Sunday, June 25, 2017
Tags Posts tagged with "iso 9001:2015"

iso 9001:2015

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    Documented Information for ISO 9001:2015

    With the relatively recent release of ISO 9001:2015, many companies are still asking themselves what documentation is required. Back with the 2008 release, most companies were comfortable with the six mandatory procedures that were expected of them as well as the need for a quality policy and manual. The update to 2015 has however removed the requirement for a quality manual and blurred the distinction between procedures and records.

    With the new release, both documents and records are termed “documented information” and must be controlled and maintained. This is what will form the evidence required to show that you are conforming to the requirements of your quality management system.

    Clause 4.4 of ISO 9001 requires your organization to maintain the documented information that is required to support the operation of your processes and to retain that information to be able to have confidence that those processes are being completed as planned.

    So what is required by the standard?

    The following is a clause-by-clause breakdown of what is required by the standard. However, some of these clauses can be excluded if the company does not perform the relevant processes:

    Mandatory records:

    • 7.1.5.1 – Monitoring and measuring equipment calibration records
    • 7.2 – Records of training, skills, experience and qualifications
    • 8.2.3.2 – Product/service requirements review records
    • 8.3.2 – Record about design and development outputs review
    • 8.3.3 – Records about design and development inputs
    • 8.3.4 – Records of design and development controls
    • 8.3.5 – Records of design and development outputs
    • 8.3.6 – Design and development changes records
    • 8.5.1 – Characteristics of product to be produced and service to be provided
    • 8.5.3 – Records about customer property
    • 8.5.6 – Production/service provision change control records
    • 8.6 – Record of conformity of product/service with acceptance criteria
    • 8.7.2 – Record of nonconforming outputs
    • 9.1.1 – Monitoring and measurement results
    • 9.2 – Internal audit program
    • 9.2 – Results of internal audits
    • 9.3 – Results of the management review
    • 10.1 – Results of corrective actions

    Other Mandatory Documents:

    • 4.3 – Scope of the QMS
    • 5.2 – Quality policy
    • 6.2 – Quality objectives
    • 8.4.1 – Criteria for evaluation and selection of suppliers

    So what does this mean?

    You should still tailor your quality management system to meet the requirements of your own business and all of the interested stakeholders. This can be done in any way that your organization sees fit; although a quality manual is still one of the easiest methods. As long as these processes and associated records can be shown to meet the requirements of ISO 9001:2015 effectively then that is fine. If not then the relevant action should be taken to ensure that all of the required clauses are covered.

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      Quality

      Have you ever stood staring at a range of products in a supermarket trying to make up your mind which one to buy?  They all look quite similar, but one stands out and you buy it.  Why?  It’s got a sign on the shelf and a logo on the product to tell you that it’s won an award for quality.

      So you’ve just based your purchase on Quality – Your customers are making the same decision every day!

      Quality is more than just finished product, it’s the processes, systems and people that are behind the product.   Quality is everybody’s responsibility.

      Quality is the pursuit of excellence, striving to be the best we can and getting ahead of our competitors.  It is meeting the needs and expectations of all stakeholders – our customers, our suppliers, our staff and the community at large.

      How can we ensure that we are exploiting all avenues to be the very best?  A recognized standard such as ISO 9001 certification promotes the use of quality tools in business.   The ASQ (American society for quality) estimates that for every €1 spent on a quality management system, such as ISO 9001, returns €6 in revenue, €16 in cost reduction and €3 in profit – that’s €25 for every €1 spent!

      93% of organisations agree that the implementation of a quality management system such as ISO9001 was a significant driver of success and most would agree that without it they could not justify their pricing to customers.

      If you are looking at ways to improve your ROI by improving your quality then consider ISO certification.   Using an expert to help you implement a quality management system will ensure ISO 9001:2015 accreditation which will in turn help you make significant improvements and lead to significant growth.

       

      This post has been a guest posting from Joann O’Brian over at our friends at CG Business Consulting Ireland .

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        ISO Implementation Process

        Preparing for an ISO implementation process of any ISO standard can be overwhelming and frightening for many. How an organization prepares for implementation will depend on factors such as size and complexity of its processes, the current knowledge and culture related to the standard (quality, environmental, safety, etc), the maturity of any other existing systems related to the standard wishing to implement, and many others. Despite the differences there may be between organizations, there are a few tips that will facilitate the implementation process of any management system, these are:

        Know the standard.

        It is essential that some personnel knows the management system’s requirements. Everyone does not need to be an expert on the requirements of the specific standard that will be implemented, but key workers need to fully know and understand all of the requirements of the standard.

        Inform everyone what is going on.

        The implementation process is not a task of just a few chosen ones. Everyone needs to be involved in this process. Every worker needs to know what is being implemented, why is it being implemented, which are the benefits for the organization and for themselves, and how they will be involved in the process. When people are informed, they will be more open and willing to collaborate in the implementation.

        Analyze the organization’s current situation.

        Before starting to implement any ISO management system, an organization needs to know its level of compliance with the standard. This will allow the organization to understand beforehand its strengths and weaknesses regarding the ISO management system wishing to implement and estimate the time needed for implementation.

        Map your processes.

        Establish and record current processes in order to know the relationships between departments and how the processes flow within the organization. This will allow organizations to plan their implementation by processes and not just by areas and departments.

        Review existing procedures and work instructions.

        Many processes need written and documented information that will guarantee that activities are carried out in the correct manner. Organizations need to review which processes are documented and how many work instructions there are. It is not the same to develop a few documents and just review work instructions than to develop them from scratch. Organizations need to have an idea of how much time they will have to invest in developing and reviewing documents.

        Review current training programs.

        Evaluate existing training and awareness programs. Training and awareness are an important part in the implementation process and if an organization has not considered training its workers, it would be best to redefine these programs to make sure that a large percentage of workers are trained and informed about policies, procedures, regulations, etc that will be a part of their daily activities.

        These are some recommendations that will help organizations prepare for the implementation process of any ISO management system. The most important aspect to keep in mind is to make sure that the whole organization is working for the same objectives and pulling in the same direction.

         

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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.

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          Measuring Supplier Performance

          The new ISO 9001:2015 is currently at the Final Draft International Stage (FDIS), the fifth stage of a six stage process, and the final revision is expected to be published by September 2015. There are a lot of expectations regarding the release of the new standard and many are wondering what the differences will be between ISO 9001:2008 and ISO 9001:2015.

          The recently published draft of the standard (DIS) has shown what the main differences are about; even though both standards cover essentially the same topics, there are some important changes. Some of these are:

          1. The most notorious difference between the standards is its structure. ISO 9001:2008 had five main sections and ISO 9001:2015 has seven. The new ISO 9001:2015 aligns with high-level organizational structure established on the ISO Guide 83 (“Annex SL”), requiring all new ISO management system standards to be aligned on a high-level structure with a set of common requirements. Such structure is as follow:
            • Scope
            • Normative References
            • Terms and Definitions
            • Context of the Organization
            • Leadership
            • Planning
            • Support
            • Operation
            • Performance Evaluation
            • Improvement
          2. The new standard puts a greater emphasis on the “context of the organization”. Unlike ISO 9001:2008, the new standard will require organizations to consider the external and internal issues that may influence their quality management system (QMS) and they will need to determine how these will be addressed.
          3. With the new ISO 9001:2015, organizations will be required to take a risk-based approach to identify and address the risks that can jeopardize their ability to meet customer and regulatory requirements. In ISO 9001:2008, even though a risk-based approach is not explicit, the standard implicitly guides organizations in managing their risk.
          4. The new standard has eliminated the distinction between documents and records by referring only to “Documented information”. There also will be general requirements for documentation, with no reference to documented quality manual, documented procedures or to quality records.
          5. The specific requirements for preventive action present in ISO 9001:2008 have been removed in the new standard. This decision was motivated by the perspective that prevention is the task of the QMS in its entirety.
          6. Some concepts have been replaced in the new standard, such as the term “product” is replaced by “goods & services” and “continual” by “continual improvement.”“Purchasing” and “outsourcing” will be replaced by “external provision of goods and services”.
          7. The new standard also eliminates any reference to a “Management Representative”. Instead, management duties and responsibilities can now be assigned directly to top management (to one person in particular or to many).

          These are the main differences between the two standards which are based on the DIS version of ISO 9001:2015. There are still comments from over 90 countries that will be taken into account and it is yet to see which of these changes will be maintained in the final official version.

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          The quality management system (QMS) standard ISO 9001:2008 is currently under review. Like all ISO standards, which go through a revision every 5 years, ISO 9001 is being updated to reflect new technological advancements in the workplace and a to give a higher focus on the quality of outputs to customers.

          The review process is currently at the Final Draft International Stage (FDIS), the fifth stage of a six stage process and  the final revised ISO 9001:2015 is due to be published by September 2015. Some of the upcoming changes to ISO 9001:2008 are:

          1. The new ISO 9001 standard aligns with high-level organizational structure established on the ISO Guide 83 (“Annex SL”), requiring all new ISO management system standards to be aligned on a high-level structure with a set of common requirements. This structure aims to facilitate the implementation process and the integration of several management systems in a harmonized, structured and efficient manner. Such structure is as follow:
            1. Scope
            2. Normative References
            3. Terms and Definitions
            4. Context of the Organization
            5. Leadership
            6. Planning
            7. Support
            8. Operation
            9. Performance Evaluation
            10. Improvement
          2. Some concepts are replaced, such as the term “product” is replaced by “goods & services” and “continual” by “continual improvement.” “Purchasing” and “outsourcing” will be replaced by “external provision of goods and services”
          3. The new standard puts a greater emphasis on the “context of the organization” which implies a broader measurement, planning and implementation view.
          4. The new standard will take a risk-based approach to determine the type and extent of controls appropriate to each external provider and all external provision of goods and services. The proposed standard addresses risks which can affect conformity of goods and services as well as customer satisfaction.
          5. Senior management will be required to take a more active involvement in the quality management system.
          6. There will be general requirements for documentation, with no reference to documented quality manual, documented procedures or to quality records. The DIS refers to “Documented Information.”
          7. The need for exclusions may not be considered to be necessary in the new version of the standard but feedback on this is being sought as part of the revision process.

          Regardless of the upcoming changes, ISO 9001 will continue to be a generic standard, relevant to all sizes and types of organizations in any sector and it will continue to deliver “confidence in the organization’s ability to consistently provide product or services that meets customer and applicable statutory and regulatory requirements”.