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ISO 9001 vs ISO 13485 – verplichte procedures, documenten en registraties

12 mei 2012
tags:

gdp
Regelmatig krijg ik de vraag van toeleveranciers van fabrikanten van medische hulpmiddelen: Moeten wij voldoen aan ISO 13485? Wij hebben al een ISO 9001 certificaat, wat moeten wij nog doen?

Het toepassingsgebied van de norm ISO 13485 Medische hulpmiddelen – Kwaliteitsmanagementsystemen – Bijzondere eisen voor reguleringsdoeleinden beperkt zich tot de fabrikanten van medische hulpmiddelen. Ten onrechte eisen deze fabrikanten regelmatig dat hun leveranciers van componenten en materialen die in de hulpmiddelen worden verwerkt ook voldoen aan deze norm. Van de andere kant, als leveranciers voldoen aan ISO 13485, dan kan de fabrikant verantwoorden dat de controle van de leverancier in mindere mate wordt geborgd door een inkomende goederen keuring. We zien min of meer een verschuiving naar een beheersing die meer past bij uitbesteding van productieactiviteiten bij contract fabrikanten. Contract fabrikanten moeten net als de voor het product in de markt juridisch verantwoordelijke fabrikant voldoen aan ISO 13485.

Om te bepalen of je als leverancier of contract fabrikant kunt voldoen aan de ISO 13485 norm moet je de verschillen goed kennen. Deze verschillen worden aangegeven in de bijlage van de ISO 13485. Hieronder een overzicht van de verschillen in verplichte procedures, documentatie en registraties. Dit leert al snel dat de mate van beheersing voor fabrikanten van medische hulpmiddelen strikter is dan voor ISO 9001 fabrikanten.

Rode teksten geven procedures, documenten en registraties aan die zowel door ISO 9001 en ISO 13485 worden geëist.
Zwarte teksten zijn de procedures, documenten en registraties die alleen door ISO 13485 worden geëist.
Verplichte procedures

  • Control of documents (4.2.3)
  • Control of records (4.2.4)
  • Monitoring and control of work environment conditions that can have an adverse effect on product quality (6.4)
  • Control of contaminated or potentially contaminated product (6.4)
  • Design and development (7.3.1)
  • Manufacturing procedures (as part of the design and development outputs) (7.3.3)
  • Conformity of purchased product (7.4.1)
  • Installation activities (7.5.1)
  • Servicing activities (7.5.1)
  • Application of computer software (7.5.2)
  • Sterilization validation (7.5.2)
  • Product identification (7.5.3)
  • Identification and segregation of returned devices (7.5.3)
  • Product traceability (7.5.3)
  • Preserving the conformity of product during processing and delivery (7.5.5)
  • Control of product with a limited shelf life or requiring special storage conditions (7.5.5)
  • Control of monitoring of measuring devices (7.6)
  • Feedback system (including review of the post-production phase experience) (8.2.1)
  • Internal audits (8.2.2)
  • Monitoring and measurement of product (8.2.4)
  • Control of nonconforming product (8.3)
  • Rework processes (8.3)
  • Analysis of data (8.4)
  • Issue and implementation of advisory notices (8.5.1)
  • Adverse events notification (8.5.1)
  • Corrective action (8.5.2)
  • Preventive action (8.5.3)

Verplichte specificaties en verklaringen

  • Statements of a quality policy and quality objectives (4.2.1)
  • A quality manual (4.2.1)
  • Documents needed to ensure the effective planning, operation, and control of its processes (4.2.1)
  • Documents specified by national or regional regulations (4.2.1)
  • Responsibility and authority (5.5.1)
  • Maintenance activities (6.3)
  • Health, cleanliness and clothing of personnel as they come into contact with the product (6.4)
  • Risk management (7.1)
  • Product requirements (7.2.2a)
  • Output of design and development planning (7.3.1)
  • Criteria for selection, evaluation, and re-evaluation of suppliers (7.4.1)
  • Purchasing information (7.4.2)
  • Installation activities (7.5.1)
  • Cleanliness of product (7.5.1)
  • Defined criteria for review and approval of the processes (7.5.2)

Verplichte registraties

  • Management reviews (5.6.1)
  • Education, training,skills and experience (6.2.2)
  • Maintenance activities (6.3)
  • Evidence that the realization processes and resulting product fulfil requirements (7.1)
  • Risk management (7.1)
  • Results of the review of requirements related to the product and actions arising from the review (7.2.2)
  • Design and development inputs relating to product requirements (7.3.2)
  • Design and development outputs (can include specifications, manufacturing procedures, engineering drawings, and engineering or research logbooks) (7.3.3)
  • Results of design and development reviews and any necessary actions (7.3.4)
  • Results of design and development verification and any necessary actions (7.3.5)
  • Results of design and development validation and any necessary actions (7.3.6)
  • Results of the review of design and development changes and any necessary actions (7.3.7)
  • Results of supplier evaluations and any necessary actions arising from the evaluations (7.4.1)
  • Purchasing information (7.4.2)
  • Verification of purchased product (7.4.3)
  • Batch records (7.5.1)
  • Installation and verification activities (7.5.1)
  • Servicing activities (7.5.1)
  • Sterilization process used for a sterilization batch (7.5.1)
  • As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement (7.5.2)
  • Validation of processes for production and service provision (7.5.2.1)
  • Validation of software applications (7.5.2.1)
  • Validation of sterilization processes (7.5.2.2)
  • The unique dentification of the product, where traceability is a requirement (7.5.3)
  • Product traceability including components, materials, and work environment conditions (7.5.3)
  • Distribution of medical devices including consignee information (7.5.3)
  • Customer property that is lost, damaged or otherwise found to be unsuitable for use (7.5.4)
  • Special storage conditions (7.5.5)
  • Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist (7.6)
  • Validity of the previous measuring results when the measuring equipment is found not to conform to requirements (7.6)
  • Results of calibration and verification of measuring equipment (7.6)
  • Internal audit results and follow-up actions (8.2.2)
  • Evidence of conformity of the product with the acceptance criteria (8.2.4)
  • Indication of the person(s) authorizing release of product. (8.2.4)
  • The identity of persons authorizing concessions (8.3)
  • Nature of the product nonconformities and any subsequent actions taken, including concessions obtained (8.3)
  • Results of data analysis (8.4)
  • Complaint investigations (8.5.1)
  • Authorization of the reasons why a complaint is not followed by corrective or preventive actions (8.5.1)
  • Results of corrective action (8.5.2)
  • Results of preventive action (8.5.3)
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