I realized that many people are confused about the companies that typically get involved when a factory wants to get its quality management system (QMS) certified to ISO 9001 or ISO 13485. Let's break it down into the logical steps to get to a certification. 1. Gap analysis You need to know what the gap is. This is necessary in order to draw a QMS implementation plan (along with a budget). You may call in a certifying body (more on them in section 4, below). But, if there … [Read more...]
What Causes A Bad QMS/ISO 9001 Implementation (Reason 2)
This is a follow-up on What Causes A Bad Factory QMS Implementation? [Reason 1], as I expose a few common issues that make a factory's work much harder than it should be. If you are starting to work on a program to raise product quality in your factory, you may want to set a goal such as "get certified to ISO 9001 in 12 months", but is it the right way to frame it to your employees? You may be sending the wrong message. … [Read more...]
ISO 9001 QMS Features, Benefits, & Implementation Tips [Podcast]
![ISO 9001 QMS Features, Benefits, & Implementation Tips [Podcast]](https://qualityinspection.org/wp-content/uploads/2021/04/ISO9001QMSFeaturesBenefitsImplementationTipsPodcast-1140x445.jpeg)
In This Episode... Phil Brown, owner of Phil Brown Consultancy, who is an ISO 9001 and 14001 consultant in the UK joins us in this episode of the China manufacturing decoded podcast. Phil talks us through the ISO 9001 QMS, the requirements that make up this standard, benefits, the difference between good and bad implementations, and some tips from him to follow if you're implementing the QMS sometime soon. Just hit the play button to start listening..! Listen to the episode right … [Read more...]
What Causes A Bad Factory QMS Implementation? [Reason 1]
![What Causes A Bad Factory QMS Implementation? [Reason 1]](https://qualityinspection.org/wp-content/uploads/2021/04/WhatCausesABadFactoryQMSImplementationReason1-1140x445.jpeg)
When we look at the root causes of many quality issues in China or Vietnam, we find "there is no quality system at the factory" or "they supposedly have one, but it was a really bad QMS implementation". I thought about it and I can point to a few serious misconceptions that have derailed the QMS implementations in many factories. They are very common when a company got ISO 9001 certified, in particular. Let's cover the first reason for a bad QMS implementation in this article: Hire a good … [Read more...]
Does ISO 9001 Actually Prevent Process Improvements?
As I wrote before, I believe that a good implementation of ISO 9001 does help a manufacturer quite a bit, while a bad one will only create issues. And the reason is simple. ISO 9001 allows an organization to set any system it wants, as long as they make sense and they respect a set of minimum requirements. The problem is, many factories think "we would get more customers if we had that certificate", so they go out and find templates and make it all look like it is alive in their company... … [Read more...]
Benefits of ISO 9001 for a Chinese manufacturing organization
I wrote recently about ISO 9001: What are the standard and the certification process 10 ways it can get poorly implemented in a factory To summarize my view on this topic: It is a good standard, keeping in mind that it was designed to apply to all sorts of organizations Many companies did not implement it the right way, as they took shortcuts and they were only interested in the 'marketing impact' of a certification The real culprit is the way registrar bodies audit and … [Read more...]
Factory Audit Tips: 10 Signs of a Bad ISO 9001 Implementation
A few days ago, I wrote about the basics of ISO 9001 -- both the standard and the certification/registration process. I got some comments on Linkedin about how useless ISO 9001 is. It is useless indeed in many manufacturing facilities I have visited, and the key reasons are: Poor implementation (because managers want to take shortcuts), combined with Inadequate auditing (lack of understanding of processes and of what is important, and lax enforcement of the standard by many registrar … [Read more...]
How a Factory Can (and Should) Go Beyond ISO 9001
I wrote a few articles about ISO 9001 recently: The standard itself pushes companies in the right direction, but the auditing & certification process has many flaws: Basics about ISO 9001: The Standard and the Certification Process The standard pushes manufacturers to think in terms of systems and processes, among other benefits: Benefits of ISO 9001 for a Chinese manufacturing organization Many factories have been certified, but implementation was really bad: Factory Audit Tips: … [Read more...]
Basics about ISO 9001: The Standard and the Certification Process
How many of your suppliers claim to be ISO 9001 certified? Is it true? And, to start with, what does it mean? I want to shed some light on this topic. The purpose of the ISO 9001 standard is to "help businesses and organizations to be more efficient and improve customer satisfaction". How does it do that? First, what is a Quality Management System (QMS)? Basically, a QMS is what a company puts in place to ensure it meets its customers' requirements. Among others, it includes: … [Read more...]
How a Chinese Factory Can Get ISO 9001 Certified
I wrote before about the way certain consultants are routinely hired by manufacturers to “make paperwork look good”. It is the norm in China. However, some factory owners really want to manage their business in accordance with best practices. They are not looking for shortcuts. They understand that ISO 9001 is not very advanced but it is already a basis good basis -- if applied correctly -- on the road to operations excellence. So, how can consultants help a relatively small factory get … [Read more...]