Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing?

qualprod

Trusted Information Resource
#11
It is not yet a customer requirement, however we anticipate that it may become one in the next few years. My thoughts are moving to be in a better position to pursue certification in case it is needed but in the meantime have an actual QMS for the benefit it offers the company in general in terms of reducing waste and improving efficiency. It is a relatively small start up so there is not much structure and very few tools to manage the business from a quality aspect. There is a doc control system and a system for tracking CAPAs, SCARs and NCRs however not much in terms of procedures or quality manual. I think at the very least it is worth it to create the QMS aligned with ISO.
Yes,you can start the implementation and be ready when you decide for certificate.
 
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John Broomfield

Leader
Super Moderator
#12
Haha yes implement is a heavy word. Thanks for the insights. My approach so far is to create procedures of process that are already well defined and thought out but had not yet been committed to paper mainly so if there is turnover some of that knowledge can be retained. Also, creating procedures that mainly apply to the small quality department has been a good place to start.

I was thinking to build the barebones of a QMS with the following SOPs: control of documents, control of records, audits, control of nonconforming product, corrective action and preventive action. Any thoughts on that as a starting point?
My clients have always started by analyzing what their company does to convert customer needs into cash in the bank. After all, quality services and products are meant to be delivered by the business management system. By starting here you are showing your respect for your colleagues’ management system as it is before you work with them to develop it. You’ll also determine the processes and their owners within the company’s end to end core process. All of the other processes in the system exist to serve and sustain the core process.
 

greenlantern

Starting to get Involved
#13
My clients have always started by analyzing what their company does to convert customer needs into cash in the bank. After all, quality services and products are meant to be delivered by the business management system. By starting here you are showing your respect for your colleagues’ management system as it is before you work with them to develop it. You’ll also determine the processes and their owners within the company’s end to end core process. All of the other processes in the system exist to serve and sustain the core process.
Thanks for your explanation. I appreciate your point about understanding the system before helping to develop it. From my analysis, the primary thing our company does to convert customer needs into cash is providing a reliable consumable product that is defect free so that customers return to buy the product again. Additionally, providing excellent customer support when there is a defect ties into that. My intention was to implement QMS documents that focus on that.

Otherwise, I have not done extensive analysis of what actions our company takes that translate directly to more cash since I am not closely involved with that part of the company's information. Do you have any suggestions for resources to learn how to perform that kind of detailed analysis on end to end core processes?
 

John Broomfield

Leader
Super Moderator
#14
Further to my management degree, research and experience (and my accredited lead auditor training) Michael Porter’s books (see Value Chain below) were insightful to me in addition to Deming’s and Crosby’s. Online learning may still be available on this subject too. But I’ve been retired for five years so I’m somewhat out of date on what is available and how good it is.

Value chain - Wikipedia
 
#15
"Does your company outsource all manufacturing? That's kind of the situation I am trying to figure out since some of the typical ISO compliant procedures are tricky since we don't own the manufacturing process"

Yes, we outsource some, and do some ourselves. We look to utilize ISO certified suppliers when possible, but lacking that we will audit some suppliers ourselves (desk or on site), so using certified suppliers helps my schedule some, but it is not necessary if you determine the product is within conformance normally. Some of our best quality suppliers have no real quality system at all. Some of the certified ones have terrible quality levels. Certification is no guarantee of a quality product, you must determine that through monitoring quality, timeliness, responsiveness, etc.
 
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