SBS - The Best Value in QMS software

Understanding ISO9001:2015 - 8.3: Design and Development of Products and Services

J

Joe Smith

#1
#1
8.3.1 says "The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services." Apart from the addition of 'services', that's basically the same as in 2008.

No problem so far - we've got a mature and robust D & D process for production of our manufactured products. The only service we provide is the occasional assembly of a product at a customer's site, and all we do there is follow the assembly instructions that the customer would otherwise use.

However - a recent visiting CB auditor has left us some notes after taking a look at our 'Readiness Review' for the transition to 2015, and he's saying that D & D must now cover not only our products, but also the planning of our order fulfilment processes e.g. picking and packing.

How is that going to work, or am I just being obtuse? Our picking and packing processes have been in place for years, and are totally driven by the software we use (off-the-shelf, with a few tweaks just for us). What kind of evidence could we hope to provide to show how these were designed or planned? Even if we changed our software in the future (highly unlikely, at least in my lifetime), I don't see where D & D comes into it, as we would just have to follow the stages built into that software. Any advice would be welcome.
 
Elsmar Forum Sponsor
howste

howste

Thaumaturge
Super Moderator
#2
#2
Picking and packing is not a service you are providing to your customer. I see no reason to show the auditor evidence of D&D for this. This is part of Operations and it should be verified that the product picked and packed is correct.
 
J

Joe Smith

#3
#3
Thank you, howste, that's exactly what I thought. I can see we'll have to have some words with that auditor. His exact comment was "Clause 8.3 is not just design and development of the products you supply, it is also design and development of your internal processes for order fulfilment etc, e.g. designing your picking and packing processes." How he gets that from that clause I don't know!
 
howste

howste

Thaumaturge
Super Moderator
#4
#4
ISO 9001:2015 does say
clause 8.3.2h said:
In determining the stages and controls for design and development, the organization shall consider... the requirements for subsequent provision of products and services
Click to expand...
and
clause 8.3.5b said:
The organization shall ensure that design and development outputs... are adequate for the subsequent processes for the provision of products and services
Click to expand...
I believe that this requires that the Product Design Process considers manufacturability and what manufacturing processes will be used to create the product.

In the automotive industry, ISO/TS 16949 clause 7.3 and the newly released IATF 16949 clause 8.3 do require "Manufacturing Process Design" and expects the design of the manufacturing processes to meet the requirements of this section of the standard. Even with that though, picking and packing are not manufacturing processes. :confused:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
B Determining Competence - Understanding clause 6.2.2 a) of ISO9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
K Measuring Staff understanding of ISO9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M ISO 12944 Understanding the thickness guidlines Oil and Gas Industry Standards and Regulations 0
N Help with understanding Process Controls Manufacturing and Related Processes 7
Q Understanding "free movement" for CE-marked products EU Medical Device Regulations 2
D High level understanding of EUDAMED EU Medical Device Regulations 3
A 60601-1 understanding of stationary device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Surface Roughness understanding Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
P Understanding DFMEA and PFMEA - Supplier Related IATF 16949 - Automotive Quality Systems Standard 21
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Qualification and Validation (including 21 CFR Part 11) 5
B Measuring and monitoring equipment - Understanding which procedures to be compliant with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
S Understanding UDI requirements - Class 2 medical device (hearing aids) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Informational Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House Medical Device and FDA Regulations and Standards News 0
P Understanding FDA draft "Management of Cybersecurity in Medical Devices" Medical Information Technology, Medical Software and Health Informatics 3
J Properly understanding SPC - Newbie SPC questions Statistical Analysis Tools, Techniques and SPC 34
S Understanding control chart and measurement capability Statistical Analysis Tools, Techniques and SPC 2
P Minitab Data Analysis - Understanding if a Process is in Control or Not Using Minitab Software 2
R Understanding a few points on ISO 9001's Design and Development Planning ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Z Understanding Cycle Time - Why the time of the other activities are left out Lean in Manufacturing and Service Industries 11
J Understanding ISO 9001:2015 - 10.3 Continual Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
E Root Cause Analysis - Is Insufficient Understanding an acceptable Root Cause? General Auditing Discussions 9
E Understanding of TS 16949 Clause 7.6.2 IATF 16949 - Automotive Quality Systems Standard 5
K Understanding IEC 60601-2-68 requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
A Training material for interpretation & understanding Part 11 requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Understanding the absolute uncertainty specification for a Fluke 5500A Measurement Uncertainty (MU) 3
N Understanding, Challenging & Approving Supplier Control Plans FMEA and Control Plans 7
M Definition Recommendations - Understanding "recommendations" and "recommended corrective action" Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
S Understanding UDI (Unique Device Identification) Other US Medical Device Regulations 10
T Understanding USP <1112> Water Activity as applicable to Medical Devices Other Medical Device and Orthopedic Related Topics 4
K Understanding Risk Management Requirements according to AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
S MIL-HDBK-217 - Understanding the various Environmental Conditions Reliability Analysis - Predictions, Testing and Standards 1
D What is your understanding or interpretation of TS16949 7.4.1.2 IATF 16949 - Automotive Quality Systems Standard 6
C Understanding the relationship between 62304 and the MDD ER IEC 62304 - Medical Device Software Life Cycle Processes 7
S Understanding Subgroup Size - Multi Cavity (Minitab) Statistical Analysis Tools, Techniques and SPC 4
R Understanding clause 15.4.2.1 d) of amendment 1:2012? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M Understanding accreditation, MoUs, certifications Other ISO and International Standards and European Regulations 28
L Mobile Medical App - Understanding 21 CFR Part 820 Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Understanding and implementing ISO 17025 ISO 17025 related Discussions 9
M Understanding Versions of Collateral and Particular Standards IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
S Understanding, Analysis and Monitoring Quality Defects on Composite Components Statistical Analysis Tools, Techniques and SPC 3
S Understanding PMS (Post Market Surveillance) and PMCF (Vigilance and PMCF) Quality Manager and Management Related Issues 1
B Understanding why my CpK and PpK are low, and LCL Statistical Analysis Tools, Techniques and SPC 20
S Understanding Quality Objectives, Metrics and KPI ISO 13485:2016 - Medical Device Quality Management Systems 15
Q Beginner's Understanding - The Purpose and Applications of QMS/ISO Standards Philosophy, Gurus, Innovation and Evolution 12
Q Understanding Configuration Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
W Understanding PPAP Appearance Approval APQP and PPAP 22
V Understanding Automotive Coating for Seating Mechanism Components Manufacturing and Related Processes 1
M Understanding of Regression and ANOVA in Minitab Statistical Analysis Tools, Techniques and SPC 8

Similar threads

Top Bottom