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Is there a way to customize intake forms when filling out a customer complaint?
Answer:
According to the requirement 8.2.2 Complaint handling, following data are necessary for each customer complaint:
-Date of receiving the complaint
-Complaint description
-Who received a complaint
-Who reviewed it – investigated it – is it reasonable or unreasonable
-Suggestion for complaint treatment
-Who approved suggestion
-Execution deadline
-Responsible for execution
-Is there any corrective or preventive action initiated
It can be done in table form. When taking the customer description, be sure to take the Lot number and to how many pieces of the medical device this compliant referred to. When you create a form that will cover all of these elements, you must ensure that such a form is available to anyone who needs it whenever they need it.
For more about handling customer complaints, please read article: How to comply with ISO 13485: 2016 requirements for handling complaints
https://advisera.com/13485academy/blog/2017/03/21/how-to-comply-with-iso-134852016-requirements-for-handling-complaints/ -
Implementing asset register
eh investigado sobre los anexos de la iso y quisiera enfocarme en los activos de una empresa osea que el auditor pueda acceder al sitema y registrar los activos de la empresa"
("I have to make a system for an auditor, using the standard iso 27001 and investigated the annexes of the iso and I would like to focus on the assets of a company that allows the auditor to access the system and register the assets of the company ")
Answer: For the implementation of an inventory of assets I suggest you to take e look at the free demo of this Inventory of Assets at this link, to see if it can fulfill your needs: https://advisera.com/27001academy/documentation/inventory-of-assets/
The purpose of this document is to list all the important information resources and identify their owners.
This article will provide you further explanation about inventory of assets:
- How to handle Asset register (Asset inventory) according to ISO 27001 https://advisera.com/27001academy/knowledgebase/how-to-handle-asset-register-asset-inventory-according-to-iso-27001/
Regarding how to setup a system of internal audit, the main steps are:
- Develop an internal audit procedure
- Plan your audits, considering dates, criteria and scope
- Develop checklists to help you not forget something during the audit
- Elaborate the audit report which will include the non-compliances and other findings
These articles will provide you additional information about internal audit:
- How to prepare for an ISO 27001 internal audit https://advisera.com/27001academy/blog/2016/07/11/how-to-prepare-for-an-iso-27001-internal-audit/
- How to make an Internal Audit checklist for ISO 27001 / ISO 22301 https://advisera.com/27001academy/knowledgebase/how-to-make-an-internal-audit-checklist-for-iso-27001-iso-22301/
These materials will also help you regarding internal audit:
- ISO Internal Audit: A Plain English Guide https://advisera.com/books/iso-internal-audit-plain-english-guide/
- ISO 27001:2013 Internal Auditor Course https://advisera.com/training/iso-27001-internal-auditor-course/
Additionally, this toolkit can help you plan and perform an audit compliant with ISO 27001: https://advisera.com/27001academy/iso-27001-22301-internal-audit-documentation-toolkit/
At this site you can download a free preview of the documents to see how they look like and if they can fulfill your needs. -
Develop process indicators
Answer
Please consider our free webinar on demand - Measurement, analysis, and improvement according to ISO 9001:2015 - https://advisera.com/9001academy/webinar/measurement-analysis-and-improvement-according-to-iso-9001-2015-free-webinar/ There one can find the rationale for developing effectiveness indicators and a monitoring plan:
On our free webinar on demand – The Process Approach - What it is, why it is important, and how to do it - https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/ one can find an example of a flowchart that describes the flow of activities:
Any situation where a diamond question box appears can be used to develop efficiency indicators, or product/service conformity indicators. -
Equipment maintenance
Answer:
Equipment maintenance is covered under clause 7.1.3 of ISO 9001:2015.
The following materials will provide you more information about infrastructure control:
- Procedure for Equipment Maintenance and Measurement Equipment - https://advisera.com/9001academy/documentation/procedure-equipment-maintenance-measurement-equipment/
- [free course] ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
ISO 45001 - Resources needed to implement
My question is this: Our company has 350 employees, and 9 bldgs. How big a team do we need to prepare the site to understand the certification process and their important role in the implementation of the OHS, and then go through the certification process with a registrar?
Answer:
First, I want to point out that you should not be implementing both ISO 45001 and OHSAS 18001. OHSAS 18001 is an older standard that is being replaced with ISO 45001, and will be made obsolete in the next 3 years, so the newer ISO 45001:2018 standard is the one you should use.
As for how many people you need, this question can be trickier. This can depend on many things, most importantly the number of different processes in the company. For instance, the ISO 45001 standard asks that you assess the OH&S hazards for your processes, but if you use the same process in each of your 9 buildings you would not need to perform th is activity 9 times; only I time per process. What can be the best help is to us a gap analysis tool to see how much of the standard requirements you already have in place, then you can try to assess how much work is left and therefore how many people you need to do this work in the time needed. We have a free, online gap analysis that you can assess here: ISO 45001 Gap Analysis Tool, https://advisera.com/45001academy/iso-45001-gap-analysis-tool/
Another helpful tool to understand exactly what will need to be implemented is our downloadable whitepaper which explains the requirements in an easy to understand format. You can find this here: Clause-by-clause explanation of ISO 45001:2018, https://info.advisera.com/45001academy/free-download/clause-by-clause-explanation-of-iso-45001 You might also want to review our diagram for the implementation and certification process; Diagram of ISO 45001 Implementation Process, https://info.advisera.com/45001academy/free-download/diagram-of-iso-45001-implementation-process -
Good quality objectives
Answer
Good objectives must be aligned with the policy. It is easier to create good objectives when there is a clear policy based on a clear strategic orientation. What is your company’s strategic orientation? Does your company win customers based on the lowest price? Or based on the best service? Or is it innovation or design? I like to compare a company to an athlete. If you compare the body of someone competing on athletics with the body of someone that competes on weightlifting, they are very, very different. It is the same for two companies operating in the same economic sector but with different strategic orientations.
Please check image:
Each strategy determine different offers, require different main processes, or what is important in each process is different, and requires a different infrastructure.
One final point, good objectives are relevant to top management.
The following material will provide you information about quality objectives:
- Article – How to Write Good Quality Objectives - https://advisera.com/9001academy/knowledgebase/how-to-write-good-quality-objectives/
- Free webinar on demand - Measurement, analysis, and improvement according to ISO 9001:2015 - https://advisera.com/9001academy/webinar/measurement-analysis-and-improvement-according-to-iso-9001-2015-free-webinar/
Free course - ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Annex SL applicable to system documentation?
Answer:
The Annex SL structure is only the structure that the international organization for standardization has determined they want to use when they create an ISO management system standard. The standard helps the ISO group to create management system standard that better follow the plan-do-check-act cycle and are easier to integrate with other management system standards since they have many common elements that can be more easily recognized between standards since the clause structure is the same.
This structure is not required, or applicable, to procedures that a company creates for its management system.
To better understand the Annex SL format, see the article: Is ISO 45001:2018 compliant with Annex SL, https://advisera.com/45001academy/blog/2019/03/08/is-iso-450012018-compliant-with-annex-sl/ -
Evaluation of externally provided processes
Answer
All externally provided processes should be controlled as long as they are relevant for the product or service offered under the scope of the quality management system. Just like with purchasing, office paper is not relevant for a quality management system of a manufacturing company.
The following material will provide you information about externally provided processes:
- Article – How to control outsourced processes using ISO 9001 - https://advisera.com/9001academy/blog/2015/05/05/how-to-control-outsourced-processes-using-iso-9001/
Free course - ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Filling in the List of Requirements template
Thank you! Your answers are very helpful. -
Is there checklist for ISO 13485 document requirements specifically for a 3PL?
Answer:
There is no specific checklist list for ISO 13485 documentation for 3PL. However, list of all mandatory required documents for ISO 13485:2016 you can find at the following link: https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/
Documents related to production, sterilization, design and development, installation, and service for your business are not applicable and can be excluded as such. For you, in addition to general procedures, the most important procedures are: Procedures for preserving the conformity of product (clause 7.5.11), Records of traceability and name and address of the shipping package recipient (clause 7.5.9.2), Report on Changes on Customer Property (clause 7.5.10).