Sunday, June 25, 2017
Tags Posts tagged with "documentation"

documentation

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    1. Commit to improvement.

    For any QMS to improve, it is essential that everyone is committed to seeking problems, evaluating efficiency and effectiveness of processes and implementing better and improved ideas. Management should be the first to make this commitment and if management “walks the talk” then everyone will follow.

    1. Analyse and assess current QMS.

    Organizations need to take a closer look at their current practices in order to identify any gaps between what is being done and what should be done. This can be achieved by interviewing workers in critical control points, reviewing procedures and records and observing how processes are occurring. Any steps that are not adding value to the process, the system or the organization must be identified, removed or improved.

    1. Include everyone in training programs.

    A QMS is not the responsibility of one person or one department. Everyone must be involved in improving the quality of products, services and processes.

    Organizations should establish a training program for new employees and existing ones.  These programs should promote knowledge, produce skills and capacities and reduce resistance when implementing new ideas for improvement.

    1. Define clear goals and objectives and make sure everyone knows them.

    QMS should aim at achieving specific goals. If a clear path is not drawn, there’s a risk that people will be working real hard but in different directions. Time should be spent in assuring everyone knows these goals, how they’ll be achieved, how they’re measured and periodically they should be informed of where the organization is standing in relation to these goals.

    1. Make sure the right key performance indicators (KPI) are being used.

    Organizations need to carefully select and review their KPI. These should let an organization know how efficient and effective processes are and indicate where possible problems could be. If they are not giving a real overall picture of where the organization is at regarding quality, then another look should be taken to change or improve what and how performance is being measured.

    1. Listen to the suggestions of employees and customers.

    Create a system that will promote workers and customers to share improvement ideas. Many great improvement ideas come directly from the people processing a product or the people that actually use it.

    1. Give people credit.

    To encourage participation throughout the organization, motivate workers by recognizing their work and their ideas. Compensation or recognition should not necessarily be monetary, a simple public recognition in working meetings to can have great effects in lifting workers morale.

    1. Make the system simple.

    A QMS that is extremely complex and overloaded with documents is not necessarily the best one. If documents and procedures are long and complicated, it is very likely that people will never use them. Evaluate the system and make sure that it makes sense and that it’s as simple as possible.

    1. Create quality groups.

    In many organizations workers from different departments or areas are reluctant with sharing information. By bringing together people from different areas to evaluate processes and recommend improvements, an open and more effective communication can be achieved between areas that operationally seem to be apart.

    1. Have a quality attitude.

    In order to reach the goals that have been set, organizations need to identify and detect problems and weaknesses but they must focus on improvements. If managers are constantly focusing on failures and defects and not on how to remove or improve them, the right attitude and mindset for quality will never be achieved.

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      Procedures for ISO 9001:2015

      The new ISO 9001:2015 does not identify any required documented procedures, at least not as it was required in the 2008 version of the standard. The new standard refers to requirements of “documented information” and in the clause 7.5 it states that:

      The organization’s quality management system must include:

      1. documented information required by this International Standard;
      2. documented information determined by the organization as being necessary for the effectiveness of the quality management system.

      Throughout the new version of the standard, there are a number of references for organizations to maintain and retain documented information. It can be inferred that where the standard states that the organization is required to maintain documented information sufficient to support the operation of processes it is implying the need of documented procedures.

      The specific procedures required for the quality management system will depend on the organization itself. The standard also states that:

      The extent of documented information for a quality management system can differ from one organization to another due to the:

      1. size of organization and its type of activities, processes, products, and services;
      2. complexity of processes and their interactions;
      3. competence of persons

      Each organization will need to identify which procedures are essential for the correct operation of their processes in order determine which ones they’ll need to create. If an organization does not have any documented procedures, it will need to demonstrate how people know what to do and show acceptable evidence to support that their processes are carried out effectively without them.

      Organizations that have already implemented ISO 9001 will not need to throw away the procedures that are in place. If these procedures serve as a useful tool within the organization, they should be maintained. However, the new standard presents an opportunity for organizations to take a second look at the procedures that are part of their management system in order to determine which add value to the system and which don’t.

      Organizations wishing to be certified with the new ISO 9001:2015 must meet all of the requirements within a standard, including those regarding documented information, and they must be able to show evidence that they have all the necessary procedures in place.

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      The new ISO 9001:2015 represents a major change to the 9001:2008 version. One of these changes regards the Quality Management Systems (QMS) documentation.

      The 2008 version of the standard, uses two separate terms “documents” and “records” to identify its documentation, whereas, in the recently published Draft International Standard of the new revision, both these terms are combined as “documented information”.

      For those familiar with the 2008 version, it can be said that where it refers to “documented procedures” in the new revision it is expressed as a requirement to maintain documented information. Also, where the 2008 version refers to as “records” it is now expressed as a requirement to retain documented information. Below, there’s a list of the documented information that the new standard requires to be maintained and retained.

      Documented information that is required to be maintained with ISO 9001:2015

      • The scope of the QMS, including the products and services it covers and the justification of those requirements that the QMS will not be able to apply.
      • Information that supports the operations of processes.
      • The quality policy.
      • Information that defines characteristics of products and services, activities to be performed, and the results to be achieved.

      Documented information that is required to be retained with ISO 9001:2015

      • Information necessary to have confidence that processes are being performed as planned and conform to requirements.
      • Information on the quality objectives.
      • Information as evidence of fitness for purpose of monitoring and measurement resources.
      • Information as evidence of competence.
      • Information describing the results of the review of requirements related to products and services.
      • Information resulting from the design and development process.
      • Information on review of design and development changes.
      • Information of the results of the evaluation, monitoring of performance and re-evaluation of the external providers.
      • Information necessary to maintain traceability when required.
      • Information describing the results of the review of changes, personnel authorizing the change, and any necessary actions
      • Information providing traceability to the person(s) authorizing release of products and services for delivery to the customer.
      • Information on actions taken on nonconforming process outputs, products and services.
      • Results of monitoring and measurement activities.
      • Information as evidence of the implementation of the audit programme and the audit results
      • Information as evidence of the results of management reviews.
      • Information as evidence of the nature of the nonconformities, actions taken, and the results of any corrective action.

      As it can be seen from the above list, in the new version of the standard, it will not be required to create and maintain a Quality Manual, which has been around since the creation of ISO 9001 in 1987.

      ISO 9001:2015 is still under development, and it is possible for some changes to occur before its final version is released on September 2015.