ISO/IEC 17020:2012 Conformity Assessment

Overview

The ISO/IEC 17020:2012 Standard for Conformity Assessment is an essential standard for any organization seeking to perform inspections on behalf of organizations, clients or authorities.

The standard includes all activities performed by an inspection body including examining products, installations, plants, processes, procedures, services and determining their conformity and the reporting of results. A certain degree of professional judgement and expertise is required when conducting inspections and the ISO/IEC 17020:2012 standard can be used as a required or screening document of accreditation for any organization seeking to conduct inspections.

It applies to inspection bodies of type A, B or C, as defined in ISO/IEC 17020:2012, and it applies to any stage of inspection.  Inspections, testing, and certification can often overlap due to the fact these activities all share common elements however inspections require a certain level of professional judgement and competence to determine acceptability against general requirements.

Basic Requirements for ISO 17020

ISO 17020 requires:

• 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 9001 and ISO 17025; ISO 17020 requires procedures in several important areas:

• Procedure to ensure that persons or organizations external to the inspection body cannot influence the results of inspections by the ISO 17020-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
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Who Should Get Certified?

• Any company that wants to assure customers / government that the facility has a robust system and can produce valid results on test services, saving and conserving Quality.
• A good ISO 17020 consulting firm can provide a detailed explanation of the intent of the standard and build a safe laboratory system.
• A comprehensive 17020 system creates confidence in end users, government, statutory and regulatory agencies
• An ISO 17020 consulting firm provides the techniques for implementing the system. Hence any facility seeking comprehensive system must get certified.
• Consulting firm can provide auditing services to help the facility to verify the accuracy and adequacy of implementation. Companies hoping to have world class service and accuracy in their work must get ISO 17020 Accreditation.
• Internal Quality Audit is conducted by ISO 17020 consultants help find deficiencies in their implementation, make corrections and take corrective actions. ISO 17020 Accreditation streamlines these processes.
• An annual surveillance audit is conducted to ensure maintenance of an ISO 17020 Accreditation laboratory.
• Consulting firms provide distinction in documentation between repeatability and reproducibility of test results.
• ISO 17020 Accreditation is renewable every three years.
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Process for Getting ISO 17020 Certification:

Process of ISO Accreditation starts with preparation of a Quality Management System. (QMS) and the process of ISO 17020 Accreditation starts with developing ISO 17020 Conformity Assessment and System.

ISO Consultants assist in developing a comprehensive QMS to meet all requirements of ISO 17020 and 3rdParty Accreditation Body Stage 1 Audit requirements. The Stage 1 Audit from ISO 17020 Accreditation Bodies vary depending on the selected Accreditation Bodies which verifies the documented system meeting all ISO 17020 requirements or not.

An ISO 17020 consulting firm provides the techniques for implementation, and trains the organization’s internal auditors to become competent to perform internal audits or provides ISO Internal Auditing Services to audit all processes, all ISO 17020 Standard requirements and effective implementation of ISO 17020 Standard.

Once the System is ready, one full cycle of Internal audits is performed and one Management review is conducted prior to inviting a Accreditation Body to perform ISO 17025 Accreditation Audit.

Accreditation Bodies conduct Audit in 2 stages. During Stage 1, ISO audit evaluates the documentation system and basic requirements of meeting ISO 17020 Requirements.

Accreditation Body returns for final audit where all ISO 17020 standard requirements are thoroughly audited to ensure that requirements are met and documentary evidence exists to demonstrate compliance.

Once Accreditation Body is satisfied for compliance, the recommendation is sent to accrediting agencies to issue ISO 17020 Accreditation.

Benefits of ISO/IEC 17020

• Incorporates same level of requirements for the organizational quality management system as ISO 9001 and ISO/IEC 17000 Series
• Puts greater emphasis on organizational ability to manage impartiality and conflicts of interest, as well as the technical competence of people, inspection processes and equipment
• Provides assurance of technically competent service and consistently reliable results
• Reducing costs and lowering risks
• Demonstrates products, equipment, structures and systems meeting required specifications
• Governments and industries around the world are increasingly requiring use of accredited inspection services
• Allows an organization to demonstrate integrity, reliability and Good Practices to their customers