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Procedure for performance evaluation
Answer:
In order to comply with clause 9, performance evaluation, Advisera has available 3 different procedures which can be completed with other relevant documents and records. Check the following links to download a free preview of this documentation:
- Procedure for measuring customer satisfaction: https://advisera.com/9001academy/documentation/procedure-measuring-customer-satisfaction/
- Procedure for internal audit: https://advisera.com/9001academy/documentation/procedure-internal-audit/
- Procedure for management review: https://advisera.com/9001academy/documentation/procedure-management-review/
- Matrix of key performance indicators: https://advisera.com/9001academy/documentation/matrix-key-performance-indicators/
When performing evaluation i ISO 9001:2015 you basically need to determine first what need to be measured, then how and where to measure those aspects and finally when to analyze and evaluate the measurements.
These materials can help you to create procedures for performance evaluation:
- Article - How to implement the check phase (performance evaluation) in the QMS according to ISO 9001:2015: https://advisera.com/9001academy/blog/2015/11/17/how-to-implement-the-check-phase-performance-evaluation-in-the-qms-according-to-iso-90012015/
- Article - Monitoring and measuring: the basis for evidence-based decisions: https://advisera.com/9001academy/blog/2020/09/21/how-to-perform-monitoring-and-measurement-according-to-iso-9001/
- 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 Course : https://advisera.com/training/iso-9001-foundations-course/ -
Audit follow up steps
Answer:
After an audit, in the follow up phase, for each nonconformity found, the manager of the area where the nonconformity was found, and the environmental manager should first correct the situation. That means, eliminate the nonconformity. For example, sort different types of wastes that should not be mixed, and train employees in sorting those different types of wastes. Then, evaluate the need for a corrective action, an action to target the cause behind the nonconformity. For example, what is wrong in our environmental management system that allows that employees without the necessary training are put to work in an area with significative environmental impacts? Imagine that the corrective action includes updating requirements for initial training of employees in certain functions.
Then, someone should be responsible to check if correction and corrective action were implemented. And later, at a moment determined during the definition of the corrective action someone should check if the corrective action is effective. For example, after new employees enter the area, do wastes continue to be sorted correctly?
So, the steps are:
* determine a correction and implement it as soon as possible;
* check correction implementation;
* determine the cause and a corrective action and implement it;
* check corrective action implementation;
* check corrective action effectiveness;
* close the nonconformity.
The following material will provide you information about following up and audit:
- ISO 14001 – Internal Audits in the EMS: Five Main Steps - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/internal-audits-in-the-ems-five-main-steps/
- Dealing with nonconformities from the ISO 14001:2015 certification audit - https://advisera.com/14001academy/blog/2015/11/02/dealing-with-nonconformities-from-the-iso-140012015-certification-audit/
- free online training ISO 14001:2015 Internal audit Course - https://advisera.com/training/iso-14001-internal-auditor-course/
- book - THE ISO 14001:2015 COMPANION – A A Straightforward Guide to Implementing an EMS in a Small Business - https://advisera.com/books/the-iso-14001-2015-companion/ -
Gaining buy-in for ISO 9001 implementation
Answer:
Many years ago, I learned and adopted a maxim: people do not change because of what is said to them, they do not change because of the rational side, but they are more open to change when they are shown the consequences of what is wrong with the present situation. So, I recommend you gather and show to people evidences of organizational pain that can be removed or reduced with ISO 9001 implementation. Put yourself in their shoes: What do they know about ISO 9001? What can they gain from ISO 9001 implementation? How can ISO 9001 help them in their daily work?
Can you answer those questions?
The following material will provide you information about employee buy-in in ISO 9001 implementation:
- ISO 9001 – Gaining employee buy-in for your ISO 9001:2015 implementation - https://advisera.com/9001academy/blog/2015/12/15/gaining-employee-buy-in-for-your-iso-90012015-implementation/
- How to Align Company Culture with ISO 9001 - https://advisera.com/9001academy/blog/2014/10/14/align-company-culture-iso-9001/
- free online training ISO 9001:2015 Lead implementer Course
– https://advisera.com/training/iso-9001-lead-implementer-course/
- book - ISO Internal Audit: A Plain English Guide - https://advisera.com/books/iso-internal-audit-plain-english-guide/ -
Different risks in AS9100
Answer:
The latest revision of AS9100 includes two sections that discuss risk. Clause 6.1 is a new section of the standard and brings in the concept of risk-based thinking as it was introduced into ISO 9001:2015. This section talks about identifying risk for the QMS at the top level of the planning process. These are overall company risks such as learning that a supplier or competitor is going out of business that may affect your company (Think of the opportunities and threats from a strategic SWOT analysis that top management might do). This section of the standard requires that you identify these top-level risks and determine if anything needs to be done about them.
Clause 8.1.1 on operational risk management is not a new requirement for AS9100, and is very much th e same as the previous revision of the standard. As identified in Note 1 for this clause the requirements are limited to managing the risks associated with the operational processes needed to provide products and services. This clause talks about how you control risks such as potential schedule delays, short delivery schedules, high-risk parts, etc.
For more on this see the article: 5 key elements of risk management in AS9100 Rev D, https://advisera.com/9100academy/blog/2017/05/15/5-key-elements-of-risk-management-in-as9100-rev-d/ -
ISO 9001 and ISO 13485 internal auditor requirements
Answer:
Auditors should dominate the audit criteria used.
ISO 13485 includes the entire ISO 9001 standard with additional requirements.
So, your organization’s internal auditors can have ISO 13485 awareness training or can have ISO 9001 awareness training with an additional module about what is specific of ISO 13485.
Remember, organizations have the authority to define internal auditor competence requirements.
The following material will provide you information about integrating ISO 9001 and ISO 13485:
- ISO 9001 vs. ISO 13485 - https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
- What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
- free online training ISO 9001:2015 Internal Auditor Course - https://community.advisera.com/topic/iso-9001-and-iso-13485-internal-auditor-requirements/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Integrating ISO 9001 and ISO 27001
I am part of the Quality Department and we are following ISO 9001. We are in charge of the documented information of all departments across the company, including support departments (Finance, Human Resources, and Information Technology). We are the ones who create, update, and delete the documented information. However, our Information Technology Department is the one managing our server and cloud for back-up.
Our Information Technology Department is on the process of adapting ISO 27001:2013. They have a backup policy and asset management policy.
Their asset management policy covers their documented information, which we manage in QMS.
As a company, we wish to centralize the control of documented information, and if possible, integrate the two standards.
What would be the best course of action that we have to take? Who should be handling the documented information/digital assets?”
Answer:
You can centralize the control of document ed information and have common rules because the requirements from both standards are practically the same.
About who should be handling the documented information/digital assets, that is a management decision, not a technical one. Your organization can distribute handling responsibilities among different persons.
The following material will provide you information about the integrating ISO 9001 and ISO 27001:
- ISO 9001 – How to integrate ISO 9001 and ISO 27001 - https://advisera.com/9001academy/blog/2016/09/27/how-to-integrate-iso-9001-and-iso-27001/
- Clause-by-clause explanation of ISO 27001 - https://info.advisera.com/hubfs/27001Academy/27001Academy_FreeDownloads/Clause_by_clause_explanation_of_ISO_27001_EN.pdf?t=1485510137139
- free online training 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/ -
ISO 9001 vs ISO 9011
Answer:
There is no relation between ISO 9001 and ISO 9011. ISO 9011 is a standard about “Synchronous belt drives -- Automotive pulleys”. Are you confusing ISO 9011 with ISO 19011? ISO 19011 is a standard with guidelines about auditing management systems, like quality management systems or environmental management systems.
The following material will provide you more information about the relationship:
- ISO 9001 – ISO 9011: Don’t confuse it with ISO 9001 or ISO 19011 - https://advisera.com/9001academy/knowledgebase/iso-9011-dont-confuse-it-with-iso-9001-or-iso-19011/
- free online training 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/ -
Certifying organizations
Answer:
To certify an organization your company has to be accredited by an accreditation body (e.g., UKAS for UK, or ANAB for USA), and for this purpose your organization has to be certified by an accreditation body against ISO/IEC 17065. You can have an overview of this standard here: https://www.iso.org/obp/ui/#iso:std:iso-iec:17065:ed-1:v1:en
This article will provide you further explanation about accreditation and certification:
- Accreditation vs. certification vs. registration in the ISO world https://advisera.com/articles/accreditation-vs-certification-vs-registration-in-the-iso-world/ -
Making an auditor CV more interesting
Answer:
If you normally work with organizations that use and value Lean Six Sigma, owning that competence can make your CV more interesting for potential clients of your auditing services. Remember, auditing a quality management system is not only about the standard but also about internal practices and procedures.
The following material will provide you information about auditing competence:
- Requirements for competence of IATF 16949 internal auditors - https://advisera.com/16949academy/blog/2017/10/19/requirements-for-competence-of-iatf-16949-internal-auditors/
- free online training ISO 9001:2015 Lead Auditor Course - https://advisera.com/training/iso-9001-lead-auditor-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Becoming internal auditor
And I am interested in TUV Nord certification for internal audit and also want to know how to make career in TUV organisation. I want to become internal auditor.
Answer:
To become an internal auditor you only need to attend an accredited internal auditor course and be approved on the final exam. Since you are considering a career as auditor for organizations like TUV, you should consider a lead auditor course, and you also need to perform audit hours, so you can be a certification auditor, .
Regarding career at TUV, you should contact them directly to know their career path.
These articles will provide you further explanation about becoming a lead auditor:
- How to become ISO 27001 Lead Auditor https://advisera.com/27001academy/knowledgebase/how-to-become-iso-27001-lead-auditor/
- 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/
- ISO 27001 Internal Auditor training – Is it good for my career? https://advisera.com/27001academy/blog/2016/03/29/iso-27001-internal-auditor-training-is-it-good-for-my-career/
- How to prepare for an ISO 27001 internal audit https://advisera.com/27001academy/blog/2016/07/11/how-to-prepare-for-an-iso-27001-internal-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/
These materials will also help you regarding becoming a lead auditor:
- ISO 27001 Lead Auditor Course preparation training [free webinar on demand] https://advisera.com/training/iso-27001-lead-auditor-course/
- ISO 27001:2013 Lead Auditor course https://advisera.com/training/iso-27001-lead-auditor-course/