Meeting the Common QM-Requirements: Why it is Not a Case of Re-inventing the Wheel

Meeting the common QM-requirements: not a case of re-inventing the Wheel, by VALUEADDITION

Certification and accreditation projects are strategic decisions. The standard according to which you are certified or accredited is determined by the relevant stakeholders: authorities, customers, competitors, market and technical trends, etc.

Criticism of ISO 9001 for instance comes from those who do not understand the value and impact on the organization and from those who misinterpret and confuse it with mere paperwork. See also Blog-Article# 1: Paradigm Change in QM

Here is a list of main requirements of the two common standards in the certification and accreditation world (ISO 9001 an ISO/IEC 17025) with key points. This list highlights the value for yourself and your customer so that the act of getting the certificate does not look like an end in itself but somethings that achieves a greater purpose.

Standard Requirement:

Key Points

Examples of instruments you may have anyway Value to you and to your customer
1.      Impartiality and confidentiality:
The organization to be structured in a way that quality results cannot be influenced by management or major customers or other interested parties. Laboratories / QMs should be independent in their activities. Objectivity is evident.
a)   Declaration of independency and confidentiality

b)   Compliance trainings/personnel regulation addressing gifts and other factors that may influence results

No company can earn trust if it is influenceable and if it does not treat customers data and information confidentially.

Your value: trusting the results, creating trust between yourself and your stakeholders

2.      Structural requirement / Leadership

 

a)     Legal entity with defined levels of competency and authorizations

b)     Organizational structure

Responsibility ownership within an organization. Customers trust a company with long term commitment
3.      Resources requirements:
Addressing availability of the personnel, facilities, equipment, systems and support services necessary to manage and perform its laboratory activities.  
a)   Personnel planning / shift plan, Skills matrix / talent

b)   Competence records / Trainings / certifications

c)   Investment / maintenance plans of machines

d)   IT / ERP facilities

Planning resources well is in the first place in the interest of the company to avoid failure to deliver or respond to peak times or in the event of succession planning. Your customer wants to rely on your delivery terms and on your know-how. Knowledge only creates value if applied.
4.      Process requirements
Having process steps and all necessary requirement to deliver required output and also handle items (in your organization or customers items). Addressing verification and validation of processes as well as sampling methods and technical records
a)   Feasibility study / contract review /order confirmation

b)   Technical requirements / records

c)   Reporting results of measurements or analysis/statement of conformities

d)   Using reference materials

e)   Interlaboratory comparisons or other than proficiency testing

Stability and reproducibility, reducing costs of starting processes again and again. Setting up systems that favor process reliability.

A customer feels taken seriously if reproducibility and traceability is evident and the process he is ready to pay for is under control, independent of the source (internal or external).

5.      Complains and non-conforming works: addressing handling of non-conformities, corrective and preventive actions

 

a)       Reporting systems / channels

b)      Feedback systems / channels

c)       Allocation of people dealing with customers’ complaints / non-conformities

No one and no organization is perfect. No customer expects us to be perfect but at least to address non-conformities and complaints systematically and learn from them. We take addressing root causes as opportunities to improve and motivate employees not to hide failures. Customer on the other hand will trust that we care about them and that cost of poor quality are as minimum as possible.
6.       Control of documents and records

 

a)       ERP Systems with DMS, Intranet, document editor

b)      Clear naming of files

c)       Defining access rights / authorization levels

Critical specifications may need 4 eye principles. Control of changes and knowledge sharing is ensured. The customer on the other hand trusts that specifications are under control and are understood.
7.      Internal audits: identifying risks and areas of improvement in the processes or products early enough a)       Experts in the company that can do the audits

b)      Goals of an audit, depending on review results

c)       Internal benchmarks

Whether we conform to own requirements or customer requirements is in our own interest. Systematic issues are identified early. Continuous improvement and learning from one another are enhanced. New customer requirements are addressed early.
8.      Management-Review:
at the end an organization will answer the question: is my organization / management system appropriate and effective?
a)   Management meetings (monthly, quarterly, yearly)

b)   Quality meetings

c)   Cross-organizational reviews

d)   Reporting plans from management level

Performance indicators, goals, new issues are addressed and followed up. Top management is able to get facts and data for better decision making and taking action in time. Priorities are set to enhance sales.
9.      Addressing risks and opportunities: considering risks and chances arising from an organization’s environment and those that are associated with its activities a)   SWOT analysis

b)   Risk management / insurances

c)   Strategy reviews

d)   Management reviews

To ensure the organization achieves intended results and to prevent undesired outcomes.

Both the organization and customer gain from this.

10.    Context of the organization / stakeholder management: determine scope, internal and external topics that are relevant to the organization’s purpose, identifying stakeholders’ relevant requirements a)   Stakeholder management on project, process or company level

b)   Trends / expectations that affect strategies

c)   SWOT analysis

Seeking dialog with customers and other relevant stakeholders enhance trust and sales: see Blog-Article#4: A fresh look at Stakeholder Management

To sum it up:

It is not a case of re-inventing the wheel. Many key points are already evident in existing companies. When starting a certification or an accreditation a project, avoid parallel systems, use available knowledge and templates on the internet. Use systems and tools you have already, give it structure, meaning and consistency. Communicate, train and continue working on that. Remember knowledge only creates value if applied. These projects in the first place should create value for the company. If we fail to see this then we should not proceed in allocating resources to them.

Let us not confuse doing extra paper work with meeting new requirements in the event of standards revision. Instead, review what we have been doing and work only on necessary changes. Remember interpreting the standards well is the first step to an effective management system. Done in the right way, the management system guarantees long term benefits.

Long term benefit for the company include:

  • More deals (some companies / authorities only give contracts to accredited / certified companies)
  • International recognition and acceptance
  • Continuous improvement of your competence and quality
  • Cost saving: creating documents, validation methods, processes only once. And these can be applied by all

The top VALUE to our customer is TRUST and thus more sales. They trust that everything is under control and our system is being continuously improved. A long-term relationship is ensured with such a system.

Printable version: 8_MeetingRequirementsWithoutRe-inventingTheWheel_2018-03-31

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