Auditing Senior Management to determine the Effectiveness of Management Processes

Blaest

Involved In Discussions
#1
What would be the correct answer according to the standard to the following:

I would like to audit senior management to determine the effectiveness of their management processes. Which 5 specific areas would I focus on?

1)
2)
3)
4)
5)
 
Elsmar Forum Sponsor

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
What would be the correct answer according to the standard to the following:

I would like to audit senior management to determine the effectiveness of their management processes. Which 5 specific areas would I focus on?

1)
2)
3)
4)
5)
1) Commitment

2) Management Reviews

3) Communication to all levels

4) Objectives and Goals

4a) Are the Objectives reviewed and adjusted to meet organizational
changes...

4b) Are the goals obtainable...

5) Resources

Those are my suggestions.
 

SRQAAuditor

Starting to get Involved
#3
Hi there, so auditing management to verify the system is effective is a great idea. I have followed this approach with ISO 13485:
Section 4 Quality Management System (looking at sub-clauses like document control, documented quality manual and quality records)
Section 5 Management Controls (looking at sub-clauses like management commitment, policy, management review (verify system is working here and in control)
Section 6 Resource Controls or Management (check sub-clauses like sufficient personnel, including internal auditors; competence, awareness and training; look at skill retention times, and more)
Section 7 Product Management (lots of sub-clauses like verification of process to build product; purchasing controls; calibration; design controls;
Section 8 Measurement Analysis and Improvement (various sub-clauses like controlling measurements, provision of feedback, complaints, internal audits, nonconforming product and corrective and preventive action.)
Through all of these sections, look for opportunities for improvement and how they are controlled and documented.
Those are the five sections I would suggest. Enjoy!
 

Ron Rompen

Trusted Information Resource
#7
IMO, the most important of these is #4 (Goals) and the subquestions that are driven by that.
Are the goals realistic and obtainable
Do they reflect the business plan and objectives of the company
If the goals haven't been met, are there any actions being taken and documented to correct the situation (treat this like it was an 8D for a nonconformance)
If the goals are changed (especially to a lower goal) is there documented justification for it? It is too easy to just 'downsize' a goal if it becomes apparant that you're not going to hit your original target.
 
Thread starter Similar threads Forum Replies Date
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 4
cscalise Suggestions for MDR Auditing tools EU Medical Device Regulations 1
J Auditing of Support Function IATF 16949 - Automotive Quality Systems Standard 9
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
S Risk based internal auditing Internal Auditing 6
Randy Remote auditing (for disaster, disease, disturbance etc...) during the Neo Coronavirus Pandemic and Social Distancing Registrars and Notified Bodies 7
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 0
F AS9100D Internal auditing requirements Internal Auditing 3
R Does any here use an internal auditing tool that works on different platforms? Internal Auditing 3
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
G Best Practices for IT auditing - Is a session-id necessary for a complete audit trail? IEC 27001 - Information Security Management Systems (ISMS) 0
I Questions to ask when auditing for Organizational Leadership and Planning for the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
blackholequasar Internal Auditing Inspiration - Getting volunteers to perform internal audits. Internal Auditing 22
W Internal Auditing carried out by a 3rd party - Review of previous audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
tony s What is the automotive process approach for auditing? IATF 16949 - Automotive Quality Systems Standard 2
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
R I've been auditing for a CB for 18 years General Auditing Discussions 10
P Consultant Auditing Qualifications Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 144
M We still have not received our certificate due to a 'backlog' with our auditing body Registrars and Notified Bodies 25
N Online Internal Auditing Course for ISO 13485 - Suggestions ISO 13485:2016 - Medical Device Quality Management Systems 8
A Agenda for 8D audit on Supplier's side - Auditing Corrective Actions General Auditing Discussions 5
U Internal auditing - Company employees or contract second party Internal Auditing 10
J Recomended Values - Auditing process in a supplier IATF 16949 - Automotive Quality Systems Standard 18
M Canada - Registrars that allow e-auditing for ISO 9001? Registrars and Notified Bodies 4
K Internal Auditing - Umbrella QMS and Multiple Standards Oil and Gas Industry Standards and Regulations 4
D Auditing Our Outsourced 2nd-3rd Party Internal Audit Company ISO 13485:2016 - Medical Device Quality Management Systems 6
supadrai Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones? Canada Medical Device Regulations 7
Ed Panek Supplier Auditing - No purchases from our key suppliers in the last 24 months ISO 13485:2016 - Medical Device Quality Management Systems 5
P Auditing "process validation" process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
qualprod Effective Auditing advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M Acceptance of remote auditing techniques - Can you help me with my research? General Auditing Discussions 0
GStough Auditing Against Criteria Unfamiliar to Auditee - Yea or Nay? General Auditing Discussions 11
qualprod Auditing Product and Services doubts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Auditing support and management processes General Auditing Discussions 7
F It is acceptable moving remote locations staff to manufacturing plant for auditing? IATF 16949 - Automotive Quality Systems Standard 3
D MSDS / GHS Walk-through / Auditing Occupational Health & Safety Management Standards 6
Pmarszal Supplier Auditing Services (Audit Needed?) General Auditing Discussions 4
S ISO 9001 Audit Observations - Transitioning my career into auditing Career and Occupation Discussions 16
G AS9101 Rev F - Worksheets for internal auditing AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
N API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers Oil and Gas Industry Standards and Regulations 5
M Auditing processes followed by employees placed on client's site Internal Auditing 4
S ISO 13485:2016 and MDSAP internal auditing ISO 13485:2016 - Medical Device Quality Management Systems 6
M Auditing a Contractor in EMS and Non Conformity Report General Auditing Discussions 1
Richard Regalado ISMS Auditing Guideline V2 (based from ISO/IEC 27001:2013) IEC 27001 - Information Security Management Systems (ISMS) 7
S ISO 9001:2015 - Internal Auditing - Audit to the Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
R Internal Auditor auditing Internal Audit Procedure (AS9100) Internal Auditing 18
M Is Automated Internal Auditing Possible? Internal Auditing 13

Similar threads

Top Bottom