The main changes in ISO 9001:2015 are:
- The adoption of a Higher Level Structure (HLS) as set out in Annex SL of ISO Directives Part 1.
- Normative references
- Terms and definitions
- Context of the organization
- Performance evaluation
- An explicit requirement for risk-based thinking to support and improve the understanding and application of the process approach.
- Fewer prescribed requirements.
- Less emphasis on documents.
- Improved applicability for services.
- A requirement to define the boundaries of the QMS.
- Increased emphasis on organizational context.
- Increased leadership requirements.
- Greater emphasis on achieving desired outcomes to improve customer satisfaction.
ISO 9001:2008 certifications will not be valid after three years from publication of ISO 9001:2015, which was September 15, 2015.
Organizations using ISO 9001:2008 are recommended to take the following actions:
- Identify organizational gaps which need to be addressed to meet new requirements.
- Develop an implementation plan.
- Provide appropriate training and awareness for all parties that have an impact on the effectiveness of the organization.
- Update the existing quality management system (QMS) to meet the revised requirements and provide verification of effectiveness.
- 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”:
Clause 4 – Context of the organization
Clause 5 – Leadership
Clause 6 – Planning for the QMS
Clause 7 – Support
Clause 8 – Operations
Clause 9 – Performance evaluation
Clause 10 – Improvement
Mandatory and recommended procedures and forms:
8 Mandatory Procedures
- Determining the scope of the QMS (4.3)
- Support operation of processes (4.4.2.a)
- Quality policy (5.2.1, 5.2.2.a)
- Quality objectives (6.2.1)
- Control of documented information from external providers (18.104.22.168)
- Plan, implement and control processes (8.1)
- Determine controls to be applied and criteria for evaluation, selection, monitoring and re-evaluation of external providers (8.4.1)
- 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
- Confidence processes are carried out as planned (4.4.2.b)
- Fitness for purpose of inspection persons (paragraph 22.214.171.124)
- Measurement equipment calibration (paragraph 126.96.36.199)
- Competence of persons (7.2.d)
- Confidence in and conformity of products and services (8.1)
- Results of the review of products and services requirements (188.8.131.52)
- Design and development requirements have been met (8.3.2)
- Design and development inputs (8.3.3)
- Design and development controls (8.3.4)
- Design and development outputs (8.3.5)
- Design and development changes (8.3.6)
- Controls applied to external providers (paragraph 8.4.1)
- Characteristics of product to be produced and service to be provided, activities to be performed and results to be achieved (8.5.1)
- Traceability of products and services (paragraph 8.5.2)
- Lost, damaged or unsuitable property provided by Customer or external provider (8.5.3)
- Results of the review of changes (8.5.6)
- Release of products and services, evidence of conformance, traceability to authorization (8.6)
- Disposition of nonconforming products and services (8.7.2)
- Results of monitoring and measurement (9.1.1)
- Audit results (9.2.2)
- Management review results (9.3.3)
- Nature of nonconformities, actions and results (10.2.2)
Now that the ISO 9001 standard is a little more complex, are you wondering how to begin a quality control plan? We’ll help you facilitate the changes in ISO 9001 as quickly and efficiently as possible with our “as-a-matter-of-fact” approach and with our no charge/no-expiration support by phone and email.