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Certifying a family of products under ISO13485 when company is ISO 9001 compliant
What do you recommend me in terms of elaborate an implementation plan?
Answer:
The first step of the implementation plan is to adapt your current company’s QMS to the type of medical devices that your organization will be dealing with such as the inclusion of medical device files, design and development file, software validation and sterilization process just to name a few.
Here are the steps to successful implementation of ISO 13485:
1) Get management support.
2) Identify requirements.
3) Define the scope.
4) Define processes and procedures.
5) Implement processes and procedures.
6) Deploy training and awareness programs.
7) Choose a certification body.
8) Operate the QMS / Measure the system.
9) Conduct internal audits.
10) Conduct a management review.
11) Take corrective action.
12) Perform the stage 1 certification audit.
13) Stage 2 certification audit.
For more information, please refer to:
-ISO 9001 vs. ISO 13485
https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
- List of mandatory documents required by ISO 13485:2016
https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/
-Checklist of ISO 13485 implementation and certification steps
https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/ -
Contract of consulting services
Answer:
By “facilitation body” I believe you mean “consulting company”.
I can suggest including:
What is the purpose of the project – Implementation of an EMS according to ISO 14001:2015
What are the deliverables – The success criteria will be getting the ISO 14001:2015 certification by an accredited certification body
What is the timeline agreed – When will the project start, when will the project finish, what kind of work rhythm will be followed
Who will work with us – Be careful to ensure that you will have someone with experience working with you. Sometimes, consulting companies start the negotiations with an experienced consultant and then, when the work starts they put an inexperienced junior working with you
How will the project be controlled – What kind of information they will issue, with what frequency, abo ut the project monitoring and control. And monitoring and control meeting frequency
Ownership and accountability – Who will be responsible for handling problems and complaints
Payment conditions – You can consider link partial payments to meeting and approval of project milestones
Cancellation terms and notice required
Confidentiality - Details the terms of confidentiality the consultant must uphold.
Date of contract
The following material will provide you with information about implementing ISO 14001:
- List of ISO 14001 implementation steps - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/list-of-iso-14001-implementation-steps/
- Free online training ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
- ISO 14001:2015 Documentation Toolkit - https://advisera.com/14001academy/iso-14001-documentation-toolkit/
- Book - The ISO 14001:2015 Companion – A Straightforward Guide to Implementing an EMS in a Small Business - https://advisera.com/books/the-iso-14001-2015-companion/ -
Auditing top management
Answer:
The whole management system must be internally audited every year, including top management. Your organization can prepare an internal audit program where the whole management system is audited on 3 partial audits spread over a year, and one of those audits will include in its scope auditing top management specific topics.
The following material will provide you with more information about internal audits:
- What is the ISO 9001 audit program, and how does it work? - https://advisera.com/9001academy/blog/2017/01/24/what-is-the-iso-9001-audit-program-and-how-does-it-work/
- Free online ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- eBook - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Auditing the whole QMS every year
Answer:
Actually, the management system standards do not prescribe that the whole QMS should be internally audited every year. However, all certified organizations internally audit their QMS every year because that is a requirement from the certification bodies, written in the contract between organizations and certification bodies.
The following material will provide you more information about internal audits:
- Five Main Steps in ISO 9001 Internal Audit - https://advisera.com/9001academy/knowledgebase/five-main-steps-in-iso-9001-internal-audit/
- Free online ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- eBook - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Use of ISO 27017 and ISO 27018
Answer:
ISOs 27017 and 27018 do not make sense without implementing 27001 as well, because this way you would only have the controls without the management system that can maintain and correct the controls when needed.
And although ISO 27017/18 provides more guidance and orientation for controls to be applied to cloud/virtualized companies, if you do not have specific requirements demanding implementation of cloud/virtualized related controls (e.g., to comply with GDPR) you can go with only ISO 27001, because this standard already provides a good coverage for cloud/virtualized environments.
These articles will provide you further explanation about ISO 27017 and ISO 27018:
- ISO 27001 vs. ISO 27017 – Information security controls for cloud services https://advisera.com/27001academy/blog/2015/11/30/iso-27001-vs-iso-27017-information-security-controls-for-cloud-services/
- ISO 27001 vs. ISO 27018 – Standard for protecting privacy in the cloud https://advisera.com/27001academy/blog/2015/11/16/iso-27001-vs-iso-27018-standard-for-protecting-privacy-in-the-cloud/ -
Instructions for production
Answer:
First of all, thank you for your kind words. I'm glad to hear that our site has helped you.
Yes, you are right. ISO 9001:2015 does not require that practice followed by your organization. Please check clause 4.4.2. It is up to the organization to decide what is needed or not. In your position I would like to know why they do that, what was the reason behind that practice. Can be enlightening. One mor e thing, your idea of reinforcing training to avoid extra documentation in production is, I believe, a very good one.
The following material will provide you with information about work instructions:
- ISO 9001 – How to structure work instructions in the ISO 9001 QMS - https://advisera.com/9001academy/blog/2015/06/16/how-to-structure-work-instructions-in-the-iso-9001-qms/
- free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Rules for storing documents
Answer:
Normally, organizations store them as separated documents. That way, if you update a form, you will not need to update the related procedure or policy.
The following material will provide you with information about document control:
- ISO 9001 – New approach to document and record control in ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
- free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Suggestion for closing a minor NC
A risk matrix, as an appropriate method for determination and grading of the risks associated with identified aspects, was sighted.
The business had not described as part of the risk assessment process, a criterion to determine its significant environmental aspects.
Requirement: The organization shall determine those aspects that have or can have significant environmental impact…..by using established criteria.
Objective evidence: The identification of which aspects were deemed significant environmental aspects was not clear.”
Answer:
ISO 14001:2015, according to clause 6.1.2, requires three kinds of documents:
-a list of the determined environmental aspects and impacts;
-an explanation of the criteria used by the organization to evaluate and distinguish significative environmental aspects and impacts; and
-a list of the significative environmental aspects and impacts after applying the criteria.
According to the text, your or ganization used a risk matrix to register all determined environmental aspects.
According to the text, it is not clear what criteria were used to classify some of those environmental aspects as significant.
According to the text, it is not clear which environmental aspects have a significant environmental impact.
To correct the NC I suggest:
Develop criteria to classify environmental aspects and impacts and document it. See in this article List of mandatory documents required by ISO 14001:2015 - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/list-of-mandatory-documents-required-by-iso-140012015/ - Criteria for evaluation of significant environmental aspects is a mandatory document
Include in the risk matrix columns where each of the criteria parameters are applied
Include in the risk matrix a column that clearly identifies if an environmental aspect is significant or not, after applying the criteria
The following material will provide you more information:
- ISO 14001 – 4 steps in identification and evaluation of environmental aspects - https://advisera.com/14001academy/knowledgebase/4-steps-in-identification-and-evaluation-of-environmental-aspects/
- ISO 14001:2015 – How to set criteria for environmental aspects evaluation - https://advisera.com/14001academy/blog/2016/10/31/iso-140012015-how-to-set-criteria-for-environmental-aspects-evaluation/
- free online training ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
- book - THE ISO 14001:2015 COMPANION – A A Straightforward Guide to Implementing an EMS in a Small Business - https://advisera.com/books/the-iso-14001-2015-companion/ -
What else do I need to be ISO 13485 certified when I am ISO 9001 certified?
Answer:
In order for your company to be ISO13485 certified, you need to adapt your company's current QMS to take into account the type of product that you are dealing with in your organization such as the inclusion of medical device files, design and development file, software validation and sterilization process just to name a few.
For more information, please refer to:
- List of mandatory documents required by ISO 13485:2016- https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/
- How to structure Quality Management System documentation according to ISO 1348-: https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/
-Checklist of ISO 13485 implementation and certification steps
https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/ -
Controlling forms
Answer:
We need document control to be sure:
a) we are all using the last version;
b) we are all using the same version, and
c) we are all speaking about the same document.
In your own case, how can you ensure that?
If the Form has a name or a title c) is ensured. If the Form is automatically generated after the Excel spreadsheet, if you control the Excel spreadsheet you will ensure a) and b) for everybody.
The following materials will provide you with details with documented information:
- Article - New approach to document and record control in ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
- free webinar on demand - How to use a Documentation Toolkit for the implementation of ISO 9001 [free webinar] - https://advisera.com/9001academy/webinar/how-to-use-a-documentation-toolkit-for-the-implementation-of-iso-9001-free-webinar-on-demand/
- [free course] ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/