ISO 14000 - Required Quality Records

L

lcriscoe

#1
Quality Records

Can someone please help? The follwing AR was issued to me this past April. Not all parameters of clause 4.16 are defined in procedures. (e.g. indexing, accessing, filing and maintenance.) I had a spreadsheet, listed all the requirements across the top and answered them the best I could. I am unclear of exactly what they are looking for. When you detail how a record is indexed, such as by part number, date ect. Doesn't that also explain the filing system? If anyone has an example in excel and willing to share it, I would appreciate it. Thanks in advance.
 
Elsmar Forum Sponsor
R

Roger Eastin

#2
First off, I think you should ask your registrar (I assumed the auditor was third party) for clarification. It seems to me that your Excel spreadsheet attempts to define each of the requirements of 4.16, so your registrar should be able to clear things up for you. Depending on your retention system, your indexing system could be your filing system as well. For me, indexing is a "subsystem" of our filing system. My filing system allows me to find a general type of record whereas indexing allows me to find individual information.
 
W

waberens

#3
Catagories that we have included on our Quality Record Table are: Record name, Collection, Access, Filing & Indexing, Storage, Maintenance, Minimum Retention, Disposition, and QS Reference. It may be overkill, but it certainly has caused us to think through the whole process of controlling quality records.

Bill
 
Thread starter Similar threads Forum Replies Date
D What kind of ISO 14000 do I have to use on this Company? ISO 14001:2015 Specific Discussions 9
B Registration - Integrated TS 16949 and ISO 14000 IATF 16949 - Automotive Quality Systems Standard 8
Marc List of the ISO 14000 Series of Documents ISO 14001:2015 Specific Discussions 2
Sidney Vianna New ISO standard will facilitate implementation of ISO 14000 series in 12 languages Miscellaneous Environmental Standards and EMS Related Discussions 1
G I'm interested in taking a "registered or qualified" ISO 14000 Lead Assessor Class Training - Internal, External, Online and Distance Learning 12
Sean Kelley How long have you had the same ISO 14000 auditor? General Auditing Discussions 1
S ISO 14000 Integrated into ISO 2000? Bad Idea? Miscellaneous Environmental Standards and EMS Related Discussions 8
M Implementing ISO 14000 - Currently ISO 9001 Registered - Development Schedule Miscellaneous Environmental Standards and EMS Related Discussions 7
Marc ISO Issues ISO 9000 - ISO 14000 Publicity Guidelines ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
RoxaneB ISO 14000 EMS (Environmental Management System) Surveillance Audit Results Miscellaneous Environmental Standards and EMS Related Discussions 23
R Update of ISO 14000 - Finalization Expected in 2004 Miscellaneous Environmental Standards and EMS Related Discussions 14
C ISO 14000 and mapping the flow Miscellaneous Environmental Standards and EMS Related Discussions 7
A What is ISO 14000:2000? Miscellaneous Environmental Standards and EMS Related Discussions 3
J Do we need to Register to ISO 14000? Miscellaneous Environmental Standards and EMS Related Discussions 2
V Designing an integrated ISO 9000 - ISO 14000 System in a Big Marine Port Design and Development of Products and Processes 3
V Iso 9000:2000 / Iso 14000 Integrated Management Systems Quality Assurance and Compliance Software Tools and Solutions 1
J How many companies have really benefited from ISO 14000 Miscellaneous Environmental Standards and EMS Related Discussions 12
J Integrated ISO 9000, ISO 14000 and Health & Safety OHSAS 18001 Systems Document Control Systems, Procedures, Forms and Templates 19
T ISO 9000 and 14000 Companies - Standards Based Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R ISO 9000 / ISO 14000 multiple plant registration plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Randy Continuing Professional Development - CPD for ISO 9000/14000 RAB Auditors? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 24
J Risk Management and ISO 14000 - Companies that handle or store hazardous chemicals ISO 14001:2015 Specific Discussions 3
C ISO/IEC 17021-1 clause 7.1.2 - Determination of competence criteria Document Control Systems, Procedures, Forms and Templates 2
G ISO 17023 2017-11 - Suggestions for good books ISO 17025 related Discussions 0
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 3
M ISO 9001:2015 and AS6081:2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Gage calibration frequency, ISO and IATF - What are the requirements Calibration Frequency (Interval) 3
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
C Implementation ISO 9001: 2015 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 2
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 0
L Biological Assessment (ISO 10993-1) Other Medical Device Related Standards 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
J ISO 9001:2015, ISO 14001 & OHSAS18000 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G ISO 14001 - 6.1.3 Compliance Obligations ISO 14001:2015 Specific Discussions 1
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
S Qualification question - ISO 13485 Reliability Analysis - Predictions, Testing and Standards 0
K ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay' ISO 13485:2016 - Medical Device Quality Management Systems 10
Aymaneh ISO 11607-1: 2019 main changes Other Medical Device Related Standards 2
G National Structural Steel Specification 7th Edition - Do I now have to be audited against ISO 3843-3 as well as ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
L How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO 8536-4 Contamination Index ISO 13485:2016 - Medical Device Quality Management Systems 0
S Practical Implementation of ISO 14971 ISO 14971 - Medical Device Risk Management 6
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9

Similar threads

Top Bottom