Clause 4.1. and Process Management

#1
Clause 4.1. and process management...

Clause 4.1. says:
"These processes shall be managed by the organization in accordance with the requirements of this International Standard."
I guess by words "these processes" are ment processes that are identified as needed for quality management system (clause 4.1 a))...

Emmm then what are the requirements of ISO 9001 for process management then? Well all stated in Standards clauses: such process should be established, such process should be performed including a and b and c and so on...
But how could sound this 4.1. requirement explained in quality manual?
 
Elsmar Forum Sponsor
H

HFowler

#2
Re: Clause 4.1. and process management...

MD said:

...what are the requirements of ISO 9001 for process management then?...
MD

I hope I understand your question correctly.

As I read the ISO Standard, the requirements for process management are specified in the following clauses:
- 6.3 Infrastructure,
- 6.4 Work environment,
- 7.5.1 Control of production and service provision, and
- 7.5.2 Validation of processes for production and service provisions.

All of Clause 7.0 Product Realization, address various processes needed to provide a product or service.

I hope I have provided some help. If not, keep reading and I'm sure others will provide you with better explanations.

Best Regards,
Hank Fowler
:)
 
Thread starter Similar threads Forum Replies Date
A AS9100 Clause 7.1.1 Project Management - Process vs Project. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
N Are 'Management Activities' a required Process Per Clause 4.1? IATF 16949 - Automotive Quality Systems Standard 12
D Layered Process Audits - FCA 9.2.2 - Exemption Clause? IATF 16949 - Automotive Quality Systems Standard 4
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
R Process control documents - Context of API Spec Q1, Clause 5.7.1.3 Other ISO and International Standards and European Regulations 0
C Internal Audit - Process Clause Matrix / Audit Checklist ISO 13485:2016 - Medical Device Quality Management Systems 7
MichaelDRoach ISO 9001:2015 Clause 9.3.2c)3) - What process or processes is this focused on? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
N Looking for input on the attached Process / IATF 16949 Clause Matrix IATF 16949 - Automotive Quality Systems Standard 4
P Interesting Discussion IATF 16949:2016 Clause 9.2.2.3 and Layered Process Audits IATF 16949 - Automotive Quality Systems Standard 18
M IATF 16949 Clause 8.3.5.2 sub-clause (l) - Process maintainability requirements IATF 16949 - Automotive Quality Systems Standard 15
A Escalation Process - IATF 16949 Clause 4.4.1.2 IATF 16949 - Automotive Quality Systems Standard 11
B IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change) IATF 16949 - Automotive Quality Systems Standard 24
T Temporary Change of Process Controls - IATF 16949 Clause 8.5.5.1.1 IATF 16949 - Automotive Quality Systems Standard 16
B IATF 16949 Clause 8.4.1.2 - Supplier Selection Process - Service Providers IATF 16949 - Automotive Quality Systems Standard 11
M AS9101F Clause. 3.7 Planned Activities - Process Evaluation matrix AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Compliance with IATF 16949 Clause 8.3.4.4 Product Approval Process IATF 16949 - Automotive Quality Systems Standard 2
P IATF 16949 Clause 8.5.6.1.1 - Temporary Change of Process Controls IATF 16949 - Automotive Quality Systems Standard 21
J How to understand IATF 16949 Clause 8.5.6.1.1 - Process Controls IATF 16949 - Automotive Quality Systems Standard 2
S ISO 9001 Clause 5 - Leadership (as a Process?) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
M Process standards - TS 16949 clause 7.6.3.1 IATF 16949 - Automotive Quality Systems Standard 2
S TS 16949 Clause 4.2.3.1 - Process to assure timely review - Two weeks IATF 16949 - Automotive Quality Systems Standard 2
A Q1 Clause 5.7.1.5 - Validation of process Oil and Gas Industry Standards and Regulations 10
S Process Monitoring and Measurement - AS9100 Clause 8.2.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Verification of Process Changes (AS9100 clause 7.5.1.2) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Definition Process Nonconformity - Definition and examples - AS1900 clause 8.2.3 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
K Process Auditing Clause 7.3 Design and Development Internal Auditing 11
E TS 16949 Clause 7.1.1 Process Planning-Operation Sheet Example wanted Document Control Systems, Procedures, Forms and Templates 5
T ISO 9001 Clause 7.4.1 Purchasing Process (Supplier Approval) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q AS9100 Clause 8.3 - Control of Nonconforming Product Process for Approving Personnel AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Explanation of AS/EN 9100 Clause 7.4.1 Special Process Sources AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T What is clause ISO9001:2008 for Acc/Rej Criteria and Verifying QA process Internal Auditing 2
M Changes Assessment as per AS9100 Clause 7.5.1.2 Control of Production Process Changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
G AS9100 Clause 7.5.1.1 Production Process Verification Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
B ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provision ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
C AS9100 C Clause 8.3 - Personnel Approval Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J Production Process Verification - AS9100 Clause 7.5.1.1 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
M Preventive Action Process question - ISO 9001 Clause 8.5.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
Q AS9100 Clause 7.4.1 Purchasing Process and Approved Supplier List Records AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 37
Richard Regalado ISMS Asset Identification Process - Clause 4.2.1.d.1 of ISO/IEC 27001 IEC 27001 - Information Security Management Systems (ISMS) 4
R AS9100C Special Process Procedure - Work Instruction for AS9100 Clause 7.5.2 wanted AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R TS 16949 Clause 5.1.1 Process Efficiency IATF 16949 - Automotive Quality Systems Standard 4
X Audit Findings - The Process/Clause Matrix does not identify all the processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
P Prototype Build Process per TS 16949 Clause 7.3.6.2 and APQP IATF 16949 - Automotive Quality Systems Standard 5
S Understanding of Process Validations - ISO 9001 Clause 7.5.2 Validation Qualification and Validation (including 21 CFR Part 11) 9
A Requirement for Accredited Suppliers - ISO 9001 Clause 7.4.1 Purchasing process Service Industry Specific Topics 4
C API Q1 8th ed Clause 7.4 Purchasing - 7.4.1.1 Purchasing Process (supplemental) Oil and Gas Industry Standards and Regulations 9
M Manufacturing Process Design and Development Review - TS 16949 Clause 7.3.4 IATF 16949 - Automotive Quality Systems Standard 12
L Process Measurement - ISO 9001:2008 Clause 8.2.3 - Whats your Interpretation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Product or Process Data Analysis Over Time - CQI-9 Clause 1.8 Quality Manager and Management Related Issues 1
S ISO 9001:2008 clause 4.1 Outsourcing Process control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10

Similar threads

Top Bottom