ISO 9001:2015 Requirements
The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.
This clause emphasizes the importance of having the right personnel for the successful implementation of the Quality Management System (QMS) and the effective operation and control of processes within the organization.Describe how your organization allocates its staff in order to achieve the required outcome, dependent on its size, this may be one or two people, or an entire project team. Here’s a breakdown of what this requirement entails:
- Determining Personnel Needs: The organization must identify the roles and responsibilities required to manage, operate, and maintain the QMS effectively. This involves determining the necessary skills, competencies, and qualifications for each role.
- Providing Necessary Personnel: Once the required roles are identified, the organization needs to ensure that the necessary personnel are available to fulfill these roles. This includes providing individuals with the appropriate skills, knowledge, and experience.
- Effective Implementation of the QMS: Personnel should be knowledgeable about the organization’s QMS, its processes, procedures, and requirements. They need to understand their roles in maintaining and improving the QMS.
- Operation and Control of Processes: Personnel are responsible for carrying out the processes defined within the QMS. They need to understand how to perform their tasks correctly, consistently, and in accordance with documented procedures.
- Competency and Training: The organization should assess the competency of its personnel and provide training where necessary to bridge any gaps. Competency assessments may include formal qualifications, experience, skills, and demonstrated performance.
- Appropriate Resources: Providing necessary personnel also involves ensuring they have the required tools, equipment, facilities, and support to perform their tasks effectively.
- Continuous Improvement: Personnel play a vital role in identifying areas for improvement within the QMS and its processes. Their feedback and suggestions contribute to the organization’s ongoing enhancement efforts.
- Monitoring and Evaluation: The organization should establish mechanisms to monitor and evaluate the performance of personnel in relation to QMS implementation and process operation. This could include performance reviews, audits, and feedback loops.
By addressing the requirement outlined in the statement, organizations ensure that their QMS is supported by capable and knowledgeable personnel, enabling effective process execution, adherence to quality standards, and continuous improvement. The Human Resources Manager should review the requirements and identify human resource needs when objectives are reviewed or as the need arises (e.g. to cover maternity leave, leavers etc.). The Human Resources Manager should define the competencies required for each position and draw up a job description as appropriate. Line Managers and Supervisors with the authority to appoint workers should ensure that new employees hold the required and current qualifications, certificates and licences for the position to which they are appointed. Employees are responsible for ensuring details of relevant qualifications, certificates or licences appear, are correct and are maintained. To ensure that the best recruit is selected to meet the job requirements, all permanent and contract employees should be selected on the basis of their skills, experience and competence. The recruitment and selection process is outlined below:
- Identify staffing needs versus headcount and consider options (e.g. permanent, transfer or contract);
- Define the tasks to be undertaken;
- Define the responsibilities of the post-holder;
- Define the skills and experience required;
- Draw up the contractual terms [Refer to any Standard Employment Terms & Conditions];
- Advertise the vacancy internally and externally, as appropriate;
- Ensure that the interview and selection panel is suitably qualified;
- Draw up short list of candidates;
- Interview shortlisted candidates;
- Take up references;
- Make offer of employment and arrange a start date;
- Liaise with the Payroll department
- Arrange employee induction, orientation and introductions.
Initial training requirements should be identified through this process, and recorded using an employee competency assessment form. A training file should be developed for each employee, including management, to assist in identifying and tracking employee training requirements and verifying that the personnel have received the planned training.
Example of Job Description
Job Description: Quality Assurance Specialist
Position Overview: The Quality Assurance Specialist is responsible for ensuring the quality and compliance of products and processes according to established standards and regulations. This role involves conducting quality checks, audits, and assessments to maintain high standards of quality throughout the organization.
- Perform regular quality control checks on incoming materials, in-process components, and finished products to ensure compliance with quality standards.
- Conduct inspections and audits of production processes to identify deviations from quality procedures and implement corrective actions.
- Collaborate with cross-functional teams to resolve quality-related issues and implement process improvements.
- Maintain and update quality control documentation, including inspection reports, test results, and non-conformance reports.
- Monitor and analyze quality metrics to identify trends and areas for improvement.
- Participate in the development and review of standard operating procedures (SOPs) to ensure alignment with quality standards and best practices.
- Assist in training employees on quality control procedures and standards.
- Contribute to the investigation of customer complaints and internal quality incidents, proposing solutions to prevent recurrence.
- Support regulatory compliance efforts and participate in internal and external audits as needed.
- Stay updated on industry best practices, regulations, and quality trends to proactively enhance the quality management system.
- Bachelor’s degree in a relevant field (e.g., Quality Management, Engineering, Science).
- years of experience in quality assurance, quality control, or a related field.
- Strong knowledge of quality management principles, quality standards (ISO 9001, [Other Relevant Standards]), and regulatory requirements.
- Proficiency in using quality control tools and methodologies.
- Excellent attention to detail and analytical skills.
- Effective communication and teamwork skills.
- Problem-solving mindset with the ability to drive continuous improvement.
- [Optional: Relevant certifications, such as Certified Quality Auditor (CQA)].
Reporting: The Quality Assurance Specialist reports to the Quality Manager or [Appropriate Supervisor].
Working Conditions: This role primarily operates in a [Manufacturing, Laboratory, Office] environment. Occasional travel for training or audits may be required.
Note: This job description is provided as a general guideline and may not include all tasks and duties relevant to the role. Additional responsibilities and expectations may be defined based on organizational needs.
Example of Succession Plan
Succession Plan: Key Leadership Roles
Objective: To ensure a seamless transition of leadership and maintain business continuity by identifying and developing potential successors for critical leadership positions.
- CEO (Chief Executive Officer)
- CFO (Chief Financial Officer)
- COO (Chief Operating Officer)
Timeline: Succession plans will be reviewed annually, with a focus on continuous assessment, development, and identification of potential successors.
- Identification of Potential Successors:
- HR and leadership will collaborate to identify high-potential employees.
- Performance evaluations, leadership qualities, and alignment with organizational values will be considered.
- Individual Development Plans:
- Potential successors will work with their managers to create personalized development plans.
- Plans will include training, mentorship, cross-functional exposure, and leadership courses.
- Mentorship and Coaching:
- Current executives will mentor potential successors, offering insights into leadership responsibilities and strategic thinking.
- Succession Readiness Assessment:
- Annually, a review of potential successors’ progress will be conducted.
- Skills, competencies, and readiness for leadership roles will be evaluated.
- Training and Skill Enhancement:
- Potential successors will attend leadership development programs, workshops, and seminars.
- Skill gaps identified through assessments will be addressed through targeted training.
- Job Rotations:
- Planned rotations across relevant departments to provide exposure to different aspects of the business.
- Performance Tracking:
- Regular updates on potential successors’ performance and development will be recorded.
- Adjustments to development plans will be made as needed.
- Evaluation of External Candidates:
- If internal successors are not available or suitable, external candidates may be considered.
- Criteria for external candidate evaluation will align with internal succession criteria.
- Communication regarding succession planning will be transparent, while respecting confidentiality.
- Employees involved will be informed of their inclusion in the succession plan and the potential roles they are being groomed for.
- Smooth transition during leadership changes.
- Reduced risk of leadership gaps impacting business operations.
- Enhanced employee engagement due to clear career development paths.
Succession Plan Review:
- The HR department will lead an annual review of the succession plan’s effectiveness and make necessary adjustments.
Documented Information Required
While there are no mandatory requirement for this clause , certain documents and records are generally associated with Clause 7.1.2. Here’s a list of documents and records that might be relevant:
- Organizational Chart: An organizational chart that depicts the structure of the organization, including roles, responsibilities, and reporting lines. This helps define the hierarchy and relationships within the organization.
- Job Descriptions: Detailed job descriptions for each role, outlining responsibilities, qualifications, required competencies, and any specific tasks related to quality management and process operation.
- Competency Matrix: A matrix that maps the required competencies for each role within the organization. This matrix can help identify gaps in skills and guide training and development efforts.
- Training Plans: Training plans detailing the training requirements for each role, including both initial training and ongoing development to ensure personnel have the necessary skills for their tasks.
- Training Records: Records of training activities conducted for personnel, including details such as training content, dates, attendees, trainers, and assessment results.
- Qualification Records: Documentation of formal qualifications, certifications, licenses, and other credentials relevant to specific roles within the organization.
- Skills Assessments: Records of assessments conducted to evaluate the skills and competencies of personnel, demonstrating their ability to perform their tasks effectively.
- Performance Appraisals: Performance appraisal records that document how well personnel are fulfilling their roles and responsibilities, as well as any areas for improvement.
- Employee Feedback: Documentation of employee feedback related to the QMS, process effectiveness, and areas for improvement. This feedback can help identify potential issues and improvement opportunities.
- Audit Findings: If relevant, records of audits or assessments related to personnel competencies and adherence to the QMS requirements.
- Succession Plans: Succession plans outlining how the organization plans to address future personnel needs and develop internal talent for key roles.
- Competency Improvement Plans: Plans developed based on skills assessments or performance appraisals, outlining how the organization intends to bridge competency gaps through training and development.
Remember that the specific documents and records required can vary depending on the organization’s size, industry, complexity, and context. It’s essential to develop documentation that is tailored to your organization’s needs while ensuring compliance with the intent of Clause 7.1.2 of ISO 9001:2015. The goal is to ensure that the right people with the right competencies are in place to effectively operate the QMS and carry out quality processes.