Choosing the Best Standard - ISO 9001 or ISO 13485

[Jshene]

Hi,
I am new to the "Cove" and I have found all of this information VERY overwhelming!! I have also been "the chosen one" to help implement/pass the ISO 9001 Audit for my company. I am just wondering where to start. The company is fairly new so I am starting fresh with everything. Everyone is very new and open to doing whatever it takes to become ISO Certified

The company I work for wants to implement ISO 13485 for their standards, I am a little confused because some of our work needs the 13485 set of standards and some doesn't... So is the ISO 9001 just the basics and then there are branches of standards?

Also the company has purchased the ISO 9001 manuals and 13485 manuals as well.

Again,Please go easy on me I am new!!

Thanks in advance,
Jamie

 

[GStough]

Re: Please help me

First, welcome to the Cove! As you can see, there is a wealth of information available here, and best of all - it's FREE! However, it will take some time and effort to read through the many posts and attachments to find that which you seek.

To answer your question simply, ISO 9001:2008 is the most common ISO standard to which many businesses are registered. As you've noted, there are other standards which are industry-specific, such as 13485 for medical devices, AS9100 for aerospace and related industries, etc.

I'm sure that others will step in and offer more suggestions. Just be patient and while you're waiting, feel free to read through previous posts and threads related to the subject. Go to the bottom of this page and scroll through the drop-down menu that shows the forums here by topic. You'll find plenty of material that may help give you an idea of where you want or need to begin on your journey toward ISO registration.

I hope this helps. Best of luck to you!

 

[Randy Lefferts]

Re: Please help me

Hi Jamie,

Welcome to the Cove

I have no experience with 13485 but I pulled up a copy and it appears to be based on ISO 9001.

0.3 Relationship with other standards

0.3.1 Relationship with ISO 9001

While this is a stand-alone standard, it is based on ISO 9001.
Those clauses or subclauses that are quoted directly and unchanged from ISO 9001 are in normal font. The fact that these subclauses are presented unchanged is noted in Annex B. Where the text of this International Standard is not identical to the text of ISO 9001, the sentence or indent containing that text as a whole is shown in italics (in blue italics for electronic versions). The nature and reasons for the text changes are noted in Annex B.

0.3.2 Relationship with ISO/TR 14969

ISO/TR 14969 is a Technical Report intended to provide guidance for the application of ISO 13485.

The first thing you would want to do is to perform a gap analysis to the standard. Since ISO 13485 includes all of ISO 9001, you would perform your gap analysis to the requirements of that standard.

I am not a fan of using one standard for certain customers and a different standard for other customers when you could just use one standard. I am referring to a standard such as the one you are looking to certify to (13485) and others like TS16949 (auto), AS9100(aerospace, military and defense), etc. They use ISO 9001 as the foundation and add requirements for the industry they are designed. You will find that the industry specific standards have more stringent requirements than the base ISO 9001.

I haven't found yet (Not that they don't exist I guess) a customer that we have worked with that took issue that we adhered to a stricter standard than what they wanted.

As you may know, there are some VERY knowledgeable, intelligent folks around here and we are lucky enough to have them share their knowledge and experience with us. So definitely ask away when you need assistance.

Good luck on your journey!

 

[db]

Re: Choosing the Best Standard - ISO9001 or ISO 13485

As others have said, welcome to the Cove!

ISO 13485 is based on ISO 9001, with a couple of major differences. ISO 9001 focuses on customer satisfaction and continuous improvement, whereas ISO 13485 focuses more on regulatory compliance. It also has more required documentation than ISO 9001.

With that stated, I don't think you should be looking at this as an either/or, but rather a both/and. It will not take a tremendous amount of work to comply with both requirements. Start with the ISO 13485, then add in the customer satisfaction and continuous improvement requirements of ISO 9001 (in reality, both customer satisfaction and continuous improvements make sense anyways).

I would also recommend you find someone who has a good understanding of the application of both standards to assist you. In many cases, the learning curve will be a lot less costly if you get good help.
Hope that helps.

 

[amjadrana]

ISO 9001 is the "general" standard that can be applied in many types of industries and businesses. You may want to register your organization to ISO 9001 if you want to improve your processes, or if your customers are asking for it. It is a voluntary standard.

With ISO 13485 it is different. It is a mandatory standard, if your products fall into the definition of medical devices.

Medical devices are defined as follows:


any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of

 diagnosis, prevention, monitoring, treatment or alleviation of disease,
 diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
 investigation, replacement, modification, or support of the anatomy or of a physiological process,
 supporting or sustaining life,
 control of conception,
 disinfection of medical devices,
 providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means.

If your products falls into one of the categories above and you want to sell these medical devices in Canada, EU and in most of the other countries, you will have to be registered to ISO 13485. For USA you do not have to be registered to ISO 13485 but the FDA quality system regulations (QSR) are heavily based on ISO 13485.

If your products are medical devices as well as other general products, you may consider both ISO 9001 and ISO 13485.

Remember for medical devices it has to be ISO 13485.
I hope it helps.

 

[amjadrana]

As I do not know the classification of the products, my reply was general. For class I medical devices for canada ISO 13485 is not required. However it is a good idea to go for it, as the other products being developed may fall under class II and above.

 

[AndyN]

Hi,
I am new to the "Cove" and I have found all of this information VERY overwhelming!! I have also been "the chosen one" to help implement/pass the ISO 9001 Audit for my company. I am just wondering where to start. The company is fairly new so I am starting fresh with everything. Everyone is very new and open to doing whatever it takes to become ISO Certified

The company I work for wants to implement ISO 13485 for their standards, I am a little confused because some of our work needs the 13485 set of standards and some doesn't... So is the ISO 9001 just the basics and then there are branches of standards?

Also the company has purchased the ISO 9001 manuals and 13485 manuals as well.

Again,Please go easy on me I am new!!

Thanks in advance,
Jamie

Hey Jamie - when you say the company purchased the 'manuals' do you mean the actual standards, themselves?

 

[somashekar]

Hi,
I am new to the "Cove" and I have found all of this information VERY overwhelming!! I have also been "the chosen one" to help implement/pass the ISO 9001 Audit for my company. I am just wondering where to start. The company is fairly new so I am starting fresh with everything. Everyone is very new and open to doing whatever it takes to become ISO Certified

The company I work for wants to implement ISO 13485 for their standards, I am a little confused because some of our work needs the 13485 set of standards and some doesn't... So is the ISO 9001 just the basics and then there are branches of standards?

Also the company has purchased the ISO 9001 manuals and 13485 manuals as well.

Again,Please go easy on me I am new!!

Thanks in advance,
Jamie

Hii Jshene...
Welcome here.
ISO13485 and ISO9001 are two separate standards per certification requirements. The base standard is the ISO9001.
If you work towards mapping your QMS to the ISO13485 requirements, with little efforts you can also be ISO9001 certified during the same audit cycle, by the same CB.
At the outset you define the scope of your QMS considering the ISO13485 and the ISO9001 separately.
For this, decide which of your products are medical devices and which are not. Help us by more information about your products so that you get appropriate response from experts.

 

[harry]

Choosing the Best Standard - ISO 9001 or ISO 13485

I am not sure if there is a 'best' standard but there is certainly one that best suits the needs of your organization. The clue for finding it is given in the first sentence of the ISO 9001 standard and under introduction - "The adoption of a quality management system should be a strategic decision of an organization." Go back and have a look at your organizations strategic plan (a road-map for the future). The answer is there.

 

[MIREGMGR]

If you're a medical device maker, focus on ISO 13485, which is the general foundation for conformance/marketing for Europe, Canada and Australia and will become key for US FDA compliance as they move toward harmonization.

Effort spent on ISO 9001 would be duplicative and unnecessary.