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ISO 9001 Building LeadershipImplementing good leadership and commitment is a crucial aspect of the ISO 9001 standard. As per the 2015 version, the leadership and commitment clause emphasizes the role of top management in demonstrating leadership, commitment, and direct involvement in the quality management system (QMS). Here is a guide to implementing these principles effectively:

1. Define Quality Policy and Objectives

  • Align with Business Strategy: Ensure the quality policy and objectives align with the organization's business strategy, mission, and vision.
  • Communicate: Ensure the quality policy is communicated and understood at all levels of the organization.

2. Engage and Empower Employees

  • Inclusive Culture: Foster a culture where employees at all levels feel their input is valued and considered.
  • Training and Development: Provide ongoing training to ensure everyone understands their role in the QMS.
Read more: How best to implement good leadership...

The goal of Risk Based Thinking is to reduce or eliminate nonconformities.  To meet this goal, an organization must address each process in terms of risks.  The organization must take into account risks during every planning activity.  The risks should be documented, and actions should be taken to prevent or prevent them.

On a positive note, planning for risks may be viewed as “looking for opportunities.”

Under clause 6.1 (Planning)

Clause 4.4.1 f) explicitly states, “address the risks and opportunities as determined in accordance with the requirements 6.1”  While 6.1 states,

6.1 Actions to address risks and opportunities
Read more: 2nd in the series - Risk Based Thinking

Management Standards have commonality across specific ISO Standards. ISO 9001, ISO 14001, and ISO 45001 have a typical structure, terms, and text. For example, the elements or areas covered in the standard (i.e., clauses) are:

1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement
Read more: First in the 2023 Series - PDCA

Iso 9001 certified 245x222It happened.  As the leader of your organization, you receive that call from your customers.  The one you have been holding your breath on for years, hoping they wouldn't call.  As part of the supply chain, they require you to become certified to ISO 9001.

Now what? 

You were told by your competitors and leaders from local companies that it is a time sucker.  ISO 9001 requires hundreds of documents.  You have to write down everything!  In addition, you now have to hire an employee to get this done.  There goes our bottom line this year.  Don't our customers realize what is going on in the world?  There is a pandemic and finding employees is almost impossible!

So, you do what you are good at, you call HR, put out an ad, let's find someone.  Purchasing, get a quote on ISO 9001, and order plenty of notepads and binders.  Then, you talk to your leadership group, let them know what happened, and announce we going to get certified to ISO 9001, oh my.  Great, you are on your way, on the certification path.  But are you?

Read more: Lions & Tigers & Bears Oh My!

It is critical for an organization's Quality Management System to have trained Internal Auditors.  One of the ISO 9001 Standard's clause (i.e. 7.2 Competence) requires that the organization prove with Objective Evidence that the auditors are trained.

Ingentius and ASR have been working together to provide training courses for ISO 9001 Internal Auditors and other ISO standards.
Read more: ISO 9001 Internal Auditor Training

By Rand Winters, ASR Senior Auditor

Last year, ASR focused a newsletter article on audit effectiveness and reducing potential risk. This month we address effectiveness of the audit checklist.

In the old QMS days, internal auditors planned their audit around a list of standard questions used again and again. That all changed when standard writers created the process-based quality management system.

Organizations adapted to process-based audits developing relevant questions for each internal audit. Recently, I am beginning to see a slow move away from specific internal audit questions and a return to generic questions.
Read more: Effective Checklists

ASR is continuing its practice of sharing with clients the most frequent sections of the following standards found to be nonconforming by ASR auditors.

ISO 9001:2015 - Most Frequent Nonconformance’s:

9.2 Internal Auditing

- process not fully effective
- all sections (processes) not audited
- some records of audits missing
- not all auditors competent nor had proper training
- no records audit program met requirements of standard
- internal audit procedure not followed
Read more: ISO 9001 First Quarter 2019...

Rand E. Winters - Senior ASR Auditor

As ASR clients begin their surveillance or recertification audit to the 2015 version of ISO 9001, top management and quality leaders may find it helpful to know what 2015 NC's have been written by ASR auditors during May and June 2017.

What is interesting - of the NC's found, only 1% were written against risk – a new topic for 2015. Remaining NC's were old issues including training, document control, management review, and internal audits.

Below is a list of NC findings. Highlighted findings are requirements that organizations that did not include in their revised 2015 quality management system.
Read more: Heads-up - ISO 9001:2015...

Because the new ISO 9001:2015 standard has major additions and changes to the clauses, ASR has put together a 33 page document on a clause by clause basis.

This document is a matrix showing the ISO 9001:2015 clause, the related ISO 9001:2008 clause and a commentary section.

This is a very useful document to help you prepare your organization for the transition to the new standard.

Download the pdfCorrelation Matrix Here.

If you have a QMS that is IATF 16949 certified, then you understand the importance of the internal audit function in both getting the QMS ready for audit, and maintaining the standards of performance after the audit.

An internal audit helps identify gaps in performance or the defined processes. The effectiveness of the internal audit depends on the expertise, knowledge, and attention to detail of the person appointed to conduct the audit.
Read more: IATF 16949 Internal Auditor Training

There's a failure mode missing from the PFMEA – first the auditor has to determine if product quality is affected; the auditor determines if this is simply an incomplete PFMEA and the inspection/test plan will find the NC condition or is the inspection/test plan also inadequate. If the PFMEA and the inspection/test plan are both inadequate, then product quality is affected, and the auditor goes down the left side of the decision tree. If only the PFMEA is inadequate, then go down the right side of the decision tree.
Read more: Example 1 of Major and Minor NCR -...
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