ISO 9001

Industry standards really like to use ISO 9001 as their foundation with enhancements that satisfy their own requirements.

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The main changes in ISO 9001:

1. The adoption of a Higher Level Structure (HLS) as set out in Annex SL of ISO Directives Part 1.
   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
2. Significant among the changes in ISO 9001 is an explicit requirement for risk-based thinking to support and improve the understanding and application of the process approach.
3. Fewer prescribed requirements.
4. Less emphasis on documents.
5. Improved applicability for services.
6. A requirement to define the boundaries of the QMS.
7. Increased emphasis on organizational context.
8. Increased leadership requirements.
9. Greater emphasis on achieving desired outcomes to improve customer satisfaction.

Organizations affected by changes in ISO 9001 need to consider the following actions:

1. Identify organizational gaps which need to be addressed to meet new requirements.
2. Develop an implementation plan.
3. Provide appropriate training and awareness for all parties that have an impact on the effectiveness of the organization.
4. Update the existing quality management system (QMS) to meet the revised requirements and provide verification of effectiveness.
5. Where applicable, contact the organization’s Certification Body for transition arrangements.

Here’s how ISO 9001:2015 aligns with the format for “Plan – Do – Check – Act”:

PLAN
Clause 4 – Context of the organization
Clause 5 – Leadership
Clause 6 – Planning for the QMS
Clause 7 – Support

DO
Clause 8 – Operations

CHECK
Clause 9 – Performance evaluation

ACT
Clause 10 – Improvement

Mandatory and recommended procedures and forms:

8 Mandatory Procedures

1. Determining the scope of the QMS (4.3)
2. Support operation of processes (4.4.2.a)
3. Quality policy (5.2.1, 5.2.2.a)
4. Quality objectives (6.2.1)
5. Control of documented information from external providers (7.5.3.2)
6. Plan, implement and control processes (8.1)
7. Determine controls to be applied and criteria for evaluation, selection, monitoring and re-evaluation of external providers (8.4.1)
8. Implement audit program (paragraph 9.2.2)

Recommended Procedures (when applicable)

• Calibration (7.1.5)
• Configuration management (see 8.3.1 for 8.3.6, 8.5.6)
• Contract review (8.2.3, 8.2.4)
• Control of nonconformances (8.7)
• Control of documents (7.5.2, 7.5.3)
• Control of production and service (8.5.1, 8.5.5)
• Control of records (7.5.2, 7.5.3)
• Corrective action (10.2)
• Internal audit (9.2)
• Management review (9.3)
• Purchasing (8.4)
• Receiving (8.6)
• Responsibility and authority (5.3)
• Shipping (8.2.2, 8.5.1, 8.5.4)
• Training (7.2, 7.3)

22 Mandatory Forms

1. Confidence processes are carried out as planned (4.4.2.b)
2. Fitness for purpose of inspection persons (paragraph 7.1.5.1)
3. Measurement equipment calibration (paragraph 7.1.5.2)
4. Competence of persons (7.2.d)
5. Confidence in and conformity of products and services (8.1)
6. Results of the review of products and services requirements (8.2.3.2)
7. Design and development requirements have been met (8.3.2)
8. Design and development inputs (8.3.3)
9. Design and development controls (8.3.4)
10. Design and development outputs (8.3.5)
11. Design and development changes (8.3.6)
12. Controls applied to external providers (paragraph 8.4.1)
13. Characteristics of product to be produced and service to be provided, activities to be performed and results to be achieved (8.5.1)
14. Traceability of products and services (paragraph 8.5.2)
15. Lost, damaged or unsuitable property provided by Customer or external provider (8.5.3)
16. Results of the review of changes (8.5.6)
17. Release of products and services, evidence of conformance, traceability to authorization (8.6)
18. Disposition of nonconforming products and services (8.7.2)
19. Results of monitoring and measurement (9.1.1)
20. Audit results (9.2.2)
21. Management review results (9.3.3)
22. Nature of nonconformities, actions and results (10.2.2)

Amendment 1 dated February 23, 2024

• Paragraph 4.1 adds:
  • Do climate change issues affect the Company?
• Paragraph 4.2 adds Note:
  • External parties could flowdown climate change requirements.

If your Company’s goal is to achieve certification, consider purchasing the ISO 9001:2015 standard – opens in new tab/page