Wednesday, 30 May 2012

Congratulations! You are now in charge of creating an ISO 9001 system – now what?

Archive for the ‘Environmental, Health and Safety’ Category

Quite often, the Kayzed Consultant staff is asked to recommend a plan of action for people who find themselves in the position of “being volunteered” to put together an ISO 9001 (or any other ISO 9001-based standard) system for their company. Unfortunately, for employees that have little to no experience with quality standards, this can be an overwhelming task. We recommend the following steps:

Step 1 – Before you can plan what to do, you and the management team need to know what is required. Start with an overview training session on the standard for yourself followed by a session for top management. Strongly emphasize that the standard is process based and highlight the Plan-Do-Check-Act (PDCA) model. All parties involved in the implementation must realize that the standard has a couple of key principles that are referenced all throughout the standard – customer satisfaction and continual improvement. The ultimate goal is to make all customers happy, but the method of getting to that goal is by the continual improvement of your processes. This is where top management needs to make a little paradigm shift – customer satisfaction means more than a reduction in phone calls from the customer yelling about something that wasn’t just right. It certainly means more than assuming a customer is happy if they continue to give orders for more products and services. Remember, customers can multi-task by giving your organization a new purchase order while giving a new supplier the thumbs up for the next order. By the time some realize the customer isn’t happy, it can be too late.

This is where continual improvement comes into play. By knowing what your customers think of the level of service and value they receive from your organization, your company can initiate the proper continual improvement objectives that can reduce or eliminate the problems and issues that can make their way to the customer.

This is why you need to get all of top management involved. Everyone must get a clear view of the big picture. Having a quality management system (QMS) based on the appropriate ISO standard should become the implementation of a quality philosophy and roadmap for doing things right. Stress that it is a quality management system by which the company will operate and oh, by the way, it just happens to comply with the ISO standard. After that, don’t mention the letters “ISO” – just QMS. Companies that implement systems based on the need to meet ISO requirements often find that employees put an emphasis on doing things just to meet the standard as opposed to improving the process.

It was only a matter of time – and the time has arrived.

The Environmental Protection Agency plans to establish a nationwide system for reporting GHG (greenhouse gas) emissions. It is a program that could serve as the basis for a federal cap on the buildup of carbon dioxide and other gases linked to global warming.

The registry plan would cover about 13,000 facilities that account for 85 to 90 percent of the nation’s greenhouse gas output.

The plan will be adopted by the end of the year and greenhouse gas statistics will be available by the end of 2010. The EPA requirements would apply to large industrial sources that emit 25,000 metric tons or more a year, including oil and chemical refineries; cement, glass, pulp and paper plants; manufacturers of motor vehicles and engines; and confined animal-feeding operations. In addition to carbon dioxide, emissions of methane and other greenhouse gases would have to be reported.

The good news is that most small businesses would fall well below the threshold and would not be required to report, EPA officials said.

In order to accommodate the rumored additional changes to ISO 9001:2008, you will need to incorporate the following form into your organizations Corrective and Preventive Action system. It is also rumored that these requirements will affect additional standards such as ISO/TS 16949, ISO 14001, AS9100, ISO 13485, ISO 22000 and various other standards.

During ISO 14001 implementation, the most important exercise a company will go through is identifying all possible environmental aspects. Without a proper and thorough examination of all processes, functions and grounds of a facility, the rest of the environmental management system (EMS) is an exercise in meaningless documentation.

Once all aspects are identified, a determination must be made as to what aspects are significant and if they are within the organizations ability to control. This is best conducted through some type of risk analysis format such as a failure mode and effects analysis (FMEA) type review of the aspects.

If the process of identifying all environmental aspects of your company’s activities is becoming a daunting task due to limited or stretched resources, contact the experts at Kayzed consultants today!

Tuesday, 22 May 2012


What is ISO 9001?

In short, ISO 9001 is a voluntary Quality Management System standard that helps organizations ensure they are meeting customer requirements. Note that the key word in the title is "Management." The intent of the 9001 standard is to implement systems that Management can use to better run the business.

 What is the difference between ISO 9000, ISO 9001, ISO 9002, ISO 9003, and ISO 9004?
ISO 9000 indicates the overall series of the Quality Management System standards. ISO 9001 is the number of the actual standard to which a company achieves certification. Both terms are often used synonymously to refer to the certification. The year of the current revision of the standard appears in the title, such as ISO 9001.

 What does ISO stand for?
The International Organization for Standardization decided not to use an acronym for their organization, because it would be different in different languages. Instead, they used the word "ISO," which is derived from the Greek word "isos" meaning "equal." The standards act as an equalizer for companies doing business across global boundaries.

Apart from the Quality Management System standards, there are many other standards that are maintained by the International Organization for Standardization located in Geneva, Switzerland, and their 158 member countries

4. What are the benefits of certification?
Apart from the obvious benefit of opening up market opportunities where ISO 9001 certification is a requirement, the biggest benefits stem from having a structure to improve your processes. Because the standard is really based on best practices for organizations, it provides management with the tools to objectively decide where things are working well, and where to best apply resources to make things run more smoothly. So - ideally, ISO 9000 helps your management team maximize the effectiveness of your business, thereby enhancing growth and reducing cost. From your customers' perspective, it gives them confidence that you have an organization that can consistently meet their needs.

My company is very small. Can I get certified?

Absolutely. We've worked with companies of one or two people who decided to get certified. The processes that you'll put in place would have the same intent as a much larger company; it's just that the implementation will be simpler. We work with organizations to assist them in balancing the appropriate level of documentation with what's necessary to meet requirements

6. How much will this cost?

The answer depends on a number of factors. There are costs to implement, cost related to the Registrar and costs to maintain. In terms of costs to implement, if you choose a full do-it-yourself approach, the only real costs will be in the time for resources dedicated to the implementation process and in time spent writing documents and training your staff. If you have little experience with ISO 9000, or have limited internal resources, you might choose to get some outside professional help or a consulting company like us.

Costs of registration are dependent on the size of your organization as well. Most registrars charge a certain rate per day to be on-site at your facilityTo maintain your certification, the Registrar must return at least annually to audit a portion of your system. Those costs will be less than the original visit, since the time spent will be shorter. Once every three years, the Registrar returns to audit your entire system.

7. Does ISO apply to my industry?

The ISO 9000 standards are general enough to apply to any industry. We have clients in industries ranging from manufacturing to government and defense contractors; from education to call center operations to software development and they can all apply the standard to their business model.

Do I need a consultant?

Many companies choose to attain ISO certification on their own, so having a consultant is not a mandatory but highly advisable. We do believe that having access to a consultant's knowledge and expertise can be very helpful as you try to sort out how to apply ISO in your business. And if you have an urgent need to attain certification and limited resources, using a consultant is often the most practical approach. We provide several flexible options to meet most needs

What is the Process Model?

The process model is based on the idea that an organization is a system of interlinked processes. The ISO 9001:2000 Standard is designed to manage and improve those processes. First, you identify your key processes. Second, you define quality standards for those processes. Third, you decide how process quality will be measured. Fourth, you document your approach to achieving the desired quality, as determined by your measurements. Fifth, you evaluate your quality and continuously improve

Are process flow charts required?

Flow charts are not specifically required, but more than likely expected by your registrar. The standard requires that you identify your processes and determine the sequence and interaction of the processes. This is most easily accomplished by preparing flow charts of your product realization processes

How many procedures are we required to write?

The standard specifically requires six procedures:

Control of Documents Control of Records Internal Audits Control of Nonconforming Prod cut Corrective Action and Preventive Action

That may not be enough: the standard also asks that you prepare any other documents you need to for planning, operation and control of your processes. The standard also asks that you have available the work instructions you feel are necessary. The answer to how many procedures or work instructions are required: you must decide this

What records are required by the standard?

The standard specifically requires records for the following items:

Management reviews Education, training, skills and experience Evidence that processes and product or service meet requirements Review of customer requirements and any related actions Design and development including: inputs, reviews, verification, validation and changes Results of supplier evaluations Traceability where it is an industry requirement Notification to customer of damaged or lost property Calibration Internal audit Product testing results Corrective action Preventive action Records you need to provide evidence of following your processes.

How often should we have management review meetings?

There is no specific requirement for frequency of management review meetings. We recommend quarterly meetings. This allows you to stay on top of upcoming issues and yet collect data between meetings that is meaningful. We have found annual meetings are not acceptable to all registrars. With annual meetings you may not be able to prevent issues or resolves issues in a timely manner. Management Review

Are job descriptions required?

No, there is no requirement for job descriptions. You are required to do two related tasks: define responsibility and authority and define competency in terms of education, experience, skills and training. Job descriptions are one way of accomplishing this. There are other ways including preparing organizational, job responsibility lists, and competency matrices.

What is process auditing?

Recently we have been receiving questions regarding process auditing and what it means. If you are auditing your quality management system by area or department and then auditing all the applicable ISO elements while in that department, you are doing process auditing. If you are auditing your quality system by ISO elements throughout the organization you are not set up currently for process auditing. Process Auditing.

How often should we audit each area?

There is no specific requirement for audit frequency. The audit schedule should be based on the importance of the area and on what previous audits have uncovered. In a new system, you will want to audit frequently, perhaps monthly, to make sure everything is implemented and working. In a mature, audits can be performed much less frequently. For a mature system (in place for several years) we recommend every six months to one year. Taper down your audits over time. If you start at monthly, try quarterly for a while and see if it is working. Do not audit less than annually.

How long will it take me to get certified?

Of course this depends upon several factors such as: how large your organization is; how complex your processes are; what procedures you may have in place already, etc. For a smaller company (less than 100 employees) an implementation can take 4-8 months; for a larger company (more than 100 employees) the process can take 12-18 months. The process also depends on the time and resources your company can apply to implementation.

One note about the timeframe - once you have met the requirements, there is some time needed for your systems to mature and to produce records that show evidence the systems are working. Most registrars prefer to see 2-3 months’ worth of records after you've implemented everything. That time needs to be figured in your overall timeline upfront, especially if you have to meet a deadline for registration.

2. How many documents will I need? What are the requirements?

Many people are hesitant to begin the certification process, because they incorrectly believe that they will need mounds of paperwork to comply. In fact, the ISO standard only requires a quality manual and six written procedures: Control of Documents, Control of Records, Internal Auditing, Control of Nonconforming Product, Corrective Action, and Preventive Action. Beyond those requirements, it's really up to you how much additional documentation you need to plan, operate and control your business effectively. Some companies find the need to add extra controls they didn't have previously; some use the process to delete older documents that are redundant or not worthwhile to maintain

3. My customer is asking me to become ISO certified...or...I need to bid on a project that requires ISO certification. How can I do this quickly?

You can certainly be ISO certified in as little as 4 months. It requires focused attention on your part and often the help from an experienced outside consulting resource. Another option to speed up your ISO project would be to utilize a template-based documentation package like we provide on the 9000World website.

Do I need a full-time person dedicated to run my ISO program?

There are several factors that dictate how much time to dedicate to the Quality System. Factors such as size of the organization, complexity of the process, manual administrative systems verses automated or electronic systems (ex: Document Control) all have a role in determining if there is a need for a full-time person. Of course, during the set-up of the Quality Management System there is more of a time commitment than after you are certified. For most small companies, it is a part time role.

In addition to these if you are looking at answers to the following questions, get in touch with us for the answers.

·         How does the certification process work?

·         What's the difference between being certified and registered?

·         Can you certify us?

·         How does the certification process work?

·         Can you certify us?

·         Can I say I am compliant without getting certified?

·         How do I find a Registrar?

·         Can I argue with the Registrar if I don't agree with an audit result?

·         Can I be certified as an individual?

·         Will my product be certified?

·         Does the whole company need to be certified or just a department?

·          How does it work with multiple locations?

·         What are the most common findings in a Registration Audit?

·         What is the difference between a "major" and a "minor" nonconformance?

·         How much money does it normally cost to hire a Registrar to conduct the certification?

·         Do I need to purchase a copy of ISO 9004 along with the ISO 9001 standard?

·         Who is the governing body for ISO certifications and registrations?

·         Does ISO certification include sub-divisions of a company housed in the same facility or does each division need its own certification?

·         Our vendor is QS9000,ISO9001 and TS16949 certified and is concerned about tracking, shelf life and aging of the fire retardant materials.

·          Are we able to be certified to handle certain part numbers (fire retardant materials) only and not other items that are unnecessary?

·         How do you describe an observation?

·         Can you guarantee I will get certified?

·         What is a Registrar?

·         What is the difference between a consultant and a Registrar?

·         Is a pre-assessment required by the Registrar?

·         How do I get ISO registered?

·          Will your products assist in developing and implementing ISO 9000 to meet requirements gain certification?

·         What do I need to get ISO 9000 registration?

·         What are the benefits of ISO 9000? What is ISO 9000? Help me with ISO Can I get an ISO logo?

·          What is the difference between ISO registered vs. certified?

·         What’s the difference between ISO 9000 and 9001?

·         What is an ISO firm?

·         Does my company need a certified project manager to be ISO9001 certified?

·          Where do I start ISO 9001?

·         What does ISO stand for?

·         We are a small company employing 3 people do you think ISO9001 is still relevant?

·         Why would my company need ISO 9000?What documents are required to meet ISO 9001?What are the drawbacks to ISO 9000?

·         When and where was ISO initiated?

·         Does ISO 9001 apply to small business?

·         Can we get ISO 9000 registered without consultant?

·         How is ISO 9001 implemented in a R&D center?

·          I want to implement ISO9001 2000 in our organization, what would I have to do?

·         I need a 15-20 minute video of ISO 9001 How is ISO 9000 applied to medical instrumentation companies?

·         Approximately how many documents are required for a complete set of ISO9001 compliant procedures?

·         What is ISO9000 meant to show?

·         What is the definition of ISO 9002?

·         How was ISO developed?

·         Who can apply for ISO certification?

·         What is the shortest time to implement ISO 9001 2000? Text of ISO 9001 2000?How many elements in the ISO 9001 2000 standard?

·         How do I find out if a company is ISO certified?

·         Who can lead the ISO project?

·         What are the roles of ISO 9000 and 9004?

·         What help or information is there for small companies to adopt ISO9001?

·         What product can have ISO 9001 2000?

·         Who is eligible to have ISO 9001?

·         What is the ISO 9001 logo?

·         What’s the full title of ISO 9001 2000?

·         We are not a production company, do we need to be ISO registered?

·         How can I be ISO lead auditor?

·         Do employees get enthusiastic when you introduce ISO 9001?

·         Can a sole proprietor be ISO 9001 certified?

·         Can clients demand copies of my ISO 9001 documents?

·         Why ISO 9001?

·         Why did they name ISO standards as ISO 9001 and what does 9001 stand for?

·         What does it mean to be ISO 9001 Registered?
When is ISO 9001 version getting revised?

·         What is the difference between ISO 9001 2000 and AS 9100?

·         Does a company with ISO 9001 need to renew its accreditation every year?

·         How do I acquire an ISO 9001 certification?

·         Is ISO 9001 certification for a company or a facility?

·         What does ISO do?

·         Does my company need ISO9000?

·         When does ISO-9001 1994 expire?

·         What happens to your ISO 9001 registration if you are acquired by a company that does not have registration?

·         What is the definition of design in ISO 9001 2000

·         What is ISO 9003?

·         What is ISO 9004What companies need ISO?

·         Why do I need ISO?

·         How do I apply for ISO-9001?What is the hierarchy of documents for ISO 9001?

·         Is it possible to get ISO certification in just 3 months?

·          Will my ISO registration be recognized in other countries?

·         What is ISO 13485 ?

·         How much does it cost to get registered ?Do you have internal auditor training?

·         Do you have employee training?

·         Tell me about your employee training

·         .How do your training products help?

·         What training is required as we implement ISO 9001?

·         What is the difference between the computer based Understanding-ISO-9001-2000 and the 58 slides training An -introduction-to-the-standard?

·         I want lead auditor training.

·          Detailed ISO 9001 2000 Training General Introductory Training Training for management and project leaders On going training Training recordsIs an ISO registered company required to conduct on going training in their process and if so how much?How can we evaluate the effectiveness of training?

·         What is included in the Internal Auditor Training Package?

·         What is Quality Management System Standard?

·         Why did they name ISO standards as ISO 9001 and what does 9001 stand for?

·         What role do standard procedures play in strong business performance?

·         Is 9001 the comprehensive standard?

·         How many elements are in the standard?

·         We are a software development company. Is ISO 9001 a good standard for us?

·         Where can I find the actual ISO 9001 2000 Standard?

·         What is standard 10012-1Do you sell standards?

·         Standard operating procedure template

·         What procedures do you use in your ISO 9001 2000 quality management system?

·         Management review meeting requirementsManagement review schedule

·         How often should we hold management review?

·         Who should attend management review?

·         Is once per year enough for management review?

·         Can an organization exclude design from their Quality Management System?

·         I would like to know what are the difficulties for small business in obtaining ISO 9001-2000 quality management system?

·         What is a management representative?

·         What are ISO 9001 management responsibilities?

·         What is the purpose of a quality management system?

·         Do you agree that ISO 9000 Quality Management System is 'write-what-you-do-and-do-what-you-write?

·         What are the audit questions for management?

·         What is process management?

·         What are advantages of Integrated Management Systems?

·         Who is Top Management?

·         How does Top Management involvement affect QMS?

·         What procedures are required?

·         How can your procedures help develop my system?

·         What software is used to generate the Quality Manual and Procedures?

·         Do I have to have hard copies of procedures available?

·         Define procedures Will this program help me write better procedures?

·         What is QS9000?

·         Contents of procedures Do you have procedures for 17025?

·         Describe the advantages of documented quality procedures

·         How can we implement procedures in our organization?

·         Explain purchasing procedures

·         What are the procedures involved in obtaining an ISO 9001 2000 certification

·         What parts of AS9100 require documented procedures

·         How does the quality manual help us?

·         How many pages is the quality manual?

·         Is the quality manual hard copy or on disk?

·         What is a quality manual?

·         How do I write a quality manual?

·         I need a quality manual

·         Does the Quality Manual have to be a controlled document?

·         Describe the structure of a quality manual

·         Does the ISO 9002 2000 Quality Manual and Procedure package includes a hard copy manual and a back up CD?

·         How do you develop a quality manual?

·         What is the role of the quality manager within ISO 9001?

·         Describe management techniques which can promote quality improvement.

·         What are the 8 quality management principles?

·         What are the criteria to have a service of high quality?

·          What’s the difference between quality policy and quality objectives?

·         Typical quality objectives

·         Could you explain clause 5 of the ISO 9001 Please give me some examples of measuring the customer satisfaction?

·         Do I need to sent a survey to customers to find out if they are satisfied?

·         How do I measure process performance?

·         In what way does ISO 9001 contribute to continuous

·         If our company does a corrective action, and it prevents the problem from reoccurring, is this considered preventive action?