ISO 13485 (EN 46000) or ISO 9001 - Which Standard? Sterilization within a Hospital

If you are specialists for the sterilisation within a hospital, which is the better, or more appropriate demarch to be chosen: ISO 9001:2000 or ISO 13485:2003 ?
Have you good arguments to choose a way ?

phicarre said:

If you are specialists for the sterilisation within a hospital, which is the better, or more appropriate demarch to be chosen: ISO 9001:2000 or ISO 13485:2003 ?
Have you good arguments to choose a way ?

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I'm not a specialist for sterilization, but I am familiar with ISO 13485 QMS standard and its application.

Although, sterilization is specifically addressed in ISO 13485 as it applies to medical device manufacturing, ISO 9001 would be the better choice in my opinion. There is a lot in ISO 13485 that would not apply to your hospital setting. ISO 13485 is a QMS that was developed for Medical Devices not hospitals.

ISO13485 said:

0.1 General

This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation, and servicing of medical devices, and the design, development, and provision of related services.

It can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.

Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.

It is emphasized that the quality management system requirements specified in this International Standard are complementary to technical requirements for products.

The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed, and the size and structure of the organization. It is not the intent of
this International Standard to imply uniformity in the structure of quality management systems or uniformity of
documentation.

There is a wide variety of medical devices, and some of the particular requirements of this International Standard only apply to named groups of medical devices. These groups are defined in Clause 3.

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Speak to your registrar before implementation.

Hello phicarre!

phicarre said:

...sterilisation within a hospital...

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What is your intention/scope?

Do you want to establish a Quality Management System for the sterilization department of the hospital, or do you want to write SOPs for sterilization.

There are standards especially for sterilization (processes):

- EN 285 Sterilization - Steam sterilizers - Large sterilizers
- EN 550 Sterilization of medical devices - Validation and routine control of ethylene oxide sterilisation
- EN 552 Sterilization of medical devices - Validation and routine control of sterilisation by irradiation
- EN 554 Sterilization of medical devices - Validation and routine control of sterilisation by moist heat
- EN 556 Sterilization of medical devices - requirements for medical devices to be labelled sterile
- EN 867-2 Non-biological systems for use in sterilizers - Part 2 : process indicators (class A)
- EN 867-3 Non-biological systems for use in sterilizers - Part 3 : specification for class B indicators for use in the Bowie and Dick test
- EN 868-1 Packaging materials and systems for medical devices which are to be sterilized - Part 1 : general requirements and test methods
- EN 1174-1 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: requirements
- EN 1174-2 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: guidance
- EN 1174-3 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: guide to the methods for validation of microbiological techniques
- EN 1422 Sterilisers for medical purposes – ethylene oxide sterilisers – requirements and test methods

Maybe some of these standards are helful for you

Hello,

I want to establish a QMS for the department of sterilisation and I know these standard !
In fact, nobody is able to give me an official orientation maybe because they don't know themselves
That's why I try to feel the good practice ...

Hello again,

Some paragraphs of the ISO 13485:2003 are specific for the sterilisation to the "service" point of view. Then I am not sure that I can follow your suggestion.

You are right.

Sterile processing of surgical instruments and textiles is in fact "production" of medical devices. Some of our customers earn their money that way, and therefore they are certifiec acc. MDD and EN ISO 13485.

Within your hospital you are doing "in-house production".
At swissmedic.ch there is a (german) guideline for sterile processing in hospitals (also available in italian and french).

Also available are documents for sterilization in hospitals validation sterile processes in hospitals.

I think the swissmedic documents could help you with this special domain. If you see potential demand, you should follow EN 13485 for your QMS.

HTH

13485 in Hospital Sterile Supplies Departments

In the UK the Medical Devices Directive has been interpreted to mean that since we 'place on the market' (Sometimes decontaminate and sterilize for other organisations) we come under the scope of the Directive. Because of this it has been decided that all sterile supplies departments must comply with ISO 13485 and the other related standards.

I have several years of experience in 46002 and now 13485. I am producing electronic documentation which I intend to provide on the www.

I believe that the UK and Ireland are the only countries within the EU or the states that have been doing this for any length of time. Can anyone give me any other information of other country's activities in this area.

When is the ISO 14969 final version coming out?

Hello Jackie,

Jackie said:

I believe that the UK and Ireland are the only countries within the EU or the states that have been doing this for any length of time. Can anyone give me any other information of other country's activities in this area.

When is the ISO 14969 final version coming out?

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I am not quite sure, what topic you address with your opinion ?-)

When you sterilize goods which are used by a third person, you are within the scope of the MDD in any european country.

I think the next/final draft will be issued in autumn, so it will take some more time (next year?)

Re: ISO 13485 (EN 46000) or ISO 9001 - Which Standard? Sterilization within a Hospita

please see the thread: ISO 13485 in Hospital Central Sterilization and Clinical Engineering Services