Understanding the Key Standards Documents and Importance of ISO 17021

 

The important standard ISO 17021 lays out requirements for organizations that audit and certify management systems. These organizations are essential in ensuring that companies follow globally accepted standards in a variety of industries.

Several important readymade ISO 17021 documents that describe the processes, standards, and requirements needed for certifying organizations to function efficiently and impartially are hidden behind the scenes of ISO 17021 audits.

Understanding ISO 17021

The purpose of ISO/IEC 17021 is to evaluate certification organizations to make sure they meet all kinds of management system requirements and are competent. Typically, these entities are referred to as registrars or Certification Bodies (CBs). In 2015, a revised version of ISO/IEC 17021 was released. The standard contributes to the assurance of CBs' objectivity and the consistency of their audit findings.

Important Key Documents for ISO 17021

·         Requirements for Audit and Certification Bodies, ISO/IEC 17021-1: The general conditions that certification organizations need to fulfil to successfully perform audits and certify management systems are outlined in these documents. It addresses standards including staff competency, impartiality, independence, and secrecy. Accreditation of certification bodies is contingent upon their demonstration of conformity with these conditions.

·         ISO/IEC 17021-2: Standards for Management System Audit and Certification: Additional standards unique to the audit and certification process for different management systems are outlined in ISO/IEC 17021-2. It contains standards for organizing audits, carrying them out, and deciding which ones to certify. This document guarantees uniformity and dependability in the way that audits are carried out and certification judgments are made amongst various certification authorities.

·         ISO/IEC 17021-3: Requirements for Competency in Environmental Management System Auditing and Certification: The competency standards for individuals conducting audits and certifications of environmental management systems (such as ISO 14001) are outlined in this section of ISO 17021. It guarantees that auditors have the know-how, expertise, and experience needed to evaluate environmental management systems successfully.

Why ISO 17021 Documents Are Important?

·         Ensuring Consistency and Impartiality: ISO 17021 standards provide certification bodies with explicit criteria and recommendations to ensure impartiality and consistency. By doing this, audits are carried out impartially, free from bias or conflicts of interest, and auditing methods are encouraged to be consistent.

·         Enhancement of Credibility: Certification organizations increase their dependability and credibility by adhering to ISO 17021 standards. Accredited certification bodies have proven their competence and ability to perform thorough audits in compliance with international standards, so organizations pursuing ISO 17021 accreditation can feel secure in their qualifications.

·         Encouraging Worldwide Accreditation: ISO 17021 certification encourages worldwide recognition of credentials from recognized organizations. Ensuring that certifications are acknowledged and accepted globally, facilitates trade and improves certified firms' access to markets.

·         Continuous Improvement: To keep ISO 17021 compliance, certification bodies need to keep an eye on and refine their procedures on regularly. Because of this dedication to ongoing development, auditing procedures are guaranteed to adapt to new legal mandates and industry best practices.

To sum up, ISO 17021 and the documents that go along with it are essential for guaranteeing the reliability, consistency, and objectivity of audit and certification procedures for management systems all over the world. These standards give certification bodies the structure they need to function effectively and independently, giving stakeholders and certified firms trust. Certification organizations exhibit their dedication to quality and bolster the dependability and credibility of the certification procedure by complying with ISO 17021 standards. Organizations aiming to achieve operational excellence and sustainability are supported in their efforts by the strong framework offered by ISO 17021. In summary, ISO 17021 is more than just a series of guidelines; it is the foundation of quality control in the certification sector, encouraging transparency,

 

 

 

Explore the Steps for ISO/IEC 17065 Audit Preparedness

 

When considering an ISO/IEC 17065 audit, the sense of excessive complexity is frequently evoked. The rigorous requirements specified by ISO/IEC 17065 guarantee the knowledge and objectivity of conformity assessment agencies. A complex web of processes, documents, and systemic complexity must be navigated to prepare for the audit. This guide provides a clear road map for navigating the necessary strategies and advice to prepare for an ISO/IEC 17065 audit.

What is ISO 17065?

An important international standard called ISO/IEC 17065, describes what organizations must do to certify goods, procedures, and services. It guarantees expertise, consistency, and objectivity and acts as a standard against which certifying bodies can compare their performance, giving stakeholders confidence and assurance.

Maintaining certification validity and ISO/IEC 17065 compliance requires regular audits. The standard's development aligns with other standards for conformity assessment, providing an integrated approach for certification processes.

Sector Standard Relevant to Compliance:

·         ISO/IEC 17020: Inspection Bodies

·         ISO/IEC 17021: Management Systems Certification Bodies

·         ISO/IEC 17024: Personnel Certification Bodies

·         ISO/IEC 17025: Testing and Calibration Laboratories

·         ISO/IEC 17065: Product, Process, and Service Certification Bodies

Understanding the ISO 17065 Auditing Process

An ISO/IEC 17065 audit serves several purposes.

·     As defined in ISO/IEC 17065:2012, it aims to guarantee adherence to particular international standards and management system criteria.

·   A certification body's operating procedures and certification activities are intended to be improved in areas that are identified through the audit process.

·   Checking the certification body's procedures against relevant standards like ISO/IEC 17020, ISO/IEC 17024, ISO/IEC 17025, and others that fall within its scope is a crucial goal in ensuring the processes are as effective as possible.

ISO 17065 Audit and Its Criteria

Specifying the parameters and extent of the audit process is part of defining the audit's scope. Usually, it involves the examination of:

·         Requirements for the Certifying Body's Structure: Making sure it has the right kind of structure.

·         Resource Requirements: Assessing the availability and administration of essential resources.

·         Process Requirements: Determining certification state and doing certification scheme analysis.

·    Requirements for the Management System: Assessing the quality management system's efficacy, taking remedial action and reviewing procedures.

Each of these elements is necessary to guarantee that the certification body complies with ISO/IEC 17065, offering dependable and skilled service certification.

Steps in Preparation for the Audit

Carrying Out a Gap Analysis: Start with a comprehensive gap analysis to ensure a strong basis for the ISO/IEC 17065 audit. Finding the differences between your present procedures and the strict rules of the ISO/IEC 17065 international standard is part of this process. To effectively

·         Perform a gap analysis: Examine the requirements of ISO/IEC 17065:2012 about the practices of your certifying authority.

·         To identify differences, compare your current procedures with the standard.

·         To create a precise action plan for filling the gaps, record the results.

Building a Team for Preparation: An efficient audit preparation team is the first step towards an effective audit. To explain the significance of the audit to the entire strong, high management participation is essential. The group should have clear responsibilities, like:

·         Head of the Project: Supervising the setup and making sure that all deadlines are fulfilled.

·         Internal auditor(s): Evaluating internal procedures and proposing ideas for advancement.

·         Quality Manager: Ensuring that the requirements of the quality management system are met.

·  Technical Expert(s): Offering advice on the complicated procedures involved in the certification process.

Allocate Resources: Completing an ISO/IEC 17065 audit successfully depends on obtaining the required resources. The following should be included in resource planning:

·         An established budget to pay for the planning and execution of the audit.

·         Sufficient infrastructure and technology support to fulfil the requirements of the conformity assessment body.

·         Levels of staffing to assist the auditing process and carry out any corrective measures.

Documents and Record Keeping

Keeping Accurate Records: Precise record-keeping and readymade ISO 17065 documents are essential for a certifying body preparing for an ISO/IEC 17065 audit. Internal audit reports, remedial action records, certification decision records, and complaint and appeals records are among the many types of documents that must be kept. Correct internal audit records that show compliance with management system specifications and product/service certification programs are essential to the effectiveness of audits.

Document Control System: Ensuring that all required records are arranged, easily accessible, and protected from loss or unauthorized changes requires a strong document control system. This system needs to be able to manage different versions of documents, maintain the confidentiality of the certification operations, and keep the integrity of the management review process.

Review and Update the Documents: To ensure continual improvement, conformity with ISO/IEC 17065:2012 standards, and preparedness for internal and external audits, certification documentation must be reviewed and updated regularly.

Training and Awareness

Staff Training Programs: Programs for staff training like ISO 17065 awareness training are crucial for preparing for ISO/IEC 17065 audits because they guarantee competence with procedures of certifying bodies and global standards and encourage ongoing development.

To Build Audit Awareness: Audit awareness is crucial for compliance with ISO/IEC 17065 and other standards, and personnel should be educated on audit processes and objectives during preparation.

 

The 12 Essential Components of an ISO 15189 Quality Management System in Medical Laboratories

 

In medical laboratories, quality management is more important than anywhere else. Even a small mistake, such as misidentifying a patient or mixing up a specimen, might have disastrous consequences. The life sciences laboratories are subject to rigorous quality management regulations that cover everything from equipment to customer service. Understanding the 12 key components of quality management implementation in medical laboratories will enable you to confidently push your lab's quality management to new heights in 2024 and steer clear of potentially fatal errors.

Maintaining the highest standards of quality is critical in the field of laboratory operations. The foundation of a laboratory's operations is its Quality Management System (QMS), which guarantees process and procedure dependability, correctness, and consistency. Under the guidance of prestigious institutions such as ISO 15189 and the Clinical and Laboratory Standards Institute (CLSI), laboratories endeavour to exemplify excellence in all aspects of their functioning. Let's take a closer look at the 12 crucial elements that make up a strong QMS.

·         Establishing a Quality System in Organization: A structured QMS that promotes a culture of quality is the cornerstone of any successful laboratory. Every person, from the management group to the quality unit, is essential to maintaining standards and guaranteeing uniformity in practices. The structure of the organization should facilitate continuous evaluation and enhancement of the quality procedures.

·         Employee Development in Terms of Skill and Knowledge: The people working in a laboratory are its most precious resource. Employees who possess these qualities are the foundation of high-quality operations. Using all-encompassing ISO 15189 training, incentive, and engagement programs, laboratories enable their employees to continuously provide quality work. Transparency and accountability are ensured through the QMS's documentation of training procedures.

·         Equipment that Ensures Reliability and Safety: To ensure safe operation, all laboratory equipment needs to be maintained. To maintain the best possible quality, laboratories must also keep an eye on the installation of equipment, the suppliers of that equipment, calibration procedures, and the need to replace that equipment.

·         Purchasing and Inventory for Safeguarding Supply Chain Integrity: For supplies and raw materials to be consistent in quality, effective supply chain management is essential. Good inventory management procedures ensure that items are stored without contamination or deterioration. Sustaining greatness requires collaborating with reliable suppliers who adhere to strict quality management requirements.

·         Process Control for Ensuring Accuracy and Precision: The basis of laboratory quality assurance is process control. Rigorous Quality management procedures guarantee testing techniques' precision and accuracy from sample collection to validation. Laboratories maintain the integrity of their results by following defined processes, which gives stakeholders confidence.

·         Information Governance: Maintaining Data Integrity: Data from test findings to patient information are produced in enormous quantities in laboratories. It's critical to handle this data precisely and safely. To preserve data integrity and comply with legal requirements, controlled access protects confidentiality while making information accessible to authorized workers.

·         Create and Maintaining Records and Documents: Standardized records and editable ISO 15189 documents, most notably Standard Operating Procedures (SOPs), are essential to efficient quality management. These records provide as a guide for procedures, guaranteeing uniformity and adherence to industry standards. The core values that guide document management in the QMS are security, accuracy, and accessibility.

·         Occurrence Management for Finding and Solving Problems: Errors or non-conformances in laboratory activities are inevitable. Through thorough surveillance and investigative processes, a strong QMS makes it easier to identify and address such incidents. Laboratories reduce hazards and maintain quality standards by addressing the underlying causes and putting corrective measures in place.

·         Evaluation: Comparing laboratory performance to internal quality standards or external data sets, like industry benchmarks, is the process of assessment. The actions of lab or quality management managers, internal auditors, or external inspectors are all included in laboratory quality management assessments.

·         Enhancement of Process that Encouraging Ongoing Improvement: An efficient QMS places a strong focus on ongoing improvement. Laboratory operations promote a culture of innovation and improvement by combining quality assurance, control, and corrective actions. Processes are improved by rigorous analysis and feedback loops, which raise productivity and produce higher-quality results.

·         Client Support: A laboratory's ultimate purpose is to serve its customers. The creation of consistently high-quality products or other missions that consistently give a positive customer experience should be supported by a laboratory's QMS. To progress, the laboratory must comprehend its clients' demands and make use of their input.

·         Maintaining Highest Quality Standards for Safety: Maintaining a clean, safe, and secure environment is essential to laboratory operations. Thorough protocols oversee the operation of the facility; these include ergonomic concerns, hazard containment processes, and physical security measures. Laboratory safety and environmental management are given top priority, demonstrating the labs' dedication to excellence.

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