Audit Definition in ISO 9000:2000 includes "documented process"?

L

lou hannigan

#1
Audit Definition

Does anyone know why the definition of "audit" in ISO 9000:2000 includes "documented process"? The definition in ISO 10011 omits "documented." A strict application of this definition introduces a questionable situation…

ISO 9001:2000 requirements by reference include the definitions of ISO 9000:2000; therefor any audit activities claimed by the organization to part of the ISO 9001 quality system must, by definition, be a documented process. For internal audit activities both the standard and the definitions require the activity to be a documented process or procedure. There is no problem for internal audits.

However, do audits of other types, such as supplier audits, have to be supported by a documented procedure? The standard does not require the other types of audits to be supported by a documented procedure, however the definition of audit does.

Take an example: An organization prides itself, as described in their quality manual, in the conduct of supplier audits. However there is no documented process as per the ISO 9000 definition of audit. The undocumented process works, evidence exists, and the results are reviewed and action taken. The process simply is not documented.

Can this organization claim that supplier audits are part of their ISO quality system in the absence of a documented process?

Could a registrar auditor raise a nonconformity, and if so on what element?

Or am I missing something?

Any guidance on this query is gratefully appreciated.

Lou
 
Elsmar Forum Sponsor

JodiB

Still plugging along
#2
Good one Lou!

This is an excellent topic to stretch our brains on!

You are absolutely correct that the definition of audit includes the word "documented". Now I'm going to play semantics. It says that it is a documented "process" - not "procedure". It is a slight distiction, but we can make it work. So how do we document a *process *without using a documented procedure? Well, a process can be documented by the use of the forms and reports that may be generated, the actions that are taken based on the audit, the records that are kept. These provide documentation of the process.

Internal audit is the only one that requires a documented procedure for the process. The others just need documentation of the process.

That's my story if an auditor brings this up! How does it play to everyone else's ears?:)
 
Thread starter Similar threads Forum Replies Date
R Critical suppliers (Definition of) and MDSAP (Medical Device Single Audit Program) ISO 13485:2016 - Medical Device Quality Management Systems 15
M Inputs on definition of very similar processes for multi site audit sample - IAF MD1 2018 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Definition Would a wrong definition constitute an Audit Finding? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
K Definition of Repeat Audit Findings Internal Auditing 11
W Definition Product Audit - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
K Definition Audit - Time for a new definition of the word Audit? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 15
B Definition of Calibration Frequency - Dispute during Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Audit "Finding" Definition and Significance General Auditing Discussions 7
sathis Audit Trails - Definition, Description and Software Internal Auditing 9
D Definition Major Audit Nonconformance - Definition of Major Nonconformance Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
J Definition of Special Characteristics Delta C and Delta S - Need for Customer Audit Capability, Accuracy and Stability - Processes, Machines, etc. 2
M Definition Audit - Definition of what an audit is - Is there more to auditing? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 34
E Definition Audit Finding - In 'Registrar Language' what is the Definition of a 'Finding'? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 11
A Definition Major vs. Minor Nonconformance (Finding) - Internal Audit - Definition & Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 38
Marc Definition Process Audit - Internal and External - ISO9000 - A Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
N Definition Discovery Audit - Can someone give me a text book definition? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
K MDSAP Audit Approach 2020 for Brazil Other Medical Device Regulations World-Wide 1
K MDSAP Audit Approach 2020 ISO 13485:2016 - Medical Device Quality Management Systems 0
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
T COVID, Furlough and ISO9001 Surveillance Audit Coffee Break and Water Cooler Discussions 2
R External Audit and Certificate prorogation due to the pandemic General Auditing Discussions 10
Dean Bell Implementation of Controls as per SOA for Stage 2 Audit IEC 27001 - Information Security Management Systems (ISMS) 0
G Logistic organization and controls - IATF/ISO 9001 audit Nonconformance and Corrective Action 2
Geoff Cotton Performing a Delta Audit General Auditing Discussions 12
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
G MSA check list to audit IATF 16949 - Automotive Quality Systems Standard 8
L Open Positions During AS9100 Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L Stage 2 audit - Requirement for 3 months of records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
F Who can sit in/perform an API audit? Oil and Gas Industry Standards and Regulations 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 4
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
Q Internal audit plan template Internal Auditing 6
G Self Assessment Audit from a new potential customer General Auditing Discussions 3
L Internal audit during COVID-19 restrictions ISO 13485:2016 - Medical Device Quality Management Systems 5
M OEM asking for NC report after certification audit. IATF 16949 - Automotive Quality Systems Standard 3
Ooi Yew Jin Customer E audit preparation Quality Manager and Management Related Issues 2
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 5
J Remote Audit Experiences - June 2020 General Auditing Discussions 26
F Product audit sampling plans IATF 16949 - Automotive Quality Systems Standard 3
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
M Supplier Audit Report - Template for second party audit wanted Lean in Manufacturing and Service Industries 1
Stefan Mundt AS9100D Major nonconformity due to recurrence of a NC during a subsequent CB audit. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q ISO 9001:2015 man days for surveillance audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
F ISO 13485 - EU countries that could request another audit ISO 13485:2016 - Medical Device Quality Management Systems 2
H Layered audit updates after COVID-19 shutdowns Process Audits and Layered Process Audits 0
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0

Similar threads

Top Bottom