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Preparing for a surveillance audit
Answer
Surveillance audits exist to check if your management system is working as designed. So, pay special attention to records. Are all the incidents being recorded? Measurements, complaints, corrective actions, non-conformities, internal audits, and management review, etc. Remember, if your organization had any minor non-conformity or observations during the certification audit, be sure that auditors will look into those issues with special care.
The following material will provide you more information about surveillance audits:
- 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/
- Enroll for free course - ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- book – Preparing for ISO Certification Audit: A Plain English Guide - https://advisera.com/books/preparing-for-iso-certification-audit-plain-english-guide/ -
Integrating management systems
Answer:
Congratulations for your successful certification project. It is nice to know that Advisera could help you and your organization. Yes, you can integrate ISO 45001 and ISO 14001 without ISO 9001.
I would not make any of the standards the leading one. I rather would draw a process map of how your organization works and is it doing that work so that health and safety and environmental issues should be considered. So, instead of “while doing things relevant for the environment I must also consider this health and safety topics” I would follow the approach “while doing our work to fulfill the organization’s purpose of existence we have to consider both environmental and health and safety iss ues”.
The following material will provide you more information about management systems integration:
Article - - How to integrate OHSAS 18001 and ISO 14001 - https://advisera.com/9001academy/blog/2016/10/18/what-is-an-iso-9001-surveillance-audit/
Free webinar on-demand - How to integrate ISO 9001:2015 and ISO 14001:2015 - https://advisera.com/14001academy/webinar/how-to-integrate-iso-90012015-and-iso-140012015-free-webinar-on-demand/
Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/ -
Certified suppliers
Answer:
Even if your supplier is ISO 27001 certified you have to perform a risk assessment to identify the risks this supplier can bring to you organization, so you can include proper information security clauses in your contract or service agreement with it.
The fact the supplier is ISO 27001 certified brings more confidence that it can handle customer's information properly, but you as a customer still have to perform your own risk assessment regarding the supplier.
These articles will provide you further explanation about managing security of suppliers:
- 6-step process for handling supplier security according to ISO 27001 https://advisera.com/27001academy/blog/2014/06/30/6-step-process-for-handling-supplier-security-according-to-iso-27001/
- Which security clauses to use for supplier agreements? https://advisera.com/27001academy/blog/2017/06/19/which-security-clauses-to-use-for-supplier-agreements/ -
Format as controlled document
Answer
Yes, the auditor will accept the memo format as long as your organization can demonstrate document control over that memo. One designation, changes controlled, distribution controlled, approval controlled.
The following material will provide you more information about document control:
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 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/ -
Certification benefits
Answer
ISO 9001 certification is not mandatory. Your company should first evaluate what can be the benefits from ISO 9001 certification and then decide. For example, does ISO 9001 certification bring marketing/image benefits?
The following material will provide you more information about certification benefits:
Six Key Benefits of ISO 9001 Implementation - https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/
Free webinar – Overview of ISO 9001 implementation steps - https://advisera.com/9001academy/webinar/overview-of-iso-9001-implementation-steps-free-webinar-on-demand/
- Enroll for free course - ISO 9001:2015 Foundations Course - https://traini ng.advisera.com/course/iso-90012015-foundations-course/
- book – Discover ISO 9001:2015 Through Practical Examples – https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Duration estimation
I think that a small manufacturing enterprise with up to 20 employees can develop implement and request a certification audit in about 6 to 9 months. So, just for developing the system I believe that 6 months are enough. The following material will provide you more information about implementing a quality management system: Should you use a gap analysis in your ISO 9001 implementation? - https://advisera.com/9001academy/17/use-gap-analysis-iso-9001-implementation/ Free ISO 9001:2015 Gap Analysis Tool - https://advisera.com/9001academy/iso-9001-gap-analysis-tool/ ISO 9001 Implementation Duration Calculator - https://advisera.com/9001academy/iso-9001-duration-calculator/ ISO 9001 Implementation diagram - https://info.advisera.com/9001academy/free-download/iso-9001-implementation-diagram
Free webinar – Overview of ISO 9001 implementation steps - https://advisera.com/9001academy/webinar/overview-of-iso-9001-implementation-steps-free-webinar-on-demand/ - Enroll for free course - 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/ Perhaps a documentation tool kit could help slash developing time - ISO 9001:2015 Documentation Toolkit - https://advisera.com/9001academy/iso-9001-documentation-toolkit/ -
How to mark and identify Company Policies?
Answer:
It is not mandatory for these documents to have document ID, version number and review date. In ISO 13485:2016, in point 4.2.4 it is stated that Organization must ensure that documents are identified according to the current revision status, must prevent the unintended use of obsolete documents and must apply suitable identification to them. Therefore, how you will identify them and how you differentiate them is absolutely up to you, but you must ensure that the above requirements are secured.
According to the ISO 13485:2016, for Quality Policy it is not mandatory to have document ID and version number. However, in requirement 5.3 Quality policy, in subsection e) it is stated that Top management must ensure that it is re viewed for continuing suitability. Therefore, you have to have a date on it to know when it was last reviewed.
For more about common mistakes in document control, please read article:
Common mistakes with ISO 13485:2016 documentation control and how to avoid them
https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them/ -
Quality manual for corporation
Answer
First, ISO 9001:2015 no longer mandates the existence of a quality manual. So, organizations have a lot of freedom to decide what do they want to include if they decide to write a quality manual.
The corporation has a purpose, has a mission, each business unit work on its own way to contribute to that purpose. One of the big advantages of corporations is the synergy among different business units, like the case you mention: sharing common processes.
Start with a description of the corporation, then describe the business units and their processes and underline the existing synergies.
The following material will provide you more information about the quality manual:
How to write a short, concise Quality Manual - https://advisera.com/9001academy/knowledgebase/writing-a-short-quality-manual/
The future of the Quality Manual in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/the-future-of-the-quality-manual-in-iso-90012015/
- Enroll for free course - 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/ -
Auditing Environmental Compliance
Answer:
First, a clarification: ISO 14001:2015 does not ask for an internal compliance audit. ISO 14001:2015 asks for a complete verification and several actions if needed (clause 9.1.2).
In my country auditors want to check the actual Environmental Compliance Register. Certification auditors are bounded by confidentiality. Some organizations prepare a kind of legal document for the auditor(s) to reinforce that confidentiality. If an organization has any non-compliance that will appear, for example, in the management review record, a basic document for any certification audit.
The following material will provide you more information about legislation in an environmental management system:
Compliance requirements according to ISO 14001:2015 – What has changed? - https://advi sera.com/14001academy/blog/2015/09/14/compliance-requirements-according-to-iso-140012015-what-has-changed/
How to achieve regulatory compliance in ISO 14001 - https://advisera.com/14001academy/blog/2015/06/15/how-to-achieve-regulatory-compliance-in-iso-14001/
Enroll for free in this course – ISO 14001:2015 Internal Auditor Course - https://advisera.com/training/iso-14001-internal-auditor-course/
Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/ -
ISO 14001 and legislation
Answer:
ISO 14001:2015 has no specific requirements for shipboard waste oil incinerator. You have to check which national or international legislation your organization has to comply. Different countries have different air emission limits for each chemical.
The following material will provide you more information about legislation in an environmental management system:
How to achieve regulatory compliance in ISO 14001 - https://advisera.com/14001academy/blog/2015/06/15/how-to-achieve-regulatory-compliance-in-iso-14001/
Enroll for free in this course – ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/