ISO 13485 - List of required / needed procedures and records attached

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Al Rosen

Staff member
Super Moderator
#2
ISO MAN said:
Dear All,
Please find attached a list I prepared for the Procedures and records required for compliance with ISO13485:2003. If any one has any improvement, please share it.

Thanks
Looks pretty good to me! This is a comprehensive list that answers the question: "What procedures and records are required for ISO 9001:2000 and ISO 13485:2003?
 
#3
I did notice on a few of those (such as 7.5.5), the requirement is "documented procedures or docuemnted work instructions".

But still a good job
 
M

mickb

#5
Maybe a little too keen!!

I may have misinterpreted the list of required documents to mean that there should be a document for each of these points. I disagree that there is a need for a specific document in every case.

For example if to handle substance X you need gloves to prevent contamination of the product, the "Substance X" SOP can document the need to wear gloves, you do not need a seperate procedure to detail when gloves are needed.

I am interested if others interpret things the same way.

Mick B
 

Al Rosen

Staff member
Super Moderator
#6
mickb said:
I may have misinterpreted the list of required documents to mean that there should be a document for each of these points. I disagree that there is a need for a specific document in every case.

For example if to handle substance X you need gloves to prevent contamination of the product, the "Substance X" SOP can document the need to wear gloves, you do not need a seperate procedure to detail when gloves are needed.

I am interested if others interpret things the same way.

Mick B
What you are referring to as a "substance x" SOP is what I would call a work instruction. The SOP could somehow generally say that proper preventative measures are used to prevent contamination. The work instruction for processing will require that gloves to be used during the processing.
 
M

maherpaul1

#7
Al Rosen said:
Looks pretty good to me! This is a comprehensive list that answers the question: "What procedures and records are required for ISO 9001:2000 and ISO 13485:2003?
It was my understanding that there was only 17/18 documented requirements required by ISO13485 and these included

1. Control of documents
2. control of records,
3. design and development,
4. purchasing,
5. validation of -computer software,
6. validation of sterilization processes,
7. identification,
8. traceability,
9. preservation of product,
10. control of monitoring and measuring devices,
11. feedback system,
12. internal audits,
13. control of nonconforming product,
14. analysis of data,
15. issue of advisory notice/adverse event reporting,
16. corrective action and
17. Preventive action.
 
K

kdplaskon

#8
My analysis of the standard produced the following results

Required Procedures

The six standard sections that require documented procedures in ISO 9001:2000 also require documented procedures under ISO 13485:2003. These are:

4.2.3 Control of Documents
4.2.4 Control of Records
8.2.2 Internal Audits
8.3 Control of Nonconforming Product
8.5.2 Corrective Actions
8.5.3 Preventive Actions​

In addition, the following standard sections of ISO 13485:2003 require the establishment of documented procedures to define and control the requirements and practices of these operational areas:

7.3.1 Design & Development – to ensure a controlled, consistent design and development process

7.4.1 Purchasing Process –to ensure the purchased product conforms to specified purchase requirements

7.5.2.2 Particular Requirements for Sterile Medical Devices – to ensure validation of sterilization processes.

7.5.3.1 Identification –to ensure that devices returned are identified and distinguished from conforming product

7.5.3.2.1 Traceability –to define the extent of product traceability and the records that must be kept

7.5.5 Preservation of Product – to ensure the conformity of product during internal processing and delivery to the intended destination

7.6 Control of Monitoring and Measuring Devices – to ensure that monitoring and measurement can be and is carried out consistently with the monitoring and measurement requirements

8.2.1 Feedback – to ensure an adequate system to provide early warning of quality problems and for input into the CAR/PAR processes

8.4 Analysis of Data – to ensure that data demonstrating the suitability and effectiveness of the quality management system is determined, collected and analyzed and to evaluate any improvements to QMS effectiveness

8.5.1 Improvement, General – to address the issuance and implementation of advisory notices and notification to regulatory authorities, as required. Such procedures must be capable of implementation at any time.​

In addition, there are certain clauses that require documented procedures only under specific conditions as well as requirements that require documentation, but not necessarily a 'documented procedure'. These are:

6.3 Infrastructure – When maintenance activities, or their lack, may affect product quality, documented requirement for such activities will be defined

6.4 Work Environment – When contact between personnel and the product or work environment may adversely affect product quality:

• documented requirements for health, cleanliness and clothing of personnel will be defined

If work environment conditions may adversely affect product quality:

• documented requirements for work environment conditions and
• documented procedures/work instructions to monitor and control work environment conditions

Document any special arrangements to control contaminated or potentially contaminated product so that other product, personnel or the work environment are not contaminated.

7.1 Planning of Product Realization – Requirements for risk management throughout product realization will be documented.

7.2.2 Review of Requirements Related to the Product – Customer product requirements are defined and documented

7.5.1.1 Control of Production & Service Provision – The documented procedures, requirements, work instructions and reference materials required to complete production and service activities in a controlled manner must be identified.

7.5.1.2.1 – Cleanliness of Product and Contamination Control – Documented requirements for cleanliness of product, under the conditions defined in the standard. Please review for applicability.

7.5.1.2.2 – Installation Activities – Compare your product requirements to standard for applicability. For example, the application of a bandage would not be considered installation; however, if its application must be effected in a particular fashion in order to work properly, documented requirements may be needed.

7.5.2.1 Validation of processes for Production and Service Provision – Is computer software used that might affect product conformance to specified requirements? If so, documented procedures for software validation are required.​


My summary list, developed for a customer who was beginning a 13485 QMS implementation, was specific to documentary requirements and did not address records requirements.
 
H

HDIGuy

#9
Hi, all,

In the Forum's experience with ISO 13485 registrars, have they required a separate procedure for Corrective Action and a separate procedure for Preventive Action?

I was thinking that a separate section of the Corrective and Preventive Action procedure could be devoted to Preventive Action so long as that section clearly defined Preventive Action and its activities.

Any opinions on this? Could you mention the registrars you have had experience with? I will be using NQA-USA as my registrar.

Thanks again, Jeff
 

Al Rosen

Staff member
Super Moderator
#10
HDIGuy said:
Hi, all,

In the Forum's experience with ISO 13485 registrars, have they required a separate procedure for Corrective Action and a separate procedure for Preventive Action?

I was thinking that a separate section of the Corrective and Preventive Action procedure could be devoted to Preventive Action so long as that section clearly defined Preventive Action and its activities.

Any opinions on this? Could you mention the registrars you have had experience with? I will be using NQA-USA as my registrar.

Thanks again, Jeff
You can combine the two. For discussion on this subject look at the thread, Corrective Action (CA) and Preventive Action (PA) - One or Two Procedures?
 
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