Permissible Authorities of CB (Certification Body) Auditors

MVladimir

Involved - Posts
#1
Dear friends,
Has the external (CB) QMS auditor authorities to examine auditee QMS documents of INTERNAL origin which are not interrelated (insufficiently related) with ensuring of the effective planning, operation and control of its processes? (For example - job description). Has he authorities to write NC against that documents? If "YES" what is a reason for that opinion? May be, examination of some QMS requirements (additional to ISO 9001) is a theme of internal QMS audit?
 
Elsmar Forum Sponsor
#2
Re: Permissible authorities of CB auditor

If the job descriptions are outside the scope (not referenced) of the QMS, then no. But this situation begs the question, why did the auditor discover these documents? Also, why were they not part of the QMS?
 

Big Jim

Super Moderator
#3
Looking at job descriptions very likely would be something a CB auditor would need to look at to confirm that the organization has determined the competencies needed to fulfill the requirements of element 6.2.

Do you have some other means to demonstrate you have determined what competencies (skills) are needed for each position?
 

John Broomfield

Staff member
Super Moderator
#4
Dear friends,
Has the external (CB) QMS auditor authorities to examine auditee QMS documents of INTERNAL origin which are not interrelated (insufficiently related) with ensuring of the effective planning, operation and control of its processes? (For example - job description). Has he authorities to write NC against that documents? If "YES" what is a reason for that opinion? May be, examination of some QMS requirements (additional to ISO 9001) is a theme of internal QMS audit?
MVladimir,

The auditor can examine any document as necessary to fulfill the audit objective. I do not work for CBs and I offer to sign nondisclosure agreements.

I avoid looking at some confidential documents (in HR for example) and will ask the auditee's representative (an authorized person) to provide specific information from the file.

Failure to provide the document may jeopardize fulfillment of the audit objective and this could be sufficient to stop the audit.

If the job descriptions specified the required attributes, skills and knowledge of job titles directly or indirectly affecting quality then, in order to determine conformity to ISO 9001, I would need to see some job descriptions.

If the job descriptions are repeating parts of the procedures then my concern would be for avoiding discrepancies in the upkeep of the system so again I would need to sample some job descriptions related to recently revised procedures.

What other information could the job descriptions contain that would put them out of bounds of a process or system auditor?

Or whose job descriptions are you concerned about? After all just about everyone has a direct or indirect impact on quality.

BTW, idle curiousity is not a legitimate reason for any auditor looking at any document let alone confidential ones.

No auditor should abuse his or her authority and should always be prepared to explain the reason for examining a document in context with the audit objective.

John
 
Thread starter Similar threads Forum Replies Date
Marc Definition MPEE - Maximum Permissible Error for Length Measurement Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
M What is the maximum permissible period of delaying the validation of equipment? Other Medical Device Regulations World-Wide 4
N Permissible Exclusions for QM ISO9001:2008 Audit and Consultancy Services Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Y No permissible error statement on the thermometer calibration report General Measurement Device and Calibration Topics 7
C Permissible ISO 9001 Exclusions/Omissions for the Service Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
B Permissible Exclusion for Clause 7.5.2 in a Real Estate Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J IEC60825 - Laser Safety - Calculating Maximum Permissible Exposure Correctly Other ISO and International Standards and European Regulations 1
D What is the difference between Tolerance and Permissible Error General Measurement Device and Calibration Topics 5
T Are Form Taps permissible to use? Manufacturing and Related Processes 3
D How to compute the Permissible Errors for Class 2 Weighing Scale General Measurement Device and Calibration Topics 2
S How to define Permissible Error for Measurement and Test Equipment? Measurement Uncertainty (MU) 3
J Blueprint Note: Rectangular Distribution is Permissible - Concentricity of Two Holes Capability, Accuracy and Stability - Processes, Machines, etc. 5
N ASME B89.1.13 question regarding Resolution and Maximum Permissible Error General Measurement Device and Calibration Topics 3
P Design & Development in Food and Beverage Services - Permissible exclusion or not? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
R ISO 9001:2008 Permissible Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
A Permissible exclusions in ISO 9001:2008? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Is this exclusion Permissible by the standard - Company Divisional Differences ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Maximum Permissible Error for Monitoring and Measurement Devices General Measurement Device and Calibration Topics 19
K Permissible Exclusions - ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 158
S EN AS 9100 Permissible Exclusion and Provision - Aerospace design and development Design and Development of Products and Processes 4
D Permissible Exclusions - How is 6.2.2.1 Product design skills being handled Design and Development of Products and Processes 24
J Subcontracted Services - Permissible Exclusions Service Industry Specific Topics 9
J Is it permissible to use data from calibrations as part of a gage R&R? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
W Permissible Exclusions in Section 7 - Design control requirements - No design Design and Development of Products and Processes 19
C Quality Manager vs Warranty (service) Manager - Authorities & Responsibilities Customer Complaints 2
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
M Informational EU – Meeting minutes – Competent Authorities on Substances of Human Origin Expert Group Medical Device and FDA Regulations and Standards News 0
I Document Signature Software? (Certificate Authorities) Document Control Systems, Procedures, Forms and Templates 15
M Medical Device News CAMD – Patient Safety – The Focus For All Competent Authorities For Medical Devices (CAMD) Members Medical Device and FDA Regulations and Standards News 0
C Do Distributors need to register with competent authorities in the EU? EU Medical Device Regulations 2
M Medical Device News EU - List of national market surveillance authorities by sector and country EU Medical Device Regulations 0
Jane's Do you have an SOP for communicating with regulatory authorities ISO 13485:2016 - Medical Device Quality Management Systems 8
rob73 Worldwide device regulatory authorities at country level Other Medical Device Regulations World-Wide 6
gard2372 Line or Process Stoppage - Andon Authorities and Process Manufacturing and Related Processes 1
K AS9100 5.3 Authorities (Looking for examples) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M List of Contact Info for Asian Regulatory Authorities Other Medical Device Regulations World-Wide 0
N Notified Body excessive reporting onto Competent Authorities via the Eudamed database ISO 13485:2016 - Medical Device Quality Management Systems 7
R Age Discrimination by Chinese Authorities and supported by Automakers IATF 16949 - Automotive Quality Systems Standard 6
A FSC not accepted by authorities in Argentina - Does any one know why? Other Medical Device Regulations World-Wide 6
0 EU Medical Device Requirements and Government Authorities EU Medical Device Regulations 3
J Responsibilities, Authorities and Relationships - What does Relationship mean? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J How do you Create SOPs for Multiple Authorities? EU Medical Device Regulations 8
Ronen E FDA Must Have New Authorities to Regulate Pharmacy Compounding US Food and Drug Administration (FDA) 8
Q Where to define Authorities and Responsibilities in Documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Ajit Basrur Websites - Medicines Regulatory Authorities (global) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
G Armenia adopts GMP (Good Manufacturing Practices) - Armenian Health Authorities Other Medical Device Regulations World-Wide 0
W Company Inspection Policy for Third Parties or Regulated Authorities Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Ajit Basrur Links to Global Health Authorities and Organizations US Food and Drug Administration (FDA) 1
T Writing and Authorising Documents - Responsibilities and Authorities Document Control Systems, Procedures, Forms and Templates 3
E Should the Competent Authorities Audit the Manufacturer? Other US Medical Device Regulations 1

Similar threads

Top Bottom