Frequently asked questions about ISO and the Common Mistakes Companies make

1. ISO FREQUENTLY ASKED QUESTIONS AND COMMON MISTAKES What You Need to Understand Before You Get Started © MOCG LLC 2010

2. WHO WILL HELP US GET ISO REGISTERED? Registrar also known as Certification Body and Registration Agency – this is the organization that will come in and review your system and recommend you for registration and issue a certificate. Their representative is called an auditor. Consultant – this is who will come in and work with you to design and develop your ISO system and help you select a registration agency NOTE: A registrar’s auditor is prohibited from providing advice to a company that is implementing ISO as this is considered a ‘conflict of interest’ as they could not be impartial when performing the certification audit if they have offered advice on the construction of the program. Therefore if you need an audit to find out where you are in relation to the ISO requirements this is much more effectively performed by a consultantwho can perform the audit andoffer advice and recommendations on how to address the findings. © MOCG LLC 2010

3. ARE ALL ISO REGISTRARS THE SAME? No, like other industries there are good ones and bad ones. You should be looking at the ‘top ten’ registrars as they will be accredited in the industries and countries where you do business The choice of registrar says a lot about your program if you go with the less reputable, less well known , this creates a perception that your program is inferior. Contrary to popular belief a ‘top ten’ registrar isn’t more expensive and probably has auditors who are local (minimizing expenses) to you. Top 10 criteria # of certificates issued each year # of auditors # of US states with an auditor presence # of continents with auditor/office presence Please call us at 1.800.452.6828 or email client_services_MOCG-ISO.com for a free list of the top ten registrars © MOCG LLC 2010

4. IN ADDITION TO TOP MANAGEMENT, WHO NEEDS TO BE INVOLVED IN THE ISO PROCESS? AManagement Representative (term specified in the ISO requirements) is the person who coordinates the program, reports to management, customers and outside entities on the ISO System. The Management Representative does not need to be from the quality function, but the person chosen does need to be neutral, understand the ‘big picture’ and potential improvement possibilities, be a proponent of the process and be well respected by others within your company. Process Owners these are the people who take responsibility for each process within your company’s system, they define, document, improve the process and keep it current over time and educate others to ensure the process is followed. A team of Internal Auditors who, once your ISO system goes ‘live’, will audit each process to ensure that the ISO requirements are being met and people are conforming with the system. The findings of this group is the basis for your improvement process. © MOCG LLC 2010

5. CAN WE IMPLEMENT A SYSTEM USING ISO SOFTWARE ? The short answer is no. For an ISO system to be effective it needs to be developed specifically for your company and the uniqueness of your products, services and processes and how you do business with your customers and suppliers. So to pull a ‘canned’ set of documents from an ISO software program and copy and paste in your company information will mean that you have to start operating in an identical manner to the company for which the software was written. – Not going to happen right? However, there is other functionality/modules within ISO software packages that are very useful. © MOCG LLC 2010

6. WHY IS ISO SOFTWARE SO POPULAR? An ISO software package is useful for: Document Control Control of Non-Conforming Product Corrective/Preventive and Improvement Actions Training Internal Auditing Control of Suppliers and Vendors These packages can drastically reduce time spent managing and distributing the information and records manually and ensure the information is complete and consistently recorded , and offer wonderful tools for trend analysis and data collection feeding your improvement process and enabling your company to make timely and dramatic improvements. Please call us at 1.800.452.6828 or email client_services_MOCG-ISO.com for a free list of the top ISO software packages available. © MOCG LLC 2010

7. WHO SHOULD WRITE OUR ISO DOCUMENTS? Many companies choose to have one person dedicated to the task. The drawbacks to this approach are: Doing is understanding – if process leaders don’t write their own documents they don’t truly understand, feel comfortable or buy into the process necessary for long-term success The knowledge leaves with the person and is harder and more time consuming to replace It is more expensive and can often represent a full time position compared to many people taking a small piece and absorbing the time required. © MOCG LLC 2010

8. WHAT ‘S THE DIFFERENCE BETWEEN A PROCEDURE AND A WORK INSTRUCTION ? It is important to understand the difference : A procedure describes how a process is performed, while a work instructiondescribes how a task is performed. In theory a work instruction is at such a level of specificity that a person off the street could follow it and perform the task without training or supervision, in reality no company would do this. If an organization isn’t consistent in the level of detail in their procedures, and get to the level of detail more commonly found in work instructions people get confused what to expect and what has been documented and where it can be found. ISO is all about consistency. © MOCG LLC 2010

9. DO WE NEED WORK INSTRUCTIONS? A common mistake companies make is over documenting by creating work instructions for everything. In a non-changing part of the business, with a very experienced workforce this is overkill, the documents are not helpful to anyone. A good rule of thumb is to create work instructions in areas of your business where the task being performed is: Particularly complex Carried out infrequently Undertaken by temporary personnel/or an area of high turnover where a written guide is helpful, ensuring quality and reducing supervision time. © MOCG LLC 2010

10. WHAT SHOULD OUR DOCUMENTS LOOK LIKE? Avoid long text based documents, they aren’t user friendly or effective. Flowcharts are the most efficient way to analyze a process, identify issues with missing information/data/material/ product flow and communicate the steps, decision points, outputs and inter-relationships with other processes. Pictures are worth a thousand words – it is true and the same goes for screen shots, diagrams and photos to communicate on work instructions how something should look, be performed or produced. Keep it short and concise – nothing could be truer than the Quality/ Policy Manual – this isn't supposed to be a regurgitation of the Standard, but instead a roadmap to your system that is helpful to your registrar, customers and employees it should include scope, standards being met, exclusions, what procedures have been documented, terminology, policies that haven’t been covered in lower level documents. © MOCG LLC 2010

11. SO ONCE OUR DOCUMENTS ARE WRITTEN WHAT ELSE IS THERE? Having the pieces of paper that describe your processes is just the tip of the ice berg in terms of your people having what they need. As an example: Vendor control process It can’t be implemented without knowing and having the following: Who are the critical vendors – definition and list What is important to us that they need to do/provide – selection criteria How will we know if they are meeting our requirements long-term – performance criteria and data collection method How are they performing against our requirements – tolerance level What are we going to do when they are below our tolerance – response/escalation criteria So you see, without criteria, tools and collection methods the piece of paper has no value. Every one of your processes needs to be analyzed to ensure it has the support tools/mechanisms. © MOCG LLC 2010

12. STILL HAVE QUESTIONS? If we missed anything please contact us. We will answer your questions free of charge and update our guide: MOCG-ISO.com Linkedin Biznik YouTube Twitter Facebook Call 1(877) 452 6828 Email: Client_service@MOCG-ISO.com © MOCG LLC 2010

14. Guaranteed registration

15. Never had a failure

16. Program pays for itself

17. Top Ten Certification Bodies amazed at how seasoned our systems are

18. Integrate with strategic, financial and other systems to create a single business management system

19. Experience applying the Standards in all industries including non-manufacturing

20. Always on time and on budget

21. Confirm ROI upfront© MOCG LLC 2010