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ISO 9001:2002 Training

ISO 9000:2000 Home
ISO 9000 Implementation ISO 9000 Improvement Program

There are three paths to ISO 9001:2000 training:

The ISO Standard

To understand how ISO can transform an organization through change requires a close look at the standard, the full text of which is attached at the end of this document. The requirements are organized in the tried-and-true format of the PDCA (plan, do, check, act) cycle. There are 3 introductory sections, 1 section on documentation, and the 4 PDCA working sections with the "meat" of the standard. The sections of the standard are as follow:

Scope: what is covered.
Normative reference: ties the standard to other international standards.
Terms and definitions: brings in the additional document ISO 9000 which contains technical (but not very valuable) definitions.
General requirements: presents the overall quality management system and the details of documentation requirements.
Management responsibility: defines the role of management, how they have to set objectives and act to lead the ISO program (Act of PDCA).
Resource management: defines the requirements for human and other resources needed to achieve the management objectives (Plan of PDCA).
Product realization: lays out the requirements for defining and fulfilling the customer requirements (Do of PDCA)
Measurement, analysis, and improvement: presents the minimum for determining that activities met requirements, and then taking action to change (Check of PDCA)

Within this overall structure are the clauses with details of the requirements. These are easiest to understand as "questions" requiring the organization to "answer" how they address that subject. This is why an ISO audit is similar to an oral defense of an academic thesis. For example in clause 5.4.1 Quality objectives, "Top management shall ensure that quality objectives … are established….The quality objectives shall be measurable and consistent with the quality policy." This does not say anything about the nature of the objectives, but alerts top management that they will have to defend them as "measurable" and "consistent with the quality policy."

Top management has to decide what their "policy" is, and what are their "objectives," which are the measurable achievements of everyone’s efforts to reach their policy. If the policy includes developing new customers and improving operational efficiency, then the whole organization is focused on these aspects of the business. The intent of the standard is that top management regularly change their policy and objectives in response to the changing organization and business environment. This could be each year or even sooner, depending on the speed of change in the organization.

The policy and objectives become the focus of the organization. Everyone has to know them and know how their activities help achieve them. The first step of change to reaching a goal is that everyone know what that goal is, and how they will be measured along the road. It is unfortunate that many top managers in ISO registrations never realize the importance of this tool and throw away the opportunity with a meaningless policy such as that of Essex "Provide our customers with the best quality products and services at all times."

The ISO 9001:94 standard was correctly derided for being bureaucratic and leading to a "paper system." The 2000 version was written to shift focus to the organization’s ability to change (improvement), and to arm the auditor to be able to cite an organization which did not meet the agreed customer requirements. This goal of protecting the customer is clear in many clauses of the ISO document.

For example, the auditor has the opportunity to "lay the blame" for a failure to meet a customer’s needs at management’s door step. Clause 5.2 Customer focus states that "Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction." These clauses can be thought of as "bullets" in the auditor’s gun, and are not as valuable as those questions which require management to figure out how to bring about change in an aspect of the business.

The team

Who gets trained? The obvious answer is those who need it. But training needs vary:

Position	Need	Recommended sections
Top managers or owners	Understand and guide use of the quality system so that the organization is a greater success	The whole thing, but at least the top manager has to understand section 5 Management, and parts of section 6 Resources
Management representative and guide, with at least one backup person (the backup could be a member of management)	Understand and guide use of the quality system so that they can intelligently guide the registration auditors, and effectively help the team	The whole thing
Top managers or owners	Determine what processes in the business the system will cover	4.1 General Requirements
"Secretary" or administrative person	Document control and record keeping	4.2.3Document Control, 4.2.4 Records
Human resources person	Training	6.2 Training
Maintenance	Facilities maintenance including PM	6.3 Infrastructure
Sales/order entry	Quote generation, order taking, and customer communication	7.2 Customer-related processes
Design engineering	If you design, the designers need this section	7.3 Design and development
Purchasing	Defend your purchasing system	7.4 Purchasing
Production or service provision	How do you do it?	7.1 Planning, 7.4 Product realization
Calibration technician	Defend your calibration system	7.6 Control of monitoring and measuring devices
Marketing or sales person	Collect information relating to customer perception of you	8.2.1 Customer Satisfaction
Accounting or quality person	Learn about internal auditing	8.2.2 Internal audit
Accounting or management person	Monitoring or measuring (M&M) your processes	8.2.3 (M&M)
Quality control	Say how you are sure and have evidence that product met agreed customer requirements	8.2.4 Monitoring and measuring of product
Production or quality	Control of nonconforming product (also what you track as nonconforming product)	8.3 Nonconforming product
Accounting or quality	Describe what data you collect ad analyze, and how you use it to improve	8.4 Analysis of data
Management or quality	Maintain the corrective and preventive action systems	8.5 Improvement

You have to select your team, and Midwest is always available to help with this process. But, it is very common that during the training, some new people are added, and some drop out. The sooner you can jell your team, the better, since time (your time) training someone who doesn't need it is obviously wasted. And someone who will need to know will miss the opportunity. But don't worry, the team always adjusts some.

In small organizations, we cover the material once, in 2 hard day days (we combine the documentation with the class). The classes cover the entire text of the ISO 90091:2000 standard, which we use as the class guide, and the only text book.

For big companies who may have large teams, or even "sub teams" There may have to be more than one set of classes. The best format is to run the classes in 50 minute segments with published class schedules, and have each class 2-3 times. This lets people sign-up as they need, and lets those who want to to take a class more than once. People regularly say "Well, I liked the class, but Joe or Sally should have been there." Multiple classes let that happen.

These classes use PowerPoint presentations and have the slides duplicated 2 up as handouts for the students to annotate. There can be up to 25 in a class (more is possible, but you need a pretty good facility, and the class discussion suffers).

A typical large organization class schedule (note that similar sections are grouped, so the sales people are there day 1 morning, etc.). Students change each hour, or can stay as much as they need (see schedule above).

Day	Start time	End time	ISO Element
1	8:00	8:50	7.2 Contract review, order entry
	9:00	9:50	7.2 Contract review sales and quoting
	10:00	10:50	8.2.1 Customer perception
	11:00	11:50	7.5 Production
	1:00	1:50	8.2.4 M&M Product quality
	2:00	2:50	6.3 Infrastructure (preventive maintenance)
	3:00	3:50	7.6 Calibration
	4:00	4:50	7.1 Production planning
2	8:00	8:50	7.4 Purchasing and supplier control
	9:00	9:50	7.3 Design part 1
	10:00	10:50	7.3 Design part 2
	11:00	11:50	6.2 Human resources and training
	1:00	1:50	5 Whole management section
	2:00	2:50	4.1 Processes and 8.2.3 M&M of processes 8.4 Analysis
	3:00	3:50	8.3 Nonconforming and 8.5 Corrective/preventive action
	4:00	4:50	4.2.3 Document Control, 4.2.4 records

And of course there are the middle sized organizations who have to decide which way to go.

The classes use slides to communicate the concepts in the standard, as the following showing the importance of internal audit in your system.

Or this one showing the relationship between procedures, training, and a person's background:

Transition from ISO '94

Midwest is proud to offer a 2 day Registration Accreditation Board (RAB) approved transition training course.

This course meets the upgrade requirements for RAB Certified Quality Management Systems Lead Auditors and other auditors. You’ll gain an understanding of the changes in the new standard and develop insight into the new auditing requirements. Taught by a RAB Certified Lead Auditor, this class gives you the opportunity to participate in the same two days of intense study and discussion as your registrar. A full copy of the standard will be provided.

You Will Learn…

The differences between the 20 elements of the ’94 version and the new text of ISO 9001:2000, including a unique side-by-side comparison of the entire text.
The new concept of process and process auditing required by ISO 9001:2000.
The evidence required to demonstrate compliance with the new requirements of ISO 9001:2000.

Who Should Attend? Individuals with RAB QMS Lead Auditor or Auditor certification, or internal auditors wanting the same training as certified auditors. A certificate will be given for successful completion of the course (1.4 c.e.u.’s).

The class uses our own "side by side" comparison of the standards (RAB approved) showing the differences:

ISO 9001:1994 text in 20 element order	Equivalent ISO 9001:2000 text
	4.2.3 Control of documents Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given 4.2.4.
4.5.1 General The supplier shall establish and maintain documented procedures to control all documents and data that relate to the requirements of this American National Standard	A documented procedure shall be established to define the controls needed
including, to the extent applicable, documents of external origin such as standards and customer drawings.	f) to ensure that documents of external origin are identified and their distribution controlled, and
NOTE 15 Documents and data can be in the form of any type of media, such as hard copy or electronic media	4.2.1 NOTE 3 The documentation can be in any form or type of medium.
4.5.2 Document and data approval and issue The documents and data shall be reviewed and approved for adequacy by authorized personnel prior to issue.	a) to approve documents for adequacy prior to issue,
A master list or equivalent document-control procedure identifying the current revision status of documents shall be established and be readily available to preclude the use of invalid and/or obsolete documents.	c) to ensure that changes and the current revision status of documents are identified,

Or we can tailor our normal class to your unique needs.

Transition from QS-9000

Transition from QS is a special situation, since many clients want to keep their QS system intact (at least to 2006). So we work on understanding where ISO 9001:2000 fits into QS-9000, which it does very nicely.

For More Information Contact: tony@midwestquality.com or 800 464-9008

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