In this phase a quality policy will be implemented. In phase 1 and 2 the more technical quality management system was established. To make sure the system is functioning satisfactorily, good planning, leadership and management are needed. The policy cycle first creates direction and focus in the planning of the laboratory. Then the adherence to the planning is monitored, the results of this will be input for the creation of a new planning. This cycle will automatically lead to continuous improvement of the laboratory; the most important characteristic of a quality management system.
The first step to create the focus and direction to the laboratory improvement activities is formulating a vision. A vision is a statement of the organization in which it expresses its hope, something it truly wants to create. It is a long-term goal upon which the organization bases its current activities. It can be very general and may never be achievable. This doesn’t matter since the vision is there only to provide a fixed aim for management of the laboratory serving as the foundation for the mission, formulating policy and developing plans.
An example of a vision is: Tuberculosis and leprosy diseases are controlled until they are no longer a public health problem in [country name]. Companies (such as Philips, the International Union against Tuberculosis and Lung Diseases) have frequently posted their vision on their websites. See the example sheet with vision, mission and core values of several organizations.
A good way of developing a vision is to do this in a group session with all personnel members. This increases the involvement of personnel members and subsequently the motivation and acceptance to change. The development of the mission (next activity) can be done in the same way in the same session. The vision should in any case be communicated to all personnel members.
A good idea is to produce a large sign with the vision on it that is mounted on the wall of the laboratory near the entrance. This may leave a good impression on clients and customers visiting the laboratory. The same applies to presenting the vision on the website of the laboratory, if applicable.
Later in this phase the quality manual will be developed. The vision will be part of the contents of the quality manual. Store the vision for so long on a good place where you can find it when you need.
Activities related to Phase 3 - Organization
The vision is a far future aim, the incentive for existence of the laboratory. However, based on the vision it is impossible to plan for the daily work in the laboratory. The second step is to make the vision more practicable and more tailor-made to the laboratory. The result of this is called the mission of the laboratory. In developing the mission, ask yourself the question: What can the laboratory do to fulfill the vision? The answer to that is the laboratory’s mission. Hence a mission is a statement in which the organization explains the methods and approaches with which it tries to fulfill its vision.
An example of a mission could be: “Our mission is to provide quality laboratory services and to strengthen the national tuberculosis laboratory diagnostic network through leadership and expert guidance in support of the national tuberculosis control program to reduce the burden of tuberculosis and leprosy in [country name].” For examples: missions are often posted on websites of organizations. See the example sheet with vision, mission and core values of several organizations.
The mission will, just like the vision, be content of the quality manual that will be developed later in this phase. Store the mission for so long in a place where you can easily find it when you need it.
Communicate the mission clearly to all personnel members. If applicable, you can also show your mission on the laboratory’s website and, the same as with the vision, you can produce a large sign with the mission on it and mount it near the entrance of the laboratory on the wall.
Formulate the values deemed most important and best representing the laboratory. This can also be done in group context with all the laboratory staff.
Examples of core values for a TB reference laboratory can be:
“In working towards the mission of the national tuberculosis reference centre:
- We are committed to deliver quality work, to be professional, competent, knowledgeable, responsible and accountable;
- We perform our work guided by ethical values, honesty, integrity, punctuality, and standards;
- Important in our work is our relationship with our country, the community and each other as we value respect, trust, cooperation, loyalty, helping and caring for each other, friendship, pleasure and feeling secure;
- Furthermore, we value freedom, decidedness, creativity and having an independent means of living. We all share the responsibility to fulfill our mission and to fulfill our customer’s needs and expectations."
For more examples: See the example sheet with vision, mission and core values of several organizations.
The next step to make the direction of the laboratory planning even more practical is the formulation of the long-term goals of the laboratory. In the vision the overall incentive for existence of the laboratory was defined. The mission translated this incentive into a more laboratory specific aim, including the methods the laboratory is using to achieve this aim. The long term goals will add even more practicality to achieving this aim. These goals indicate how the laboratory will contribute to achieving its mission and vision.
Examples of long term goals could be:
- Performing reliable examinations on research material delivered to the laboratory.
- Producing objective, complete and scientifically sound reports to the requesters.
- A timely completion of examinations, results, etc. within agreed turnaround times.
- Development of, and research into new methods and techniques for improving diagnosis.
These goals will assist in formulating the quality policy.
Based on the long-term goals, the quality policy of the laboratory can be written. In essence the quality policy is the description of the intention, means, and how to reach the long-term goals.
Hence, the long-term goals formulated in the previous activity are an integral part of the quality policy. Take into account that the policy shouldn’t become a huge document with endless descriptions; keep it concise, covering a maximum of 4 pages.
ISO 15189 sums up the following elements that a quality policy should contain:
- The scope of the service of the laboratory
- The management’s statement of the laboratory’s standard of service
- The objectives of the quality management system (long-term goals)
- The requirement that all personnel must be aware of the policies and procedures of the laboratory and implement these
The commitment of the laboratory to good professional practice, quality of examinations and compliance with the quality management system and commitment with the international ISO 15189 standard. This management commitment declaration will be included in the Quality Manual of the laboratory.
To get a better picture of a typical quality policy an example is added as additional material.
All personnel members should read the quality policy. Use the same procedure as used already for the SOPs: include the quality policy in the reading and understanding list. Also make sure to present the quality policy to all personnel members, so that they know what it serves to and why they should read it.
Quality Policy Example
Now that the quality policy has been formulated, the actual short-term planning can start. Develop a set of goals for the quality management system. The number of goals should be such that all are achievable; keeping in mind the number of available human resources that can be used for achieving these goals. Make sure that the goals are achievable within one year.
These goals will assist in developing the quality year plan for the coming year in the next activity.
An example of subdivision of goals over different aspects could be:
- Maintenance of the quality management system: what are the goals for the coming year regarding maintenance of the quality management system?
- Regular activities within the quality management system
- In- and external audits: how many audits on which elements of the QMS?
- Policy cycle: what are the goals regarding maintenance of the policy cycle?
- Internal and external quality control (IQA/EQA)
- Other activities within the quality management system: other goals for activities that cannot be counted under the above topics.
- Working conditions and environment
- Educational plan
- Specific improvement projects: goals on activities such as validation of methods, introduction of a new technique, etc.
Other frameworks are also possible. Think of the CLSI QSE framework (formulate goals regarding every QSE).
Based on the short-term goals formulated in the previous activity, a plan can be developed for the quality management system for coming year. This plan includes the goals formulated in the previous activity and adds an explanatory description on the why and how of each goal. With every goal an indicator is also identified that helps the monitoring process of implementing the quality year plan. An example outline could be:
- Title page
- Table of contents
- Introduction: a repetition of the long-term plans included in the quality policy, supplemented with a short description of the current situation in the laboratory (status of the quality management system) and the highlights contained in this quality year plan.
- Maintenance of the quality management system
- Regular activities within the quality management system
- In- and external audits
- Policy cycle
- Internal and external quality control (IQA/EQA)
- Other activities within the quality management system
- Working conditions and environment
- Educational plan
- Specific improvement projects
Note that above outline is just an example; it is not required to exactly follow the same outline. Another way to subdivide the quality year plan per element of the quality management system is to take every QSE and formulate the plans regarding that QSE. In that case there will be 12 sections.
Archive the quality year plan in a new file titled: “Quality Year Plans, period yyyy – yyyy”.
To make this quality year plan workable and achievable, the plan should be translated into specific action points contained in an action plan. These action points should be formulated according to the SMART principles, identifying a deadline for each point, and the person assigned with carrying out the action point.
Present the quality year plan and accompanying action plan to all personnel members to make sure everybody is familiar with them and knows what his/her role is in fulfilling the plan towards the end of the year. Don’t forget to explain the meaning behind the quality year plan (giving structure and guaranteed continuation to the improvement process in the laboratory.
Store the action plan in the file with all other action plans, under a new tab titled: “Quality Year Plan” (or “QYP”).
In the quality year plan indicators for monitoring the execution were identified for every goal. The task for the quality officer is to monitor the status of executing the quality year plan using these indicators. Do this at the end of each quarter of the year. Document the findings in a quarterly report and send this to the laboratory management.
Other monitoring techniques that provide input to the quarterly reports are:
– Review of complaint records received by the laboratory
– Review of results of corrective action taken
– Trend and risk analyses
– Internal audits
– External audits
– External quality assessment (participated in phase 2)
– Internal quality control scheme (established in phase 2)
Archive the quarterly reports in a new file titled: “Quarterly Reports, period: yyyy – yyyy”.
See the example quarterly report to get a better picture of the outline and contents.
The extent to which the organization has reached its goals set in the quality year plan is annually reviewed in a management review. Important sources for the management review are the quarterly reports in which the execution of the quality year plan was already monitored and documented.
According to the ISO 15189, input in management review can include:
- Overview of notifications, complaints and improvement suggestions
- Reports of internal and external audits and the follow-up
- Result of the selection and assessment of suppliers
- Changes in the volume and character of the work activities and related to that the appropriateness of the competence of personnel and their educational backgrounds (and possible needs)
- Achievement of goals set in the quality policy/quality year plan
- Follow-up of corrective actions originating from the last management review (one year ago).
- Assessment of adherence to turnaround time.
- Findings from competency assessments
In the management review the laboratory manager needs to ask himself the questions:
- Have our goals been achieved?
- Are there currently any shortcomings within the quality management system and the laboratory in general?
- Is our quality conforming set criteria
- Are there discrepancies in the system in view of future developments?
Document the findings in a Management Review Report. To get a better picture of a management review report, an example is added as additional material.
Nb: A year doesn't necessarily have to run from January to December. It can also be from July to June if the quality year plan was finished in July.
After finishing the report communicate the findings to the personnel members of the laboratory. Use the findings to develop the quality year plan for the next year (see next activity).
Store the Management Review Report in a file titled: “Management Reviews”.
Develop a quality year plan for the following year based on the conclusions in the management review.
You can now clearly see that this QSE describes a cycle. This cycle is called the policy cycle. To summarize:
- Plan:the improvements were planned in the former quality year plan, including the drafting of an action plan.
- Do:The action plan was carried out and monitored through drafting quarterly reports.
- Check:throughout the year internal audits will be organized (later in phase 3). In the management review the implementation of action plans was reviews and thus the achievement of goals set in the quality year plan.
- Act:that is this step, namely: drafting a new quality year plan, based on the outcome of the management review.
Hence, this quality year plan has the same outline and structure as the former quality year plan. Only now new goals will be formulated for the new year and are largely based on the findings of the management review. Also keep in mind the quality policy with the long-term goals of the laboratory.
When the new quality year plan has been finished, the policy cycle starts over again from the activity where an the quality year plan needs to be translated into a SMART action plan. This cycle will be repeated every year.
Present the new quality year plan, including the outcome of the management review as basis, to all personnel members.
The quality manual of a laboratory describes the complete quality management system of the laboratory. It describes the structure of the quality management system, how it is implemented and how it is functioning. It further refers to all SOPs of the laboratory for more in-depth instructions.
It is recommended to read ISO 15189 article 4.2.4 as this provides a clear explanation on the quality manual and its required contents.
A logical outline of the quality manual can be following the CLSI QSE framework (as does this implementation guide):
Facilities and Safety
Including a description of the facilities (map, description of location, etc.).
Include the quality policy written earlier in this phase. Also include the document from the national/regional authorities recognizing the laboratory as reference laboratory. This document was obtained in phase 2 (in the QSE Organization). Also describe the complete quality cycle as established in this phase.
Including a statement that personnel is not allowed to participate in activities that could cause a conflict of interest with the work of the laboratory. Also include a reference to personnel regulations when available (e.g. the occupational and safety law of the Ministry of Health).
Purchasing and Inventory
Including a description of how budgets are made and decided. Also describe the policy on selecting and purchasing items, and to which quality requirements these should generally comply.
- Process Control
- Information Management
Documents and Records
Describing how the laboratory treats its documents, which is a description of the document control system without the technical explanations (written in a way that somebody without knowledge of document control can also understand this).
- Customer Service
Describe the procedures in place for handling of nonconformities, complaints, etc.
Describe (among others) what the laboratory does on process improvement. Examples are the management review, quarterly reports, internal audits, etc.
Describe for each QSE the global measures in place regarding the management of quality in the laboratory.
A template for a quality manual is provided in this GLI accreditation package. This may give you the best picture on what the content and meaning of the quality manual should be. However, the quality manual of each laboratory is highly unique. The laboratory manager and quality officer are required to adapt the text of the template to the local situation. If this is not done, the complete meaning of having a quality manual in place is lost (a quality manual describing a quality management system other than that of the laboratory itself is useless).
The quality manual is part of the document control system. This means that this manual will need to be reviewed annually (and revised when necessary) and therefore has a version number and is verified and authorized by different staff members before printing and using (following the procedure described in the laboratory’s SOP of SOPs/Master SOP). This also means that the quality manual must be accessible to all personnel members while properly stored protected from damaging.
When the quality manual is finished, it must be presented to all personnel members, including its meaning and use.
Example Quality Manual
- Facilities and Safety
SOPs should be read by all personnel members. This is controlled using a Reading and Understanding list. The same must apply to the quality manual: every personnel member must read the quality manual so that he/she has a good understanding of the meaning, structure, and functioning of the quality management system and can contribute evenly to the functioning and improvement of this system.
Therefore, incorporate the quality manual chapters in the Reading and Understanding list which you already started using in phase 1. Thereby clearly communicate to the personnel members why they should read it (the quality management system can only function correctly when all personnel members are involved and contributing to it).
Generic Reading and Understanding List