Sunday, June 25, 2017
Tags Posts tagged with "how to"

how to

    1 2910
    ISO 9001

    A Standard Operating Procedure (SOP) is a document that consists of a set of instructions or steps on how to execute a task. A Standard Operating Procedure serves as a tool to ensure that activities are performed properly all the time and following operational, quality, environmental and safety requirements.

    Here are some recommendations on how to write Standard Operating Procedures that have a  positive impact in operations:

    1. Choose the correct format.
    Depending on the activity, the correct format should be chosen:

    • A simple steps format. This is used for routine procedures that are short and simple. These are usually a set of simple sentences highlighting step-by-step what needs to be done.
    • A hierarchical steps format. This is for long procedures (more than 10 steps) where decisions need to be made and clarifications and terminology is essential for the activity to be performed correctly. These consists of a list of main steps with substeps.
    • A flowchart format. This is used for complex procedures that could have many possible outcomes.

    2. Consider who the Standard Operating Procedure is for.

    Standard Operating Procedures are written for a variety of activities performed by a variety of people. The factors that should be considered to guarantee that the Standard Operating Procedure is understood by the person reading it are age, education, knowledge, skills, language abilities, etc. This information will determine if it’s necessary to include basic terminology, pictures, diagrams, etc.

    3. Keep the purpose of the Standard Operating Procedure in mind.

    Keeping the purpose in mind will help to include all relevant information. Some of the main reasons for creating Standard Operating Procedures are:

    • Provide all the safety, health, environmental and operational information required to perform a job properly.
    • Protect the health and safety of employees, the environment and/or the community.
    • Ensure consistency in operations and quality control of processes and products.
    • Ensure activities are completed on time.
    • Prevent failures in manufacturing and related processes.
    • Ensure compliance with company and regulatory requirements.

    4. Consider different views/perspectives.

    Ideally, Standard Operating Procedures should be written by a team that includes personnel from different areas. However, in the real world, they are written by just one person. If this is the case, the person in charge of creating them should:

    • Interview someone that performs the job, a supervisor and the people in charge of ensuring that quality, health, safety and environmental requirements are met.
    • Have people from different areas review and comment before releasing the final Standard Operating Procedure.

    5. Keep the writing simple.

    Standard Operating Procedures should be clear and concise. Sentences must be as short as possible. People usually don’t want to read Standard Operating Procedures, they have to, so making them clear and easy to read is essential.

    These are some recommendations for writing effective Standard Operating Procedures. What is most important to remember is that these documents need to be comprehensive and easy to read. If they are never read or understood by the intended audience, they are not likely to serve as an effective tool in any process.

      0 1438

      Organizations that have successfully implemented a management system may choose to seek certification by an independent third party audit from a registrar/certification body (CB). Certification can serve as a valuable tool to add credibility and to demonstrate to clients, customers and other stakeholders, that an organization’s management system meets the requirements of a given standard; thus, finding the right registrar is an important decision to be made.

      When choosing a registrar, organizations should consider the following:

      Accredited or non-accredited.

      Organizations should decide if they will contract an accredited registrar or a non-accredited one. Accreditation means that an independent, objective body (an accreditation body) recognizes that an organization is qualified to provide specific services.  Accreditation is not an obligation, and non-accreditation does not necessarily mean that an organization is not reputable; however, accreditation provides confirmation of competence by an independent body.

      If an organization is seeking certification as a regulatory or industry requirement, it is important to ensure if they are required to be certified by an accredited registrar; some clients and customers require their suppliers to do so. Organizations should ask the accreditation bodies in their countries for a lists of the registrar they have accredited.

      Relevant experience and sector expertise.

      There are many standards that an organization can be certified to (ISO 9001, ISO 14001, OHSAS 18001, ISO 22000, ISO 13485, AS9100, TS 16949, ISO/IEC 27001, ISO/IEC 50001, etc.) and when choosing a registrar, organizations should verify the registrar’s experience in the relevant standard.

      Also, it is important that the registrar has experience in the organization’s industry sector. Organizations need to ensure that the auditors know and understand the processes involved in their operations.

      The cost is important, but…

      Cost is an important factor for all organizations; however, not always the most inexpensive registrar is the most appropriate. It is possible that a certificate issued by a low-cost registrar, will not be recognized by clients, customers and other stakeholders. Therefore, even though the cost needs to be considered, it should not be the determining factor for the selection of the registrar.

      Meet them before choosing them

      Organizations should evaluate several registrar and schedule a meeting with them before making their final choice. This will allow them to “sense” if a good working relationship will be possible to establish. After the certification audit, the registrar auditors will visit the organization once or twice a year if they consider it necessary to maintain certification, so an active and reliable relationship will need to be developed between the two.

      Choosing a registrar should not be a decision taken lightly. A good selection process will ensure the credibility and value of the certificate issued, which will ultimately provide a valuable asset to the certified organization.

        0 2181
        Accreditation bodies allow organizations seeking accreditation can demonstrate to their customers that they have been successful at meeting the requirements of international accreditation standards.

        Third-party auditors are those who perform an external and independent audit of an organization’s management system to evaluate if it meets the requirements of a specific standard; if successful, this third-party audit will provide the organization with certification or registration of conformity with the given standard.

        A third party audit is carried out by a Registrar/Certification Body (CB) hired by the organization; therefore, in order for someone to be a third-party auditor, he/she needs to be employed by a CB. All CB, before hiring an auditor, need to ensure that the auditor possesses the knowledge and skills necessary to achieve the intended results of the audits they are expected to perform. Some of these are described below.

        • Personal attributes that will enable them to act in accordance with the principles of auditing, which include ethical conduct, fair presentation, due professional care, independence, and free use of an evidence-based approach.
        • Knowledge on the contents of ISO 19011: 2011, Guidelines for auditing management systems.
        • Knowledge and skills on audit principles, procedures and methods, which will enable them to conducted audits in a consistent and systematic manner.
        • They should be able to exhibit professional behavior during the performance of audit activities, including being ethical, open-minded, diplomatic, observant, perceptive, versatile, tenacious, decisive, self-reliant, open to improvement, culturally sensitive, and collaborative.
        • Knowledge and skills on management system and reference documents that will enable them to comprehend the audit scope and apply audit criteria.
        • Sector specific knowledge which will enable them to comprehend the organization’s structure, business, management practices and the legal and contractual requirements applicable to the organization being audited.

        As indicated in ISO 19011, someone pursuing to become a third-party auditor can acquired all these knowledge and skills by using a combination of the following:

        • Formal education/training and experience that contribute to the development of knowledge and skills in the management system discipline and sector the auditor intends to audit.
        • Training programs that cover generic auditor knowledge and skills.
        • Experience in a relevant technical, managerial or professional position involving the exercise of judgment, decision making, problem solving and communication with managers, professionals, peers, customers and other interested parties.
        • Audit experience acquired under the supervision of an auditor in the same discipline.

        After acquiring all the necessary knowledge and skills and successfully being employed by a CB, third-party auditors must pledged to advocate a particular code of ethical conduct in the performance of an audit and they must abide the internal policies and rules of the CB that hires them. All these requirements must be followed in order to protect everyone involved in the audit process.

          0 973

          If your organization is ready to become ISO 9001 certified, there are a number of steps you can expect to go through on your path to certification. Once an organization has decided to obtain certification and has made a choice of the certification body (CB), the organization must:

           Make a formal certification application to the CB.

          • Fill out the application forms, which require a large amount of information about the organization and its operations. This will enable the CB to determine the scope of the certification activities and to appoint the team leader for the audit process.

           The initial certification audit consists of a two-stage audit as described below:

           The Stage 1 Audit determines if an organization is ready or not for a compliance audit.

          • Organizations need to supply all relevant management and quality documentation to the CB.
          • The CB determines if the organization is ready or not to undergo Stage 2 or compliance audit.
          • If the organization is not ready, the CB will inform accordingly and stop the process.
          • If the organization is ready, but a few nonconformities have to be rectified before the compliance audit can take place, the CB will provide the organization with a report.
          • After nonconformities have been corrected, the organization must inform the CB, and if they concur with the actions taken, a compliance audit is arranged.

           The Stage 2 Audit evaluates the implementation and effectiveness of the organization’s QMS.

          • The team leader assembles a team of auditors and experts concomitant with the organization’s scope of activities, complexities and size of operations.
          • A time for the audit is agreed and scheduled.
          • Auditors will assess whether the contents of the documentation provided is consistent with the activities of the organization as well as the requirements of the standard.
          • Overall findings and the list of non-conformities (if any) are presented.
          • If the QMS complies with the requirements, the team will recommend to the certification committee of the CB that the organization should be certified.
          • If there are non-conformities found, the team will agree with the organization a time schedule (typically 3 months) and the modalities for rectifying the non-conformities.
          • The team may wish to witness the new procedures, or if the non-conformities are of a minor nature, the organization can send them evidence that these non-conformities have been fixed.
          • The team will recommend to the certification committee of the CB that the organization should be certified.

          Learn more about Stage 1 and 2 audits.

          Certification

          • Authorized persons or a committee which was not involved in the audit will review the audit report and the clearance report of the nonconformities and make a decision regarding certification.
          • The decision will be followed by the issue of certification documents.

           Surveillance Audits

          • The CB will conduct a surveillance audit usually once a year.
          • There are a few areas that will always be included in the surveillance audit, such as internal audits and management reviews as well as the non-conformity system.
          • If any non-conformity is raised during the surveillance audits, the organization must correct them efficiently within an agreed time frame, otherwise certification may be lost.

           Recertification Audit

          • In the third year of certification, a re-certification audit will be conducted, similar to the original compliance audit.
          • If this is negotiated successfully, the organization will be recertified for another three-year period, and the whole cycle repeats itself.