Post on 30-Jul-2018
Accreditation for ISO 13485 Medical Device Quality Systems
3rd December 2015
PRESENTATION TOPICS:
Accreditation & Accreditation Body
Support of Accreditation
Understanding Certification
Requirements of CB’s
Accreditation process of CB’s
• Accreditation is the independent evaluation of conformity assessment bodies against recognised standards to ensure their impartiality and competence. Through the application of national and international standards, government, procurers and consumers can have confidence in the calibration and test results, inspection reports and certifications provided.
• Accreditation bodies are established in many countries with the primary purpose of ensuring that conformity assessment bodies are subject to oversight by an authoritative body.
SANAS is mandated by government through the Accreditation for
Conformity Assessment, Calibration and Good Laboratory Practice Act (Act No.19 of 2006) to provide accreditation services
in South Africa.
SANAS’s primary role is to serve South Africans by providing a reliable, internationally recognised accreditation infrastructure to
government, industry and the wider community.
Government
ACCREDITATION SUPPORTS:
Private Sector (Industry & community)
Government
ACCREDITATION SUPPORTS:
Private Sector
- Client - User - Specification Body - MRA
(government-to-government
- Trade negotiations
Government
ACCREDITATION SUPPORTS:
Private Sector (Industry & community)
GENERAL BENEFITS: - Independent confirmation or benchmarking tool - Recognition of competence (enhance acceptance)
- Marketing benefits
INTERNATIONAL BENEFITS - International recognition of competence due to MLA - Output acceptance in foreign markets (reduce risk) - Import/export (no duplication due to signatory status
IAF – International Accreditation Forum
Department of Trade & Industry
SANAS – Accreditation Body
Certification Body
Manufacturer/Service provider LEV
ELS
OF O
VER
SIG
HT
• Accreditation - evaluation against a standard/requirement ensuring impartiality & competence
• Accreditation bodies – Provides authoritative oversight
SANAS creates an impartial and transparent mechanism for organisations to independently demonstrate their competence and facilitate the beneficial exchange of goods, services and knowledge and provide a service that is recognised as equitable to best international practice while reflecting the demographics of South Africa in all that we do. Within SANAS there are different programmes of which the Certification programme applies in the context of todays topic.
Role of SANAS
Role of SANAS
SANAS’ FUNCTION: ACCREDITATION NOT CERTIFICATION
SANAS CONDUCTS ASSESSMENTS,
NOT AUDITS
Confusing??
In South Africa, SANAS is one of the 4 institutions or bodies that form the Technical Infrastructure under the DTI
The role of SANAS under the DTI
DTI
Financial & Small Business Development
Agencies Regulatory Agencies Technical Infrastructure
NRCS – Mandate to control National Regulatory activities
& enforce compulsory regulations
NMISA – Mandate to maintain & develop scientific standards
of physical & ensure global measurement equivalence
SABS - Mandate to develop, promote & maintain National
& International Standards
SANAS – Mandate to Accredit & facilitate
Trade
ILAC / IAF
Testing Inspection Certification
ISO/IEC 17025 ISO/IEC 17020 ISO/IEC 17021
ISO/IEC 17065
ISO/IEC 17024
…and more
ILAC / IAF
Testing Inspection Certification
ISO/IEC 17025 ISO/IEC 17020 ISO/IEC 17021
ISO/IEC 17065
ISO/IEC 17024
…and more
Management Systems
Product Certification
Personnel Certification
ILAC / IAF
Testing Inspection Certification
ISO/IEC 17025 ISO/IEC 17020 ISO/IEC 17021
ISO/IEC 17065
ISO/IEC 17024
…and more
Management Systems
Product Certification
Personnel Certification
Management Systems – QMS/EMS/OHSAS
Product Certification –GlobalGAP/OAPP/PEFC
Personnel Certification – Training/ Auditor reg
ILAC / IAF
Testing Inspection Certification
ISO/IEC 17025 ISO/IEC 17020 ISO/IEC 17021
ISO/IEC 17065
ISO/IEC 17024
…and more
Management systems
IAF MD Requirements
IAF MD9 IAF MD10
ILAC / IAF
ISO/IEC 17011
ISO/IEC 17021 IAF MD
ISO 13485
SUMMARY
SANAS (AB)
Certification Body
Manufacturer
Client/Consumer
Organizations that apply for accreditation or maintain
accreditation are assessed against the applicable standards, scheme requirements, SANAS requirements, IAF Mandatory
documents, regulatory requirements etc.
Accreditation
Accreditation Cycle
APPLICATION FOR ACCREDITATION
APPLICATION REVIEW
DOCUMENTATION REVIEW
PRE-ASSESSMENT
INITIAL ASSESSMENT GRANTING
ACCREDITATION
6 MONTH FOLLOW UP VISIT
SURVEILLANCE ASSESSMENT
RE-ASSESSMENT
SANAS CONTRACT
MANAGEMENT SYSTEM DOCUMENTATION
F14CB & OTHER REQUESTED INFORMATION (F155)
APPLICATION
DOCUMENT REVIEW
INITIAL ASSESSMENT
PRE- ASSESSMENT (IF REQUIRED)
QUOTATION
The Field Manager (FM) reviews the extent of
effort required to meet the objectives required
WITNESSING’S
Once the quotation is accepted and payment is received, the review of documentation
submitted by the CB will proceed.
Document Review - Lead Assessor assigned to review documents - Report drawn up by LA detailing deficiencies/omissions/compliance to standard requirements (ISO/IEC 17021) - A recommendation will be made on the way forward - Additional information can be found on the website, P05 policy document
Pre-Assessment (where required) - It is not mandatory. - Conducted in one day by the Lead Assessor - Recommendation (F04) will be supplied to CB - List of findings (F03) to be addressed & completed
Application for
Accreditation Application
Review
Document Review
Pre-Assessment
Initial assessment
Granting accreditation
6 Month Follow up
visit
Surveillance Assessment
Re-Assessment
Initial Assessment - Normally takes place over two (2) days - Lead Assessor and Technical Assessor assigned - Organizations files and management system compliance will be established against applicable standards, scheme requirements, SANAS requirements, IAF Mandatory documents etc
Initial Assessment (continued) SANAS assessors will seek to establish that the CB’s Management system is appropriate for the intended certification activities in terms of: - Organizational structure - Processes - Scope - Scale of operations - CB competence to conduct activities
Initial Assessment (continued) The Assessment team will establish if the Certification Body (CB) has implemented all the requirements of its Management system effectively so that SANAS can have confidence in the validity of the certification Decisions made.
Initial Assessment and witnessing must be successfully completed and any findings correctly cleared prior to certification being granted. Recommendation report (F04) Non-conformance reports (F03) The assessment team does not grant accreditation – only recommend
Application for
Accreditation Application
Review
Document Review
Pre-Assessment
Initial Assessment
Granting Accreditation
6 Month Follow up
visit
Surveillance Assessment
Re-Assessment
6 Month Follow up visit - Conducted at the main office - Normally only by the Lead Assessor - Follow up previous non-conformances raised - Ensure management system is still implemented and functioning properly - Does not include witnessing or vertical assessment
Surveillance Assessments -Following accreditation, SANAS will check for continued compliance with accreditation requirements by carrying out regular surveillance assessments every 12 months - A representative sample of the scope of accreditation will be assessed - Non-conformances raised require corrective action within 25 working days
Surveillance Assessments (continued) -Assessment team: LA & TA (or TE) - Witnessing: TA - If the team has recommended “on-site clearance of findings” P40 will apply - If NC’s raised are not corrected (unless justified) within 51 days, R51 will apply (Suspension and re-instatement of accredited organizations)
Re-Assessments - Comprehensive re-examination of CB’s Management system and certification activities (similar to the approach taken during initial assessments) - Emphasis will be made on historic performance and changes over the past 3 year accreditation cycle - NC’s raised – 25 working days - Accreditation can then be renewed
Application for
Accreditation Application
Review
Document Review
Pre-Assessment
Initial Assessment
Granting Accreditation
6 Month Follow up visit
Surveillance Assessment
Re-Assessment
Witnessed Assessments Demonstration of competence and conformity with relevant accreditation requirements Witnessing activities are essential in confirming the CB’s personnel: - Apply CB’s procedures and instructions - exhibit auditor characteristics (CB procedure) - demonstrate competence in specific activity - CB’s ability to assign appropriate personnel - Conformity Assessment activity is effective - Conform to requirements of SANAS, IAF and sector schemes
Once accreditation is achieved, the CB is responsible to maintain and continually improve
their own management system. The accreditation cycle is 3 years and during this
period, surveillance assessments, file reviews, extension of scopes and witnessing's will be
conducted by SANAS to ensure continued compliance and competence of the CB
Application for Accreditation
Re-application
Document-Review
1st Surveillance Assessment
2nd Surveillance Assessment
Re-Assessment
FOR FURTHER INFORMATION, VISIT OUR WEBSITE
www.sanas.co.za
THANK YOU
Contact email details
John Ndalamo – JohnN@sanas.co.za
Victoria Wagener – Victoriaw@sanas.co.za