ISO 9001:2015 Transition Plan is not that hard for those that are preforming Advanced Quality Planning (AQP) to address risk based thinking. ISO 9001:2015 changes include the numbering to the clauses, but many of the clauses have not changed that much. First let’s look at the clauses and the major changes. Then let’s look at a plan to address the changes.
ISO 9001:2015 standard is ten clauses
- Normative Reference
- Terms and Definitions
- Context of the Organization
- Performance Evaluation
Clauses 1-3 – General Information
Clauses 1 through 3 of the ISO 9001 standard contain no requirements. The three clauses barely take up a page. The clause on scope basically says the standard is useful for any organization that wishes to produce consistent product and enhance customer satisfaction, and that it can be applied to virtually any organization.
Clause 2 cites ISO 9000:2015, “Quality Management Systems – Fundamentals and Vocabulary” as its normative reference, and Clause 3 references the same document for terms and definitions.
Clause 4 – Context of the Organization
In Clause 4 we start with the Context of the Organization and then introduce the needs and expectations of interested parties. These are a new clauses that introduce the strategic context of the organization. The organization must determine the strategic direction, which sets the stage for how management will review the alignment of the organization with the strategic direction, on an ongoing basis within management review.
In clause 4.3, we learn that organizations need to determine the scope of the QMS so it meets the requirements of the standard, and we learn that meeting the requirements is really about processes.
In clause 4.4, Processes that affect product quality need to be determined and their sequence and interaction must be understood. Plus, we need to know if processes are effective, what resources they require, and how to monitor, analyze, and improve them. This is the same as clause 4.1 in ISO 9001:2008.
In the remaining sections of Clause 4, documented information is introduced as optional or to the extent necessary.
Clause 5 – Leadership
The responsibilities of top management are established in Clause 5. There must be evidence that top management is committed to using and improving the QMS by communicating the importance of the following to all members of the organization:
- Enhancing customer satisfaction
- Meeting customer and regulatory requirements
- The effectiveness of the QMS
- Establishing a Quality Policy
- Establishing Quality Objectives
- Promoting the use of the process approach and risk-based thinking
- Ensuring resources are available to maintain and improve the QMS
- Responsibilities and authorities for the QMS are clearly communicated
Clause 6 – Planning
Clause 6 is new focusing on actions to address risks and opportunities. Clause six replaces the old preventive action clause. Risk-based thinking has been introduced throughout the standard and is no longer one small clause at the end. The goal is to identify, prevent or reduce undesirable effects.
An increased emphasis has been placed on planning to achieve quality objectives. More specific action plans defining who will do what by when requiring what resources to achieve what results.
Clause 7 – Support
Clause 7 lists requirements about providing resources. Most are very general, and perhaps some are subjective. For example, requirements to provide the proper equipment, facilities, and work environment are listed. Unless there are overwhelming deficiencies in these areas, it might be difficult to find objective evidence of non-compliance. However, organizations implementing ISO 9001 should review their level of compliance in these areas.
Another section of Clause 7 that may need extra attention is the control of measuring and monitoring equipment. This clause 7.1.5 requires that all measuring instruments and equipment are calibrated according to established standards (typically these come from national or government organizations like NIST in the US).
This is an area many organizations struggle with, and ISO 9001 companies are no different. If you wish to obtain and maintain ISO 9001 certification, however, you will have to establish and maintain a calibration program or process for your measuring instruments and equipment (unless you can claim an exclusion to this requirement, meaning it does not pertain to your organization).
Another section of Clause 7 is competence and awareness of employees (Clause 7.2). Here the requirement is to identify the members of the organization that are trained and competent to perform the work they are assigned, and that documented information exist to verify it. Many auditors point to the training and competence requirements as the most common area of findings because organizations do not put the effort into meeting the requirements in this area as they do others.
Clause 7.5 Documented Information
Many professionals and consultants associated with ISO 9001 registration recommend organizing the documentation into four levels.
Level I – Quality Policies, Manual and Objectives
This first level of documentation is separate and distinct from the procedures. The purpose of this level of documentation is to state in a concise and brief format, the policies and objectives of the company for achieving a desired level of quality for the organization or division.
Then there is the Scope document, which may be thought of as the optional Quality Manual. At a minimum, the Quality Manual should normally include three parts:
- The Scope portion should simply state the area of ISO 9001:2015 registration. This could be a product line within the plant, the whole plant or the whole organization. You should explain if your registration will include design and development. Any exclusion will require a justification within the scope portion. Common exclusions may involve parts of design, process validation or calibration.
- The Documented Procedures portion should include a list or reference to any procedures used in your QMS. Some organization even put the actual procedures in the Quality Manual. If you do not have a lot of them this can simplify document revisions. There are no longer any required procedures, only documented information you require to be effective. What you require is up to you.
- The Process Description portion should describe the sequence and interaction between processes of the QMS. A process map or text description will suffice.
Although there is no standard format or requirement for the Quality Manual, a sample manual is provided in this guide for you to use as a template to create your own Quality Manual.
Level II – Departmental Procedures and Responsibilities
The second level of documentation, procedures, should be more detailed and address the processes of a department or function as well as the personnel (generic titles or positions) responsible for carrying out the process. These procedures can be organized on a departmental basis.
Samples of Level II style departmental procedures and responsibilities documentation are provided in this guide. ISO Quality Procedures start with the designation “QP” and may be used as a template to create your own procedures. They are not the only format or method to accomplish the requirements.
The procedures in this manual provide format and verbiage to describe tasks and activities that are typical for organizations that meet ISO 9001:2015 requirements. They certainly are not the only format nor functional descriptions of these tasks and activities. They are intended to provide a foundation for you to develop the procedures that work for your company. As you rewrite the procedures for your application, be sure to verify your modifications against the requirements of the ISO standard to ensure all requirements are still addressed.
An example of where you may want to change format is the Effectiveness Criteria section of certain procedures. Section 4.4 (c) of the ISO 9001:2015 standard requires organizations to determine the criteria and methods needed to ensure that both the operation and control of processes are effective. It does not require the methods and criteria to be defined in the procedures; other methods may be used.
The primary reason this section was included in the procedures was to encourage thought in this area. Often, effectiveness of a process, task, or activity is assumed to be known. The assumptions may not be verbally expressed and frequently there is no agreement between departments or even between employees in the performing department. Defining these criteria and obtaining consensus among interested parties can result in significant improvement.
When determining these criteria, a holistic approach should be used. An obvious example involves Purchasing. In the past, purchasing effectiveness was measured by the purchase price of materials. The obvious fallacy with this measure is that out of specification or marginal components result in increased costs downstream and may actually result in higher total costs.
Level III – Work Instructions
This level of documentation should be very detailed on “how” to accomplish a specific job, task or assignment.
For example, a work instruction could be developed for assembling the final housing of a product with step-by-step instructions including such detail as the torque requirements of the fastening screws.
Individual work instructions are very specific to an industry or company. Samples of level III type work instructions are not provided in this guide.
Level IV – Forms and other Documents
The last level of documentation can include forms, records and other documents used in the production or delivery of a product or service.
Samples of quality level IV type forms and other documents are provided in this manual and may be used as a template to create your own forms. The forms provided should be used as guides, not necessarily as final documents. Again, they are there to provide examples and foundations for you to work from.
Clause 8 – Operation
Clause 8 contains much of the substantive requirements of the ISO 9001:2015 Standard, so it is difficult to summarize briefly. A lot of the documented information comes from Clause 8. Much of these come from design and development of products – understanding where requirements come from, reviewing that requirements are clearly defined and understood, along with design reviews, design verification and validation.
Clause 8 also covers requirements regarding purchasing, product realization, customer property, identification and traceability, and product preservation during storage and shipping. One new clause introduces post-delivery activities, which can include requirements or at least collecting feedback after the sale.
There is also a requirement for control of nonconforming product. It was moved here to be included as part of product realization. Nonconforming materials should be appropriately marked, segregated, stored, evaluated, and then scraped, repaired, etc., as appropriate.
Clause 9 – Performance Evaluation
Clause 9 is about monitoring and improving your processes and your quality management system, and improving your products. In the general requirements of Clause 4 it was stated that processes must be monitored and measured. Clause 9 provides some specific requirements for areas and methods of measurements. For example, customer perception of satisfaction, products, and processes should be measured.
Besides these general areas of measurement, analysis, and improvement, there are some specific requirements. First is conducting internal audits. Internal audits really serve as a primary measurement device for the ISO 9001 QMS. Is it meeting requirements and improving the organization? Clause 9.2 lays out some specific requirements for the internal audit program that need to be reviewed closely to ensure they are fulfilled.
Management review is now a part of clause 9. Management must review the organization’s quality management system at planned intervals to ensure the effectiveness of the system and actions taken to address risks.
Clause 10 – Improvement
Finally, Clause 10 includes nonconformity and corrective action requirements. These are key activities to improve products and processes in the organization because they involve determining the root cause of problems, then preventing their reoccurrence.
Recommendations to transition to ISO 9001:2015
- Rewrite QM to address updated procedures
- Reduce page count Note: QM is no longer required.
- Focus on procedures that are used Note: procedures are no longer required.
- Define Interested Parties
- Develop needs analysis
- Develop communication plan
- Add strategy to management review
- Integrate FMEA and Control Plans into all products
- Add risk analysis to management review
As you can see, there are a few changes. Those companies performing Advanced Quality Planning (AQP) should have no problem with the addition of the risk based thinking. Those companies performing some type of marketing segmentation analysis will just have to fold that into the Quality Management System. If your are unsure of what AQP is or market analysis then you may a little work figuring out how that applies to your business. Now you know where you need to focus your efforts in the transition to ISO 9001:2015.