SBS - The best value in QMS software

Procedures Required by ISO 9001:2008

C

Chris_Anderson

#21
Re: ISO 9001:2008 Required Procedures

Welcome to the Cove. :D

There were no substantive changes in the 2008 version, so the documentation requirements are the same. In addition to the six you cite, 4.2.1 says that you must also have "... documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes."
ISO 9001 Six Required Procedures
Clause 4 Documents (2 procedures)
1) 4.2.3 Document Control
2) 4.2.4 Record Control

Clause 8 CAPA (4 procedures)
3) 8.2.2 Internal Audit
4) 8.3 Nonconforming Product Control
5) 8.5.2 Corrective Action
6) 8.5.3 Preventive Action

ISO 9001 21 Required Records
1) 5.6.1 Records from management reviews (minutes, results, actions)
2) 6.2.2 (e) Education, training, skills and experience records/files.

Clause 7 Product Realization (14 records)
3) 7.1 (d) Evidence that the realization processes and resulting product fulfill requirements.
4) 7.2.2 Results of the review of requirements relating to the product and actions arising from the review.
5) 7.3.2 Design and development inputs.
6) 7.3.4 Results of design and development reviews and any necessary actions.
7) 7.3.5 Results of design and development verification and any necessary actions.
8) 7.3.6 Results of design and development validation and any necessary actions.
9) 7.3.7 Results of the review of design and development changes and any necessary actions.
10) 7.4.1 Results of supplier evaluations and actions arising from evaluations.
11) 7.5.2 (d) As required by the company to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement.
12) 7.5.3 The unique identification of the product, where traceability is a requirement.
13) 7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use.
14) 7.6 (a) Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist.
15) 7.6 Validity of previous results when measuring equipment is found not to conform with its requirements.
16) 7.6 Results of calibration and verification of measuring equipment

Clause 8 CAPA (5 records)
17) 8.2.2 Internal audit results.
18) 8.2.4 Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product.
19) 8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained.
20) 8.5.2 Results of corrective actions.
21) 8.5.3 Results of preventive actions.
 
Last edited by a moderator:
Elsmar Forum Sponsor
C

Chris_Anderson

#22
Re: ISO 9001:2008 Required Procedures

An ISO system must have a Quality Manual, Quality Policy, Quality Objectives, ISO management rep., six procedures (minimum), and 21 record types. Many more optional documents are used for example: training plan, skills matrix, realization plan, organization chart, job descriptions, process maps, infrastructure/work environment plan, validation plans, FMEA/control plans, etc.
 

Stijloor

Staff member
Super Moderator
#23
Re: ISO 9001:2008 Required Procedures

An ISO system must have a Quality Manual, Quality Policy, Quality Objectives, ISO management rep., six procedures (minimum), and 21 record types. Many more optional documents are used for example: training plan, skills matrix, realization plan, organization chart, job descriptions, process maps, infrastructure/work environment plan, validation plans, FMEA/control plans, etc.
Let me help you. ;)

ISO to the rescue... Look at Annex B, then check your listing of records in Post 21...

Stijloor.
 
J

JaneB

#25
Re: ISO 9001:2008 Required Procedures

Bizmanualz,
Nice to see you participating, but this is actually a quite old thread, as are many of the others you're posting in.

For example, the poster raised this question in September, almost 6 months ago.

(You'll see each post has the date it was posted in it)
 
C

Chris_Anderson

#28
Re: ISO 9001:2008 Required Procedures

Bizmanualz,
Nice to see you participating, but this is actually a quite old thread, as are many of the others you're posting in.

For example, the poster raised this question in September, almost 6 months ago.

(You'll see each post has the date it was posted in it)
They may be old threads but people still read them and are looking for answers. Are you suggesting that I should only post to new threads?

BTW, I do not think 6 months ago is that old...
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#29
Re: ISO 9001:2008 Required Procedures


Bizmanualz - I'll email you tomorrow but for now I think it's time for you to chill out.
 

Mikishots

Trusted Information Resource
#30
Re: ISO 9001:2008 Required Procedures

To list the processes will meet the requirements of 4.2.2.c. this is how I interpret the standard. The procedures will just make it easier to understand the process.
I don't see how this response relates to 4.2.2 (c). To respond to the OP, ISO 9001:2008 remains the same as the previous revision in its requirements for documentation. Six are required to be defined in procedures, the remainder as needed.
 
Thread starter Similar threads Forum Replies Date
Gman2 Can I use ONLY the six required procedures in my ISO 9001 QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K List of procedures and forms or records required by ISO 15189:2012 Document Control Systems, Procedures, Forms and Templates 2
I Quality Procedures (as required by ISO 9001) for Inspection Bodies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Quality Manual - ISO 17025 required Mandatory and Operational Procedures ISO 17025 related Discussions 7
E List of Sales Procedures required for ISO 13485 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Identifying procedures that are NOT required by ISO 9001 Quality Manager and Management Related Issues 17
G Rookie to the ISO 9001:2008 World - Required Procedures and Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
V List of Required Procedures as per ISO 13485 & MDD EU Medical Device Regulations 8
D ISO 9001:2008 Six (6) Required Procedures Presentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
V Mandatory Procedures required by ISO 14001-2004 ISO 14001:2015 Specific Discussions 10
M The 6 documented procedures required by ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
Ajit Basrur ISO 17025 - Required Procedures and Records ISO 17025 related Discussions 11
H Any examples of the required ISO 9001 Procedures for a Small Recruitment Company Document Control Systems, Procedures, Forms and Templates 7
M Adding More Procedures than are Required by ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D How many procedures are required by ISO 14001? ISO 14001:2015 Specific Discussions 12
I ISO 13485 - List of required / needed procedures and records attached ISO 13485:2016 - Medical Device Quality Management Systems 51
M Input Needed (Help): My List of 'Required' ISO 9001 Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I Required ISO 9000:2000 Procedures - Are procedures still necessary? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P ISO 9001:2000 - Required Procedures or minimum required number? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 45
Marc ISO 9001:2000 Required Procedures Listing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Are 2 Hard Copies of Procedures and Instructions Required? ISO 13485:2016 - Medical Device Quality Management Systems 6
A AS9100 Rev D - List of Required Procedures Document Control Systems, Procedures, Forms and Templates 5
K AS9100:2016 (Rev. D) Required Procedures AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 19
O QMS / EMS required procedures ISO 14001:2015 Specific Discussions 4
S Forecasting and Material Planning - Are formal procedures required? Document Control Systems, Procedures, Forms and Templates 3
M Mining Operation Sand Plant - Required Standards and Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
N AS9110 Audit Stage 2 - What procedures are required? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Changes required to procedures after introduction of SAP Document Control Systems, Procedures, Forms and Templates 3
M Additional Procedures required for QA Department Document Control Systems, Procedures, Forms and Templates 10
J How to determine what procedures are required - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
S Number of Documented / Controlled Procedures Required by TS 16949 IATF 16949 - Automotive Quality Systems Standard 6
E TS 16949 Clause 4.2.3 - How many Procedures are Required? IATF 16949 - Automotive Quality Systems Standard 13
A Policies and Procedures are required but what is the reason? General Measurement Device and Calibration Topics 16
Q What are the required procedures for Medical Device Specification Developer? ISO 13485:2016 - Medical Device Quality Management Systems 24
E Are we required to update our procedures even though no changes? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
M List of FDA Required Procedures Other US Medical Device Regulations 5
A Are two separate procedures required for Corrective action and preventive actions Document Control Systems, Procedures, Forms and Templates 38
B What other Procedures are required apart from the Basic Six & Management Review? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T What Are The "6" Procedures Required by ISO9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Ajit Basrur List of mandatory or required procedures for 21 CFR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 9
S EN AS 9100 Procedures and WI (Work Instructions) Required Document Control Systems, Procedures, Forms and Templates 3
T Sarbanes Oxley Act (SOX) linkage to a documented QMS - Detailed Procedures Required? Document Control Systems, Procedures, Forms and Templates 21
P Procedures Required by TS 16949 Document Control Systems, Procedures, Forms and Templates 3
F How many procedures are required by TS 16949:2002 Document Control Systems, Procedures, Forms and Templates 6
A The 7 Procedures Required by TS 16949 IATF 16949 - Automotive Quality Systems Standard 15
S Detail Required in Documented Procedures Document Control Systems, Procedures, Forms and Templates 7
Y Procedures on Contract Review Document Control Systems, Procedures, Forms and Templates 3
L Separate Corrective Action and Preventive Action Procedures ISO 13485:2016 - Medical Device Quality Management Systems 13
L Where to place the what/when/how/who/where procedures in a multi-regulation AS9110C organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
F Standard Calibration Procedures: Recommended Practice ISO 17025 related Discussions 0

Similar threads

Top Bottom