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  • ISO Certification 9001, 13485, 14001 & 45001 In Carlsbad California - MSI International

    ISO Certification FAQs

    ISO Certification FAQs

    This document contains answers to frequently asked questions (FAQs) that might be encountered during the initial investigation period of ISO certification. Click any question in the list below to go directly to the answer.

    How do I get started?

    Usually individuals within companies are tasked to find out what an ISO Standard is and what is required to become certified. They typically begin to search the Internet and find that there are an overwhelming number of web sites available to them. By reading a few of these sites they can educate themselves enough to get an overview of the ISO Standard and the process necessary to become certified. First and foremost is to know by your top management what areas or all of the companies are to earn ISO certification and to which Standard. The next question ISO consultants will ask is how many people and processes are within that scope of potential certification. The below question as to which Standard our company should pursue should help answer that questions. Most companies begin the process by selecting a professional ISO consultantMSI provides ISO consulting that is customized to your needs, knowledgeable about the steps to certification, and cost effective. Thanks for visiting our website and call with any immediate questions. ^Top

    How do I know which ISO Standard applies to our company?

    The three main management system topics within ISO are Quality, Environmental, Health and Safety.  Other topics include: laboratory, business continuity, security management, risk management and food safety. Depending on your specific industry there are different standards.  Below is a list of several ISO standards and the applicable industries.

    For example, if you are in the aerospace industry and have a key customer requiring AS 9100 (the aerospace specific standard), at some point they will flow down that same requirement to you, their key supplier. Instead of waiting for that to happen consider taking a proactive “phase approach” to this business situation and implement ISO 9001 now. In another year add the AS 9100 requirements to your procedures then strategize with your registrar as to when you should arrange for the additional scope audit. Below is a listing of some of the most common ISO standards.




    ISO 9001 Quality Management Systems This is the basic international standard of fundamentals for a Quality Management System. It can be used by any organization of any size and is the foundation for other industry standards.
    TL 9000 TL 9000 Quality System Requirements Same as ISO 9001 but with a focus on specific standards used in the telecommunications industry.
    ISO 13485 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes Same as ISO 9001 but with a focus on specific standards used in the medical device industry.
    ISO TS 16949 Automotive Standard Same as ISO 9001 but with a focus on specific standards used in the automotive industry by companies that are suppliers to the auto parts industry.
    AS 9100 Aerospace Same as ISO9001 but with a focus on specific standards used in the aerospace industry.

    See all encompassing list Link to Standards Page ^Top

    What does it take to get certified?

    To be certified, your company needs to define and develop procedures that follow the International Standards Organization requirements. Whether you choose ISO 9001 or another standard you are required to address such issues as:

    • Planning:
      • Who are your interested parties and what are their needs and expectations
      • Define the scope of the management system and establish the company policy.
      • Determine and plan how the management system objectives will be met.
      • Identifying and providing the resources needed to ensure that operations are conducted in accordance to the management system requirements.
      • Identification of risks and how they are controlled
      • Identification of key processes and how they are monitored and measured
    • Do:
      • Development and implementation of processes and procedures to ensure planned results are achieved, the objectives are achieved, and the management system requirements are achieved.
      • Performing operations in accordance to the ISO requirements and your organizations requirements.
      • Maintaining documented information to support the implementation of the management system.
    • Check:
      • Monitor and measure key performance indicators for the established processes and for the needs and expectations of interested parties.
      • Monitor and measure the extent to which the management system objectives have been met.
      • Conduct internal audits of the management system to the ISO requirements and requirements of the organization.
      • Conduct management reviews to ensure the continued adequacy, suitability, and effectiveness of the management system.
    • Act:
      • Implement actions to continually improve the management system
      • Implement actions to prevent unplanned results from occurring again

    Other topics to be thought through are:

    • How documents are controlled within your company.
    • How to determine and manage the records your company must maintain.
    • How to establish and implement methods for dealing with nonconforming product issues.
    • How to perform internal process audits. This activity is entirely new to most companies and takes an annual investment commitment
    • How to determine and manage suppliers and their performance
    • How to manage the minimum required procedures for problem and potential problem identification and resolution.

    In addition, it may be advisable to define and document other processes such as: acceptance of customer contract awards, the issuing of purchase orders to your suppliers, supplier selection and evaluation, various design and development processes as well as consistent implementation of processes to ensure that all initiatives are successfully carried out in your company. The environmental and health Standards require initially discovering the environmental and hazard aspects. There are also required training courses plus a third party qualified certification audit. ^Top

    What are the benefits to our company becoming ISO certified?

    When determining whether to have your company become ISO certified consider three of the most important benefits you will achieve.

    First, you will establish a foundation for continuous improvement thereby increasing your competitive market position.

    Second, you will ensure that your company’s processes are being performed to your expectations.

    Third, you will improve your employees’ quality of life at the workplace by establishing universal standardized methods to carrying out their day-to-day activities.

    All of these can increase your profitability and decrees your liability. It should be considered a capital expenditure that will increase the value of your business. ^Top

    How do I know if I need a consultant or not?

    Unless you have in-house experts who can devote two to three days a week to determine the scope of the project, to focus on implementing and managing the required upfront development, as well as to understand how to apply the generic requirements to your operations, you will need to hire a professional ISO consultant. ^Top

    How do I know if ISO Standards certification is right for our company?

    There are many options to consider once you have decided to take the next step forward in making your company more competitive. Initiatives such as 6 Sigma, CMMI and various homegrown quality-management systems can be very beneficial to achieving your goal. However, ISO 9001 is the most established system and is highly recognized by today’s commercial and government entities as well as international companies. Achieving ISO certification will make your business much more attractive in the global marketplace. ^Top

    How long does it take to get certified?

    With the assistance of a qualified ISO consulting firm, many averaged size companies (up to 200 employees and single locations), can be certified in six (6) to eight (8) months. ^Top

    How do companies get started?

    Many companies begin their journey because their customers require them to earn ISO certification. For other companies, certification is driven by new management who experienced success when working in ISO certified companies. Or perhaps they have seen the results of sister companies or they have read about the success of various companies who have gone on the ISO journey. However, they decide to begin the process, most hire experienced consultants like MSI to help them get there. ^Top Schedule an Appointment

    What are the phases of implementation?

    The concept used to implement ISO certification and the guiding principal used by MSI is Deming’s PDCA (plan-do-check-act)- an iterative four-step problem-solving process typically used for carrying out change. Once you have accepted a contract with MSI a program plan custom-designed for your organization is developed and presented to ^Top management. Once approved, documentation development is created through a series of interviews and training. When complete the implementation phase for your organization is launched. We use an implementation task map and training courses at your facility to launch the management system. Later we determine that each procedure has been implemented effectively by performing the required internal audits. We then ensure that any issues identified by the internal audits are corrected. ^Top

    How was the methodology created?

    Our methodology was developed and continually improved upon over the last 21 years by a team consisting of experts in international operations, supply chain management as well as other appropriate fields. By focusing on one customer at a time, meticulously documenting results and then using customer feedback to correct and improve the process, our turnkey methodology was developed and refined. We continue to invest in our methodology by being present at every one of our customers’ audits. We incorporate any “lessons learned” in our plans, templates, trainings and work sheets. We demonstrate continuous improvement by practicing it ourselves. ^Top

    How can I get more detailed information?

    Extensive, detailed documentation of our approach as well as easy printable brochures are available on our Web Site at www.msi-international.com. For additional information please contact Management Systems International (MSI) at 760 434 9141. ^Top

    How much will it cost?

    There are three main segments to our pricing: consultation, internal labor costs and Certification fees. Consulting and certifying body fees are both daily rates and vary from $1,000-$1,600 per day depending on the size and complexity of your organization. You can call us to discuss a formal fixed fee proposal. Typically, smaller companies with 20 or so employees and a straight forward service and manufacturing processes will range from $16,000 to $25,000 while organizations that have approximately 60 employees with several production lines and complex services can range from $38,000 to $50,000. For a complimentary budgeting purpose proposal submit our RFI Begin gathering Budgeting information ^Top

    Will our company see improvement in our operations?

    MSI guarantees improvement in your operations when you implement and follow our recommendations. If you are looking for continuous process improvements that lead to increased productivity and increased profits call MSI today. 760-434-9141 or visit www.MSI-International.com. ^Top

    How will our ISO certification be kept current and up-to-date?

    By using your system routinely such as implementing changes through revising documents and maintaining the internal audit program, the system should be able to stay up to date. In order to keep your certificate, your company is audited by the registrar at what is called the surveillance audit either every six months or annually. MSI offers our SurePathTM Maintenance Program for clients who would like to have us help them with their on-going support see MSI’s Ongoing Maintenance SureResults Program. ^Top