The 9000 Resource

What's the big deal with ISO 9001:2008?

ISO 9001:2000 is finally changing after 8 years. ISO 9001:2008 is available as a draft document with an expected approval by Q408.  You can buy a copy by clicking here http://www.techstreet.com/cgi-bin/joint.cgi/210223/cgi-bin/detail?product_id=1516270, and you can compare the proposed changes for yourself. 

So what is the big deal?  In my opinion: not much.  I hate to critique it since many people spent many hours on it, but it's hard to believe that after 8 years the changes are mostly grammatical.  It is almost the equivalent of bringing your car into the shop and getting it back 8 years later with new air in the tires. 

Behind the scenes there are some things happening which will allow the integration of ISO 9001 & ISO 14001 for easier dual certification. And there are some genuine clarifications to ensure that people understand that the focus of ISO 9000 is to exceed customer expectations. But on the surface it really won't change anybody's QMS - except in the technicalities. You can read more about it here: http://www.the9000store.com/iso-9001-2008.aspx.  But I wouldn't worry about having to make too many changes in your QMS just yet...

If you were a baker...ISO 9000 as applied to making cookies

Sometimes to understand the impact ISO 9001 has on a company, it's helpful to think about a simple and common example anyone can relate to.  So let's say you wanted to bake cookies.

ISO 9001 doesn't determine the quality of the cookie, your customers have already determined that they like them.  ISO 9001 just helps you deliver consistent product to your customers. The market decides if they like them soft and chewy or crisp and crunchy, you just choose your recipe and try to repeat it exactly every time so customers can count on the consistency.  Continuous improvement helps ensure that your recipe can adapt with the customers' needs (low fat, etc.)

ISO 9001 DOES enforce these types of items:

• Do you always use the same ingredients?
• Do you always measure them the same way?
• Is your oven always the same temperature?
• Do you calibrate your ovens to ensure this?
• Are employees trained to ensure consistent performance?

ISO 9001 DOESN'T try to tell you:

• Crispy or chewy?
• Oatmeal or Chocolate Chip?
• How should you inspect: 100% or Random Sample?

For a further look at how ISO 9001 would impact a common cookie recipe, please download the attached document.  Download cookies_and_iso_9001.pdf  I have picked apart the entire recipe for a deeper look.  If nothing else, it gives you a good recipe for chocolate chip cookies.

Step 8 Registration Audit

First you will need to select a Registrar. When you choose a Registrar you are starting a relationship that will last at least 3 years, most likely longer. You will want to make a careful decision to lay the groundwork for a smooth and lasting relationship. Read our blog post about how to select a Registrar.

When the day of your Registration Audit has arrived, it is time to showcase your Quality Management System. The Auditor or Auditors are coming in to see how you have addressed the requirements of ISO 9001, and how you have designed your QMS.

Preparing for the Audit

Prepare the employees

• Before the Audit you will want to make sure that all employees know that the audit will be taking place, and the purpose of the audit. This will help them understand how to respond to the auditors' questions. You want employees to respond openly and honestly to the auditor.  The auditor is looking for evidence that you are complying with the requirements of ISO 9001, your employees are the ones that will be providing that evidence. Preparing them to answer the auditors questions will make the audit go more smoothly.
• This is not a test. If the auditor asks a question, they are looking for information on how something works, not if the employee has all the answers but how the employee goes about finding answers and information. Do procedures provide information? If the information is not in a procedure, where does the employee go next, do they ask a supervisor? Use our Employee Flyers to update employees on this issue and other implementation steps throughout your project.

Prepare the facility

• Make sure all areas of the facility are clean and neat; there are potential nonconformances hiding in any given mess.
• Make sure documents are available where every they need to be used.
• Check bulletin boards, counters, cupboards, drawers for uncontrolled documents, un calibrated measuring and monitoring instruments and unidentified parts or supplies.

Prepare for the Auditor

• Have a copy of the Quality Manual and Quality System Procedures available for the auditor.
• Designate a place for them to work when they are not out in the facility. They will need to work on their documentation and reporting.
• Assign someone to go with the Auditor to show them where different areas and departments are. Coach this person to let employees answer the auditors questions, not answer the questions themselves unless the question was directed to them.

Step 7 Internal Audits

It is necessary to demonstrate that your ISO 9001 Quality System is effective. During an internal audit you will compare your quality system against the requirements of the standard. You will select a group of internal auditors from within your company to perform the audits.

You will begin once your system has been implemented and will need to perform internal audits before your Registration Audit. The Registration Audit is the audit which is performed by the Registrar who will issue your ISO 9001 Certificate upon successful completion of that audit.

Before your Registration Audit you will need to use and improve your system for 2-3 months. Read our blog post about using and improving your system for more details.

Choose your audit team

You will want to have a number of trained internal auditors for your audit program. You will be auditing each area of your facility once or twice a year, with an audit team of 1 to 4 auditors depending on the size of the area. You will want to have enough auditors trained so that the auditors will not audit their own area, and so that you are not pulling one person away from their work too often. A general guidance number is 10% of the total number of employees; a company with 50 employees would train 5 auditors, and company of 100 would train 10. As the number of employees goes up, the percentage would go down.

Look for employees that have a strength in investigating issues and that are good communicators. The better people skills the auditors have, the smoother your audits will be performed.

Step 8: The Registration Audit

Step 6 Training

Setting up an effective ISO 9001:2000 system will require training.

1. Train the ISO 9001 Project Manager
   Having your project manager trained on ISO 9001 and implementation will result in a more effective and efficient system and implementation process.
2. Train Employees
   The ISO 9001 standard requires that employees are trained in on ISO 9001.
3. Train Internal Auditors
   Your team of Internal Auditors will need an understanding of ISO 9001 and on ISO 9001 Internal Auditing.

Training Resources available from The 9000 Store:

1. Implementation Training for Project Managers: computer-based, in-depth training about ISO and the implementation process.
2. Employee Training: Computer-based individual training  or Introductory Training PowerPoint Presentation
3. Internal Auditor Training Materials: allows you to conduct your own training class in-house for your audit team.

Step 7: Internal Audits

Step 5 Document your System

Implementation of Section 4 should take place early on in your project. It may be assigned to management or even your project steering team.

A. General Requirements
Have the team review the requirements in section 4.1, notice that many are very general and will be a natural outcome of building your Quality Management System(QMS). However, this team must identify the processes that will make up the QMS and outline these processes to show how they interrelate.

Identifying Processes

1. Start by outlining broad categories or by listing your departments. For example:
2. Purchasing, Receiving, Production Control, Sales and Marketing, Customer Service, Production (or Service), Quality Control, Shipping,
3. You will need to show how these processes relate to each other, by use of a flow chart or diagram. A simple way of diagramming is to chart the processes. Download free trial of flow charting software
4. Once you have listed the categories or departments, have management in those departments add the detail. You will want to include all the QMS processes, and all production, service and administrative processes that affect the quality of your product or service. The chart or flow chart that you come up with should be included in your Quality Manual.

B. Documentation Requirements

• As you review the requirements for QMS documentation, pay particular attention to the requirement for your organization to identify documents that are needed for your quality system and production or service processes. You will need to have a method to identify what processes must be documented. Remember that as you add new processes, products or services to your organization in the future you will need a method of identifying when documentation is required.
• During implementation, set guidelines for identifying processes that need documentation as part of their control. Have management identify the processes that need documentation as they identify the processes to be included in the QMS.
• After implementation, include the identification of documentation requirements as part of your quality planning for new processes and changes. The "Planning of Product Realization Procedure" from the The 9000 Store covers this step for you.

C. Quality Manual & Procedures

• A complete quality manual and procedures package, with text to help you customize the manual for your organization, is available at The 9000 Store. It will definitely save you money over the hours you would spend developing one from scratch. It is designed with the same approach to the QMS as we follow in these sessions, so you will find it very compatible with this approach.

D. Document and Records Control

• You must have a procedure for control of documents and control of quality records. This task should be on your task list and assigned to a team or individual for completion.

Step 6: Training

ISO 9001 Gap Analysis Report

Summarize the audit findings in the form of a task list.

You will usually identify several categories of tasks.

1. Processes that comply with the standard and are documented.
2. Processes that comply with the standard and must be documented.
3. Processes that do not comply with the standard and must be redesigned.
4. Processes required by the standard that are not currently in place.

For each requirement (or set of requirements) of the standard you will want to identify the status of the current system. The ISO 9001:2000 Steering Team will use this information as they assign responsibility and timelines to Teams. Task Teams will be assigned responsibility for development of a procedure.

Conducting a Gap Analysis

1. Follow the schedule that you have prepared. Go into each area of the facility to evaluate the current quality system.
2. Focus on what is in place, and what is not in place. Remind auditors that you are not focusing on compliance or non compliance to the current system, but on the design of the current system, and how it matches the ISO 9001:2000 requirements.
3. Take notes on what is in place, and what will need to be developed and changed. Take complete notes, reference documents and examples.

Next: Gap Analysis Report

Scheduling the ISO 9001 Gap Analysis

Review the project plan

1. Schedule the Gap Analysis, and communicate to all employees what is being done, and why.
2. You will want to be able to make the employees comfortable with answering your auditor's questions.You may want to consider sending out a newsletter to inform employees that the Gap Analysis will be performed, by whom, when and why the Gap Analysis is being performed. Use the Employee Newsletter which is included in the Gap Analysis Checklist Toolkit.
3. Determine whether you will audit by process/procedure or by area of the facility. Our approach is usually to audit by area of the facility.
4. Divide the facility into manageable areas.
5. Schedule time to audit each section of the standard that applies to the area.
6. If you are using an audit team, assign the team to cover the various areas of the facility.
7. Arrange your Gap Analysis checklists so each auditor will have the sections of the standard that are applicable in the areas they will cover.

Next: Conducting the Gap Analysis

Step 4 Gap Analysis

What is an ISO 9001 Gap Analysis?

One of the first steps in your Quality Management System (QMS) transition or implementation project is to compare your current QMS to the requirements of the ISO 9000:2000 standard. This is most commonly called a Gap Analysis.

ISO 9001 Gap Analysis Checklist

• The most important tool for the Gap Analysis is the Gap Analysis Checklist. This is a list of the requirements in the standard, written in question format.
• The auditor will use this list to compare the QMS that is in place with the requirements of the ISO 9001:2000 Standard.
• The checklist provides the auditor with recommendations of what documents to look for, examples of what will meet the requirements and other guidance on auditing to the standard. The checklist also gives the auditor a specific place to document what they saw that did or did not meet the standard.
• Scheduling the Gap Analysis
• Conducting the Gap Analysis
• How to use the Results of the Gap Analysis: The Report

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The 9000 Store  sells a  Gap Analysis Checklist Toolkit for $39. The toolkit includes

• Gap Analysis Checklist: a detailed, 37 page checklist with guidance on what to look for to evaluate your current processes and their compliance to the ISO 9001:2000 Requirements.
• Project Plan
• Project Plan Template
• Employee Flyer to use to explain the Gap Analysis to employees
• Buy one now

Step 5: Documenting your system