SBS - The best value in QMS software

ISO 8 classified medical manufacturing room

#1
Hi everyone,

We are a company that manufactures medical devices in a validated ISO 8 clean room. This room is recertified every year. We have just purchased a new equipment, robotic cell which will be fitted at the end of a press. My question is, do we need to recertify this room? If so, what kind of recertification would we need? Dust particles? Bacterial? It would be greatly appreciated if you have any supportive documents or websites.

Thanks in advance,

Jocelyn Lecompte
 
Elsmar Forum Sponsor

chris1price

Trusted Information Resource
#2
As always, start with your risk assessment that should be part of the change control for the equipment, and your Monitoring Plan required under ISO1464 Part 2. Re-certification may not be required, but you may want to perform additional monitoring after the installation or as part of PQ. Unless there is a concern over bioburden, then its probably not needed, but additional particulate monitoring might be required.
 
Thread starter Similar threads Forum Replies Date
I Medical Gases Installation - Can be classified as MD and ISO 13485 certificated? ISO 13485:2016 - Medical Device Quality Management Systems 5
J Can subsidiaries use the holding company's ISO 9001 QMS and be classified as ISO 9001 certified? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q ISO 9001-2015 Internal audit finding Internal Auditing 10
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
K PDCA cycle and ISO processes alternative model Quality Management System (QMS) Manuals 14
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
V ISO 10360-5: 2020 Gap analysis and Action plan Excel .xls Spreadsheet Templates and Tools 1
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 45001 6.1.2.1 Hazard Identification Occupational Health & Safety Management Standards 1
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
S Any ISO standards around Artificial Intelligence and Machine Learning? Medical Information Technology, Medical Software and Health Informatics 4
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
N ISO 9001 - Training business with fewer than 5 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
B ISO 6508 and portable hardness measurement instruments General Measurement Device and Calibration Topics 0
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
K Integrating ISO 9001:2015 with ISO 17025:2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
R Remote Audits for ISO 9001 (or any other standard) General Auditing Discussions 31
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7

Similar threads

Top Bottom