The standard includes requirements for the development and maintenance of the certification scheme for persons upon which the certification is based. The major changes between the version and the version is the detailed information regarding the development of the scheme for certification of persons. The version required the Certification Body to have a Scheme Committee who had overall responsibility for the development of the scheme but did not elaborate on the components that must be included in the scheme.
The version has an entire clause Clause 8 that provides detailed information regarding the components that must be included in the development and maintenance of the scheme but allows the scheme owner to be outside of the Certification Body for Persons.
Other changes include a change in reference of " Personnel Certification Body " to "Certification Body for Persons", defining of additional terms such as "validity" and "reliability", and the addition of a "principles" section that defines the foundational principles for the standard. This section describes the general requirements for Certification Bodies for Persons. General requirements include criteria for the legal status of the Certification Body for Persons the certification body must be a legal entitycriteria associated with the financial resources and liability responsibilities of the Certification Body for Persons the certification body must have sufficient finances to cover its liabilities and for the operation of the entityrequirements regarding the impartiality and impartial operation of the Certification Body for Persons, and requirements that the Certification Body for Persons maintains responsibility for the decision on certification the decision to award certification to a person cannot be outsourced to any other body.
This section describes the structural requirements for Certification Bodies for Persons. Structural requirements contain criteria for the organizational structure of the Certification Body for Persons including how it is managed. Specific requirements relating to the structure of the Certification Body in relation to training is included in this section. Specifically, if the certification body also offers training it must demonstrate how the impartiality of the certification is not compromised by the training.
This section describes the resource requirements for Certification Bodies for Persons. Resource requirements include criteria for the personnel and staff of the Certification Body for Persons. Specific requirements for persons both internal to the organization and external to the organization such as consultants and volunteers involved in certification activities are included as are criteria associated with outsourcing to other bodies.
This section also includes requirements for other resources such as examination equipment required to operate the certification activities. This section describes the records and information requirements for Certification Bodies for Persons.
The requirements include criteria relating to the records of applicantscandidates and certified persons. Requirements regarding information that must be made public as well as information that must be kept confidential are included in this section and criteria for the information security exam papersetc. This section includes requirements for the development and maintenance of the certification scheme. The certification scheme is the competence and other requirements for awarding the certification to a person and includes a scope of certification, job and task descriptionrequired competence, abilities when applicableprerequisites when applicableand a code of conduct when applicable.
Criteria for the initial certification and recertification must be part of the scheme and includes description of the assessment methods, and the criteria for suspending and withdrawing the certification. This section includes requirements for the certification process including criteria for the certification application process, assessment process, examination process, and the decision on certification.
Criteria for suspending, withdrawing or reducing the scope of certification and recertification requirements are included in this section.UKAS accredited inspection bodies are classified into three types Type A, Type B and Type C based on the inspection body's relationship to the parties involved, its organisation structure, and its responsibilities and ownership.
Type A bodies provide third party services; Type B bodies are separate and identifiable entities, and can only provide inspections to its parent company. Type C bodies are identifiable entities but may not be a separate part of the organisation. Type C can also supply inspection services to parties other than the parent organisation. It is UKAS' task to assess the competence and to establish the type of independence for each applicant for accreditation.
New comprehensive FAQs available and positive feedback on preparing for accreditation Read More. With immediate effect, UKAS will be conducting all assessments remotely. EC's urgent request regarding capacity for testing surgical masks in EU. Includes EA guidance communication. Watch this webinar for an update on our Biobanking accreditation project to ISO See our latest article about blockchain, an emerging technology leading Industry 4.
In April, we will be implementing changes to the structure of our Operations Team to IAF CertSearch, the largest global database for accredited certifications, has been launched. A list of the most frequently asked questions in relation to UKAS and accreditation is New industry position statement published regarding accredited certification. Inspection body accreditation Apply for accreditation What are the costs of accreditation?
Get Accredited The Route to Accreditation. Further information: Apply for accreditation The route to accreditation What are the costs of accreditation?Ocjenjivanje sukladnosti provode tijela za ocjenjivanje sukladnosti laboratoriji, inspekcijska tijela i certifikacijska tijela.
Inspekcijska tijela su tijela koja provode ocjenjivanje sukladnosti proizvoda, procesa ili sustava. Inspekcijska tijela koja provode inspekcijske aktivnosti moraju biti nepristrana i osigurati povjerljivost informacija koje saznaju tijekom inspekcije.
Inspektori koji provode inspekciju moraju biti objektivni i nepristrani u svojemu radu. Dana 1. Hrvatsko izdanje norme nije prevedeno na hrvatski jezik, jedino je dostupna verzija na engleskome jeziku. Zahtijeva se da inspekcijsko tijelo prepozna rizike nepristranosti na trajnoj osnovi. To mora obuhvatiti one rizike koji proizlaze iz njegovih aktivnosti, njegovih odnosa ili odnosa njegova osoblja.
Inspekcijsko tijelo mora biti neovisno do mjere koja se zahtijeva s obzirom na uvjete pod kojima obavlja svoje usluge.
Inspekcijsko tijelo mora ispunjavati minimalne zahtjeve propisane u dodatku norme. Inspekcijsko tijelo koje je dio pravnoga subjekta koji obavlja i druge aktivnosti osim inspekcije mora biti prepoznatljivo unutar toga subjekta. Inspekcijsko tijelo mora imati dokumentaciju koja opisuje aktivnosti za koje je ono osposobljeno.
Rezultati monitoringa moraju se koristiti kao sredstvo prepoznavanja potreba za osposobljavanjem. Noriaki Kano poznato je ime u svijetu upravljanje kvalitetom. U RH je trenutno akreditirano tijela za ocjenjivanje Tvrtka SGS Adriatica d.
Cilj seminara: Seminar predstavlja kombinaciju One daju kratke upute o tome kako ostvariti UDEM Adriatic d. IFS je pokrenuo Program Akademije je modularan. Sastoji se od 4 modula namijenjena za rad u skupinama i individualnog mentoringa.
U srijedu, SGS grupa izradila je dva pregledna dokumenta o promjenama u novim izdanjima normi ISO i ISO te smjernicama po pitanju aktivnosti koje, organizacije koje su certifirane prema starim izdanjima normi, trebaju provesti u cilju U odnosu na broj izdanih certifikata u In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. There have been three releases; inand The most significant changes between the and release were a greater emphasis on the responsibilities of senior management, explicit requirements for continual improvement of the management system itself, and communication with the customer.
It also aligned more closely with the version of ISO . The version of the standard comprises five elements; Normative References, Terms and Definitions, Management Requirements, and Technical Requirements.
Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements include factors that determine the correctness and reliability of the tests and calibrations performed in the laboratory.
General Requirements and Structural Requirements are related to the organization of the laboratory itself. Structure Requirements cite those issues related to the people, plant, and other organizations used by the laboratory to produce its technically valid results.
Process Requirements are the heart of this version of the standard in describing the activities to ensure that results are based on accepted science and aimed at technical validity. Management System Requirements are those steps taken by the organization to give itself quality management system tools to support the work of its people in the production of technically valid results. Some national systems e. Additionally, the laboratory will be expected to keep abreast of scientific and technological advances in relevant areas.
In common with other accreditation standards of the ISO series and unlike most ISO standards for management systemsassessment of the laboratory is normally carried out by the national organization responsible for accreditation. In short, accreditation differs from certification by adding the concept of a third party Accreditation Body AB attesting to technical competence within a laboratory in addition to its adherence and operation under a documented quality system, specific to a Scope of Accreditation.
Around the world, geo-political regions such as the European Communityand Asia-Pacific, the Americas and others, established regional cooperations to manage the work needed for such mutual recognition. In the U. These bodies accredit testing and calibration labs, reference material producers, PT providers, product certifiers, inspection bodies, forensic institutions and others to a multitude of standards and programs.
It does not matter which AB is utilized for accreditation. The MRA arrangement was designed with equal weight across all economies.
ABs include:. The CLAS program provides quality system and technical assessment services and certification of specific measurement capabilities of calibration laboratories in support of the Canadian National Measurement System.
In other countries there is often only one Accreditation Body. Typically these bodies encompass accreditation programs for management systems, product certification, laboratory, inspection, personnel and others:. From Wikipedia, the free encyclopedia. It also aligned more closely with the version of ISO  The version of the standard comprises five elements; Normative References, Terms and Definitions, Management Requirements, and Technical Requirements.
Retrieved 27 March McIntyre Retrieved 28 February Archived from the original on Retrieved American Association for Laboratory Accreditation. Retrieved 29 May ISOentitled "General Criteria for the Operation of Various Types of Bodies Performing Inspection", is an internationally recognized standard for the competence of inspection bodies. In addition EHS recommends the following additional procedures as a minimum supplement to the required procedures:.
We can:. Click Contact Us to send us your comments or to request information about our ISO services and capabilities. Of course, you may also contact us by telephone, toll-free, at In Maryland - In Virginia - Or email us: info ehsservices. We can: Conduct an initial gap analysis Help you establish policies and objectives Identify documentation requirements Make assignments and prepare schedules Prepare documentation Coordinate document preparation, reviews, approvals, and production Prepare the following key documents: Quality Policy Quality Manual Procedures Master List of Documents Manage implementation schedules, training, follow-up actions Help you select a Registrar that has experience in your industry Prepare status reports and monitor progress Conduct training Conduct internal audits Request registration Conduct vendor and supplier audits Conduct customer satisfaction surveys Develop quality system intranets to help you manage your documents For additional information: Click Contact Us to send us your comments or to request information about our ISO services and capabilities.
Overview of ISO The requirements of ISO are contained in 14 major sections including: Administrative requirements Requirements for independence, impartiality, and integrity Confidentiality Organization and management Quality system Personnel Facilities and equipment Inspection methods and procedures Handling of inspection samples and items Control of records Inspection reports and inspection certificates Subcontracting Complaints and appeals Cooperation with other inspection bodies Like ISO and ISOISO requires procedures in several important areas, including:.
Procedure to ensure that persons or organizations external to the inspection body cannot influence the results of inspections by the ISO accredited organization. Procedure for feedback. Procedure for corrective action. Procedure for the care and maintenance of equipment. Procedure for selecting qualified suppliers. Procedure for purchasing. Procedure for inspection of materials received by the organization.
Procedure for appropriate storage facilities. Procedure for protecting the integrity of data produced by the organization.
Procedure for ensuring the security of data produced by the organization. Procedure for dealing with defective equipment. Procedure s for performing inspections. Procedure s for performing non-standard inspections. Procedure s for avoiding deterioration or damage to inspection items. Procedure for dealing with complaints. Procedure for dealing with appeals against the results of inspections.
Control of non-conforming work. Preventive action. Internal auditing. Management review. Calibration of equipment. Contract review. Document control. Records control. Reporting the results of an inspection. Conduct an initial gap analysis.
Help you establish policies and objectives. Identify documentation requirements. Make assignments and prepare schedules. Prepare documentation. Coordinate document preparation, reviews, approvals, and production. Prepare the following key documents:.Ovisno o stupnju neovisnosti, razlikuju se inspekcijska tijela vrste A, B, C. Inspekcijsko tijelo mora provoditi svoje aktivnosti potpuno nepristrano.
Rizici koji bi mogli ugroziti nepristranost moraju se prepoznavati u svakodnevnom radu. Uprava inspekcijskog tijela mora se opredijeliti za nepristranost. Neovisnost inspekcijskog tijela definirana je kroz tri vrste tijela: A, B, C, i za svaku pojedinu vrstu navedeni su potrebni zahtjevi.
Inspekcijsko tijelo mora biti pravni subjekt, ili biti dio pravnog subjekta. Ono mora imati dokumentaciju koja opisuje njegove aktivnosti. Zahtjevi za osposobljenost moraju biti definirani. Svaki inspektor mora se provjeriti u radu. O osoblju se moraju voditi zapisi. Nadalje, inspekcijsko tijelo mora imati na raspolaganju objekte i opremu koja mu je potrebna za pravilno obavljanje inspekcijskih poslova.
Za opremu koja se umjerava mora biti uspostavljen program umjeravanja. Inspekcijsko tijelo mora imati dokumentirane postupke za postupanje s neispravnom opremom i mora voditi sve potrebne zapise o opremi.
Nadalje, mora koristiti prikladno dokumentirane upute za planiranje inspekcije. Inspekcijsko tijelo mora imati sustav upravljanja ugovorima i radnim nalozima. Read more Dobra laboratorijska praksa DLP - Dobra laboratorijska praksa GLP - Good Laboratory Practice je sustav upravljanja laboratorijima koji osigurava pouzdanost rezultata ispitivanja koja provode laboratoriji. Opisujemo postupak akreditacije od upita za akreditaciju do dobivanja Potvrde o akreditaciji na osnovu vlastitog iskustva akreditiranog laboratorija.
Many of these industries and governments are shifting towards requiring third-party accreditation of the CBs which certify the products, processes, or services entering or being used in the country or region where the regulators have oversight responsibilities. Without a Certification Scheme, there is no information about the criteria with which the certified product, process, or service complies.
ISO has begun harmonizing the general layout of its international standards and is moving towards an 8-section layout with which future standards new documents as well as revisions to current standards will align. Impartiality is stressed throughout the standard, and the deviation away from requiring complete independence from other bodies is a positive change in the modern world.
The writers of this international standard acknowledged the intricate web of relationships between businesses including their employees and contractors and other people and organizations, and realized that to require pure independence would create significant barriers to the certification of products and to their final market destinations.
There are some independence-like restrictions placed on certain personnel within the CB in Section Four of the standard, but these are generally set forth in such a manner as to clearly ensure that the final certification decisions are made by persons without a material interest in the product receiving its desired certification.
Business relationships between the CB and other interested parties are permitted so long as the CB can account for any potential risks to its impartiality, and can address those risks in an appropriate manner.
This section is relatively short and straightforward, but the publication of this standard incorporated something that was not present in previous iterations, that is, the mechanism for impartiality. Evaluation is discussed in more detail in section seven of the standard, but typically involves process es such as testing, inspecting, auditing, or otherwise gathering information on the characteristics of the product being certified in order to later compare that information against the scheme requirements.
If a CB chooses to use an external resource subcontractor for its testing or other evaluation tasks, the standard further defines the requirements that the CB must meet in order to justify use of that external resource.
Ultimately, the CB is responsible for the evaluation results it chooses to use in its decision-making process, but the standard has laid out steps that must be followed in all cases. Section Seven of the standard covers the requirements the CB must follow while performing the various steps in the certification process. This section also includes the required information on documents given to the client to signify that their product, process, or service has been certified.
Furthermore, Section Seven of the standard discusses the situations when surveillance activities are necessary. Many of the requirements are similar to those found in ISO The CB must have a collection of management system documents note that this standard has done away with the concept of requiring a central quality manual, an idea present in many previous conformity assessment standardscontrolled documents and records, and must perform management reviews and internal audits in accordance with defined procedures and schedules.
We have mentioned previously the fact that many regulators are beginning to or currently do leverage existing conformity assessment infrastructures in their regions, leaning on recognized third-party Accreditation Bodies ABs to accredit CBs for certain types of products, processes, and services that are the responsibilities of those regulatory agencies.
Oftentimes these regulators also attend the peer evaluations as observers in order to form their own opinions of the AB before beginning a business relationship to recognize the accreditations granted. Many ABs and other independent organizations offer training on the standard to educate CBs, their clients, and other stakeholders in the certification process about these requirements in depth.
Save my name, email, and website in this browser for the next time I comment. Section Seven—the Certification Process Section Seven of the standard covers the requirements the CB must follow while performing the various steps in the certification process.
Accrediting the Certification Bodies We have mentioned previously the fact that many regulators are beginning to or currently do leverage existing conformity assessment infrastructures in their regions, leaning on recognized third-party Accreditation Bodies ABs to accredit CBs for certain types of products, processes, and services that are the responsibilities of those regulatory agencies. Conclusion Many ABs and other independent organizations offer training on the standard to educate CBs, their clients, and other stakeholders in the certification process about these requirements in depth.
Leave a Reply Cancel Reply Your email address will not be published.