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