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Maintaining certification
I would like to know if: a) a consultant is necessary to achieve/maintain ISO standards Answer It is not mandatory to have a consultant to achieve or maintain ISO certifications. The only requirement is being compliant with ISO standards and internal requirements. Of course, in your particular situation perhaps a consultant can be useful for maintaining the certifications, because she or he already has an overall idea of how your Integrated Management System works and how things are interrelated. Another possibility can be to use the consultant to train you and other people about the Integrated Management System. b) it is mandatory to audit the company's supply chain and if so how? Answer Nothing in the standards make that mandatory, unless your own internal rules define that as mandatory. Remember, internal rules can be changed by organizations if they are not effective or if context changes. The following material will provide you more information about maintaining certification and supplier evaluation: How to maintain your ISO 9001-based QMS after certification - https://advisera.com/9001academy/31/how-to-maintain-your-iso-9001-based-qms-after-certification/ How to evaluate supplier performance according to ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/10/27/how-to-evaluate-supplier-performance-according-to-iso-90012015/ - [Free webinar on demand] - How to integrate ISO 9001:2015 and ISO 14001:2015 - https://advisera.com/9001academy/webinar/how-to-integrate-iso-90012015-and-iso-140012015-free-webinar-on-demand/ - [free course] ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/ [there is also a free course about ISO 14001:2015] - [free course] ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/ - book - ISO Internal Audit: A Plain English Guide - https://advisera.com/books/iso-internal-audit-plain-english-guide/ -
Consultants and maintaining certification
Answer
No, it is not mandatory to have a consultant to get or maintain ISO 9001 certification. The only requirement is being compliant with ISO 9001 and internal requirements.
The following material will provide you more information about maintaining certification:
How to maintain your ISO 9001-based QMS after certification - https://advisera.com/9001academy/31/how-to-maintain-your-iso-9001-based-qms-after-certification/
- [free course] ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- book - ISO Internal Audit: A Plain English Guide - https://advisera.com/books/iso-internal-audit-plain-english-guide/ -
Section A.18.1 Compliance with legal and Contractual Requirements
Answer:
To record the legal and contractual requirements relevant to your ISMS you can use the List of Legal Regulatory Contractual and Other Requirements template. To document your approach to identify these requirements you can use the Procedure for Identification of Requirements template.
Both templates are located in folder 02 Identification of Requirements of your toolkit.
By the way, included in your toolkit there is a List of Documents file which shows you which requirements and controls from ISO 27001 are covered by each document in the toolkit. -
BIA questions
Answer:
First of all thanks for this feedback.
Legal penalties refer to penalties related to laws and regulations defined by governments, while contractual penalties refer to penalties related to contracts and service agreements established between the organization and customers, organization and suppliers, or organization and partners or other third parties.
If you have other explanation you need about specific questions on BIA questionnaire, could you please send it to us, so we can have a better understanding on which details we must provide? -
Document control of handwritten documents
Answer
Handwritten documents can be controlled documents under an ISO 9001 quality management system.
First, identify that kind of document, give it a name or designation, and identify its version.
Then, determine the authority to approve that kind of document and evidence that approval.
Then, determine where and how will those documents be available and whom should have access to them.
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/
Some Tips to make Document Control more useful for your QMS - https://advisera.com/9001academy/blog/2014/05/20/tips-make-document-control-useful-qms/
- 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/ -
Corrective actions and records
Answer:
Please check ISO 9001:2015 clause 10.2.2 and ISO 14001:2015 clause 10.2.
It is mandatory to retain a record that evidences the results of any developed correction action.
The following material will provide you more information about corrective actions:
Article - How to proceed once a corrective action is initiated in the EMS - https://advisera.com/14001academy/blog/2016/10/24/how-to-proceed-once-a-corrective-action-is-initiated-in-the-ems/
Free webinar – 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/
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/ -
Context and interested parties in Construction
Answer
Clause 4.1 is about determining those internal and external issues that can be relevant to influence your organization’s future. You can think about political, economic, social, technological, environmental and legislative as external issues, and about performance, complaints, experience, market presence as internal issues.
Clause 4.2 is about determining who are the relevant interested parties for your organization’s business ecosystem: customers; customer’s customers; regulators; influencers; universities; suppliers; unions; competitors.
The following material will provide you more information about the context and interested parties:
Case study for ISO 9001:2015 transition in a construction company - https://advisera.com/9001academy/
- How to identify the context of the organization in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/
- How to determine interested parties and their requirements according to ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/11/10/how-to-determine-interested-parties-and-their-requirements-according-to-iso-90012015/
- Free webinar - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-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/ -
Managing processes in a process map
We have a simple process map:
Managing process?
Main processes: 1. Take over the order and material 2. Preparation of production and production 3. Control and packaging 4. Expedition
Supporting processes: 1.Training of people, 2. Internal audit, 3. Maintenance and calibration
What will be the inputs and outputs of the Managing process, please?
Answer:
I understand that you are refering to the different management processes that you should include in the process map. This is something that differs from one organization to another, but to give you an example, some of the managerial processes usually are:
- Financial and resources management
- Roles, responsibilities and authorities
- Measurement, analysis and improvement
A Process map is just one way to provide a high-level view of the processes that conforms your quality management system and also shows how different processes interact. However this is very helpful is not mandatory in ISO 9001:2015.
These materials can help you to understand the process map of your organization:
- Article - ISO 9001:2015 process vs procedure - some practical examples: https://advisera.com/9001academy/blog/2016/01/19/iso-90012015-process-vs-procedure-some-practical-examples/
- Article - ISO 9001: The importance of the process approach: https://advisera.com/9001academy/blog/2015/12/01/iso-9001-the-importance-of-the-process-approach/
- Book – Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free on-line training – ISO 9001:2015 Foundations: https://advisera.com/training/iso-9001-foundations-course/ -
An ISO 9001 audit
Answer
First, what is an audit?
It is a systematic, independent (to ensure objectivity) and documented process to get audit evidences and compare them with the audit criteria to conclude about the extension these criteria are fulfilled.
I use this image to explain what an audit is:
An auditor goes into reality, collects audit evidences (facts) and compares them with the audit criteria (the rules).
Each comparison is an audit finding.
Comparing the audit objective with the sum of all audit findings the auditor can draw a conclusion.
Second, what types of audits can we talk about?
There are three types of audits: first, second- and third-party audits. In a first party audit the audit manager belongs to the organization being audited. In a second party audit the audit manager belongs to a customer. In a third party audit the audit manager belongs to a certification body.
Third, what is an ISO 9001 audit?
An iso 9001 audit is an audit where the audit criteria is based on ISO 9001, a quality management standard.
The following material will provide you more information about audits:
Article - First-, Second- & Third-Party Audits, what are the differences? - https://advisera.com/9001academy/blog/2015/02/24/first-second-third-party-audits-differences/
Free webinar – How to perform an ISO 9001:2015 internal audit - https://advisera.com/9001academy/webinar/how-to-perform-an-iso-9001-2015-internal-audit-free-webinar-on-demand/
- Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- Enroll for free course - ISO 9001:2015 Internal Audit Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- ISO 9001:2015 Documentation Toolkit - https://advisera.com/9001academy/iso-9001-documentation-toolkit/
- Book - ISO Internal Audit: A Plain English Guide - https://advisera.com/books/iso-internal-audit-plain-english-guide/ -
FSMS 22000 vs QMS
Answer
First, there is an updated version for ISO 22000 from 2018.
Normally, a QMS is based on ISO 9001:2015. A general usage standard that can be applied in all economic sectors. ISO 22000 is for the food industry and is very concerned with food safety along the food chain with special requirements for food safety prevention, emergency response and communication.
The following material will provide you more information about the difference between ISO 9001 and ISO 22000:
Article - Similarities and differences between ISO 9001 and ISO 22000 - https://advisera.com/9001academy/blog/2018/11/20/similarities-and-differences-between-iso-9001-and-iso-22000/
- Article – Six Key Benefits of ISO 9001 Implementation - https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/
- Free webinar on demand - Overview of ISO 9001 implementation steps - https://advisera.com/9001academy/binar/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/
- ISO 9001:2015 Documentation Toolkit - https://advisera.com/9001academy/iso-9001-documentation-toolkit/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/