What's meant by ISO9001 clause 8.7 non conforming output?

sunrizenew

Involved In Discussions
#1
What mean by clause 8.7 non conforming outpt?

Is this mean non conformin in final products and services or is it mean nonconforming output from any enteire process such as sales, hr, production, maintenance.... Etc
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
The standard viewpoint is that the clause is directed to production. The specification ISO TC 9002:2016, Quality management systems — Guidelines for the application of ISO 9001:2015, clarifies by saying
8.7.1 The intent of this subclause is to prevent the unintended delivery or use of non-conforming outputs (at all stages of production and service provision).
I hope this helps.
 

sunrizenew

Involved In Discussions
#3
i understand that any other activities or process related to the final product or services have a nonconformity could treated as a non confiming outputs from these process or activities ?

is i am correct
 

malasuerte

Involved In Discussions
#4
Good business = Non conforming anywhere! It can be a single step, it can be the final product. It can be an incorrect PO/order.

You should have defined the "scope of your QMS". So at minimum, it would anything within that scope.
 

Tagin

Trusted Information Resource
#5
i understand that any other activities or process related to the final product or services have a nonconformity could treated as a non confiming outputs from these process or activities ?

is i am correct
As Jen indicated, the "outputs" in 8.7 refer to the deliverables (services or products) to the customer.

Yes, you can certainly have nonconformances in your processes that either do or do not affect deliverables. For example, part of the production process might be to store a record internally of some activity, yet for some reason employees are failing to do so. They are doing the activity properly but not recording it properly. You now have a nonconformance in the process, but the delivered product to the customer is conforming because this particular internal paperwork nonconformance did not affect the final output. In other cases, nonconformances (e.g., forgot to screw the cover onto the widget) could affect the final output.

The point is that 8.7 is a special subset of of nonconformances that is called out explicitly, because it speaks to what the customer receives. The more general clause regarding nonconformances is 10.2, which is how you want to handle nonconformances in general throughout the QMS.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
As Jen indicated, the "outputs" in 8.7 refer to the deliverables (services or products) to the customer.
I don't agree with that.

For example, if a foundry produces a defective mold, that's a non-conforming "output". The mold is not a deliverable item for the end customer, but still, needs to be addressed.

If purchasing issues an incorrect PO to a supplier mis-specifying the raw material to be purchased, the PO is a non-conforming output (of the purchasing process). That PO, obviously is not a deliverable to the end customer, but can lead to defective products which would reach the customers.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#7
I want to make clear that non conforming outputs that could affect the customer can certainly be in upstream production, as Sidney described. We should absolutely not forget that good outputs rely on good inputs. Remember the key phrase "...at all stages..."
 

Tagin

Trusted Information Resource
#8
My interpretation is based on the ISO Correlation matrix which correlates 2015 8.7 with 2008 8.3, the latter which specifically refers to "product":
The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product...
It also seems that the placement of 8.7 in clause 8, directly after 8.6 Release of products and services, indicates that 8.7 refers to nonconforming products or services, and not to nonconformances in outputs of intermediary steps.

It also seems that since 10.2 covers all nonconformities, whether they are input ncs, output ncs, process ncs, etc., that 8.7 would be redundant unless it had a particular intent.

I could be wrong...there's a first time for everything. :)
 

Jim Wynne

Staff member
Admin
#9
My interpretation is based on the ISO Correlation matrix which correlates 2015 8.7 with 2008 8.3, the latter which specifically refers to "product":


It also seems that the placement of 8.7 in clause 8, directly after 8.6 Release of products and services, indicates that 8.7 refers to nonconforming products or services, and not to nonconformances in outputs of intermediary steps.

It also seems that since 10.2 covers all nonconformities, whether they are input ncs, output ncs, process ncs, etc., that 8.7 would be redundant unless it had a particular intent.

I could be wrong...there's a first time for everything. :)
The bit you quoted says that NC product shall be controlled "...to prevent its unintended use or delivery." (My emphasis) It seems that "use" is being differentiated from "delivery."
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
My interpretation is based on the ISO Correlation matrix which correlates 2015 8.7 with 2008 8.3, the latter which specifically refers to "product":
As Jen already mentioned, earlier in the thread, the ISO TS 9002 could not have been clearer: at all stages of production and service provision. We can't spin that. If your interpretation was correct, the title of the subsection 8.7 would have been Control of non-conforming PRODUCTS.
 
Thread starter Similar threads Forum Replies Date
R What is meant by Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIPMENT (clause no 4.9) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
P Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Review ISO 13485:2016 - Medical Device Quality Management Systems 7
J APQP Requirements - What is meant by "among other items" IATF 16949 - Automotive Quality Systems Standard 2
Mikael "Value", A product that really meant something to you Coffee Break and Water Cooler Discussions 15
T Are Control Plans "Summary Documents" not meant to replace Work Instructions? IATF 16949 - Automotive Quality Systems Standard 3
T What is meant by a Characteristic Classification within GR&R? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
G What is meant by FAI (First Article Inspection) and how do we comply? AS9102 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 26
G AS9100 - Clarify what is meant by Statutory & Regulatory Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
A DMR (Device Master Record): What is meant by these words - Software Specifications? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
P Non EASA Aircraft - What is meant by Non EASA Aircraft? EASA and JAA Aviation Standards and Requirements 4
K Subgroup Size - Understanding what is meant by Subgroup Size Six Sigma 13
S Does 7.4 apply to products or services meant for Environment or OHS management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
B What is meant by "Configuration Management"? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 36
H AS9102A - What is meant by 5.2.5, "... approved Special Process sources..." AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
Chennaiite What is meant by 'Lesson Learned' in the context of Problem Solving Quality Tools, Improvement and Analysis 6
C What is meant by two throws, three throws etc, when applied to Compressors? Manufacturing and Related Processes 4
W What is meant by Process Approach Auditing and What questions should be asked? Process Audits and Layered Process Audits 11
J What is meant by number of "items"? Chrysler Layered Process Audit Question Process Audits and Layered Process Audits 10
G What is meant when a datum (feature) is called a "6 way"? GD&T help Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
R What is meant by "Test Specimens" per AS9100 Clause 7.4.2 f) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
R Purchasing Information - Trouble understanding what is meant by a), b),and c) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A TS 16949 Clause 7.4.3.2 Promotion of supplier monitoring - What is meant by promote? Supplier Quality Assurance and other Supplier Issues 6
F Scheduling Internal Audits - What is meant by 'based on status and importance'? Internal Auditing 35
M Para 4.6.3c - What is meant by the last part; ...number and issue of...? QS-9000 - American Automotive Manufacturers Standard 4
S Are there ISO9001:2015 Requirements for Preventive Maintenance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
D ISO9001 for one man company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A ISO9001:2015 Document control and training aids ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
G Calibration: Conforming to ISO9001 Requirements General Measurement Device and Calibration Topics 6
H Communication plan according to ISO9001 - Pharmaceutical field Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
R Major nonformance finding was given during a closing meeting of a ISO9001 certification audit General Auditing Discussions 76
S ISO9001:2015 Clause 9.1 - What the external auditor will look at? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
N Is consultant prohibited in ISO9001 audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 66
S ISO9001:2015 6.3 - Planning of Changes - OFI from auditor ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
I ISO9001:2015 9.1.2 - Customer Satisfaction Feedback ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
L Is writing out the ISO9001:2015 standard full name a requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 37
R ISO13485/ISO9001 Convenient Document Management System Document Control Systems, Procedures, Forms and Templates 3
E Interesting Discussion Was this the fastest ever stage 2 ISO9001:2015 audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 76
R ISO9001 & ISO13485 QMS for 2 types of products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
ScottK Question for Auditors on 7.1.4 in the ISO9001:2015 revision ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T In house Calibration? Measurement equipment traceability requirements - ISO9001 General Measurement Device and Calibration Topics 12
Q ISO9001:2015 Cl. 9.1.1 and 9.1.3 evidenced with only improvement actions? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
a_bardi Excluding ISO9001 Cl. 8.4 - Supplier Selection and Evaluation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G Effect of ISO9001 2015 transition on ISO IEC 80079-34 Other ISO and International Standards and European Regulations 2
A ISO9001:2015 Process Matrix with clauses General Auditing Discussions 13
S ISO9001:2015 Cl. 4.4.1 - What Processes Do I Need Documented ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
B Bare Bones/Under the Radar ISO9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
W Is ISO9001:2015 required for AS9100:2016 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
Icy Mountain ISO9001:2015 & IATF 16949:2016 Gap Analysis Tool IATF 16949 - Automotive Quality Systems Standard 7
D Internal Audit During the Transition Period from ISO9001:2008 to ISO9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Similar threads


















































Top Bottom