Technically yes. ISO requires that you have processes and procedures describing these processes but it doesn’t tell you how to document them. It is thus conforming if your complete process is spread over a number of different documents. However, this is unlikely to be a very useful structure to your documentation and probably does not make the documents effective at defining and communicating the process.

There structures can originate from many situations but typically when the procedure was written, the author was trying to “get ISO” and that’s what they did. The easy way for them to do it was to write a procedure that just mimicked the words in the standard. Thus the procedure meets ISO. Unfortunately it really doesn’t describe the actual processes that are followed to achieve say document control and thus often work instructions are written to explain the different activities — so although they are called work instructions and third level documents they often describe the management processes that would normally be in a procedure. Usually they also contain detail too. That alone would be bad enough, but over the years auditors, customers and others change the procedures and work instructions to suit their needs and what is left is a complex set of documents to describe a simple process, at different levels and containing both detail and management processes.

The goal of documentation is not just to achieve conformance by saying “we have addressed it somewhere” but to focus on what would be the most useful structure of our documentation so that it is easy to communicate the process, to train people in it and to refer to it if we need to.

ISO is such a useful standard. It focuses on the processes for “managing” the activities it introduces. It is the management of document control that is important in clauses 4.2.3 and this can practically be presented in a single document at an appropriate level of detail. ISO got it about right when they included the requirements under each section. Covering these requirements, expanding those that are more important and minimizing those that are less (if any) can be practically achieved in a single document. Thus it is a useful hint (not particularly just for ISO conformance but also for addressing the most common document control requirements) that these subjects could (and perhaps should — because it is useful and practical) be described in a single procedure.

It is still possible that some work instructions are necessary. Typically these would cover the detail of a specific activity but the “management procedure” (the procedure which explains how the process is managed), should describe the overall process including relevant variations and exceptions. How to operate software or levels of authorities would be better covered in lower level documents.

The simple answer is no!

The philosophies behind these disciplines are fundamentally different.  ISO is about establishing a defined way of running the whole business so that it is effective and successful.  Lean is about eliminating (seven types of) waste from processes and is usually applied as a project based philosophy to production type processes.  Six Sigma is also a project based philosophy with the reduction of variation being its main goal.

Although Lean and Six Sigma purists will claim that these techniques apply to the whole organization (and truthfully they can be), they are normally applied to a single process (at a time) where a variety of techniques are applied to reduce waste, reduce variability and increase efficiency.  Such tools as Kanban, one-piece-flow, standard work, tact time, 5S, statistical techniques, etc. are applied to and around the process in order to achieve improvement.  While these techniques can be applied to combined processes and even the management system of the organization as a whole, nowhere in the origins of these philosophies is there discussion about an organizational model or a breakdown of key processes that is found in ISO.

“Doing” ISO first will establish basic definitions for all processes in the organization including fundamental controls for such things as record keeping and document control.  Once the basic discipline exists within an organization, Lean and Six Sigma can be successfully applied to improve individual areas.

There are no big problems with doing Lean and Six Sigma before ISO.  It is possible that during ISO you will reorganize the way that your processes operate (as you define what they are and what they are trying to achieve) and this could cause effort in a Lean or Six Sigma project to be wasted – although the same could be said about an ISO project.  However,  ISO establishes processes for document control, records management, corrective action, competency definition, and management responsibilities that would be extremely beneficial during any project – including Lean and Six Sigma projects.  It is not unusual for a Lean or Six Sigma project to become “lost” when it does not use established document control, competency control and records management processes.

ISO is intended to provide a fundamental base to organizing a business.  Operating by design and not by accident.  While it does then actually require organizations to improve, it does not restrict how that is achieved.  To many people rush off to the promise of a Lean or Six Sigma project without strong basics in place.

Cavendish Scott, Inc. has been implementing ISO management systems for over 25 years.  We have been exposed to thousands of organizations some of which have adopted Lean and Six Sigma philosophies.  We have relationships with Lean and Six Sigma training organizations and can help you implement a strong management system in an organized and successful way.  Contact us for more information including supporting activities which are often overlooked.  With this discipline and organization established ISO pushes for and Lean and Six Sigma can deliver project based imprv

Lean Manufacturing (From Wikipedia)

http://en.wikipedia.org/wiki/Lean_manufacturing

Lean manufacturing or lean production, often simply, “Lean,” is a production practice that considers the expenditure of resources for any goal other than the creation of value for the end customer to be wasteful, and thus a target for elimination. Working from the perspective of the customer who consumes a product or service, “value” is defined as any action or process that a customer would be willing to pay for. Basically, lean is centered on preserving value with less work. Lean manufacturing is a generic process management philosophy derived mostly from the Toyota Production System (TPS) (hence the term Toyotism is also prevalent) and identified as “Lean” only in the 1990s.[1] [2] It is renowned for its focus on reduction of the original Toyota seven wastes to improve overall customer value, but there are varying perspectives on how this is best achieved.

Six Sigma (From Wikipedia)

http://en.wikipedia.org/wiki/Six_Sigma

Six Sigma is a business management strategy originally developed by Motorola, USA in 1981.[1] As of 2010[update], it enjoys widespread application in many sectors of industry, although its application is not without controversy.

Six Sigma seeks to improve the quality of process outputs by identifying and removing the causes of defects (errors) and minimizing variability in manufacturing and business processes.[2] It uses a set of quality management methods, including statistical methods, and creates a special infrastructure of people within the organization (“Black Belts”, “Green Belts”, etc.) who are experts in these methods.[2] Each Six Sigma project carried out within an organization follows a defined sequence of steps and has quantified targets. These targets can be financial (cost reduction or profit increase) or whatever is critical to the customer of that process (cycle time, safety, delivery, etc.).[2]

The term six sigma originated from terminology associated with manufacturing, specifically terms associated with statistical modeling of manufacturing processes. The maturity of a manufacturing process can be described by a sigma rating indicating its yield, or the percentage of defect-free products it creates. A six-sigma process is one in which 99.99966% of the products manufactured are free of defects, compared to a one-sigma process in which only 31% are free of defects. Motorola set a goal of “six sigmas” for all of its manufacturing operations and this goal became a byword for the management and engineering practices used to achieve it.

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Simple answer. Yes.

Although it does not say in the standard, this is a common sense requirement that has been established as a rule imposed on certification bodies by the accreditation agencies.

Technically once you have audited thoroughly for a “few” years you might have collected evidence that will allow you to reduce the amount of auditing.  In practice this rarely happens.

Cavendish Scott, Inc.  performs internal auditing for many clients.  We are professional, quick and effective.  And it allows you to concentrate on your normal work.  Click here for more information

Accelerated learning is a theory/practice of learning that acknowledges that we all learn differently.  It also builds on that fact and provides the premise that we all learn better if we see, here and practice things.   The theory incorporates the concepts of left-brain vs right-brain.

We adopt the basic principles of this in our training.  We ensure that training is substantially exercise based so that you have to learn for your self, so that you dont get bored and tired and so that you learn more.  Our training is fun and effective and better than the traditional style of training.  For instance, in our lead auditor training – 5 days,  we have about 30 powerpoint slides!

We use these same principles when we customize our training and bring it in house to your organization.

For information about our training - click here

The ISO standards do not dictate how you conduct your audits.  They merely require that they are effective.  It has been argued by some ISO proponents that a one-time event cannot be effective.

Cavendish Scott performs internal audits for many organizations.  We are ISO and auditing experts and take all of the problems and worry out of your ISO system.  Outsource your internal audits and relax.

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