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Ensuring control of Quality Policy
Answer:
The way of ensuring that the Quality Policy is controlled is to apply your procedure for document control to it as for any other document in your Quality Management System. The policy should be approved by the top management, preferably signed, and it should have its version number. Having version number will enable you to keep track whether the right version of the policy is available on the website, lobby and other places where it is published.
For more information, see: How to Write a Good Quality Policy https://advisera.com/9001academy/blog/2014/03/25/write-good-quality-policy/
These materials will also help you regarding internal audit:
- Book Managing ISO Documentation: A Plain English Guide https://advisera.com/books/managing-iso-documentation-plain-english-guide/
- Free online training ISO 9001:2015 Foundations Course https://advisera.com/training/iso-9001-foundations-course/
- Conformio (online tool for ISO 9001) https://advisera.com/conformio/ -
Questions on IATF 16949 transition
1. what are the changes to the Non conformance Report (Internal Audit) closing format?
There are no changes in requirements regarding nonconformity record or internal audit report. You can continue to use your existing records for nonconformities or internal audit report. For more information, see: Five Main Steps in an IATF 16949:2016 Internal Audit https://advisera.com/16949academy/knowledgebase/five-main-steps-in-an-iatf-169492016-internal-audit/
2. Who will be audited for areas covered by erstwhile MR?
Thee fact that the management representative is no longer a mandatory role doesn't mean that it is forbidden. If the organization finds management representative as an important role for its QMS, it can keep it. What areas or what persons will be audited in case when there is no management representative will depend on how the organization assigned roles and responsibilities, but it is usually quality department or quality manag er, who will take charge and be audited. For more information, see: What will be the destiny of the management representative in the new ISO 9001:2015? https://advisera.com/9001academy/knowledgebase/what-will-be-the-destiny-of-the-management-representative-in-the-new-iso-90012015/
3. Who shall make plans for internal audits - i.e. whose responsibility will it be?
The standard doesn't prescribe who will be responsible for making plans for internal audits, so the organization can assign this responsibility to any person that it finds the most appropriate. Usually, this will be quality manager or some other member of quality department. For more information, see: What is the job of the Quality Manager according to ISO 9001? https://advisera.com/9001academy/blog/2016/08/23/what-is-the-job-of-the-quality-manager-according-to-iso9001/
4. What shall be the responsibilities and authorities of person(s) replacing MR/
The above are some of the doubts I have. Some of my clients are in the process of transition to ISO 9001 2015 and TS 16949 2016,
Besides requirements of ISO 9001:2015 regarding roles and responsibilities that include ensuring compliance of the QMS with the standard, effectiveness of the processes, reporting on the performances of the QMS to the top management and promoting continual improvement, IATF 16949 has additional requirements to define roles and responsibilities for meeting customer requirements, ensuring conformity of products and services and initiating and enforcing corrective actions.
All these roles and responsibilities don't have to assigned to one person, but can be spread to several persons so they don't become too big burden.
These materials will also help you regarding internal audit:
- Free online training ISO 9001:2015 Internal Auditor Course https://advisera.com/training/iso-9001-internal-auditor-course/
- Conformio (online tool for ISO 9001) https://advisera.com/conformio/ -
Legal requirements
I assuming you are referring to clause 4.2 (determination of requirements of interested parties) instead of clause 4.1 (understanding the organization and its context). Considering that, besides this clause and section A.18.1 you mentioned, ISO 27001 refers to legal issues also in control A.8.2.1 (classification of information).
You should also consider clause 9.3 (management review), because it covers among other things interested parties feedback, changes in organizational context and the performance of security controls, as well as controls that regulate agreements, like A.7.1.2 (Terms and conditions of employment), A.13.1.2 (Security of network services), A.13.2.2 (Agreements on information transfer), A.13.2.4 (Confidentiality or nondisclosure agreements), and A.15.1.2 (Addressing security within supplier agreements).
This article will provide you further explanation about 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/
This material will also help you regarding audit:
- ISO Internal Audit: A Plain English Guide https://advisera.com/books/iso-internal-audit-plain-english-guide/ -
ISO 27002 NIST and the Cybersecurity Framework
Answer: All these references provides guidance on the implementation of security controls. ISO 27002 provides guidance on the controls from Annex A from ISO 27001 standard. NIST Special Publications from 800 series (SP-800), provides a series of documents with more detailed recommendations either on implementation of controls (e.g., cryptography, access control, etc.) as well as about implementation of a risk management framework. Cybersecurity Framework is kind of a specific application of NIST documents related to cyber environment.
These articles will provide you further explanation about these documents:
- ISO 27001 vs. ISO 27002 https://advisera.com/27001academy/knowledgebase/iso-27001-vs-iso-27002/
- How to use the NIST SP800 series of standards for ISO 27001 implementation https://advisera.com/27001academy/blog/2016/05/02/how-to-use-the-nist-sp800-series-of-standards-for-iso-27001-implementation/
- How to use NIST SP 800-53 for the implementation of ISO 27001 controls https://advisera.com/27001academy/blog/2016/05/10/how-to-use-nist-sp-800-53-for-the-implementation-of-iso-27001-controls/
- Which one to go with – Cybersecurity Framework or ISO 27001? https://advisera.com/27001academy/blog/2014/02/24/which-one-to-go-with-cybersecurity-framework-or-iso-27001/ -
Monitoring and measuring results and management review inputs
Among the inputs for a sound management review should be information:
• to evaluate if the particular monitoring and measurement methods (clause 9.1.1) have been used and are adequate to demonstrate the organization's ability to achieve planned results. For example, if top management considers important to know if customers are lost after complaining, or if complains are answered in a timely manner, it must assess if the indicators chosen to monitor how the organization handle complains allow to know that.
• to evaluate the performance and effectiveness of the QMS and identify trends and opportunities for improvement (clause 9.1.3). For example, the level of defects with raw materials received in the warehouse is within acceptable limits or are a sign that supplier selection procedures must be improved?
These materials will also help you regarding monitoring and measurement, and management review:
- article - Monitoring an d Measurement: The basis for evidence-based decisions https://advisera.com/9001academy/blog/2020/09/21/how-to-perform-monitoring-and-measurement-according-to-iso-9001/
- article - How to make Management Review more useful in the QMS https://advisera.com/9001academy/blog/2014/01/21/make-management-review-useful-qms/
- free online training - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/ -
Product safety
Hi Elvina,
The element of the product safety can be combustibility of the product, chemical that dissolve over the course of time, It can also be resistance to impact, fire, chemicals, etc. It depends on the type of the product and its purpose. In some cases there are no significant product safety requirements. -
Joining QA/QC team
Answer:
The best way to join the QA/QC team is to get relevant competency and be able to contribute to the team. I suggest you get knowledge on the quality management system and being a document controller makes you already familiar with some parts of the standard. You can also take a look at our free ISO 9001:2015 Internal Auditor Course https://advisera.com/training/iso-9001-internal-auditor-course/ -
Preparing for internal audit
Answer:
When conducting the internal audit you need to check all requirements of the standard and determine to what level the organization is compliant to requirements of the standard. Documents to be reviewed are all documents and records required by the standard and those that the organization determined as necessary for maintaining the EMS (Environmental Management System). For more information about the mandatory documents, see: List of mandatory documents required by ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
The best way to develop internal audit checklist is to read the documentation fir st and make notes on what needs to be checked during the audit along with requirements of the standard. For more information, see: Writing an Audit Checklist for ISO 9001 Processes https://advisera.com/9001academy/blog/2014/11/25/writing-audit-checklist-iso-9001-processes/
These materials will also help you regarding internal audit:
- Book ISO INTERNAL AUDIT: A PLAIN ENGLISH GUIDE https://advisera.com/books/iso-internal-audit-plain-english-guide/
- Free online training ISO 9001:2015 Internal Auditor Course https://advisera.com/training/iso-9001-internal-auditor-course/
- Conformio (online tool for ISO 9001) https://advisera.com/conformio/ " -
Sustainability policy as Environmental Policy
Answer:
If the sustainability policy meets all requirements of ISO 14001 regarding environmental policy, you can use it as environmental policy. The standard requires for environmental policy the following:
- to be appropriate to the purpose and context of the organization;
- to provide framework for setting environmental objectives;
- to include commitments to protection of the environment, fulfillment of the compliance obligations, continual improvement and other commitments relevant to the context of the organization
For more information, see: How to write an ISO 14001 environmental policy https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/how-to-write-an-iso-14001-environmental-policy/
These materials will also help you regarding the environmental policy:
- Free online training ISO 14001:2015 Foundations Course https://advisera.com/training/iso-14001-internal-auditor-course/
- Conformio (online tool for ISO 14001) https://advisera.com/conformio/ "