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ISO 9001 - FAQ


What is a Quality Management System?

A Quality Manual will describe briefly how your quality system meets the requirements of the standard.

There will be procedures for required areas of the standard and procedures you determine are needed.

Work Instructions will describe how specific tasks are done. You decide what work instructions you need to provide a consistent product or service and to serve as training tools. Work instructions can be detailed or outline or checklists.

Records will be kept demonstrating that documented procedures and work instructions were followed. All required records must be maintained.

Procedures, and work instructions, and job descriptions or other responsibility documents will clearly describe employee responsibilities.

An internal audit program will continually evaluate the quality system and highlight areas for improvement.

Corrective and preventive action processes will allow problems to be fixed and verified for effectiveness.

Information from corrective actions, internal audits, process measurements and product measurement will be reviewed by management on a regular basis. Management will be informed on the quality system performance and will take action for continual improvement.

Registration and surveillance audits by the registrar will confirm your system is working effectively.

What are the benefits of ISO 9001:2008 Quality Management System?

Increased Quality Awareness and Internal Advantages
There are many reasons to implement an ISO 9000 based quality management system. Often the market or client is the driving factor. Once an ISO quality system is in place, companies realize that there are internal benefits which are as important as the external ones.

Benefits during implementation:

  • Process Improvements
    As you implement the system; you have the opportunity to improve your processes. You will outline the current process, and the requirements of the standard, and then optimize the process with input from the process users.
  • As the system is implemented, quality awareness will increase because all staff must be trained on ISO 9000 and the processes as they are implemented. Staff will have "ownership" of processes they are involved in developing and improving.

Benefits after implementation:

  • Market Advantages
    Surveys of registered companies show more than 40% were asked by a client to obtain registration. Using a registered supplier reduces the amount of vendor audits a company must perform.

    When a client requests a vendor to seek ISO registration, it can take anything from 6 to 18 months or more to comply. Therefore, the vendor who is already registered has an advantage. This can be used as a strong marketing tool.

    ISO is becoming a requirement to do business in many markets. Registered companies currently have an advantage over their competition. As registration becomes more common, this will shift and the unregistered companies will be at a disadvantage.
  • Once registered, companies often find the greatest payoffs are internal, as processes experience continual improvement.

    A survey of 100 registered firms reported the average improvement in their operating margin was at 5% of sales. Firms also report improvements in order turnaround time, scrap and overtime.

    The quality system has built-in systems to report on key quality indicators: Corrective and Preventive Action, Internal Audits and Management Review. Management is required to take action based on this information.

    These built-in systems also contribute to continual improvement by significantly reducing the reoccurrence of problems. Corrective actions issued must be addressed, the root cause determined, and action taken to prevent reoccurrence. Follow-up will make sure the action was effective.

    Internal audits will evaluate the effectiveness of the system, and identify opportunities for improvements. Nonconformities must be addressed. Internal auditors are also able to make observations and suggestions.

    Management review is a chance for management to evaluate the performance of the quality system. Information is provided from corrective actions, internal audits, purchasing information and client complaints.

    The operation will run more smoothly, with fewer crises and "fires". The quality system promotes consistency in how work is done and recorded. It helps employees learn more easily and quickly what should be done. It reduces misunderstandings with customers.

    When a problem occurs, it is corrected at the root cause. It does not have to be "fixed" again and again by someone else, meanwhile productivity is lost.

    There is a strong quality culture. Internal audits, corrective action and training result in "top of mind" awareness of the system. Increased confidence in workmanship results in a more confident staff. Systems in place allow staff to address problems. Staff recognises problems as systems or process issues. Problems are solved, not blamed on anyone.

What is Process Approach?

The process approach is an activity that uses resources to transform inputs to outputs, for an organisation to function effectively, they need to identify and manage a numerous interrelated and interacting processes. The ISO 9001:2008 Standard is designed to manage and improve those processes.

  • 1. Input to a process are generally output to another process (e.g.: the output, becomes an Input to a process)
  • 2. Processes in an Organisation are generally planned and carried out under controlled conditions to add value to your business.
  • 3. A process where the conformity of the resulting product, cannot be readily or economically verified is frequently referred to as a "special process".
  • 4. The ISO 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 required by the standards?

The standard specifically requires a Quality Manual, Quality Policy and 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, this is decided by your organisation during the developing of the Quality Management Systems.

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 meets the requirement
  • 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
  • Nonconforming product and actions taken
  • 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 at lower management level and six monthly at senior management level. This allows you to stay on top of upcoming issues and collect data between meetings that are meaningful to the organisation. We have found annual meetings are not acceptable to all registrars. With annual meetings you may not be able to prevent issues or resolves problems in a timely manner. Management Review

Are Job descriptions required?

In the ISO standards do not specifically mentions that a job description is required. The standard requires that the organisation:

  • define responsibility and authority, and
  • define competency in terms of education, experience, skills and training.
Normally Job descriptions are one way of accomplishing this, there are also other ways by, including preparing organizational, job responsibility lists, and competency matrices.

Who in the organisation should be involved?

Everyone needs to be involved, either in the planning, implementation or maintenance of the Quality Management Systems.

Management involvement is critical. Management must support the project by providing resources, removing roadblocks, and watching the timeline. Employees should be involved in evaluating and documenting the processes in which they are involved.

Employee involvement is critical to getting buy-in and support from people throughout the facility. Their support will help successfully implement the new processes. Employee involvement also gives employees a chance to give input into changes and modifications for process improvements. For more suggestions on which employees need to be involved, read our planning page..

Should we use outside help - Consultant?

A consultant can help you use your time and resources effectively. Consider using a consultant:

  • To help plan your project
    An efficient implementation begins with a solid plan, taking into account those things you need to work on, leaving out those things which are already in place, and developing an accurate estimate of how long each implementation phase should take.
  • To help keep your project on time and on budget
    Everyone is stretched thin on their jobs these days. Staff working on the implementation internally is often pulled to help fights fires or assist with production. With external assistance it is easier to keep the focus on the plan without interfering with day-to-day operations.
  • To help interpret the standard A consultant who understands the standard's requirements can prevent wasted time doing things the standard does not require, or that otherwise might be spent on unnecessary or noncompliant work. QCG Quality Consulting Group experienced staff is very familiar with ISO standards and requirements.
  • To allow you to benefit from experience
    Using a consultant allows you to begin work right away without having to learn things on your own, and without having to learn by your mistakes.

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 department or process?

The ISO standard requires that all processes are audited within the certification scope. The audit schedule should be based on the level of importance and on the results from the previous audits and customer complaints. In a new developed system, you will need to audit frequently, perhaps monthly, to make sure that all processes are implemented and working. For established systems, normal recommended practice is every three months to one year with options to increase the audits if nonconformity is identified (Internally or by the customer).

How long will it take to implement ISO 9001:2008?

  • An implementation project will typically take about 12 months, but ranges from 6-18 months. You will need a minimum of three months of records to show your registrar. Plan your registration audit no less than three months after finilising you ISO QMS.

    Factors that affect the timeline include:

    • Size and complexity of the organization
    • How much existing documentation is available
    • Amount of resources available for the project
    • Amount of ISO expertise available

    Recommendation : Start with a gap analysis, this should help you determining the correct timeline for implementation a QMS and obtain a consultant to assist your organisation.