The 9000 Resource

How long does ISO 9001 Registration Take?

Getting ready for registration involves building your Quality Management System, documenting that system, and implementing it throughout your organization. The time that it takes a company to complete these tasks depends on several factors:

• Do you have a Quality Management System or parts of a system in place?
• How much time can personnel devote to working on the Quality Management System development each week?
• What tools or assistance will you use?
• As you plan your project you will need to think about those questions. You can measure your current Quality Management System against the ISO 9001 System by performing a Gap Analysis.

A Gap Analysis is an audit you perform to see what parts of the ISO 9001 Standard you already are complying with. It is useful information for planning a timeline for your project.

You will also want to determine how much time will be spent on the project by internal people. Will they be able to spend 5 hours a week on the project? One hour a week? Answer this question so you know what internal resources are available.

Look for tools or assistance to help make your project efficient and effective. A professionally designed and documented ISO 9001 Quality Management System will save you a tremendous amount of time spent designing your system by trial and error and documenting the system.

By using a professional system you will have a system of procedures that are designed to give you running head start at a well designed, time tested Quality Management System. Our system has been used in thousands of companies from a variety of industries, all over the globe.

Download Four-Month-Plan.doc

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Download Ten-Month-Plan.doc

Ready to use Gap Analysis Checklist

The Gap Analysis is one of the most important steps in your project.

It helps you determine your path:

• You know where you are.
• The Standard tells you where you need to be
• Anytime they differ you need to change your processes to bridge the gap

The 9000 Store has developed the Gap Analysis Checklist to help you map your path.

The Gap Analysis Tool Kit will:        

• Provide the tools and checklist you need to conduct your Gap Analysis         
• Provide a detailed checklist to use to compare your current systems to the requirements of ISO 9001.
• Help you identify the requirements that your organization is already meeting, and those that need to be addressed
• Give you the information you need to determine resources and a timeline for your project.

It includes:

• A detailed, 43 page checklist (MS Word) with guidance on what to look for to evaluate your current processes and their compliance to the ISO 9001:2000 Requirements.          
• Space for notes and observations                
• Project Plan               
• Project Plan Template
• All for $49 (that's like getting a GPS for the price of a map!)
               

When traveling to unknown areas, a map is a necessity. Likewise, a Gap Analysis will provide you with valuable information to help you plan your Implementation Project. Our Checklist will give you the information you need to bridge the Gap.

You can buy and download today. USD$49

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Flowcharting Software

When you document your system, you will need to make an organizational chart as well as a flowchart of your processes. We like to use the flowcharting software from SmartDraw.com.

We have found Smartdraw the easiest software to use for creating ISO 9000 models and flowcharts. SmartDraw has over 60,000 professionally designed symbols and over 1,200 industry specific templates to use in your drawings.

View ISO 9000 chart samples

 

Download a free  7 day trial version

Where to buy ISO 9001 Standards

 

ISO 9001 Standards are available from Techstreet.com in either electronic or printed format

       

ISO 9001:2000 Standard
Document Number: ISO 9001
International Organization for Standardization
Replaces and incorporates ISO 9001, ISO 9002, & ISO 9003.

       

This single certifiable Standard now applies to all organizations regardless of size, industry, product or service. It's more flexible than its predecessors, and has an emphasis on customer satisfaction, continual improvement and efficiency. Organizations currently certified to ISO 9002 or 9003 will work to this new Standard.

       

16949 Standard (automotive)                               

The ISO/TS 16949 Checklist is used to determine conformance to the ISO/TS 16949. Proper use of this manual will promote consistency between activities and personnel determining ISO/TS 16949 conformance.

       

ISO 13485 Standard (medical device)
Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related products.

 

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

Planning your ISO 9001 Planning Meetings

A. Planning your meeting

Determine who should attend. Include top management. Answer these questions:

1. Who will be able to decide which employees will be assigned tasks?
2. Will they know whether the employees' workload will be able to accommodate the assigned tasks?

Create an Agenda, items to include:

1. Review Task list.
2. Determine how to group tasks.
3. Group tasks by the area responsible for the requirement where possible. (If you can group requirements, you can assign a set of requirements to an individual or team from the relevant area.)
4. Assign the tasks to individuals or teams.
   
   • Review the responsibilities to make sure that they are well dispersed, not assigned heavily to one group or one individual.
5. Determine resources required for completion of the tasks.
6. Will teams or individuals need assistance with other responsibilities during the ISO 9001:2000 project?
7. What kind of technical guidance will be needed to allow these teams or individuals to complete the tasks efficiently and effectively?
   
   • An external consultant?
   • An internal consultant?
   • Assistance from the management representative?
   • Prepared materials?
   • Special Training?
8. Assign dates to tasks.
   
   • Stagger start dates according to resources available.
   • Determine which tasks you need to complete in the beginning to allow others to build on, for example: Management Responsibility. Complete the Quality Policy and Quality Goals as well as identifying key processes and their interrelation early on in the project.
   • Estimate the amount of time needed to complete each task based on the amount of resources available to the task.

B. Holding the meeting

1. Follow your agenda, fill in responsibility and dates on your task list as you proceed.
2. Keep minutes of the meeting, including attendees. This will show top mana

ISO 9001 Resource Management

The Scope of Resource Management includes

• Human Resources
• Facilities and equipment
• The manufacturing or service environment

Your organization needs to be asking whether these resources are sufficient to create quality products or service and customer satisfaction? Auditors will be looking to see if the lack of these resources is at the root cause of nonconformances. You should consider these resources or insufficient resources as a potential cause of nonconformances. As internal audits or your corrective action system identify problems with resources as a root cause, improvements to the resources are necessary. Providing adequate resources is a core element of your QMS.

Human Resources

In addition to employees being trained for a job, the effectiveness of that training must be measured, the criteria for competence determined. The employee must be aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. Can you tell an auditor what the competency requirements are for a specific position? Are you then able to show the auditor that employees in that position have met those requirements and been effectively trained as required?

Facilities and Equipment

Auditors will evaluate the buildings, workspace, equipment, and supporting services to determine if they contribute to nonconformances. Issues would be identified in this area if it is evident that the inadequate provision of resources is at the root cause of QMS nonconformances.

Work Environment

Environmental factors have a direct impact on product or service quality. Factors such as cleanliness, temperature, ergonomics, or lighting can all affect quality or cause nonconformances. Auditors will consider environmental issues, and may determine that inadequate control of the working environment is the root cause of a QMS nonconformance.

ISO 9001:2000 Implementation Resources and Assistance

The 9000 Store is here to help you create a QMS to meet the requirements of ISO 9001:2000. Project managers don't need to do it alone; our documents outline tried and proven Quality Processes to address the requirements of the standard. Our experts answer your questions by email as you tailor these processes to your organization, creating your own unique Quality Management System. We provide the tools you need to train your employees efficiently and effectively. Visit our store today to see how we can help you make your project a simple success!