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SPC, linearity distribution and PV value

SPC monitoring is necessary for customer-specific requirements and products/processes at a high-risk level. You monitor SPC based on customer requirements for the given product/process.

If you are referring to the Normal distribution and the relation between the distribution and the P-value, please note that when P-value is lower than 0.05 distribution is Normal.

On the other hand, if you are referring to linearity, linearity is a relation between X and Y which can be, for example, positive or negative.

The relation between a normal distribution and SPC can be explained as follows:

When Y has a normal distribution, it means that it follows a central tendency. It also means, based on the theory of central tendency, that it has a variation that we can use to predict the values of our Y.

A normal process has special causes that are easy to spot on the SPC chart when they occur. We cannot predict with certainty a Y that does not have a normal distribution.

That is why we always strive to identify and eliminate special causes and to identify and reduce the impact of common causes so that our process would be as normal (pointy) as possible.

For more information please read our article: „How to establish QMS Statistical process control according to IATF 16949“ https://advisera.com/16949academy/blog/2017/08/30/how-to-establish-qms-statistical-process-control-according-to-iatf-16949/

Implementation of policies

To implement policies you must consider:

• Study the requirements you must fulfill (e.g, contracts, laws, regulations, etc.)
• Take into account the results of your risk assessment, to determine which issues you have to address in your document, and detail level
• Optimize and align your document(s) (i.e., define the total number of documents)
• Structure your document (observe your corporate rules for formatting the document)
• Write your document (basically, the smaller the organization and the smaller the risks, the less complex your document will be)
• Get your document approved
• Training and awareness of your employees

These articles will provide you further explanation about polices development and implementation:

- ISO 27001 implementation checklist https://advisera.com/27001academy/knowledgebase/iso-27001-implementation-checklist/

- How to structure the documents for ISO 27001 Annex A controls https://advisera.com/27001academy/blog/2014/11/03/how-to-structure-the-documents-for-iso-27001-annex-a-controls/
- Seven steps for implementing policies and procedures https://advisera.com/27001academy/knowledgebase/seven-steps-for-implementing-policies-and-procedures//
- 8 criteria to decide which ISO 27001 policies and procedures to write https://advisera.com/27001academy/blog/2014/07/28/8-criteria-to-decide-which-iso-27001-policies-and-procedures-to-write/

To see how policies and procedures for ISO 27001 look like, I suggest to take a look at the free demo of our ISO 27001 Documentation Toolkit at this link: https://advisera.com/27001academy/iso-27001-documentation-toolkit/

ISO 27001 toolkit - which standard is it compliant with?

Advisera's ISO 27001 toolkits are compliant with ISO 27001:2013 - this standard was reviewed in 2019 by ISO and was confirmed as the current standard, which means that no changes have been made to the initial 2013 revision. For more information, please see the official ISO 27001 page: https://www.iso.org/standard/54534.html

Please be aware that standardization bodies of some countries have re-published ISO 27001 in a different year (e.g. ISO 27001:2016, ISO 27001:2017, etc.), however, the text of the standard has remained identical in all those standards. See more here: European 2017 Revision of ISO/IEC 27001: What has changed? https://advisera.com/27001academy/blog/2017/10/25/european-2017-revision-of-isoiec-27001-what-has-changed/

ISO/IEC 27701 Privacy information management standard

ISO 27701 is not mandatory, and it doesn't change nor influence the implementation of ISO 27001 and GDPR . Therefore, by using our toolkits you will be fully compliant with ISO 27001 and/or EU GDPR. 

As with any new standard, it remains to be seen if ISO 27701 will become popular, i.e. useful. Of course, we're considering it, and will most probably publish some articles and free webinars on this topic. 

Action plan for non-conformity

To prepare a corrective action to treat a non-conformity you need to:

• Define the problem
• Define the scope
• Containment Actions
• Find the Root Cause
• Plan a Corrective Action (steps needed to eliminate the root cause of the problem)
• Implement the Corrective Action
• Follow up to make sure the Plan worked

This article will provide you further explanation about corrective actions:
- Seven Steps for Corrective and Preventive Actions to support Continual Improvement https://advisera.com/9001academy/blog/2013/10/27/seven-steps-corrective-preventive-actions-support-continual-improvement/ (although this article is about ISO 9001, the same concept applies to ISO 27001)
 
This material will also help you regarding corrective actions:
- ISO Internal Audit: A Plain English Guide https://advisera.com/books/iso-internal-audit-plain-english-guide/

ISO 13485 vs. ISO 9001

No, you can not relay completely to ISO 9001:2015 because ISO 13485 does not have the same structure as ISO 9001 (ISO 9001:2015 has 10 sections, while ISO 13485 still have 8). Also, ISO 13485 has some specific requirements (like requirements for sterilization, implantable medical devices, service or installation). So, you need to get acquainted in details with ISO 13485:2016.

For more information please read the following articles:

ISO 9001 vs. ISO 13485 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/

What are the ISO 13485 structure and requirements https://advisera.com/13485academy/what-is-iso-13485/

What are the requirements for Production and service provision process in ISO 13485 https://advisera.com/13485academy/blog/2017/12/13/production-and-service-provision-process-in-iso-13485/

E-mail use

ISO 27001 does not prescribe specific rules on email security, only that related unacceptable risks are treated. Considered that, it is possible to create exclusions for the use of email service to fulfill this specific need, provided that unacceptable risks related to e-mail forwarding/relay are treated.

Condominium administrator

I really don't think it is necessary for the owner and tenants to attend this course as the GDPR is not applicable to household processing of personal data.

I think that the only interested party should be the representatives of the company administering the property.

However, if you want to find out more about the EU GDPR check out this free EU GDPR Foundations Course (https://advisera.com/training/eu-gdpr-foundations-course//).

Document signatures requirement

Please check ISO 9001:2015 clause 7.5.2 c).

There are no requirements about how many signatures are needed. So, it is up to your organization to decide.

As a minimum, one signature by document can evidence check and approval simultaneously. Or, your organization can decide to have two signatures by document, one for check and another for approval. Or, your organization can decide to have three signatures by document, one for writing, other for checking and another for approval.

The following material will provide you more information about document control:

- 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/
- Enroll for free in this 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/
 

AS9100 Revision C vs Revision D

The biggest change in the AS9100 standard from Rev C to Rev D is the incorporation of ISO 9001:2015, which brings in some necessary processes like identifying the context of the organization, identifying the needs and expectations of interested parties, as well as risk-based thinking at the top level. Additionally, they have brought in aerospace requirements for controlling counterfeit parts and product safety.

For more detail please see the articles: AS9100 Rev D vs. Rev C: What has changed?, https://advisera.com/9100academy/knowledgebase/as9100-rev-d-vs-rev-c-what-has-changed/  and 12 Steps to transition from AS9100 Rev C to Rev D, https://advisera.com/9100academy/knowledgebase/12-steps-to-transition-from-as9100-rev-c-to-rev-d/