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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/ -
ISO 27001 and ISO 22301
Answer:
First it is important to note that it is not mandatory to implement ISO 27001 to implement and get certified against ISO 22301.
Regarding performing BIA complaint with ISO 22301 you need:
- to identify activities that support the products or services you want to ensure the continuity
- to assess the impact over time in case these activities are disrupted
- to define prioritized timeframes for returning these activities
- to identify dependencies and supporting resources
These materials will provide you further explanation about performing BIA:
- How to implement business impact analysis (BIA) according to ISO 22301 https://advisera.com/27001academy/knowledgebase/how-to-implement-business-impact-analysis-bia-according-to-iso-22301/
- Implementing Business Impact Analysis according to ISO 22301 [free webinar on demand] https://advisera.com/27001academy/webinar/implementing-business-impact-analysis-according-to-iso-22301-free-webinar-on-demand/
- Risk assessment vs. business impact analysis https://advisera.com/27001academy/knowledgebase/risk-assessment-vs-business-impact-analysis/ -
Lead Auditor or Lead Implementer
What do you suggest please? Lead Auditor or Implementer, and is you provider have better reputation than IRCA?
Answer:
You must consider your personal and business objectives to define the proper approach. If you plan to implement an ISMS, then you should go for Lead Implementer certification, but if you plan to work as an auditor, then Lead Auditor would be probably better for you.
These articles will provide you further explanation about ISO 27001 certifications:
- What does ISO 27001 Lead Implementer training look like? https://advisera.com/27001academy/blog/2016/11/28/what-does-iso-27001-lead-implementer-training-look-like/
- What does ISO 27001 Lead Auditor training look like? https://advisera.com/27001academy/blog/2016/08/29/what-does-iso-27001-lead-auditor-training-look-like/
- Lead Auditor Course vs. Lead Implementer Course – Which one to go for? https://advisera.com/27001academy/blog/2014/06/16/lead-auditor-course-vs-lead-implementer-course-which-one-to-go-for/
Regarding reputation, both Examplar Global and IRCA are well seen in the market, the difference being that Exemplar Global is more recognized in North America, Pacific and Australia; IRCA is more popular in Europe. -
BS25999 and ISO 22301
Answer:
BS 25999 is the British standard from which ISO 22301 was developed, and we decided to leave both references in the toolkit's name to make it easier for customer that it can cover a Business Continuity Management System based on both standards.
These articles will provide you further explanation about BS25999:
- What is BS 25999? https://advisera.com/27001academy/what-is-bs-25999/
- ISO 22301 vs. BS 25999-2 – An Infographic https://advisera.com/27001academy/blog/2012/05/22/iso-22301-vs-bs-25999-2-an-infographic/