ISO/IEC 17065:2012
Objective
• Identification of new/changed requirements in
ISO/IEC 17065:2012 and the implications of
these changes for certification bodies
• Transition rules
• Belac documents
ISO Website
• More detailed information on the
development etc of ISO/IEC 17065 can be
found via the ISO website:
– www.iso.org/iso/home/about/conformityassessment/conformityassessment_resources.htm
What is new/revised in ISO/IEC
17065:2012?
• General:
?
What is new/revised in ISO/IEC
17065:2012?
• General:
– maintain proven requirements of ISO/IEC Guide
65 but improve where necessary
– aligned with new structural requirements decided
by ISO CASCO (i.e. now 8 ‘sections’ not 15)
– requirements of ISO/PAS included (i.e. 1700117005) re impartiality, confidentiality, complaints
etc etc
– no detailed requirements for ‘certification
schemes’ (& replacing ‘certification system’)
– principles (Annex A)
What is new/revised in ISO/IEC
17065:2012?
• Terms & definitions (3):
?
What is new/revised in ISO/IEC
17065:2012?
• Terms & definitions (3):
– client
– consultancy
– evaluation
– product, process, service
– certification requirement, product requirement
– certification scheme, certification scheme owner
– scope of certification
– certification body
– impartiality
What is new/revised in ISO/IEC
17065:2012?
• General requirements (4):
?
What is new/revised in ISO/IEC
17065:2012?
• General requirements (4):
– Legal responsibility/Certification agreement/Use
of license, certificates & marks of conformity
– Management of impartiality
– Liability & financing
– Non-discriminatory conditions
– Confidentiality
– Publicly available information
What is new/revised in ISO/IEC
17065:2012?
– Management of impartiality (4.2):
• Identification of the risks to impartiality
• Impartiality in relation to other parts of the same legal
entity and entities under organizational control
• Impartiality in relation to separate legal entities
• Firewalls for organizations or personnel providing
consultancy
What is new/revised in ISO/IEC
17065:2012?
• Structural requirements (5):
?
What is new/revised in ISO/IEC
17065:2012?
• Structural requirements (5):
– Organizational structure & top management
– Mechanism for safeguarding impartiality
What is new/revised in ISO/IEC
17065:2012?
• Resource requirements (6):
?
What is new/revised in ISO/IEC
17065:2012?
• Resource requirements (6):
– Certification body personnel
– Resources for evaluation
• internal resources
• external resources
What is new/revised in ISO/IEC
17065:2012?
• Process requirements (7):
?
What is new/revised in ISO/IEC
17065:2012?
• Process requirements (7):
– general
– application
– application review
– evaluation
– review
– certification decision
What is new/revised in ISO/IEC
17065:2012?
• Process requirements (7) (ctd):
– certification documentation
– directory of certified products
– surveillance
– changes affecting certification
– Termination, reduction, suspension or
withdrawal…
– records
– complaints & appeals
What is new/revised in ISO/IEC
17065:2012?
• Management system requirements (8):
?
What is new/revised in ISO/IEC
17065:2012?
• Management system requirements:
– options (A or B)
– general management system documentation
– control of documents
– control of records
– management review
– internal audits
– corrective actions
– preventive actions
ISO/IEC 17065:2012 ‘transition’
• ISO/IEC 17065 published on 15 September
2012
• 3-year-transition from date of publication (IAF
resolution 2012-09)
• all certification bodies accredited to ISO/IEC
17065 by 15 September 2015
• ‘Gap- analysis’ approach