ISO 28000 Internal Audit Checklist wanted

MichaelDRoach

CAAA Business Management Systems Specialist
#11
All, myself and a coworker just returned from auditor training in 28000. The instructor was very knowledgeable and provided lectures and workshops in how to prepare, how to conduct, and how to close out an audit. This was a refresher for me and it reopened those closed areas that had been ignored or passed over. My organization is on the journey to compliance and we are the second pair of auditors that have been trained in 28000. The first pair have moved on to other positions and are no longer able to audit the organization. Checklists are a fundamental element of any audit program. And as stated above, as the program matures, the checklist will evolve from a mirror of the standard to a representation of the management system. How fast does it get there is in the hands of management, I just point out the gaps and deficiencies and start the correction process.
 
Elsmar Forum Sponsor
#13
All, myself and a coworker just returned from auditor training in 28000. The instructor was very knowledgeable and provided lectures and workshops in how to prepare, how to conduct, and how to close out an audit. This was a refresher for me and it reopened those closed areas that had been ignored or passed over. My organization is on the journey to compliance and we are the second pair of auditors that have been trained in 28000. The first pair have moved on to other positions and are no longer able to audit the organization. Checklists are a fundamental element of any audit program. And as stated above, as the program matures, the checklist will evolve from a mirror of the standard to a representation of the management system. How fast does it get there is in the hands of management, I just point out the gaps and deficiencies and start the correction process.
Michael, do you have a sample internal audit checklist you can share?
 
Thread starter Similar threads Forum Replies Date
MichaelDRoach Oganization's Self Declaration of Conformance to ISO 28000 wording example wanted Supply Chain Security Management Systems 1
B ISO 28000 Implementation Gantt Chart Supply Chain Security Management Systems 5
E Certification of ISO 28000 Lead Auditors - Which organisations are actually qualified Supply Chain Security Management Systems 3
D I wish to know about ISO 28000, ISO 14001 and OHSAS 18001 Other ISO and International Standards and European Regulations 7
Marc ISO 28000 - Supply Chain Security Management Systems Supply Chain Security Management Systems 0
Sidney Vianna ANAB Accreditation Program for ISO 28000 for Supply Chain Security. Any interest? Other ISO and International Standards and European Regulations 0
C ISO/ PAS 28000 Implementation Guide - I'm interested in its risk based approach Other ISO and International Standards and European Regulations 4
Sidney Vianna ISO 28000 - Specification for security management systems for the supply chain Supply Chain Security Management Systems 3
Ed Panek ISO 9001 Cert Scope Adjustment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P ISO 9001: Quality Management as a process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
K ISO 2859-5 (single run production) control plan issues FMEA and Control Plans 2
K ISO 17025 Method Validation and Verification for Test Lab ISO 17025 related Discussions 4
K ISO 13485 Design Requirement with respect to "component" manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 3
P Registrar Cancelled ISO 13485 Auditors multiple times? Registrars and Notified Bodies 1
rob3027 ISO 13485 justification for design and development exclusion for medical packaging ISO 13485:2016 - Medical Device Quality Management Systems 18
A Help understanding what it takes to implement a QMS that is ISO 13485 compliant ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO 17025 Lead Assessor Training ISO 17025 related Discussions 0
H Active Implantable Medical Devices - ISO 14708 and EN 45502 Other Medical Device Related Standards 0
L ISO 10993-18 vs ISO 18562-4 Other Medical Device Regulations World-Wide 4
J Iso 9001 Clause 7.1 - Advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
D ISO 14001 Finding - Missing Safety Data Sheets ISO 14001:2015 Specific Discussions 2
J ISO 17025 Calibration Other Medical Device Related Standards 2
FuzzyD ISO 13485:2016 Customer Assessment OFI ISO 13485:2016 - Medical Device Quality Management Systems 2
K Applicable ISO 9001 clauses for Human Resources? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 4
I IEC 60812 or ISO 14971 for PFMEA? What should we use? ISO 14971 - Medical Device Risk Management 3
I ISO 9000 Where to Start ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 81
M ISO 13485 consultants and auditors with design oriented focus ISO 13485:2016 - Medical Device Quality Management Systems 7
D ISO 9001:2015 Internal Audit Check Sheet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
H Does ISO state in anyway that we MUST keep physical first piece parts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B ISO cl. 5.3 - Ensuring that the integrity of the QMS is maintained ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A ISO 9001- any advise please with transitioning from a paper based system to eQMS and multi site scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
L ISO 20417 crucial changes Other Medical Device Related Standards 1
R ISO 27001 Mandatory Policies , Procedures and Records IEC 27001 - Information Security Management Systems (ISMS) 0
R Use of historical version of ISO standards CE Marking (Conformité Européene) / CB Scheme 3
I QMS and ISO 9001 Misc. Quality Assurance and Business Systems Related Topics 11
E ISO 17025 Key Performance Indicators (KPIs) ISO 17025 related Discussions 5
A ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J ISO 9001:2015 Clause 8.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
LabCat Internal SOP for a validated (ISO) method? ISO 17025 related Discussions 2
L Confusion about ISO 14644 Other Medical Device Related Standards 2
GStough Audit Nonconformances (?) for Suppliers Not Registered to ISO and No Supplier Quality Agreement Exists General Auditing Discussions 24
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 3
Aliken Recommendation for the ISO 13485 certification company ISO 13485:2016 - Medical Device Quality Management Systems 7
ISO-tired ISO 13485: file structure overview ISO 13485:2016 - Medical Device Quality Management Systems 11
J ISO 10993-1:2018 Format to Perform Risk Management Process US Food and Drug Administration (FDA) 1
B ISO 9001:2015 Registered Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C ISO Cert and Parent Company is not Certified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
B Is 14971 Annex C checklist now in ISO/TR 24971 required to complete prior to 510k filing? ISO 14971 - Medical Device Risk Management 3

Similar threads

Top Bottom