IMO our people don't need to read manuals or procedures and document changes to them

[JaneB]

In Reply to Parent Post by ValleyGirl

The process of becoming AS9100 certified was a terrible experience. I started working here on the second day of the audit. We were not even closely prepared and the auditor was a jerk. Instead of changing the audit to a pre audit the auditor proceeded to rip the company apart. I had very little knowledge of what was going on. I have learned a lot and am not afraid to challenge an auditor if I feel what he is requesting something that isn't necessary.

I'm really sorry to hear it was a terrible experience. It is not supposed to be, in my opinion. And an auditor who's a jerk is a hideous experience for all concerned - I've only come across such on rare occasions, but they cause huge, huge amounts of damage.

Glad you've learned a lot, keep challenging them, and do keep your system as minimal as you possibly can. It's not supposed to be a mountain of paperwork.

[achorste]

WOW - great discussion so far

Just to put my 2 cents worth in - There have been a couple of people in the thread mentioning QMS's not adding value to their organisation. I would question their implementation of the systems - a well implemented and developed QMS will add value with minimal added cost to the organisation beyond the existing QA / QC personnel. It may be time to look at the basics again.

Also - systems like ISO 9001/ AS9100 aren't there to be a burden, but to help structure a QMS and provide customers with the confidence that their supplier at least has the basics in place - but they aren't always mandatory either - I have seen a few organisations with their own "homebrew" QMS that would shame many ISO 9001 / 13485 registered companies (not too sure on the AS front though)

[Wes Bucey]

FWIW:
My experience in business certainly predates the ISO series of management Standards, but when I began in business, almost everyone in business was affected in some way by the business Standards promulgated by the United States Department of Defense with its associated Military Standards.

Most of the Military Standards dealt with materials and products because it was imperative businesses have a consistent yardstick for materials and products which they would incorporate into other, more complicated products. Hence, something as relatively simple as a nut, bolt, and washer assembly was an important link to building a ship or aircraft upon which the lives of people would rely. The manufacturer of the nut, the bolt, and the washer wanted to be sure the material he made them from was consistent from batch to batch. Similarly, when he heat-treated those products and applied [or not] rust preventatives, he was looking for consistency in the process. This philosophy was inherent all the way up and down the supply chain. When it was ignored or deliberately sidestepped (often due to either ignorance, lack of education and training, or just plain greed), the consequences could be disastrous - think of the Challenger disaster.

From Standards for materials and products, it was a logical and efficient and profitable step to escalate Standards to an entire SYSTEM of doing business. The current iteration of ISO Standards is merely the latest step in this evolution. The entire supply chain for ANY product depends upon the confidence each link has in every other link to perform its functions efficiently and consistently (an old adage begins, "For the want of a nail, the shoe was lost, for the want of a shoe, the horse was lost . . .")

When ANY link in the chain unilaterally chooses to become a "rogue" and refuses to provide documentation about the consistency of its SYSTEM of operation, it immediately becomes "suspect" to the other links in the chain, who are then forced to make expensive individual investigations about the efficacy of the SYSTEM (if any) of that particular link to provide consistently conforming products or services. Uncertainty breeds increased inspection (increasing net cost of the material, product, or service.) When the economics of dealing with the rogue become a burden, the other links in the chain usually find a replacement link to eliminate that economic burden.

In Quality, we have a mantra: "Documented evidence, not anecdotal evidence." More simply stated: "It isn't sufficient to say you are good, you have to show proof!"

Bottom line:
It's perfectly OK to opt out of the ISO system, but most supply chains will require some strong documentation to back up a claim of delivering consistently good product or service. My own personal experience is that showing such independent documentation is often more expensive than simply documenting adherence and compliance to an accepted International Standard for Business and/or Quality Systems.

[chaosweary]

In Reply to Parent Post by jwperry

I've only been around the Cove about a week, as my company is just now starting the ISO implementation, with a target certification date sometime late next year, and this forum has been very informative in helping me understand a lot of what is going to happen. Personally, I see it as something that is going to paperwork me to death. When it is all said and done than maybe it will be better.

As for our increase in personnel and lack of increased revenue it has gone mostly to overhead positions; receptionists, IT guys, logistics, shipping receiving, and a para-legal. In any of the small businesses that I have worked for/started you have to wear many hats to get all tasks accomplished. As we've decided to expand we are wearing fewer hats, but the few that we keep are just greater in responsibility. There is no way that I would have been able to document my responsibilities before and keep up with the workload.

Semper fi, with that I think that your analogy using a claymore and the USMC, isnt very convincing in my experience. When I was in, there is tons of documentation and training in the corps, even for claymores. I still have my head space and timing manual for the 50 cal machinegun. If you have as much documentation and training in your company as we did when I was in wpns 2/7 then you have adequate documentation and training for an ISO audit. It makes me wonder if you even track the amounts and types of process defects or issues in the business probably firefighting and nothing preventive. I worked part time at a vegetable stand, only 4 people. We would have numerous issues with prices, staffing, job responsibilities and assignments, and even how to work and audit the register at the end of the day. The owner had the same attitude, documentation for a little veggie stand was no value added...we probably could have ran it with just 2 people if we had good training and documentation. It ended up going bankrupt because the person the owner put in charge bought too many christmas trees, then the owners father came and just took money out of the register, no one questioned it...to say the least his father was not supposed to have that authority...oh well. There is nothing in ISO that is not just good business sense. I definitely would question the quality of your service or product if the business you work for cannot do what I see as the bare minimum.

[John Broomfield]

In Reply to Parent Post by jwperry

I have to agree with this. I work for a small company (less than 50 people) seeking ISO 9001 certification. This seems to be a self perpetuating system. When we were smaller (less than 10) we were able to handle a similar sales volume (only $500k less) with a quality objective in mind and got the job done. We didn't need written procedures to do our job right and excel, we just got it done. Confident, competent people will always be more valuable than written procedures. As our company has expanded from our small group of motivated workers to a larger manufacturing team we've had to dilute our talent pool; hence the need for procedures. Those of us that have been around since we started the company don't use the procedures and can operate every machine in the workshop. I haven't touched some of our calibration rigs in years, but have every bit of confidence that I can still go and produce a quality product with them without looking at the procedures.

I don't see the need for small businesses to be enslaved by ISO standards when they produce quality work.

I do see the need for medium to large size businesses to document their operations, because this will track the errors and non-conformity easier than being able to recognize someones hand writing.

When I was in the Marines I saw a guy blow his hands off up with a claymore mine...what does it say on the front of the claymore? FACE TOWARDS ENEMY. But it didn't tell him not to hold it while doing so; written procedures can only take you so far.

Written procedures cannot make up for a lack of competence. They are for use by competent people when planning, operating, controlling and improving processes (as are work instructions for critical or tricky tasks within processes).

Instead of feeling "enslaved" by unnecessary procedures (and instructions) why not rid your system of the wasteful documents per clause 4.2.1d? Any more than the six documented procedures (not necessarily 6 procedure documents) specified by ISO 9001 are determined by system and process analysis (please study clause 4.1).

Overdocumented management systems come not from ISO but from people who do not understand how to analyze how an organization's system determines the success of its processes (and then to enable the system to improve itself). Instead they may say to themselves if some procedures are good, more must be better!