sfs-en iso 13485:2016 -standardin pääsisältö ja merkitys

Terveydenhuollon laitteiden

laatustandardin

SFS-EN ISO 13485:2016

esittelytilaisuus

6.6.2016

Suomen Standardisoimisliitto SFS ry

1

Standardin pääsisältö ja merkitys

Tom Ståhlberg

vt. toiminnanjohtaja

Terveysteknologian Liitto ry - FiHTA

FiHTA

ISO 13485:2016 - tausta ja

muutokset käytännössä

Tom Ståhlberg

Johtaja, Viranomaisasiat ja

vt. Toimitusjohtaja

6.6.2016

…mutta nyt, tervetullut muutos!

ISO 13485:2016/muutokset: Usein muutosvastarinta…

Onks pakko?

”Ihan hyvä laadunhallintasysteemi jo nyt!”

”Kuka maksaa näistäkin muutoksista?”

”Ei tartte tehdä mitään – on jo tullut hoidettua

US FDA:n ja Kanadan CMDCAS’n takia”

Älä laita pää pensaaseen!

Hyödyllisiä muutoksia!

Eikä enää vain valmistajan osalta

hyödyllinen, vaan soveltuu koko arvoketjuun!

Potilas fokuksessa

Products and services

must be safe and effective

Medical Device Directives

Goals are:

• To ensure the safety, quality and performance

of medical devices

• To ensure that medical devices do not compromise the health and safety of patients, users, third parties and environment

http://www.solarnavigator.net/animal_kingdom/humans/humans.htm

ISO 13485:2016 hyväksytty 1.3.2016 (julkaistu noin klo. 10.06)

ISO 13485:2016 hyväksytty 1.3.2016 – muutostarpeita!

Siirtymäaika 3 vuotta

Suositus: 2 vuoden jälkeen vain sertifiointi/uudelleen sertifiointi vs.

ISO 13485:2003.

Huom! Jos nyt sertifiointi vanhaan standardiin, niin max.

voimassaoloaika 28.2.2019 asti!

Suunnittele yhdessä sertifioijan kanssa! Ei tarvitse olla sidoksissa

olemassa olevaan sykliin!

Ei vielä harmonisoitu (EN ISO 13485:2012), päämäärä (?) 30.9.2016

Toinen muutos tulossa

Directive 93/42/EEC on Medical Devices

Directive 90/385/EEC on Active Implantable MD

Regulation on MD and Active Implantable MD

Directive 98/79/EC on IVD MD

Regulation on IVD MD

FiHTA

Johtamisjärjestelmä

Regulaatiot huomioitava alusta alkaen!

www.reguloiko.fi

Tuotespesifiset vaatimukset

1. Intended use

2. Which regulations

apply?

3. Define risk class

4. Essential requirements

5. Conformity assessment

6. Declaration of conformity and CE

marking

7. Product registration

8. Throughout the product life

cycle

Quality Management Systems: subsystems

Suunnittelun

hallinta

Materiaalin

hallinta

Tulosteiden,

dokumenttien ja

muutosten hallinta

Laitteistojen ja

tilojen hallinta

Prosessien ja

tuotannon hallinta

Korjaavat ja

ehkäisevät

toimenpiteet

Johtaminen

Standardi – periaatteessa vapaaehtoinen, mutta…

Tarvitaanko laadunhallintajärjestelmää?

Riippuen pakollisuudesta:

EU: ei tarvetta, osittain tai kokonaisuudessaan – riippuen

riskiluokituksesta

Luokka I: ei pakollinen, mutta vaaratilanneilmoitukset kylläkin!

Riippumatta pakollisuudesta:

Liiketaloudellisesti järkevä – johdetaanko yritystä vai määrääkö sattuma?

Fokuksessa ”from QMS to MS”

Päätelmä: oikein tehtynä erittäin hyödyllinen, kannattaa rakentaa alusta

alkaen, oikeassa järjestyksessä ja yrityksen lähtökohdista

Regulatiivinen strategia

ISO 9001:2008 NYT ISO 9001:2015

General quality management system standard – not enough for medical device

manufacturers

QMS standards

ISO 13485:2003/EN ISO 13485:2012 NYT ISO 13485:2016

Medical devices – Quality management systems – Requirements for regulatory purposes

Ed Kimmelman,

New Orleans, 2010

ISO 210 ja CEN/CENELEC TC 3

Incorporated by reference in the Canadian Medical Devices Regulations

Recognized by Australia as satisfying the quality management system

requirements of the Australian conformity assessment procedures

Harmonized within the Japanese QMS Ordinance for medical devices

Adopted as a European standard and harmonized under the medical devices directives. EN ISO 13485:2012 that is identical to ISO 13485:2003 with the revision of the European Foreword and Annexes ZA, ZB and ZC.

Incorporated into the Medical Device Single Audit Program (MDSAP)

”ISO 13485 kaikkialla”

Recognized standard by Health Canada

Note!! Any ISO 13485 certificate is not enough for Health Canada! The

certificate must by issued by a recognized registrar to fulfill CMDCAS

requirements!

Early warning 1! ISO 13485 not enough...

ISO 13485:2003

Recognized standard by the US FDA

Early warning 2: Still, strong emphasis on QSR!

US FDA has been very active in the revision process!

Several QSR (quality system regulation) features are integrated

into the new version!

Brazil

Pre-qualification requirement (inspection) for public tenders

I.e. factory inspections obligatory

EU and USA opposed strongly...

Early warning 3: inspection leaning on Brazilian regulations

Formal objection

ISO 13485 does not cover QMS requirements as set in the EU MD, AIMD and IVD Directives

http://www.google.fi/url?sa=t&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAQQjRw&url=http://www.fidelix.fi/tuki/&ei=zmYhU8yFK4qv4ASV94GgBA&usg=AFQjCNFDe734gcEtDTzpnLX4jOVUSQ6GQw&bvm=bv.62922401,d.bGE

EU other regulatory issues: standardization

Several harmonized standards in trouble since 2010

E.g.

“The date of cessation of presumption of conformity when applying EN 60601-1:2006 is

31.12.2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the

presumption of conformity with the Essential Requirements of Directive 93/42/EEC on

31.12.2015. As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006

corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-

1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of

Directive 93/42/EEC, to the extent indicated in the Annex ZZ to EN 60601-

1:2006/A1:2013.”

What in ... can this mean?

3rd Edition Paljon muutoksia! Oleellisia! Ennakoi osittain ISO 9001:2015 muutokset, mutta ei voinut huomioida ISO ylästruktuurien vaatimuksia! IMDRF ja US FDA QSR käsialaa mm. EN ei vielä

ISO 13485:2016/muutokset

Focus

Regulatory requirements

Risk management – ISO 14971:2007 ei tietenkään ollut olemassa 2003

Verification, validation, design transfer

Outsourced processes and supplier control

Feedback

Flexibility – more exclusion possibilities


Scope

Added: storage and distribution ... (technical support)

Also suppliers, service providers (sterilization, calibration) who may

voluntarily chose to conform or by contract

Tärkeä: supply chain – identify and incorporate regulatory requirements

Läpi linjan: risk management focus, regulatory requirement focus 9 vs. 37

kertaa!,

”implement and maintain”, life-cycle

Linked processes: added value - customer focus!

Manufacturer’s responsibility for outsourced processes! Identify parties,

and monitor, maintain and control the processes within the QMS!


Scope

Not only manufacturer!

Organizations can be involved in one or more stages in the product life

cycle:

Design, development

Production

Storage

Distribution

Installation

Servicing

Technical support

External suppliers, service providers


New definitions

Authorized representative

Clinical evaluation

Distributor

Field safety corrective action

Field safety notice

Importer

Labelling includes now also electronic information and ”intended

purpose and proper use”

Life-cycle

Manufacturer

Additive note to definition of MD

Medical device software

Post market surveillance

Performance evaluation

Pre-clinical evaluation

Risk

Risk management

Sterile barrier system


General requirements – some new issues

Roles (e.g. manufacturer, distributor) establish, document...

Establish process based on the different roles and responsibilities

Risk management (each process!)

Records to demonstrate conformance to the standard and with regulatory

requirements

Outsourced process: monitor/control vs. risk involved

Validation of software incl. production and services, determine and justify

the specific approach vs. risk

Requirements on personnel affecting product safety and quality:

competence, training, awareness, effectiveness of training vs. risk


General requirements – some new issues

For each type or model...files with long list of required information

Control of documents

Documents of external origin

Secure risk of loss

Customer focus

Customer specs yes, but: meet regulatory requirements


Quality policy

Add commitment to risk management

Management review

Predefined/documented intervals, rationale for frequency

Review output: input reviewed! QMS suitability


Infrastructure and work environment

Several additions throughout: e.g. prevent mix up, orderly handling, maintenance of equipment, control of environment

Competence for temporary work ( ISO 14644, ISO 14698)

Additional section on sterile MDs; control of microbial/particulate matter, cleanliness during assembly/packaging


Planning of product realization

Including customer-related processes

Risk management focus with documented procedures

Planning for verification, validation, monitoring, measurement…

Design and development planning

Traceability of design requirements vs. output

Resources needed including competencies


Determination of requirements related to the product

Any user training needed to ensure safe and effective use

Review that applicable regulatory requirements are met

Communication with regulatory authorities as needed

Inputs, even usability (ISO 62366!), standards, ability to verify/validate

Review


Design and development verification

Verification plan requirements, including methods, acceptance criteria, rationale for sample sizes

Also for connections and interfaces

Also of device interfaces

Design validation

To be done on production units or equivalents (document equivalency)

Validation records including traceability to input/output, acceptance criteria, rational for sampling siz and conclusions


Control of design and development changes

Outputs of risk management

Regulatory compliance and approvals

Process to review changes throughout life-cycle, significance...


Purchasing

Shall be in accordance with risk management activities

Supplier selection, criteria, evaluate and approve

Criteria for selection, (re-)evaluation consistent with risk management

Purchasing information to include as applicable product specifications

Verification activities of purchased product in line with risk management, supplier evaluation and link to change control

Suppliers to agree to prior notification of changes


Control of production and service provision

Conforms to specifications – long list of controls (three new ones)

Servicing – analyze to see if shall be handled as complaint and as an input to improvements

Production processes and service provision

Validation in line with risk

Conditions triggering revalidation (including software)

Appropriate statistical techniques, rationale for sample sizes


Identification and traceability

UDI when required

Returned products identified and distinguished (separated) from conforming products

Identify where the device has been delivered

Preservation of product

Long list of requirements on packaging, shipping, including validation

Sterile barriers and validation of changes prior to implementation


Monitoring and feedback

Define feedback process and link to risk management, statistics

Validation of software applications used for monitoring/measurement

Link to risk management, improvement

Very long chapter on complaint handling added

timeliness, regulatory notification, procedures for reporting

Test equipment to be identified (Huom.! Test method validation)


Control of non-conforming product

Controls, responsibilities/authorities for taking care of the non-conforming product

Escalation mechanism

Link to risk management

Rework

Form of correction, determine (potential) adverse effects, retesting

Analysis of data

Audits and service reports added


Improvement

Post-market surveillance added as source of imoprovements needs

CAPA

Link to risk management

Link to management review

Check that CAPA is effective, no adverse effect

Timeliness


Mitä kuuluu tehdä?

Hanki uusi standardi, tutki sitä!

Tee gap analyysi nykytilanteeseen

Toteuta tarpeelliset muutokset

Varmista muutosten haltuunotto sisäisesti

Neuvottele sertifioijan aikatauluista

Audit vs. 13485:2016

Milloin? Suositus: mahdollisimman heti, koska ”rutiini-asia”

verrattuna EU:n asetuksien tuomat muutokset!

sfs-en iso 13485:2016 -standardin pääsisältö ja merkitys

Healthcare