SBS - The best value in QMS software

ISO 9001 4.4.1 "...shall determine the processes needed..."

John Broomfield

Staff member
Super Moderator
#21
Some auditors used their knowledge of business process flow (see Deming* or get work, do work, get paid) as follows:

Auditor: As you can see, we’ve agreed our audit plan in line with your business instead of the clauses in the standard. Please show me how the company organizes its work.

Auditee: We ensure our work is organized to convert the needs of our customers into cash in our bank account as quickly as possible. We call this our core process.

Auditor: Please show me how that happens.

Auditee: Marketing and design work together with our client to determine their needs, then translate these needs into specifications for manufacturing (and suppliers via purchasing).

Auditor: Then what happens?

Auditee: Carefully selected suppliers fulfill our purchase orders with conforming materials while manufacturing plan their activities to add value to these materials and assemblies to result in products that fulfill specified requirements.

Auditor: How do you ensure suppliers are paid only for conforming materials/assemblies?

Auditee: We evaluate evidence of their conformity and inform accounts payable accordingly; any nonconformity is immediately brought to the attention of the supplier and A/P put payment on hold.

Auditor: Please continue.

Auditee: Accounts receivable invoice customers as soon as we tell them and we tell the, as soon as we are sure that we’ve fulfilled the specified requirements.

Auditor: You mentioned cash, why is this part of quality?

Auditee: Because we need prompt payment to invest in improvement and for the enduring success of the company.

Auditor: Your system mentions support processes, how do these interact with your core process?

Auditee: Our support processes sustain, direct and improve our core process. Which support processes would you like me to show you?

...

Here we can see the importance of planning the audit around the auditee's business or core process. From this overview, the auditor determines which processes/controls need deeper investigation and further sampling to fulfill the objectives of the audit.

* Out of the Crisis - diagram on page 4.
 
Elsmar Forum Sponsor

Big Jim

Super Moderator
#22
Wonderful, but that won't help with the ANAB directive of planning the audit based on the IOP, unless, heaven forbid, an auditor goes into the audit searching for an explanation of the IOP and creates the audit plan after the opening meeting. Confusion and disruption will prevail.
 

John Broomfield

Staff member
Super Moderator
#23
Jim,

With just the auditee’s org chart an auditor can plan the audit using the process approach (from needs to cash for 9001 or quote to cash for 9002).

It the way I’ve done it since 1986, but I do admit those early Registrar boilerplate checklists did not help.

John
 

Kronos147

Trusted Information Resource
#24
They have never "specified." There has been gobbledygook about "promoting" it, but no one knows what that means.
One might say the same of change management, or risks and opportunities, as they are not written as topics, but rather as threads that re-appear in the standard.

As for ISO 9001, the organization has a few to consider regarding their "processes"



0.1 General-The process approach enables an organization to plan its processes and their interactions.


0.2 Quality Management Principles
− customer focus;
− leadership;
− engagement of people;
− process approach;
− improvement;
− evidence-based decision making;
− relationship management.


0.3.1 Process Approach General - Specific requirements considered essential to the adoption of a process approach are included in 4.4.


4.4.1 QMS and its Processes -

The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:
a. determine the inputs required and the outputs expected from these processes;
b. determine the sequence and interaction of these processes;
c. determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;
d. determine the resources needed for these processes and ensure their availability;
e. assign the responsibilities and authorities for these processes;
f. address the risks and opportunities as determined in accordance with the requirements of 6.1;
g. evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
h. improve the processes and the quality management system.


5.1.1 Leadership and Commitment: General

Top management shall demonstrate leadership and commitment with respect to the quality management system by:
c. ensuring the integration of the quality management system requirements into the organization’s business processes;
d. promoting the use of the process approach and risk-based thinking...


5.3 Organizational Roles, Responsibilities and Authorities

Top management shall assign the responsibility and authority for:
b. ensuring that the processes are delivering their intended outputs;


6.1.2 Planning: Actions to Address Risks and Opportunities

6.1.2 The organization shall plan:
a. actions to address these risks and opportunities;
b. how to:
1. integrate and implement the actions into its quality management system processes (see 4.4);


7.1.4 Environment for the Operation of Processes
The organization shall determine, provide, and maintain the environment necessary for the operation of its processes...


8.1 Operational Planning and Control

The organization shall plan, implement, and control the processes (see 4.4) needed to meet the requirements...



9.2.2 Internal Audit
9.2.2 The organization shall:
a. plan, establish, implement, and maintain an audit program(s)... which shall take into consideration the importance of the processes concerned...


9.3.2 Management Review: Inputs
The management review shall be planned and carried out taking into consideration:
c. information on the performance and effectiveness of the quality management system, including trends in:
3. process performance and conformity of products and services;


It is difficult to apply these requirements to a procedure.
 

Big Jim

Super Moderator
#25
All the more reason TC-176 needs to better delineate / define the term "process". It would be easy to read into 4.4 all of the manufacturing processes. Assembly, soldering, fabrication, plating, heat treating, painting, calibration, measuring, testing, ad infinitem.
 

John Broomfield

Staff member
Super Moderator
#26
Yes, our ability to differentiate between an activity (or task) and a process is essential.

I would always ask myself if the activity was part of a process in order to clarify this distinction exactly in keeping with our internationally accepted definition of process.

Another useful rule is that a process usually involves more than one department or function. In fact, smoothing out processes between interacting departments so they play well together is a distinct benefit of process management.
 

Big Jim

Super Moderator
#27
Yes, our ability to differentiate between an activity (or task) and a process is essential.

I would always ask myself if the activity was part of a process in order to clarify this distinction exactly in keeping with our internationally accepted definition of process.

Another useful rule is that a process usually involves more than one department or function. In fact, smoothing out processes between interacting departments so they play well together is a distinct benefit of process management.
And where are these internationally accepted definitions of a process? They certainly are not well known.
 

John Broomfield

Staff member
Super Moderator
#28
ISO 9000 defines a process as a “set of interrelated or interacting activities which transforms inputs into outputs”.

Ergo, activities are not processes.
 
Thread starter Similar threads Forum Replies Date
J Safety Special Equipment (e.g. lift, boiler) shall be audited by ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
GStough REACH and ISO 9001:2000/13485:2003 - Never the Twain Shall Meet? RoHS, REACH, ELV, IMDS and Restricted Substances 4
Gman2 ISO 9001:2000 Internal Audit: Someone PLEASE find me the "Shall" on "Process Audits" Process Audits and Layered Process Audits 37
Q Audit report template ISO 9001/14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q Process matrix examples of ISO 9001 & 14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 4
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
N ISO 9001 - Training business with fewer than 5 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
K Integrating ISO 9001:2015 with ISO 17025:2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Remote Audits for ISO 9001 (or any other standard) General Auditing Discussions 31
T Relationship between ISO 9001 and ISO – IEC BS EN 870079- 34 2020 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Sequence of ISO 9001:2015 Implementation Steps ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
qualprod Business Continuity Planning in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S ISO 9001:2015 Internal Auditing Internal Auditing 8
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P ISO 9001 certification with zero customers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A What must be recorded? (ISO 9001:2015, subclause 10.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Updated IATF 16949 - Will IATF 16949 get revised when ISO 9001:202X is released? IATF 16949 - Automotive Quality Systems Standard 4
S ISO 9001:2015 vs 21 CFR Part 211 matrix Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
S ISO 9001 implementation in a Gold exporting business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
A Tips and Tricks to understand ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
B ISO 9001 - "Remote Audit Fee" Registrars and Notified Bodies 13
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
M ISO 9001:2015 and AS6081:2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Implementation ISO 9001: 2015 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
J Audit Checklist for Integrated Management System for ISO 9001:2015, ISO 14001 & OHSAS18001 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
G National Structural Steel Specification 7th Edition - Do I now have to be audited against ISO 3843-3 as well as ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
lanley liao How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
G Logistic organization and controls - IATF/ISO 9001 audit Nonconformance and Corrective Action 2
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T ISO 9001 8.5.2. - Identification and traceability to Identify Outputs - Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T ISO 9001:2015 - Small Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7

Similar threads

Top Bottom