Start a new topic and get direct answers from the Expert Advice Community.
CREATE NEW TOPIC +Search results
11269 results
Guest
Guest
Create New Topic As guest or Sign in
Assign topic to the user
-
Certificates of products bought
Answer:
ISO 9001:2015 does not mandate that organizations get certificates for all products they buy. Having said that, one must not forget that some legislation may require that. I as an auditor, auditing a company that manufactures a product with CE marking for example, can require to see if they have CE certificates of the raw materials.
The following material will provide you information about purchasing:
- ISO 9001 – Purchasing in QMS – The Process & the Information Needed to Make it Work - https://advisera.com/9001academy/blog/2014/03/18/purchasing-qms-process-information-needed-make-work/
- 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/ -
Environmental conditions and operations
Answer:
Normally, I consider warehouse temperature monitoring and control under clause 7.1.4. This clause is specifically about environmental items relevant for product or service conformity. Clause 8.5.1 is more general. For example, would you have the same doubt about 8.5.1 b) versus 7.1.5 about assuring thermometers calibration?
The following material will provide you information about environmental conditions:
- ISO 9001 – Understanding Resource Management in ISO 9001 - https://advisera.com/9001academy/blog/2014/02/11/understanding-resource-management-iso-9001/
- 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/ -
Use of templates
Answer:
As long as your documents comply the ISO 27001 standard requirements, you can use any format you think will fulfill your organization needs. We recommend to use our templates, adjusting them to your needs, since they are fully editable, because they are already compliant with standard requirements, saving your time an effort. Additionally, parts of each document that can be changed or must be kept as is are indicated in comments included in each template. -
Cancelled change
Answer:
I think you should not mix failed/unsuccessful changes with cancelled changes. With cancelled change - actually nothing happened (no resources used, no money/time spent, no new/changed functionality, etc.). So, if you have possibility, define "cancelled" as one of the statuses change can have. And, investigate why change was raised and cancelled, afterwards. It could be start of improvement initiative.
Read the article "How to measure Change Management efficiency according to ITIL" https://advisera.com/20000academy/blog/2016/10/11/how-to-measure-change-management-efficiency-according-to-itil/ to learn more about Change Management process efficiency. -
Subject Matter Expert (SME) and SOP
What I meant is - if you have 7 functions, and if you have SME in certain technology - use it (one or more persons) for all functions. -
Internal review
Documents in our toolkit(s) contain section with monitoring and measurements i.e. CSF's and KPI's (few examples as well). Please fill in the form and I will be glad to make a demo for you. https://advisera.com/20000academy/free-consultations/ -
IATF 16949 and ISO Compatibility
Answer:
IATF 16949 covers all requirements of ISO 9001:2015 plus additional requirements specific to the automotive industry. If you are compliant with ISO 9001:2015, you need to implement only the additional requirements of IATF 16949. Some of IATF 16949 requirements require the organization to implement changes to the existing ISO 9001 processes (e.g. document control, internal audit, management review, etc), and some require entirely new processes to be established (e.g. product safety, total productive maintenance, etc) -
Traceability of calibration
Answer:
The measuring equipment should be calibrated by either accredited laboratory, in which case the accreditation testifies that the calibration is performed properly, or by the organization itself, in which case the master equipment should be calibrated by the external laboratory. -
Interested parties in ISO 45001
Answer:
The ISO 45001 requires understanding who are the interested parties related to the OH&SMS (Occupational Health and Safety Management System) and the implications that the OH&SMS might have on these parties. In order to be more detailed the standard specifies which types of parties are expected. We have the internal and external interested parties. Internal interested parties are employees, unions and so on, external interested parties are customers, of course, suppliers, subcontractors, related authorities and so on.
After identification of the interested parties, you need to identify their relevant needs and expectations. Considering that the focus of the standard is occupational health and safety, only needs and expectations related to it are considered relevant. For example, needs and expectations related to the product packaging are not relevant to OH&SMS, but requirements regarding protective equipment used in processes are relevant.
For more information, see: Determ ining interested parties according to ISO 45001 https://advisera.com/45001academy/blog/2018/03/14/determining-interested-parties-according-to-iso-45001/ -
Preparing for a surveillance audit
Answer:
The surveillance audit, like the certification audit, is an on-site audit done by the certification body, will have corrective actions issued that need to be addressed, and will have an audit report issued to your organization as a record of the audit. The difference is the number of hours devoted to processes in the audit.
For the certification audit, the certification body auditors will look at the implementation of every process within your management system to check for conformance to the applicable standards, as well as your organization documentation, process effectiveness, and continual improvement.
However, the surveillance audit will spend less time on only some portions of your management system. They will start each time by looking at your key activities (such as management review, internal audit, corrective actions and complains treatment), and will then only look at some of the remaining parts within your management system. They may also only look at a portion of the whole organization, such as only one out of two operating activities, or even only certain sites chosen by the auditors, rather than multiple sites. Surveillance audits will take less time to perform than the original certification audit. The goal for the certification body is to audit all of the processes and business sites at least once within the management system during the three-year surveillance cycle.
There are no special documentation requirements different from the certification audit.
The following material will provide you information about surveillance audits:
- ISO 9001 – What is an ISO 9001 surveillance audit? - https://advisera.com/9001academy/blog/2016/10/18/what-is-an-iso-9001-surveillance-audit/
- Surveillance visits vs. certification audits - https://advisera.com/27001academy/knowledgebase/surveillance-visits-vs-certification-audits/
- 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/