Home
Contact Us
CIS Software
References
Site Map
Questions and Answers

Services Available

 

ISO 9001 Implementations

AS 9100C Implementations

Internal Auditing

Supplier Auditing

GAP Assessments

3rd Party Auditing

Quality Systems Software

 

   
 

 


 

Questions and Answers

10 Questions and Answers, Before You Hire a Consultant

Those organizations who recruit good consultants get the job done roughly twice as fast. By helping you avoid mistakes, a good consultant can help you get the job done faster. But only a good consultant can do this. Not all consultants are created equally, and it is important to select a consultant that is right for you.

How do you tell the difference? Before you hire ISO 9000 consulting help, here are questions to ask ISO 9001 consultants. (These questions are relevant to consultants for ISO 14000, AS9100, etc.). The consultant who gives you the best answers is the one for you! 

1: How much will it cost us to get ready for ISO 9001, AS9100,or ISO 14000 registration?

A reputable consultant will give you a range based on the amount of time they estimate, through experience, the process will take.  

2: How long does it take to get ISO 9001 set up and ready for registration?

Again, a reputable consultant will give you a range of time. Ask for references to back up any claims made concerning time lines and success. 

3: What Standard will you help us work toward?

Make sure your consultant is versed in the current standards and can explain to your satisfaction which Standard fits you best. The right consultant is so fluent in all these technical details that he or she will be able to guide you with confidence and complete credibility. 

4: How much do we have to pay up front?

Reputable consultants may ask for a small advance for the first visit or progress payments as the project meets certain milestones.  

5: Who will be the lead consultant on our project?

Accept nothing less than to meet and interview the person who will actually be working with you on an ongoing basis - Before you hire the consulting firm.  

6: What do you charge for phone consultation during, and after, the project?

The answer had better be "not one red cent." 

7: What registration firms are you tied to?

The acceptable answer is "None." A reputable consultant is 100% independent, with no fiduciary or corporate relationship with any registration firm.  

8: Will you be present during our registration audit?

That option is up to you and should be considered part of the closeout to the project, (Not an additional cost to you). Keep in mind, the consultant cannot help you during a registration audit; the assessors will not allow any participation on the consultant’s part.  

9: What will you charge to help us deal with noncompliances found during our registration audit?

The answer is Zero, not one penny. This should be part of the closeout of the project, not an additional cost. 

10: How often will you have to come back to help us keep up our system after we are registered?

The answer should be, "Not ever." A reputable consultant works hard to ensure that you fully own your quality management system at the time of registration.

 

What are the benefits of implementing an effective QMS based on the ISO 9001:2008 standard? 

Benefits include:

External

  • Improves customer satisfaction due to an organization's QMS capability and consistency in meeting requirements.
  • Improves conformity to quality requirements
  • Increases competitive edge and market share
  • Increasingly recognized as a requirement for contractual relationships in the global arena.

Internal

  • Improves business efficiency and productivity
  • Reduces organizational waste, inefficiencies, and defects
  • Facilitates continual improvement in business processes and customer satisfaction
  • Improves process consistency and stability
  • Facilitates employee competence and consistency of performance
  • Improves employee motivation and empowerment through improved participation, communication and interaction.
  • Generates objective evidence to support the assessment of QMS conformity and effectiveness
  • Improves supplier performance by developing relationships that foster cooperative interaction in understanding and fulfilling customer requirements.
   

Myths, Urban Legends, and Perceptions

Everyone has their interpretation of the ISO 9001 standard. Let’s discuss some common misunderstandings, some of these myths, urban legends or perceptions of different requirements that may still exist:

Myth: Implementing and maintaining ISO 9001 is expensive.

  • False: it does not have to be expensive. A company simply needs to document its management system based on what it already does and put in place the programs required to improve on them.

Urban Legend: The ISO 9001 system is a quality system (belongs in the quality department or is the responsibility of the quality manager), or many organizations feel they need to hire somebody full time to manage the ISO 9001 system (for example, internal audit coordinator, corrective action coordinator, ISO coordinator).

  • False: the ISO 9001 system covers an entire business, starting with customer requirements, review and acceptance of those requirements, executing those requirements, measuring and monitoring processes to ensure requirements are being met and then, ultimately, delivery of a product or service that meets those requirements to ensure customer satisfaction.

Perception: a quality manual has to plagiarize the ISO 9001 standard.

  • False: the ISO 9001 standard states, “The organization shall establish and maintain a quality manual that includes:
  • The scope of the quality management system, including details of and justification for any exclusions,
  • The documented procedures established for the quality management system, or reference to them, and
  • A description of the interaction between the processes of the quality management system.”

Perception: it is mandatory to have a document—for example, work instruction, flow chart, procedure—for every process in the company.

  • False: ISO 9001 states, “NOTE 2 of the standard, the extent of the documentation can differ from one organization to another due to the size of organization and type of activities, the complexity of processes and their interactions, and the competence of personnel."

This is just a short list of reasons why organizations struggle with ISO 9001 implementation. Do you have some of these myths, urban legends, misconceptions in your organization?

Visit our Blog for Valuable Information

Our Blog provides a wealth of information for those interested in becoming registered to ISO9001, AS9100, and any other quality topic our contributors decide to post. Join us at www.qicguru.com.

 

 

 
  1. ISO 9001:2008 requires top management to actively participate in their organization's quality management system by developing and implementing quality objectives and periodically evaluating the health of the system. This concept may seam foreign to some top managers, as some organizations still subscribe to the notion that the management of their quality system belong to the quality manager. As a lead quality management systems auditor I have seen this time and time again, often with bad news for those at the top.  Without the ongoing participation and commitment from top management, it is virtually impossible to maintain a quality system that consistently meets the ISO 9001 standard or any other standard for that matter.

    Top management must be involved at all stages of the quality system, from planning to implementation and ongoing maintenance. Some key areas where management should be involved are as follows:

    • Setting Quality policies, planning, and objectives
    • Appointing a Management representative and giving them the authority to fulfill their job responsibilities.
    • Conducting Management Reviews that involve all of the required inputs and outputs of the QMS and making decisions that will promote continuous improvement.
    • Enlisting and Utilizing customer feedback to meet customer satisfaction requirements
    • Being visibly involved so that employees know that this is a business management system that is being driven from the top down.

    What is most important is that “everyone” is involved with your quality management system, realizing that no one person in the organization owns it, “everyone” owns it. Everyone must do their part, or as sure as I’m sitting here, the quality system will never deliver the results that is expected. When I hear someone say that ISO 9001 is just another expense, (No Benefit), to be endured for the sake of the customer, I know that these companies do not understand the overall commitment, (Involvement), required to receive any benefit. What type of company do you work for?

  2. Business owners know that it’s important to make continual efforts to improve the quality and efficiency of business.  For this reason, the ISO 9000 quality management system was created to ensure that a business runs at maximum potential.  Businesses that can claim they are ISO 9001 certified receive a certain degree of respect from other business owners, indicating the business is formalized and operating efficiently.  There are several requirements in an ISO 9001 certification, including:

    ~ maintaining adequate records
    ~ regular reviews of process and the effectiveness of the quality system
    ~ monitoring processes to ensure effectiveness
    ~ checking for defects with appropriate corrective action
    ~ fostering continual improvement

    Businesses must adhere to stringent standards in order to meet the requirements of ISO 9001 certification.  The standards for ISO 9001 were originally used to monitor manufacturing, but now are applied to several other fields.  You can purchase ISO 9001 software to work towards meeting ISO 9001 requirements and a more efficient business.

  3. The third party auditor will audit your system once or twice a year, so why do you have to conduct internal audits? The first and most obvious reason is, if you wait for the third party auditor to tell you your system is in trouble, you are missing the point of continuous improvement all together. The second reason is that the third party registrar does not consider the surveillance audit as an internal audit. The standard requires that “you” perform planned internal audits of your system based on status and importance of the processes and areas to be audited. If you do not know whether or not your quality management system conforms to your planned arrangements, or the standard, then how can you determine if you are improving? The ISO 9001 standard is based on the Plan, Do, Check, Act principle of continuous improvement. Internal Auditing is the “Check”, and without it you may never know when to act.

    The internal audit process need not be a time consuming; there are many ways an internal audit can be accomplished. Every day we conduct countless audits without even knowing it. A manager who walks the plant floor may notice a process which is not working as intended, a worker may notice that the forms he, or she is using are outdated , receiving may find that the same supplier never send the correct paperwork with the products they provide; these are audits that never get documented. These audits are not planned, but they are audits none the less. The planned audits do not have to include all of the processes in your facility once a year, remember “Status and importance”. Go after the low hanging fruit first, (areas where you are having issues), then review the other areas as needed. Whatever you do, DO SOMETHING, or your entire quality system will fail to accomplish the goals and objectives you have set for your organization. My philosophy is simple, if you are going to invest the time and money to become certified, get the full value of certification or you will be wasting your resources for nothing.

  4. When setting up your quality management system it is important to understand your options and their advantages and disadvantages. I have been involved with developing and implementing ISO 9001 and AS 9100 quality management systems both through a manual paper system and an automated software system.  Each option has very distinct advantages and disadvantages which can help you determine which way your organization should go.

    Option # 1 the paper system. This system is best implemented in a small to mid size organization where control is easily maintained. A paper system can get extremely convoluted in larger companies, which can result in inadequate control and subsequent non-conformances during a third party audit. The key to implementing a successful paper quality management system is to keep it simple and manageable. If your system requires excessive maintenance it will become a burden  which may result in the failure of the system to yield the continual improvement objectives that it was set up to achieve.

    Option # 2 the software approach. This system is advantages in both small and large companies and offers the added advantage of organization and control for your entire quality management system. By setting up your system digitally you can automatically control revisions and distribution of your documentation. You will also be able to communicate non-conformances, progress towards objectives, internal audits, calibration control, preventive actions, and supplier control and customer satisfaction. Your only real limitation with this system is the level of access your organization is capable of providing. If the rank and file is unable to access the system it does you little good. The best digital systems are internet based SaaS systems which offer access anywhere, anytime to internal and external users such as customers and suppliers.

  5. The ISO 9001:2008 stand requires follow-up for effectiveness when corrective or preventive actions have taken place. Many companies do a great job of identifying corrective and preventive actions, some even excel at following through and completing these actions. But where most organizations fall short, is following up to see if what they have enacted, actually had the desired affect and corrected or prevented something from happening again or in the future.

    Some organizations do follow-up for effectiveness, but never take the time to record the results of this activity. There are serveral areas in the ISO 9001:2008 which actually require follow-up activies take place:

    1. Section 8.2.2 Internal Audit states follow-up actives shall include the verification of actions and the reporting of verification results.

    2. Section 8.5.2 Corrective Action states that a documented procedure shall be established to define requirements for reviewing the effectiveness of the corrective actions taken, and records of the results of actions taken.

    3. Section 8.5.3 Preventive Action states that a documented procedure shall be established to define the requirements for reviewing the effectiveness of the preventive actions taken, and records of the results of actions taken.

    If you are certified to ISO 9001 or some other quality management system, my question to you is this; Why wouldn't you want to know if the time and energy you put into implementing a corrective or  preventive action actual paid off? If you are going to invest the time and money to have a quality management system which is certified to a standard, shouldn't you get something out of it? Without the data to support your decisions, aren't you just spinning your wheels?

  6. You are a small business owner who has just been told you must become certified to AS9100 in order to continue to receive business from your largest customer. You have been putting this off for some time, hoping you would be able to wait until the economy gets better. Now what, you have a deadline and you haven’t got a clue how to get there from here? The best advice, find a competent consultant and get some training to the standard.

    Those organizations who recruit good consultants get the job done roughly twice as fast. By helping you avoid mistakes, a good consultant can help you get the job done faster. But only a good consultant can do this. Not all consultants are created equally, and it is important to select a consultant that is right for you. A reputable consultant works hard to ensure that you fully own your quality management system at the time of registration. Key services you will require, if you have no idea what you are doing or how you will do it are as follows:

    1. Required documentation development and implementation

    2. Training: Quality policy and objectives, Management review, Corrective and Preventive action, Internal auditing, AS9100 Overview, Risk analysis, Overview of the Complete QMS, Collecting and analyzing data.

    3. If software is being used to facilitate and run your quality system, you will also need training and implementation services for this.

    4. Implementation of a competency, awareness and training program, internal audit, corrective and preventive action programs, management review and overall continual improvement programs.

    5. Conduct internal audits for entire system (all processes), one high level internal audit to the AS9101C checklist in preparation for registration audit.

    This is just a short list of services that you may need to accomplish your goal of certification to AS9100. Depending on the size and complexity of your organization and processes more may be needed. A good consultant can help you determine your individual needs.

  7. Why the new focus on "sustained success? ISO 9004 is trying to answer the question, what is the purpose of quality?  In 2000, the standard looked at customer requirements in the widest possible sense. Now with the 2009 rewrite, it is addressing why you should do that. The answer to this: to achieve sustained success for an organization over the long term.

    Does the new direction of ISO 9004 indicate the future direction of ISO 9001?  Quite possibly yes, ISO 9001 has to be written to provide consistent objective assessment across different organizations, but ISO 9004 calls for subjectivity. Wherever we can transfer the subjective advice in ISO 9004 into ISO 9001 in the future, it will probably be done.

    For a small business to survive in the current economy, sustained success is a driving force that can sometimes determine whether or not an organization will survive. Although this standard is not intended for certification purposes, a strong business management consultant can assist an organization, which is already ISO 9001 certified, by coaching them on how to implement this standard.

  8. Corrective and Preventive Action Processes are two different processes within ISO 9001 requirements.

    There is a great deal of confusion between the 3 areas covered under the ISO 9001 standard, corrective action, preventive action and preventive maintenance.

    Corrective action treats a nonconformity or problem that has already occurred. The problem exists. The nonconformity lives and needs to be addressed.

    Preventive maintenance focuses on the care of machines. It is a system that protects machines from breaking down. ISO 9001 auditors do not look at preventive maintenance as preventive action. Preventive maintenance is important for the infrastructure (resource management) section of the ISO 9001 standard.

    Preventive action determines and eliminates potential causes of non conformities. This means the non conformity has not yet happen. If you act to prevent a problem from occurring then this is a preventive action. The ISO 9001 standard requires you to take preventive action to eliminate potential nonconformities.

    There are ISO 9001 software applications that can help guide an organization through this murky area within the ISO standard.  A certified CIS consultant can show an organization just how simple it is to report, track and follow-up on corrective and preventive actions. If that’s not enough, there are also ISO 9001 templates available to help clarify the standard requirements for these and other areas of your business management system. So if you are looking to start a new quality management system, or just take your old system and reengineer your process to promote continual improvement, help is not far away.

  9. There are various ways in which your supplier can claim that its quality management system meets the requirements of ISO 9001:2008. These include:
    • Supplier's declaration of conformity: Your supplier makes a declaration affirming that its QMS meets ISO 9001:2008 requirements, usually supported by legally-binding signatures. This declaration can be based on your supplier's internal audit system, or on second party or third party audits;
    • Second party assessment: your supplier is audited directly by its customer (e.g., by you, or by another customer, whose reputation you respect) to check if its QMS meets ISO 9001:2008 requirements and your own requirements - sometimes used in contractual "business-to-business" transactions;
    • Third party certification: your supplier uses an accredited Certification Body (Registrar) to audit and verify it's conformity to ISO 9001:2008 requirements. This third party then issues a certificate to your supplier describing the scope of its QMS, and confirming that it conforms to ISO 9001:2008.
  10. The goal of the AS9101 rewrite is to provide requirements on process auditing and development of  the AS9100 audit approaches and tools that focus not only on conformity, but also on effectiveness of a quality management system (QMS). The AS9101 proposal is to develop an enhanced audit process for evaluating process-based management systems that aligns with ISO 17021 and consists of:

    • Process-based information gathering.
    • Assessment or analysis and audit planning.
    • Development of performance-based and process-oriented audit methods and techniques.
    • The ability to capture objective evidence of process conformity and effectiveness.

    The AS9101 Rev D has aligned itself with the process approach for quality management systems as indicated in the 9100-series of standards.  There are four basic questions asked when evaluating quality management systems which is linked to each process which is being audited:

    1. is the process identified and appropriately defined?
    2. are the responsibilities assigned?
    3. are the procedures implemented and maintained?
    4. is the process effective in achieving the desired results?
  11. The goal of the AS9101 rewrite is to provide requirements on process auditing and development of  the AS9100 audit approaches and tools that focus not only on conformity, but also on effectiveness of a quality management system (QMS). The AS9101 proposal is to develop an enhanced audit process for evaluating process-based management systems that aligns with ISO 17021 and consists of:

    • Process-based information gathering.
    • Assessment or analysis and audit planning.
    • Development of performance-based and process-oriented audit methods and techniques.
    • The ability to capture objective evidence of process conformity and effectiveness.

    The AS9101 Rev D has aligned itself with the process approach for quality management systems as indicated in the 9100-series of standards.  There are four basic questions asked when evaluating quality management systems which is linked to each process which is being audited:

    1. is the process identified and appropriately defined?
    2. are the responsibilities assigned?
    3. are the procedures implemented and maintained?
    4. is the process effective in achieving the desired results?

Software Solutions With Real Pay Back!


What Does Your Organization Think Is Important?

What Is The Top Reason You Have For Not Getting Certified?

Increase your website traffic with Attracta.com
Home  ·  About Us  ·  Contact Us  ·  Privacy Policy  ·  Links

Copyright © Quality Improvement Consulting,LLC
All Rights Reserved Fountain Hills, AZ
dleary@cox.net