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.
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