What it Takes to Become an ISO-Certified Machining Company

Earning ISO 9001 certification has become essential for machining companies to meet customer quality expectations, expand business opportunities, and keep pace with competitors. However, implementing a quality management system (QMS) to meet ISO standards is no trivial task. In this comprehensive guide, we will explore the step-by-step process and requirements to become an ISO-certified machining facility.

Why Get ISO 9001 Certified?

Here are some of the key benefits that motivate machine shops to get ISO-certified:

• Many major customers mandate or prefer ISO-certified suppliers
• Certification provides a marketing advantage and builds credibility
• It signals a commitment to consistent quality and customer satisfaction
• Reduces quality issues through improved processes and discipline
• Standardizes operations and reduces variability
• Ingrained documentation facilitates continuous improvement
• Provides a framework to meet other standards like AS9100 aerospace quality system

Thus, ISO 9001 certification can significantly boost business growth and profitability for machining companies by opening up new sales opportunities while also improving internal operations.

Key Steps to Achieve ISO 9001 Certification

The process of becoming ISO-certified involves several key stages:

Learn the Standard’s Requirements

Obtain the latest ISO 9001 standard and study all requirements in detail. Identify current process gaps in meeting the standard. Consider training or consulting help if needed.

Get Management Commitment

Gaining certification requires significant effort and cost. Management must be willing to allocate resources and have a long-term commitment to implementing an ISO-compliant QMS.

Establish a Steering Committee

Form a team including management and department representatives to guide QMS implementation across the organization. Appoint a Quality Manager to coordinate activities.

Create an Implementation Plan and Timeline

Develop a project plan listing specific tasks, responsibilities, and milestones to develop the QMS within a reasonable timeline of 6-12 months.

Document Processes and Procedures

Document all processes and procedures required by ISO 9001, incorporating best practices. This provides the foundation for a compliant QMS.

Train Employees on New Processes

Conduct training sessions for all employees to understand new policies, procedures, documentation requirements, and their role in the QMS.

Perform Internal Audits

Conduct internal audits across all areas to check for implementation gaps versus ISO 9001 requirements. Identify and address non-conformances.

Select Registrar and Arrange Audit

Select an accredited registrar to conduct the certification audit. Provide necessary info and arrange for audit dates once implementation is complete.

Continual Improvement after Certification

Even after achieving certification, the QMS must be continually improved through regular reviews, audits, and corrective actions to enhance compliance and business performance.

Now let’s explore the key requirements within ISO 9001 that machining facilities need to implement for certification.

QMS Requirements for Compliance

The QMS must meet all sections of the ISO 9001 standard. Here are some highlights:

Context of the Organization

Determine internal and external issues that can impact the QMS and relevant needs of stakeholders like customers and suppliers. Define the scope of QMS.

Leadership and Commitment

Top management must demonstrate leadership in the QMS through a quality policy, assignment of responsibilities like Quality Manager, providing resources, and conducting management reviews.

Customer Focus

Define and meet customer requirements. Establish communication channels for customer feedback. Measure customer satisfaction through surveys etc. Handle complaints effectively.

Risk-Based Thinking

Consider potential risks to quality or business continuity and maintain contingency plans.

Quality Objectives

Define key quality objectives like reducing scrap or improving on-time delivery. Ensure these objectives cascade through the organization.

Process Approach

Manage activities as interconnected processes that convert inputs to outputs. Outsource any processes needed for the QMS.

Documented Information

Maintain documented procedures for all processes impacting quality, and records providing evidence of compliance. Control documents to ensure current approved versions are available.

Resource Management

Determine and provide the people, infrastructure, environment, and information necessary for QMS operation and product conformity.

Competence and Awareness

Ensure that employees are competent to do their jobs through training and aware of quality objectives. Maintain records of education, training, skills, and experience.

Communication

Determine internal and external communications relevant to the QMS.

Control of Externally Provided Processes/Products/Services

Control quality of externally provided processes, products, and services from suppliers or subcontractors. Define criteria for evaluation, selection, monitoring of performance, and reevaluation of external providers.

Production/Service Provision

Implement production under controlled conditions including documented procedures, regular maintenance of equipment, availability of monitoring and measurement resources, and implementation of release, delivery, and post-delivery activities.

Identification and Traceability

Identify outputs by suitable means throughout production and service. Identify status with respect to monitoring and measurement. Control and record unique identifiers.

Property Belonging to Third Parties

Identify, verify, protect, and safeguard third-party property like customer-owned materials or intellectual property shared for production or service provision.

Preservation of Product/Service

Ensure conformity of product/service with requirements during internal processing and delivery. This includes identification, handling, packaging, storage, transmission or transportation, and protection.

Control of Changes

Review and control planned changes affecting processes, production equipment, tools, or software programs.

Measurement and Release of Products/Services

Verify all product/service requirements are met before release. Conduct inspection and testing using calibrated equipment. Maintain evidence of conformity with acceptance criteria.

Control of Nonconforming Outputs

Ensure any nonconforming outputs like defective parts are identified and controlled to prevent unintended use or delivery. Take appropriate actions based on the nature of nonconformity like rework or scrap.

Continual Improvement

Utilize policy, objectives, audit results, analysis, management review, and corrective actions to identify opportunities to improve processes, products, and the QMS.

This covers the major areas of ISO 9001 that a machining facility’s QMS must address through documented policies, processes, and records to gain certification.

Key Documentation Requirements

Maintaining comprehensive documentation is critical for ISO compliance. Key documents include:

• Quality Manual outlining the QMS including scope, policies, objectives, etc.
• Organizational Chart showing responsibility and authority structure
• Process Flow Diagrams detailing all processes in the QMS
• Documented Procedures for all Operational and Management Processes addressing relevant ISO 9001 clauses
• Standard Operating Procedures (SOPs) providing instructions for executing operational tasks
• Work Instructions and Quality Plans specific to products/services
• Forms and Templates for all records like inspection reports, training records, etc.
• Quality Policy and Quality Objectives signed by top management

All documents in the QMS must be controlled with respect to approval, accessibility, revision, etc. Records must be legible and identifiable with the machines/processes involved. Documented information provides the main evidence for auditors to verify ISO compliance.

Pitfalls to Avoid

Here are some common pitfalls that machining facilities should avoid in their ISO 9001 implementation:

• Assuming existing processes already meet ISO requirements without proper gap assessment
• Incomplete or inaccurate documentation that does not reflect actual processes
• Failing to get all employees onboard with the QMS through training and engagement
• Letting documentation become outdated or invalid over time
• Focusing too much on paperwork compliance rather than actual process improvements
• Abandoning QMS practices and procedures after getting certified
• Failure of management to provide adequate ongoing support and resources to the QMS

Avoiding these missteps is crucial to building an ISO-compliant QMS that delivers real business benefits.

Performing Internal Audits

Internal audits by the company’s trained personnel are essential to check how well the QMS conforms to ISO 9001. Audits help identify non-conformances early so they can be corrected before the certification audit. Key steps in internal audits include:

• Develop detailed audit criteria based on ISO 9001 clauses
• Plan audits covering all processes/departments over a 3-year period
• Assign competent auditors free of bias (not auditing own work area)
• Open audit with planning meeting of objectives, scope, and schedule
• Gather objective evidence through interviews, observations, and document reviews
• Record all non-conformances and opportunities for improvement
• Hold a closing meeting to discuss major findings
• Generate audit reports with evidence, non-conformances, and corrective actions
• Validate completion and effectiveness of corrective actions
• Present audit results to management in regular review meetings

Regular rigorous internal audits are invaluable preparation for the high-stakes external certification audit.

Getting Ready for the Certification Audit

Here are some final steps to take in the critical weeks before the certification audit:

• Ensure awareness of audit purpose, scope, and schedule across the organization
• Verify all personnel understand their role and responsibility in the audit process
• Confirm internal audit findings have been addressed and closed out
• Re-verify that documents and records are complete and up-to-date
• Make sure top management is available to answer questions
• Designate employees to serve as guides and coordinators during the audit
• Ensure resources like conference rooms are available to auditors

Being well-prepared avoids scrambling and delays when auditors are on-site. An organized, transparent approach creates the best impression of the company’s QMS implementation.

Maintaining ISO Certification

Just getting certified is not the end. To retain certification, the company must maintain a compliant QMS through:

• Continual reviews, audits, and improvements to the system
• Updating documentation as processes change
• Annual management reviews
• Re-certification audits every 3 years by the registrar
• Transitioning to revised ISO standards as they are introduced
• Addressing any major non-conformances from external audits immediately

ISO certification demonstrates not just compliance at a point in time but an ongoing commitment to quality, improvement, and customer satisfaction.

Conclusion

Becoming an ISO-certified machining facility requires sizeable effort but delivers a major bottom-line payoff. By methodically implementing an ISO 9001-compliant QMS, documenting activities, training personnel, and committing to continual improvement, machine shops can pass their certification audit and join the ranks of quality leaders in the industry. More importantly, they can leverage ISO certification to win new business, operate more efficiently, reduce costs, and deliver a consistently high-quality experience to customers.