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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). -
Employee motivation and empowerment
Answer:
Regarding requirement 7.3.2 of IATF 16949, an organization needs to have in place documented process (mapped, flow diagram, procedure) for Motivation of employees to achieve quality objectives (incentives for objectives, targets and what employees expect when they achieve targets, bonuses, investment in employees, other types of motivation and what and when it is performed, etc.), Continuous impro vement and promotion of innovation (what employees can expect when they promote innovation and when they have a high score in CI) and Promotion of quality and technology awareness (workshops, visual management, awards, etc.).
I highly recommend that you don’t put anything in the procedure that won’t be done. All the above is a common practice in the automotive industry that you should follow. -
Management representative in IATF
Answer:
There is no formal request for a management representative. Have in mind that standard IATF 16949 is requesting to assign other roles such as personnel for ensuring the customer requirements and similar.
For more information, please read the article:
How to define roles and responsibilities within an IATF 16949 based QMS https://advisera.com/16949academy/blog/2017/11/29/how-to-define-roles-and-responsibilities-within-an-iatf-16949-based-qms/
2. When to do MSA studies?
Answer:
Measurement system analysis (MSA) is performed for each type of measurement/inspection/test equipment system defined in the control plan.
Find out more about MSA studies in our article:
How to establish measurement system analysis according to IATF 16949: https://advisera.com/16949academy/blog/2017/11/08/how-to-establish-measurement-system-analysis-according-to-iatf-16949/ -
M & E and ISO 9001
2. In monitoring and evaluation we look at different aspect in terms of value for money, efficiency, relevance, effectiveness, impact and sustainability how can I relate all of these with ISO?
Answer 1
If you are mentioning changes between ISO 9001 versions from 2008 and 2015, there are some. ISO 9001:2015 has a higher emphasis in performance monitoring.
Answer 2
Consider what do you want from each process and from the whole quality management system. Monitoring and evaluation is about following and making decisions based on indicators. Those indicators can measure topics like value for money, efficiency, relevance, effectiveness, impact and sustainability. For example, in a manufacturing process, indicators about defects, productivity or costs are ways of monitoring efficiency and value for money. So, they can relate very well with ISO.
The following material will provide you information about monitoring and evaluation:
- Article – Infographic: ISO 9001:2015 vs. 2008 revision – What has changed? - https://advisera.com/9001academy/knowledgebase/infographic-iso-90012015-vs-2008-revision-what-has-changed/
- How to implement the Check phase (performance evaluation) in the QMS according to ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/11/17/how-to-implement-the-check-phase-performance-evaluation-in-the-qms-according-to-iso-90012015/
- 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/ -
GDPR compliance
In this case, the employer should ensure that any data on the device cannot be stored or processed locally.
One solution would be using a "remote desktop" solution such as Citrix. In this case, we would not be facing a data transfer. -
Scope and specific procedures
Answer:
As long as the rules applicable to each part of the business are clear, an organization can have specific procedures for each business unit under a common certificate. Consider the example of a construction company with a unique certificate but different procedures in different sites due to local legislation and different customer requirements and different kind of project.
The following material will provide you information about scope definition:
- Article – How to define the scope of the QMS accordi ng to ISO 9001:2015 -https://advisera.com/9001academy/knowledgebase/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/
- 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/