Impact of new standard ISO 9001:2015
We know that the most popular certification standard is ISO 9001. The applicability, adaptability and benefits to the organization are known to the industry. The standard is undergoing change and the first draft is out. It is too early to say what will be the final standard, but now the structure is defined, major changes in the requirements are known.
The changes as described in the standard are:
1. more generic and more easily applicable by service industries.
Product replaced by goods and service.
Clauses redefined related to monitoring devices, and development.
2. Context of the organization
Identify issues, requirements , & needs, expectations of the stakeholders.
3. Process Approach
Determine- the processes & their interaction, , and define for each process- inputs, stages, outputs, responsibilities, measurement, objectives, risks, resources. Determine, how these will be analyzed, changed, improved.
4. Risk and Preventive action
Identify risks, analyze and consider opportunity for improvement
5. Documented information
Document, record requirements are combined to as documented information.
6. Control of external provisions of goods and service
Combining of procurement function with outsourced processes. The new point is risk base approach.
Hence the common theme in this standard are:
a. Introduction of Risk based approach
b. Incorporating the Process approach
c. Simplification on document, record control
d. Improvements and innovations
Let us analyze the impact:
a. Understanding of the requirement by management:
This is no more just a standard oriented towards customer. This is a management standard aimed at sustainable improvement in performance.
This will increase adaptability , and will not be left for MR and team lower down to manage the standard to meet auditor requirements.
The emphasis on risk, strategy documents, reviews will ensure management will have to focus on standard.
b. Documentation:
This will also have a major change, based on process approach adaption. The processes/ SOP/ work instruction/ flow chart will have to address all the process approach requirements specified. This will make the system robust, and will support approach towards improvements.
c. Development process :
The new considerations, risk based approach, development process documentation will strengthen the process. The development process, development controls ( clause requirements in current standards) , an development transfer are essesntial stages in any new design.
d. New terminologies :
Knowledge management, strategy, Innovation, Accountability, risk based approach are the new concepts which are introduced.
Impact on organization ongoing for ISO 9001 revised std.:
1. Difficult for small companies.
The management concepts like strategy, knowledge management, risks etc. are not easily adopted for small companies. The extent of documentation, the relevance to the sector are the aspects to be reviewed.
2. Will be effectively used as tool for management.
The system was mainly driven by MR. The new standard has many elements related to top management involvement. This will ensure active participation by management.
3. No major changes at operating level.
There is no change in the contents of the clauses. The standard is aimed at management improvement.
4. Documentation will be elaborate, detailed and useful.
The documents will result in actionable plan for improvements. The risk, knowledge management, strategy and interrelation of objectives, tracking are the examples.
Impact on auditing:
a. Expect the management audit will be 10% more than earlier audits.
b. The auditor will have to understand process approach and audit processes.
Relation of strategy- objective- process measure must be understood.
The process improvements, innovations must be part of the audit as appropriate.
c. Management audit will require more competence in terms of management requirements, awareness of TQM tools.
d. Stage 1 audit will be in much more depth.
e. The auditor will have to do tight rope walking considering the findings on the management audit. The comments must not appear as consultancy and the inadequacies findings can be difficult.
To conclude,
The standard has a lot of new points for the organizations, as well as auditors. The concepts are aimed towards management related improvements.
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