systems 3
C Definition of "Manufacturing date" Other Medical Device Regulations World-Wide 4
R FMEA's for non-manufacturing sites FMEA and Control Plans 4
M How to show the effect of the failure mode on the manufacturing process as a customer of product design process? FMEA and Control Plans 3
C MDR - Annex II _3. DESIGN AND MANUFACTURING INFORMATION_a EU Medical Device Regulations 3
Vader22 IATF 16949 extended manufacturing site help IATF 16949 - Automotive Quality Systems Standard 4
V Military ranks versus Manufacturing titles Misc. Quality Assurance and Business Systems Related Topics 8
K MHLW MO169 2021 Japan Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics Japan Medical Device Regulations 2
B PSW - Organization Manufacturing Information APQP and PPAP 0
Awais Taking Pictures of Outbound Material - In the Manufacturing Shop floor Manufacturing and Related Processes 5
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
Jim Wynne Most Important Manufacturing KPI, per Oracle Coffee Break and Water Cooler Discussions 3
M Implants made by Additive Manufacturing process approved by USFDA Other Medical Device and Orthopedic Related Topics 2
D What evidence do I need to supply as a remote location in relation to manufacturing sites? IATF 16949 - Automotive Quality Systems Standard 14
P Manufacturing site vs manufacturing date symbol Medical Device and FDA Regulations and Standards News 1
D Secondary Manufacturing Site on DoC EU Medical Device Regulations 1
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Instructions for use multiple manufacturing locations ISO 13485:2016 - Medical Device Quality Management Systems 0
F [Line Balancing] Line Efficiency in Fan Manufacturing Lean in Manufacturing and Service Industries 0
S CE and Manufacturing license Manufacturing and Related Processes 1
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
P How to measure DPPM in Chemical batch manufacturing Quality Tools, Improvement and Analysis 1
M MSA Study Type 1 not capable. We are at the limit. And manufacturing wants to continue producing. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2

Similar threads

Top Bottom