Guidelines for auditing Quality Systems

#1
Good Morning Forum,

I am new to the forum and must say that I have gathered quite a bit of knowledge in a short time from the regulars, Thank You. I have finally reached a point that I need to ask the advise of the more knowledgeable.

I have modeled my companies quality system around a system developed from another life. My question comes from the Internal Auditing guidelines arena. My previous involvement with Internal Auditing revolved around the ISO 10011-1:1990, "Guidelines for auditing quality systems" I have been unable to locate a copy of this standard from the ISO site. I noticed that there are several other auditing standards. Is the ISO 10011-1:1990 obsolete? If so what standard has replaced it?

Thanks in advance for any assistance.

JRW
 
Elsmar Forum Sponsor
J

Jimmy Olson

#2
JRW,

Welcome to the Cove. :bigwave:

There is a new standard that combines auditing guidelines for both quality and environmental systems that was releases earlier this month. It's ISO 19011 'Guidelines for Quality and/or Environmental Management Systems Auditing '. You should be able to find this pretty easy. :D
 
#3
JRW said:

Good Morning Forum,

I am new to the forum and must say that I have gathered quite a bit of knowledge in a short time from the regulars, Thank You. I have finally reached a point that I need to ask the advise of the more knowledgeable.

----X----

Thanks in advance for any assistance.

JRW
Hullo JRW, and welcome...

Richard already answered your question. I'd just like to add that I keep learning new things in the company of our fellow Cove dwellers. May it continue that way.

/Claes
 
Thread starter Similar threads Forum Replies Date
Ajit Basrur GHTF (Global Harmonisation Task Force) - Guidelines for Regulatory Auditing ISO 13485:2016 - Medical Device Quality Management Systems 0
Marc FDA has auditing guidelines posted on it's web pages for QSR ISO 13485:2016 - Medical Device Quality Management Systems 3
R Design and Manufacture Guidelines for Surface Mount Technology Misc. Quality Assurance and Business Systems Related Topics 9
M Informational Final guidance – GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carc Medical Device and FDA Regulations and Standards News 0
S FDA Registration food facility - We operate under CGMP guidelines US Food and Drug Administration (FDA) 0
M Informational EU – 12th Meeting of the Working Group on Guidelines on benefit – risk assessment of Phthalates in Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational Eudamed Data Exchange Guidelines Medical Device and FDA Regulations and Standards News 0
M Informational EU – Hearing on the SCHEER preliminary Guidelines on the presence of Phthalates in certain medical devices (Brussels, 04 April 2019) – Summary records Medical Device and FDA Regulations and Standards News 0
H Invalid ISO Standard / Guidelines - ISO 22301 BCMS and a local standard Various Other Specifications, Standards, and related Requirements 1
Sidney Vianna Informational ISO 18091 - Guidelines for the application of ISO 9001 in local government Other ISO and International Standards and European Regulations 1
M Informational EMA – Guidelines for certain medical devices incorporating medicinal products – Orientações para certos medical devices que incorporam medicamentos Medical Device and FDA Regulations and Standards News 0
M Informational EU – SCHEER – Minutes of the Working Group meeting on guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devic Medical Device and FDA Regulations and Standards News 1
M Informational BSI – MDR Documentation Submissions Best Practices Guidelines Medical Device and FDA Regulations and Standards News 0
S IAQG guidelines for AS9100 report writing AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
K Rules or guidelines for quoting FDA announcements and such? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Inter/Intra assay precision study per CLSI guidelines Statistical Analysis Tools, Techniques and SPC 1
J Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
Sam Lazzara Clinical Evaluation MEDDEV Guidelines SmackDown - 2017 EU Medical Device Regulations 3
Sidney Vianna ISO 20700:2017 - Guidelines for management consultancy services Other ISO and International Standards and European Regulations 2
N FDA Guidelines for implementing Continuous Improvement Process US Food and Drug Administration (FDA) 5
Marc New FDA Cybersecurity Guidelines for Medical Devices (Dec 2016) Other US Medical Device Regulations 0
P Small company of approx 28 Employees - ISO-9001:2008 Guidelines ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Document Control Guidelines in Engineering Projects - Excel sheets with VBA coding Document Control Systems, Procedures, Forms and Templates 3
shimonv CFDA Technical Guidelines for Clinical Evaluation on Medical Devices (English) China Medical Device Regulations 8
R Wellness Device Labeling Guidelines and question Other US Medical Device Regulations 2
Sidney Vianna Informational ISO/TS 9002 - Guidelines for the application of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
X Where to find UAE medical device registration regulation and guidelines Other Medical Device Regulations World-Wide 3
Marc Are you looking for ISO 31000 - Risk Management Principles and Generic Guidelines? ISO 14971 - Medical Device Risk Management 1
R New draft guidelines for 510 (K) with Different Technological Characteristics. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q Need Procedures related to Maritime Convention, Guidelines, Legislation, etc Other ISO and International Standards and European Regulations 1
S MSA Help or guidelines - Plastics - Setting up an MSA on a multi cavity fixture Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
M Diesel Generator Stack - Sample port guidelines required Miscellaneous Environmental Standards and EMS Related Discussions 2
K Coding Standard vs Coding Guidelines vs Code Review Checklist Quality Assurance and Compliance Software Tools and Solutions 2
F Tips, Guidelines and Checklist to conduct Audit of Supplier & Subcontractor Document Control Systems, Procedures, Forms and Templates 5
optomist1 Software QA Template/Guidelines for deliverable Software Software Quality Assurance 4
G Irrigation Kits Labeling Guidelines EU Medical Device Regulations 3
M General Guidelines on how to start a Quality Campaign Misc. Quality Assurance and Business Systems Related Topics 2
A Japan Medical Devices Vigilance Regulations or Guidelines Japan Medical Device Regulations 4
I New AIAG CQI guidelines published - Are they worth buying? Misc. Quality Assurance and Business Systems Related Topics 2
G Very Basic PFMEA (Process FMEA) Guidelines FMEA and Control Plans 17
AnaMariaVR2 EMA: Guidelines on Good Pharmacovigilance Practices (GVP) US Food and Drug Administration (FDA) 1
T ISO 2230 (Guidelines for Storage of Rubber Products) - Temperature, Humidity & Light Other ISO and International Standards and European Regulations 8
M Diagnostic Guidelines, Clause 7.3.3.1 - Need to some examples IATF 16949 - Automotive Quality Systems Standard 2
H OTC (Over The Counter) Wipe Product Labeling Guidelines - Question Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
B What are Guidelines? Compliance to ISO 9001 Clause 4.2.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
V ISO10002:2004 (Guidelines for Handling Customer Complaints) Self Assessment Checklist Customer Complaints 5
M For Bulk Material (eg. paint), are there any guidelines for Ford PPAP Requirements? APQP and PPAP 1
A How does Japan PMDA classify Medical Devices - Classification Guidelines Japan Medical Device Regulations 6
A Defining the differences between Prototype vs. Production Guidelines? Contract Review Process 5
K Creation of Quality Manual, Procedures Manual, Work Instructions and Guidelines ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

Similar threads

Top Bottom