ISO 9001 is a standard that "sets out the criteria for a quality management system". Any company, regardless of the size, nature, or industry of operation, can benefit from the quality management principles that form the basis for ISO 9001. And with the ISO 9001 certification, you can ensure consistent quality products (or services) reach your customers and achieve sustainable growth and competitive advantage.
The Ten Clauses of ISO 9001
Before going for ISO 9001 certification and trying to understand the process, it is prudent to understand what the standard outlines. We can do that by evaluating the ISO 9001 clauses. The ten clauses of ISO 9001 are:
- Scope: Gives a brief idea about the nature of the standard, encouraging businesses to implement quality management systems (QMS) for consistent quality output.
- Normative references: Allows a better understanding of the ISO 9000:2015 terminologies.
- Terms and definitions: Clarifies the definitions of QMS fundamentals and related vocabulary.
- Context of the organisation: Here, you must offer a high-level overview of QMS requirements for your business, demonstrating an understanding of the organisation's context. It also necessitates a critical evaluation of whether the QMS could achieve the desired results and whether employees at every organisational level can understand the necessary change processes.
- Leadership: An organisation must demonstrate that they are committed and have the necessary resources and leadership to establish strong policies, deliver quality services, and stay customer-focused.
- Planning: You must define quality objectives and identify relevant risks and opportunities to outline how you plan to implement the necessary changes.
- Support: A successful QMS implementation needs support from the right people, the right resources and infrastructure, and access to the right tools, operational environment, skills and expertise, training, and processes. You must document and communicate this information to all the necessary stakeholders.
- Operation: This clause covers the operational planning and control to implement the necessary QMS processes. Here, you need to look critically at your internal processes, products, and services to identify the gaps and make the necessary operational changes to make operations more effective. This may also require you to look at some external processes – like supplier relations or vendor processes – critically to ensure consistency.
- Performance evaluation: Without proper measurement and evaluation of QMS processes, activities, and operations, you cannot ascertain whether you are meeting the quality objectives or not. You must measure, record, and analyse this data – from sources like internal audits, management reviews, or client surveys – to evaluate the QMS performance and track your progress towards consistent quality.
- Improvement: You must keep evaluating and improving the QMS processes and operations, taking corrective actions wherever necessary.
These are ten broad clauses of ISO 9001, each containing sub-clauses (a total of 56 clauses) detailing the requirements for QMS improvement. The first three clauses only provide general information, and the remaining seven are mandatory for ISO 9001 certification.
Twelve Steps in the ISO 9001 Audit Checklist
Once you have understood the intricacies of ISO 9001 clauses and decided to go for ISO 9001 certification, the next step is to devise an action plan and start focused efforts towards better quality management. Below are the twelve steps in a QMS audit checklist:
- Leadership buy-in: ISO 9001 certification needs dedication from the entire organisation, and unless your management is on board with it, you cannot guarantee accountability for the implementation and monitoring of the new QMS processes. Additionally, since the leadership sets the direction for quality and operational accountability, ISO 9001 certification efforts cannot succeed without leadership buy-in.
- Gap analysis: In alignment with clause 4, gap analysis allows you to formally identify the gap in your current quality management protocols and help define milestones for QMS transformation. In this step, you also need to identify and assess potential risks and their impact to ensure effective contingency planning.
- Formulating the scope: Once you have identified the gaps, the next step is to define a scope – based on the recommended course of action in step 2. Your scope needs to be specific and measurable and include actions to remedy the gaps, a timeline for change implementation, roles and responsibilities of each team member, and budget constraints.
- Implementing the QMS and creating the QMS manual: The next step is to implement the QMS processes within the scope while also documenting the changes to create QMS manuals for the team to follow. Such documentation is also necessary to maintain control over QMS and its continual improvement.
- Internal communication: Once you have drafted the QMS policies and manuals, it is time to communicate them with your teams and get them on board to implement the changes.
- Creating an audit plan: Once the QMS policies are in place and your team is comfortable following the QMS manual, the next step is to plan internal audits. During this audit, measure the QMS performance and identify any shortcomings needing corrective actions.
- Identifying roles and responsibilities: Every QMS process needs people to review and approve different elements. Identifying these roles, identifying responsible people, and clearly documenting their responsibilities are integral to maintaining accountability and consistent quality.
- Refining QMS and implementing system changes: Work on the areas identified in step 6 to refine the QMS processes and implement system changes. Follow up with regular reviews to ensure the changes are working and you are meeting the desired quality goals.
- Internal audit: Before applying for an external audit, conduct an internal audit to evaluate the QMS efficiency and identify any opportunities for final improvements. This trial run will allow you to assess whether your team is ready and prepare you for the real audit.
- Applying for Stage-1 audit: Once you are comfortable with QMS, you can apply for Stage-1 audit. The application process can take weeks to complete, so plan accordingly. Once you have the audit date, communicate it with the rest of the teams and help them prepare.
- External audit: The external auditor (from an independent certification body) will assess whether your business complies with QMS standards. Ensure you have all the necessary documents readily available and that your team is honest with the auditor.
- Moving forward: Once your hard work pays off, it is time to keep moving forward. Review and monitor your QMS processes and make necessary changes as applicable.
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